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WASHINGTON — The investigational anti-CD40 ligand agent dapirolizumab pegol (DZP) outperformed placebo in improving disease activity and reducing high-dose corticosteroid use in patients with systemic lupus erythematosus (SLE) in the phase 3 PHOENYCS GO trial.

“We really think that dapirolizumab pegol may represent a novel treatment for lupus, particularly given its broad immune modulatory effects,” said Megan Clowse, MD, MPH, associate professor of medicine and chief of the Division of Rheumatology and Immunology at Duke University School of Medicine in Durham, North Carolina. She presented the study in a late-breaking poster session at the American College of Rheumatology (ACR) 2024 Annual Meeting.

There is a “huge unmet need” for drugs for lupus, Clowse told this news organization. Patients with SLE continue to have high disease burden, including ongoing symptoms often driven by inflammation. Corticosteroids are often the best medications to control disease activity, she said, but they can result in long-term toxicity.

 

What Makes DZP Unique?

Through CD40 ligand signaling, DZP has been shown to reduce B- and T-cell activation and to downregulate interferon pathways. Previous antibodies targeting the CD40 ligand have been associated with an increased risk for thromboembolic events. However, DZP lacks the Fc portion of the antibody, which can bind to platelets and cause clotting. Data from phase 1, 2, and 3 trials thus far do not show an elevated risk for these events, Clowse explained. In fact, safety signals were strong enough that patients with antiphospholipid antibodies — a key driver for blood clots in patients with SLE — were included in the trial.

In PHOENYCS GO, investigators enrolled 321 patients with moderate to severe SLE with persistently active or frequently flaring/relapsing-remitting disease activity despite stable standard of care (SOC) medications such as antimalarials, corticosteroids, and immunosuppressants.

Patients were randomized 2:1 to receive intravenous DZP (24 mg/kg) plus SOC or intravenous placebo plus SOC every 4 weeks, with patients and investigators blinded to treatment assignments.

Patients taking a corticosteroid dose > 7.5 mg/day began a mandatory steroid taper by week 8 of the trial, with the goal of reducing that to < 7.5 mg/day. The tapering regimen was at the discretion of providers and was adapted to each patient’s individual disease activity.

The primary endpoint was British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) response at week 48.

Patients in the DZP and placebo groups were on average 43.5 and 41.5 years old, respectively. More than 90% of patients were women, all on concomitant SLE medications. About half of the participants took a daily corticosteroid dose > 7.5 mg.

At 48 weeks, half of the DZP group (49.5%) achieved BICLA response compared with 34.6% in the placebo group (P = .0110). A higher proportion of patients taking DZP achieved SLE Responder Index-4 response than those taking placebo (60.1% vs 41.1%, respectively; P = .0014), and the rate of severe British Isles Lupus Assessment Group flares in the DZP group was half that of the placebo group (11.6% vs 23.4%; P = .0257). In the subgroup of patients who underwent corticosteroid tapering, 72.4% receiving DZP and 52.9% taking placebo reduced their dose to < 7.5 mg/day by 48 weeks (P = .0404).

DZP was generally well tolerated. Over 48 weeks, 82.6% of the DZP group and 75% of the placebo group reported treatment-emergent adverse events, but serious occurrences were more common in the placebo group (14.8%) than in the DZP group (9.9%). Herpes viral infections were higher in the placebo group, although there were three ophthalmic herpes cases in the DZP group. There was one case of acute myocardial infarction and one death linked to gangrene-related sepsis in patients receiving DZP.

 

A ‘Mild to Moderate’ Response

Although these are definitely positive results, they show a “mild to moderate response” to DZP, commented Gregory Gardner, MD, an emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, and chair of the American College of Rheumatology’s annual meeting planning committee. He moderated the session where the research was presented. Although DZP showed efficacy among some patients, he noted, “there were still 51% patients that it didn’t work for.” 

The drug uses an alternative pathway to current lupus drugs, Gardner added, and more research is needed to understand how best to use this medication in practice.

Clowse noted that DZP could be particularly beneficial for patients with SLE who want to get pregnant. Many drugs used to treat the disease are teratogenic; however, “because of the lack of Fc portion on this drug, it very likely does not cross the placenta in any kind of significant amount,” she said. Although there are not yet any reproductive safety data on DZP, she added, “that is a great potential niche.”

Biogen and UCB, which are jointly developing DZP, aim to start a second phase 3 trial of DZP in patients with SLE, called PHOENYCS FLY, in 2024.

The trial was sponsored by UCB. Clowse is a consultant and has received grant/research support from GSK and UCB. Gardner had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

WASHINGTON — The investigational anti-CD40 ligand agent dapirolizumab pegol (DZP) outperformed placebo in improving disease activity and reducing high-dose corticosteroid use in patients with systemic lupus erythematosus (SLE) in the phase 3 PHOENYCS GO trial.

“We really think that dapirolizumab pegol may represent a novel treatment for lupus, particularly given its broad immune modulatory effects,” said Megan Clowse, MD, MPH, associate professor of medicine and chief of the Division of Rheumatology and Immunology at Duke University School of Medicine in Durham, North Carolina. She presented the study in a late-breaking poster session at the American College of Rheumatology (ACR) 2024 Annual Meeting.

There is a “huge unmet need” for drugs for lupus, Clowse told this news organization. Patients with SLE continue to have high disease burden, including ongoing symptoms often driven by inflammation. Corticosteroids are often the best medications to control disease activity, she said, but they can result in long-term toxicity.

 

What Makes DZP Unique?

Through CD40 ligand signaling, DZP has been shown to reduce B- and T-cell activation and to downregulate interferon pathways. Previous antibodies targeting the CD40 ligand have been associated with an increased risk for thromboembolic events. However, DZP lacks the Fc portion of the antibody, which can bind to platelets and cause clotting. Data from phase 1, 2, and 3 trials thus far do not show an elevated risk for these events, Clowse explained. In fact, safety signals were strong enough that patients with antiphospholipid antibodies — a key driver for blood clots in patients with SLE — were included in the trial.

In PHOENYCS GO, investigators enrolled 321 patients with moderate to severe SLE with persistently active or frequently flaring/relapsing-remitting disease activity despite stable standard of care (SOC) medications such as antimalarials, corticosteroids, and immunosuppressants.

Patients were randomized 2:1 to receive intravenous DZP (24 mg/kg) plus SOC or intravenous placebo plus SOC every 4 weeks, with patients and investigators blinded to treatment assignments.

Patients taking a corticosteroid dose > 7.5 mg/day began a mandatory steroid taper by week 8 of the trial, with the goal of reducing that to < 7.5 mg/day. The tapering regimen was at the discretion of providers and was adapted to each patient’s individual disease activity.

The primary endpoint was British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) response at week 48.

Patients in the DZP and placebo groups were on average 43.5 and 41.5 years old, respectively. More than 90% of patients were women, all on concomitant SLE medications. About half of the participants took a daily corticosteroid dose > 7.5 mg.

At 48 weeks, half of the DZP group (49.5%) achieved BICLA response compared with 34.6% in the placebo group (P = .0110). A higher proportion of patients taking DZP achieved SLE Responder Index-4 response than those taking placebo (60.1% vs 41.1%, respectively; P = .0014), and the rate of severe British Isles Lupus Assessment Group flares in the DZP group was half that of the placebo group (11.6% vs 23.4%; P = .0257). In the subgroup of patients who underwent corticosteroid tapering, 72.4% receiving DZP and 52.9% taking placebo reduced their dose to < 7.5 mg/day by 48 weeks (P = .0404).

DZP was generally well tolerated. Over 48 weeks, 82.6% of the DZP group and 75% of the placebo group reported treatment-emergent adverse events, but serious occurrences were more common in the placebo group (14.8%) than in the DZP group (9.9%). Herpes viral infections were higher in the placebo group, although there were three ophthalmic herpes cases in the DZP group. There was one case of acute myocardial infarction and one death linked to gangrene-related sepsis in patients receiving DZP.

 

A ‘Mild to Moderate’ Response

Although these are definitely positive results, they show a “mild to moderate response” to DZP, commented Gregory Gardner, MD, an emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, and chair of the American College of Rheumatology’s annual meeting planning committee. He moderated the session where the research was presented. Although DZP showed efficacy among some patients, he noted, “there were still 51% patients that it didn’t work for.” 

The drug uses an alternative pathway to current lupus drugs, Gardner added, and more research is needed to understand how best to use this medication in practice.

Clowse noted that DZP could be particularly beneficial for patients with SLE who want to get pregnant. Many drugs used to treat the disease are teratogenic; however, “because of the lack of Fc portion on this drug, it very likely does not cross the placenta in any kind of significant amount,” she said. Although there are not yet any reproductive safety data on DZP, she added, “that is a great potential niche.”

Biogen and UCB, which are jointly developing DZP, aim to start a second phase 3 trial of DZP in patients with SLE, called PHOENYCS FLY, in 2024.

The trial was sponsored by UCB. Clowse is a consultant and has received grant/research support from GSK and UCB. Gardner had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

WASHINGTON — The investigational anti-CD40 ligand agent dapirolizumab pegol (DZP) outperformed placebo in improving disease activity and reducing high-dose corticosteroid use in patients with systemic lupus erythematosus (SLE) in the phase 3 PHOENYCS GO trial.

“We really think that dapirolizumab pegol may represent a novel treatment for lupus, particularly given its broad immune modulatory effects,” said Megan Clowse, MD, MPH, associate professor of medicine and chief of the Division of Rheumatology and Immunology at Duke University School of Medicine in Durham, North Carolina. She presented the study in a late-breaking poster session at the American College of Rheumatology (ACR) 2024 Annual Meeting.

There is a “huge unmet need” for drugs for lupus, Clowse told this news organization. Patients with SLE continue to have high disease burden, including ongoing symptoms often driven by inflammation. Corticosteroids are often the best medications to control disease activity, she said, but they can result in long-term toxicity.

 

What Makes DZP Unique?

Through CD40 ligand signaling, DZP has been shown to reduce B- and T-cell activation and to downregulate interferon pathways. Previous antibodies targeting the CD40 ligand have been associated with an increased risk for thromboembolic events. However, DZP lacks the Fc portion of the antibody, which can bind to platelets and cause clotting. Data from phase 1, 2, and 3 trials thus far do not show an elevated risk for these events, Clowse explained. In fact, safety signals were strong enough that patients with antiphospholipid antibodies — a key driver for blood clots in patients with SLE — were included in the trial.

In PHOENYCS GO, investigators enrolled 321 patients with moderate to severe SLE with persistently active or frequently flaring/relapsing-remitting disease activity despite stable standard of care (SOC) medications such as antimalarials, corticosteroids, and immunosuppressants.

Patients were randomized 2:1 to receive intravenous DZP (24 mg/kg) plus SOC or intravenous placebo plus SOC every 4 weeks, with patients and investigators blinded to treatment assignments.

Patients taking a corticosteroid dose > 7.5 mg/day began a mandatory steroid taper by week 8 of the trial, with the goal of reducing that to < 7.5 mg/day. The tapering regimen was at the discretion of providers and was adapted to each patient’s individual disease activity.

The primary endpoint was British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) response at week 48.

Patients in the DZP and placebo groups were on average 43.5 and 41.5 years old, respectively. More than 90% of patients were women, all on concomitant SLE medications. About half of the participants took a daily corticosteroid dose > 7.5 mg.

At 48 weeks, half of the DZP group (49.5%) achieved BICLA response compared with 34.6% in the placebo group (P = .0110). A higher proportion of patients taking DZP achieved SLE Responder Index-4 response than those taking placebo (60.1% vs 41.1%, respectively; P = .0014), and the rate of severe British Isles Lupus Assessment Group flares in the DZP group was half that of the placebo group (11.6% vs 23.4%; P = .0257). In the subgroup of patients who underwent corticosteroid tapering, 72.4% receiving DZP and 52.9% taking placebo reduced their dose to < 7.5 mg/day by 48 weeks (P = .0404).

DZP was generally well tolerated. Over 48 weeks, 82.6% of the DZP group and 75% of the placebo group reported treatment-emergent adverse events, but serious occurrences were more common in the placebo group (14.8%) than in the DZP group (9.9%). Herpes viral infections were higher in the placebo group, although there were three ophthalmic herpes cases in the DZP group. There was one case of acute myocardial infarction and one death linked to gangrene-related sepsis in patients receiving DZP.

 

A ‘Mild to Moderate’ Response

Although these are definitely positive results, they show a “mild to moderate response” to DZP, commented Gregory Gardner, MD, an emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, and chair of the American College of Rheumatology’s annual meeting planning committee. He moderated the session where the research was presented. Although DZP showed efficacy among some patients, he noted, “there were still 51% patients that it didn’t work for.” 

The drug uses an alternative pathway to current lupus drugs, Gardner added, and more research is needed to understand how best to use this medication in practice.

Clowse noted that DZP could be particularly beneficial for patients with SLE who want to get pregnant. Many drugs used to treat the disease are teratogenic; however, “because of the lack of Fc portion on this drug, it very likely does not cross the placenta in any kind of significant amount,” she said. Although there are not yet any reproductive safety data on DZP, she added, “that is a great potential niche.”

Biogen and UCB, which are jointly developing DZP, aim to start a second phase 3 trial of DZP in patients with SLE, called PHOENYCS FLY, in 2024.

The trial was sponsored by UCB. Clowse is a consultant and has received grant/research support from GSK and UCB. Gardner had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

In a nearly unanimous vote at the annual research symposium of the Gout Hyperuricemia and Crystal-Associated Disease Network (G-CAN), members approved a revision to gout remission criteria first established in 2016. The new version simplifies the definition in response to patient comments that the earlier version was redundant in some areas. 

The previous version was developed following deliberations by 49 clinicians and researchers with experience in gout. They settled on a definition of gout remission that included five criteria:

• Serum urate levels lower than 0.36 mmol/L measured at least twice over 12 months, with no intervening values of 0.36 mmol/L or higher
• No gout flares over 12 months
• No tophi
• Pain score due to gout < 2 at least twice over 12 months on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values ≥ 2
• Patient global assessment of gout disease activity < 2 on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values of ≥ 2.

Some participants reported that patients sometimes misattributed pain from other sources while using patient-reported outcomes (PROs). The argument for keeping PROs was that they are validated measures and endorsed by Outcome Measures in Rheumatology. Nevertheless, there was no direct patient involvement in the development of the 2016 criteria.

Researchers later interviewed 20 individuals with well-controlled gout to get their feedback on the 2016 criteria. Those individuals endorsed the existing criteria and did not suggest any new ones, but they suggested that the pain due to gout and the absence of gout flares were redundant measures. One said: “If you have no flare-ups, you’ve got no pain; it sort of answers itself.”

“That was a bit challenging for us because it wasn’t quite what we expected, but I think it did make us look again at the definition and think about whether we could simplify the definition further,” Nicola Dalbeth, MBChB, said during a presentation at G-CAN. Dalbeth is an academic rheumatologist at the University of Auckland, in New Zealand, who was also the lead author of the original criteria.

 

Simplified Version Created With Only Three Criteria

In response to these points, researchers produced a revised version with only three criteria, including the serum urate, absence of gout flares, and absence of subcutaneous tophi at the time of assessment.

To determine if the simplified criteria performed well, they compared the original and revised remission criteria in the context of the CARES trial, the Nottingham nurse-led trial, and randomized controlled trials in patients with gout that were conducted in New Zealand (here and here).

Dansoa Tabi-Amponsah, a PhD candidate at the University of Auckland, presented results of a study comparing the two versions in the Nottingham trial, which included 517 participants who received nurse-led or usual general practitioner care. The nurse-led care included education, regular follow-up and serum urate testing, individualized advice on gout flare management, and escalation of urate-lowering therapy with a treat-to-target strategy.

Both definitions demonstrated a link between the nurse-led strategy and increased rates of remission at year 1 and year 2, although the simplified definition found that more patients were in remission (17.6% vs 9.9% at year 1 and 42.7% vs 28.4% at year 2, both P < .001). “This is something we’ve seen across all of our analyses,” said Tabi-Amponsah. 

Both criteria also found significant differences in remission rates between the nurse-led group in year 2 vs year 1 but not in the usual care group.

Participants who achieved remission had better gout impact scale scores in areas like worrying that a gout attack will occur, fears of worsening gout, and concerns about the impact of gout on future activities. “This is important because during that qualitative study, a key aspect of being in remission was no longer being worried about their gout, no longer feeling anxious about having constant gout flares, and having control over their gout. So, it’s important to note that despite the absence of PROs in that simplified definition, it’s still able to align with the patients’ perspectives of their disease state,” said Tabi-Amponsah.

During the Q&A period after her talk, an audience member asked whether the higher rate of remission found by the simplified criteria is actually a good thing. “If I compare that to rheumatoid arthritis, when you use DAS28 you have a lot more remission, but still progression. So, are we missing some people? Are we including people in remission that still have disease?” she asked. 

Tabi-Amponsah responded that the pain and patient global assessment domains seem to be quite difficult to achieve. In a separate analysis, the researchers examined tender and swollen joint counts and found that those achieving remission no longer had tender or swollen joints. “So, we don’t think the simplified definition is heavily misclassifying anyone as being in remission,” she said. 

During the Q&A following Dalbeth’s talk, an audience member asked about patients with what he described as “mountains of tophi,” despite responding well to uricase therapy. “They may take months or even a year to really resolve that burden. They may be doing very well, yet they’re not going to be in remission because they’ve still got visible tophi. So, are we underselling them, and do we need a different definition for them doing well that this doesn’t capture?” he asked.

Dalbeth suggested that patients with large amounts of tophi aren’t really in remission. “I think we do need to be thinking about the disease, not just in terms of just crystals or just inflammation, but actually trying to integrate both of those, and I think this is where these composite measures might work quite well. I think we need to be aiming for holistic disease control, which is essentially what this is,” she said. 

Tabi-Amponsah and Dalbeth did not disclose any financial relationships. 

 

A version of this article appeared on Medscape.com.

In a nearly unanimous vote at the annual research symposium of the Gout Hyperuricemia and Crystal-Associated Disease Network (G-CAN), members approved a revision to gout remission criteria first established in 2016. The new version simplifies the definition in response to patient comments that the earlier version was redundant in some areas. 

The previous version was developed following deliberations by 49 clinicians and researchers with experience in gout. They settled on a definition of gout remission that included five criteria:

• Serum urate levels lower than 0.36 mmol/L measured at least twice over 12 months, with no intervening values of 0.36 mmol/L or higher
• No gout flares over 12 months
• No tophi
• Pain score due to gout < 2 at least twice over 12 months on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values ≥ 2
• Patient global assessment of gout disease activity < 2 on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values of ≥ 2.

Some participants reported that patients sometimes misattributed pain from other sources while using patient-reported outcomes (PROs). The argument for keeping PROs was that they are validated measures and endorsed by Outcome Measures in Rheumatology. Nevertheless, there was no direct patient involvement in the development of the 2016 criteria.

Researchers later interviewed 20 individuals with well-controlled gout to get their feedback on the 2016 criteria. Those individuals endorsed the existing criteria and did not suggest any new ones, but they suggested that the pain due to gout and the absence of gout flares were redundant measures. One said: “If you have no flare-ups, you’ve got no pain; it sort of answers itself.”

“That was a bit challenging for us because it wasn’t quite what we expected, but I think it did make us look again at the definition and think about whether we could simplify the definition further,” Nicola Dalbeth, MBChB, said during a presentation at G-CAN. Dalbeth is an academic rheumatologist at the University of Auckland, in New Zealand, who was also the lead author of the original criteria.

 

Simplified Version Created With Only Three Criteria

In response to these points, researchers produced a revised version with only three criteria, including the serum urate, absence of gout flares, and absence of subcutaneous tophi at the time of assessment.

To determine if the simplified criteria performed well, they compared the original and revised remission criteria in the context of the CARES trial, the Nottingham nurse-led trial, and randomized controlled trials in patients with gout that were conducted in New Zealand (here and here).

Dansoa Tabi-Amponsah, a PhD candidate at the University of Auckland, presented results of a study comparing the two versions in the Nottingham trial, which included 517 participants who received nurse-led or usual general practitioner care. The nurse-led care included education, regular follow-up and serum urate testing, individualized advice on gout flare management, and escalation of urate-lowering therapy with a treat-to-target strategy.

Both definitions demonstrated a link between the nurse-led strategy and increased rates of remission at year 1 and year 2, although the simplified definition found that more patients were in remission (17.6% vs 9.9% at year 1 and 42.7% vs 28.4% at year 2, both P < .001). “This is something we’ve seen across all of our analyses,” said Tabi-Amponsah. 

Both criteria also found significant differences in remission rates between the nurse-led group in year 2 vs year 1 but not in the usual care group.

Participants who achieved remission had better gout impact scale scores in areas like worrying that a gout attack will occur, fears of worsening gout, and concerns about the impact of gout on future activities. “This is important because during that qualitative study, a key aspect of being in remission was no longer being worried about their gout, no longer feeling anxious about having constant gout flares, and having control over their gout. So, it’s important to note that despite the absence of PROs in that simplified definition, it’s still able to align with the patients’ perspectives of their disease state,” said Tabi-Amponsah.

During the Q&A period after her talk, an audience member asked whether the higher rate of remission found by the simplified criteria is actually a good thing. “If I compare that to rheumatoid arthritis, when you use DAS28 you have a lot more remission, but still progression. So, are we missing some people? Are we including people in remission that still have disease?” she asked. 

Tabi-Amponsah responded that the pain and patient global assessment domains seem to be quite difficult to achieve. In a separate analysis, the researchers examined tender and swollen joint counts and found that those achieving remission no longer had tender or swollen joints. “So, we don’t think the simplified definition is heavily misclassifying anyone as being in remission,” she said. 

During the Q&A following Dalbeth’s talk, an audience member asked about patients with what he described as “mountains of tophi,” despite responding well to uricase therapy. “They may take months or even a year to really resolve that burden. They may be doing very well, yet they’re not going to be in remission because they’ve still got visible tophi. So, are we underselling them, and do we need a different definition for them doing well that this doesn’t capture?” he asked.

Dalbeth suggested that patients with large amounts of tophi aren’t really in remission. “I think we do need to be thinking about the disease, not just in terms of just crystals or just inflammation, but actually trying to integrate both of those, and I think this is where these composite measures might work quite well. I think we need to be aiming for holistic disease control, which is essentially what this is,” she said. 

Tabi-Amponsah and Dalbeth did not disclose any financial relationships. 

 

A version of this article appeared on Medscape.com.

In a nearly unanimous vote at the annual research symposium of the Gout Hyperuricemia and Crystal-Associated Disease Network (G-CAN), members approved a revision to gout remission criteria first established in 2016. The new version simplifies the definition in response to patient comments that the earlier version was redundant in some areas. 

The previous version was developed following deliberations by 49 clinicians and researchers with experience in gout. They settled on a definition of gout remission that included five criteria:

• Serum urate levels lower than 0.36 mmol/L measured at least twice over 12 months, with no intervening values of 0.36 mmol/L or higher
• No gout flares over 12 months
• No tophi
• Pain score due to gout < 2 at least twice over 12 months on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values ≥ 2
• Patient global assessment of gout disease activity < 2 on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values of ≥ 2.

Some participants reported that patients sometimes misattributed pain from other sources while using patient-reported outcomes (PROs). The argument for keeping PROs was that they are validated measures and endorsed by Outcome Measures in Rheumatology. Nevertheless, there was no direct patient involvement in the development of the 2016 criteria.

Researchers later interviewed 20 individuals with well-controlled gout to get their feedback on the 2016 criteria. Those individuals endorsed the existing criteria and did not suggest any new ones, but they suggested that the pain due to gout and the absence of gout flares were redundant measures. One said: “If you have no flare-ups, you’ve got no pain; it sort of answers itself.”

“That was a bit challenging for us because it wasn’t quite what we expected, but I think it did make us look again at the definition and think about whether we could simplify the definition further,” Nicola Dalbeth, MBChB, said during a presentation at G-CAN. Dalbeth is an academic rheumatologist at the University of Auckland, in New Zealand, who was also the lead author of the original criteria.

 

Simplified Version Created With Only Three Criteria

In response to these points, researchers produced a revised version with only three criteria, including the serum urate, absence of gout flares, and absence of subcutaneous tophi at the time of assessment.

To determine if the simplified criteria performed well, they compared the original and revised remission criteria in the context of the CARES trial, the Nottingham nurse-led trial, and randomized controlled trials in patients with gout that were conducted in New Zealand (here and here).

Dansoa Tabi-Amponsah, a PhD candidate at the University of Auckland, presented results of a study comparing the two versions in the Nottingham trial, which included 517 participants who received nurse-led or usual general practitioner care. The nurse-led care included education, regular follow-up and serum urate testing, individualized advice on gout flare management, and escalation of urate-lowering therapy with a treat-to-target strategy.

Both definitions demonstrated a link between the nurse-led strategy and increased rates of remission at year 1 and year 2, although the simplified definition found that more patients were in remission (17.6% vs 9.9% at year 1 and 42.7% vs 28.4% at year 2, both P < .001). “This is something we’ve seen across all of our analyses,” said Tabi-Amponsah. 

Both criteria also found significant differences in remission rates between the nurse-led group in year 2 vs year 1 but not in the usual care group.

Participants who achieved remission had better gout impact scale scores in areas like worrying that a gout attack will occur, fears of worsening gout, and concerns about the impact of gout on future activities. “This is important because during that qualitative study, a key aspect of being in remission was no longer being worried about their gout, no longer feeling anxious about having constant gout flares, and having control over their gout. So, it’s important to note that despite the absence of PROs in that simplified definition, it’s still able to align with the patients’ perspectives of their disease state,” said Tabi-Amponsah.

During the Q&A period after her talk, an audience member asked whether the higher rate of remission found by the simplified criteria is actually a good thing. “If I compare that to rheumatoid arthritis, when you use DAS28 you have a lot more remission, but still progression. So, are we missing some people? Are we including people in remission that still have disease?” she asked. 

Tabi-Amponsah responded that the pain and patient global assessment domains seem to be quite difficult to achieve. In a separate analysis, the researchers examined tender and swollen joint counts and found that those achieving remission no longer had tender or swollen joints. “So, we don’t think the simplified definition is heavily misclassifying anyone as being in remission,” she said. 

During the Q&A following Dalbeth’s talk, an audience member asked about patients with what he described as “mountains of tophi,” despite responding well to uricase therapy. “They may take months or even a year to really resolve that burden. They may be doing very well, yet they’re not going to be in remission because they’ve still got visible tophi. So, are we underselling them, and do we need a different definition for them doing well that this doesn’t capture?” he asked.

Dalbeth suggested that patients with large amounts of tophi aren’t really in remission. “I think we do need to be thinking about the disease, not just in terms of just crystals or just inflammation, but actually trying to integrate both of those, and I think this is where these composite measures might work quite well. I think we need to be aiming for holistic disease control, which is essentially what this is,” she said. 

Tabi-Amponsah and Dalbeth did not disclose any financial relationships. 

 

A version of this article appeared on Medscape.com.

TOPLINE:

Death rates for patients aged < 50 years with early-onset colorectal cancer (EOCRC) are higher in native Hawaiian and Other Pacific Islander individuals and non-Hispanic Black individuals than in non-Hispanic White individuals (adjusted hazard ratios [aHR] of 1.34 and 1.18, respectively). The largest racial and ethnic disparities in survival were linked to neighborhood socioeconomic status.

METHODOLOGY:

• US rates of EOCRC are increasing, with differences across racial and ethnic groups, but few studies have provided detailed risk estimates in the categories of Asian American and of Native Hawaiian or Other Pacific Islander, as well as the contribution of sociodemographic factors to these differences.
• A population-based cohort study analyzed California Cancer Registry data for 22,834 individuals aged 18-49 years diagnosed with EOCRC between January 2000 and December 2019.
• Researchers examined the association between mortality risk and racial and ethnic groups, including Asian American (15.5%, separated into seven subcategories), Hispanic (30.2%), Native Hawaiian or Other Pacific Islander (0.6%), non-Hispanic American Indian or Alaska Native (0.5%), non-Hispanic Black (7.3%), and non-Hispanic White (45.9%) individuals, with a median follow-up of 4.2 years.
• Statistical models measured baseline associations adjusting for clinical features and then tested for the contribution of socioeconomic factors together and separately, with adjustments for insurance status, neighborhood socioeconomic status, and more.

TAKEAWAY:

• Native Hawaiian or Other Pacific Islander individuals demonstrated the highest EOCRC mortality risk compared with non-Hispanic White individuals (socioeconomic status–adjusted HR [SES aHR], 1.34; 95% CI, 1.01-1.76).
• Non-Hispanic Black individuals showed a higher EOCRC mortality risk than non-Hispanic White individuals (SES aHR, 1.18; 95% CI, 1.07-1.29).
• Hispanic individuals’ higher EOCRC mortality (base aHR, 1.15; 95% CI, 1.08-1.22) disappeared after adjusting for neighborhood socioeconomic status (SES aHR, 0.98; 95% CI, 0.92-1.04).
• Southeast Asian individuals’ increased mortality risk (base aHR, 1.17; 95% CI, 1.03-1.34) was no longer significant after adjusting for insurance status (SES aHR, 1.10; 95% CI, 0.96-1.26).

IN PRACTICE:

“As clinicians and researchers, we should ask ourselves how to act on these findings,” wrote the authors of an invited commentary. “The effort cannot stop with data analysis alone, it must extend to actionable steps,” such as tailored efforts to deliver culturally competent care and patient navigation services to those with greatest need and at highest risk, they added.

SOURCE:

The study was led by Joshua Demb, PhD, University of California, San Diego. The study was published online on November 22 in JAMA Network Open (2024. doi: 10.1001/jamanetworkopen.2024.46820) with the invited commentary led by Clare E. Jacobson, MD, University of Michigan, Ann Arbor.

LIMITATIONS:

The study was limited by a relatively short follow-up time and small sample sizes in some racial and ethnic groups, potentially leading to imprecise aHR estimates. The generalizability of findings beyond California requires further investigation, and the ability to examine potential associations between neighborhood socioeconomic status and other factors was also constrained by small sample sizes.

DISCLOSURES:

The study received support from the National Cancer Institute at the National Institutes of Health. One study author reported receiving consulting fees from Guardant Health, InterVenn Biosciences, Geneoscopy, and Universal DX; research support from Freenome; and stock options from CellMax outside the submitted work. No other disclosures were reported by other authors of the study or the commentary.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Death rates for patients aged < 50 years with early-onset colorectal cancer (EOCRC) are higher in native Hawaiian and Other Pacific Islander individuals and non-Hispanic Black individuals than in non-Hispanic White individuals (adjusted hazard ratios [aHR] of 1.34 and 1.18, respectively). The largest racial and ethnic disparities in survival were linked to neighborhood socioeconomic status.

METHODOLOGY:

• US rates of EOCRC are increasing, with differences across racial and ethnic groups, but few studies have provided detailed risk estimates in the categories of Asian American and of Native Hawaiian or Other Pacific Islander, as well as the contribution of sociodemographic factors to these differences.
• A population-based cohort study analyzed California Cancer Registry data for 22,834 individuals aged 18-49 years diagnosed with EOCRC between January 2000 and December 2019.
• Researchers examined the association between mortality risk and racial and ethnic groups, including Asian American (15.5%, separated into seven subcategories), Hispanic (30.2%), Native Hawaiian or Other Pacific Islander (0.6%), non-Hispanic American Indian or Alaska Native (0.5%), non-Hispanic Black (7.3%), and non-Hispanic White (45.9%) individuals, with a median follow-up of 4.2 years.
• Statistical models measured baseline associations adjusting for clinical features and then tested for the contribution of socioeconomic factors together and separately, with adjustments for insurance status, neighborhood socioeconomic status, and more.

TAKEAWAY:

• Native Hawaiian or Other Pacific Islander individuals demonstrated the highest EOCRC mortality risk compared with non-Hispanic White individuals (socioeconomic status–adjusted HR [SES aHR], 1.34; 95% CI, 1.01-1.76).
• Non-Hispanic Black individuals showed a higher EOCRC mortality risk than non-Hispanic White individuals (SES aHR, 1.18; 95% CI, 1.07-1.29).
• Hispanic individuals’ higher EOCRC mortality (base aHR, 1.15; 95% CI, 1.08-1.22) disappeared after adjusting for neighborhood socioeconomic status (SES aHR, 0.98; 95% CI, 0.92-1.04).
• Southeast Asian individuals’ increased mortality risk (base aHR, 1.17; 95% CI, 1.03-1.34) was no longer significant after adjusting for insurance status (SES aHR, 1.10; 95% CI, 0.96-1.26).

IN PRACTICE:

“As clinicians and researchers, we should ask ourselves how to act on these findings,” wrote the authors of an invited commentary. “The effort cannot stop with data analysis alone, it must extend to actionable steps,” such as tailored efforts to deliver culturally competent care and patient navigation services to those with greatest need and at highest risk, they added.

SOURCE:

The study was led by Joshua Demb, PhD, University of California, San Diego. The study was published online on November 22 in JAMA Network Open (2024. doi: 10.1001/jamanetworkopen.2024.46820) with the invited commentary led by Clare E. Jacobson, MD, University of Michigan, Ann Arbor.

LIMITATIONS:

The study was limited by a relatively short follow-up time and small sample sizes in some racial and ethnic groups, potentially leading to imprecise aHR estimates. The generalizability of findings beyond California requires further investigation, and the ability to examine potential associations between neighborhood socioeconomic status and other factors was also constrained by small sample sizes.

DISCLOSURES:

The study received support from the National Cancer Institute at the National Institutes of Health. One study author reported receiving consulting fees from Guardant Health, InterVenn Biosciences, Geneoscopy, and Universal DX; research support from Freenome; and stock options from CellMax outside the submitted work. No other disclosures were reported by other authors of the study or the commentary.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Death rates for patients aged < 50 years with early-onset colorectal cancer (EOCRC) are higher in native Hawaiian and Other Pacific Islander individuals and non-Hispanic Black individuals than in non-Hispanic White individuals (adjusted hazard ratios [aHR] of 1.34 and 1.18, respectively). The largest racial and ethnic disparities in survival were linked to neighborhood socioeconomic status.

METHODOLOGY:

• US rates of EOCRC are increasing, with differences across racial and ethnic groups, but few studies have provided detailed risk estimates in the categories of Asian American and of Native Hawaiian or Other Pacific Islander, as well as the contribution of sociodemographic factors to these differences.
• A population-based cohort study analyzed California Cancer Registry data for 22,834 individuals aged 18-49 years diagnosed with EOCRC between January 2000 and December 2019.
• Researchers examined the association between mortality risk and racial and ethnic groups, including Asian American (15.5%, separated into seven subcategories), Hispanic (30.2%), Native Hawaiian or Other Pacific Islander (0.6%), non-Hispanic American Indian or Alaska Native (0.5%), non-Hispanic Black (7.3%), and non-Hispanic White (45.9%) individuals, with a median follow-up of 4.2 years.
• Statistical models measured baseline associations adjusting for clinical features and then tested for the contribution of socioeconomic factors together and separately, with adjustments for insurance status, neighborhood socioeconomic status, and more.

TAKEAWAY:

• Native Hawaiian or Other Pacific Islander individuals demonstrated the highest EOCRC mortality risk compared with non-Hispanic White individuals (socioeconomic status–adjusted HR [SES aHR], 1.34; 95% CI, 1.01-1.76).
• Non-Hispanic Black individuals showed a higher EOCRC mortality risk than non-Hispanic White individuals (SES aHR, 1.18; 95% CI, 1.07-1.29).
• Hispanic individuals’ higher EOCRC mortality (base aHR, 1.15; 95% CI, 1.08-1.22) disappeared after adjusting for neighborhood socioeconomic status (SES aHR, 0.98; 95% CI, 0.92-1.04).
• Southeast Asian individuals’ increased mortality risk (base aHR, 1.17; 95% CI, 1.03-1.34) was no longer significant after adjusting for insurance status (SES aHR, 1.10; 95% CI, 0.96-1.26).

IN PRACTICE:

“As clinicians and researchers, we should ask ourselves how to act on these findings,” wrote the authors of an invited commentary. “The effort cannot stop with data analysis alone, it must extend to actionable steps,” such as tailored efforts to deliver culturally competent care and patient navigation services to those with greatest need and at highest risk, they added.

SOURCE:

The study was led by Joshua Demb, PhD, University of California, San Diego. The study was published online on November 22 in JAMA Network Open (2024. doi: 10.1001/jamanetworkopen.2024.46820) with the invited commentary led by Clare E. Jacobson, MD, University of Michigan, Ann Arbor.

LIMITATIONS:

The study was limited by a relatively short follow-up time and small sample sizes in some racial and ethnic groups, potentially leading to imprecise aHR estimates. The generalizability of findings beyond California requires further investigation, and the ability to examine potential associations between neighborhood socioeconomic status and other factors was also constrained by small sample sizes.

DISCLOSURES:

The study received support from the National Cancer Institute at the National Institutes of Health. One study author reported receiving consulting fees from Guardant Health, InterVenn Biosciences, Geneoscopy, and Universal DX; research support from Freenome; and stock options from CellMax outside the submitted work. No other disclosures were reported by other authors of the study or the commentary.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

This news organization recently spoke with the Centers for Disease Control and Prevention’s (CDC) Lisa Grohskopf, MD, MPH, Influenza Division, National Center for Immunization and Respiratory Diseases, about what providers need to know regarding recommendations for influenza vaccination in the United States.

Text has been edited for length. 

 

Are there any updates to this season’s influenza vaccine or vaccine recommendations?

Yes, we have updates to both the vaccine and the vaccine recommendations this year. Typically we have some changes each year, and this year there are two main changes in the recommendations. One relates to the composition of the vaccine for this season, and the other is a new recommendation for adult solid organ transplant recipients. 

We typically have changes in the vaccine composition each season. For most seasons, one or more parts of the vaccine will change, but this year is a little different in that all of the vaccines available in the US for the 2024-2025 season are going to be three-virus, or trivalent, vaccines. They are going to be formulated to protect against three viruses: an influenza A(H1N1) virus, an influenza A(H3N2) virus, and an influenza B/Victoria lineage virus. 

The reason for this change is that since the 2013-2014 season through the 2023-2024 season, we had quadrivalent vaccines that were available in the US that contained four viruses. Those vaccines contained a second influenza B virus from the Yamagata lineage (B viruses come from two main lineages).

The reason for the change to trivalent vaccines this season is that influenza B/Yamagata viruses have not been detected in global surveillance since March 2020, and so their inclusion is no longer warranted. So this season, all of the vaccines available in the US are going to be trivalent.

In addition to that change, we have an update in the influenza A(H3N2) component of the vaccine compared with last season.

The second change concerning adult solid organ transplant recipients is that Advisory Committee on Immunization Practices (ACIP) now recommends that solid organ transplant recipients aged 18-64 years can receive as acceptable options either the high-dose inactivated vaccine or the adjuvanted inactivated vaccine without a preference over other age appropriate, inactivated, or recombinant vaccines.

Those vaccines are both formulated with features intended to make them more immunogenic — ie, promote a stronger immune response — and there are data for immunogenicity that suggest they could be more immunogenic in that population.

 

Who needs an influenza vaccine this season?

That recommendation is the same as it’s been for a number of years, which is that everybody aged 6 months or older is recommended to get a flu vaccine, with some rare exceptions, mainly concerning contraindications to vaccination. 

Contraindications are detailed in the ACIP flu statement each year, and they’re relatively uncommon conditions overall, so most people are recommended, if they’re in that age group 6 months and up, to get an annual flu vaccine.

Are there groups for whom influenza vaccination is especially important?

Yes. While influenza vaccination is recommended for everybody in that age group 6 months and up — and in truth, we can never really predict who’s going to get severely ill — some people are more likely to be at risk of having serious illness or hospitalization. Those people include adults aged 65 years or older; young children; people with certain chronic health conditions such as heart disease, lung disease, and diabetes; and people from some racial and ethnic groups.

 

Are there any specific influenza vaccination recommendations for these groups or others? 

Not for most people. In general, we have a number of different influenza vaccines each season; this year we have a total of nine brands. In general, there’s no preferential recommendation for one vaccine or type of vaccine for specific groups of people, with one exception: For people aged 65 years or older, there’s a preferential recommendation for three specific vaccines — the high-dose inactivated vaccine, Fluzone High-Dose; the recombinant vaccine, Flublok; and the adjuvanted inactivated vaccine, FLUAD. 

Among those three, there’s no preference for any one of them over the other two; they’re all preferred vaccines for this age group, if available. If none of those three vaccines are available at the time that somebody aged 65 or older is there to get vaccinated, people in this age group should get any other age-appropriate influenza vaccine that is available.

 

When should people get vaccinated if they haven’t already?

CDC and ACIP recommend vaccination for most people, ideally by the end of October. But for those who missed the end of October, it is absolutely not too late. Providers should continue to encourage vaccination and people should get their vaccines as long as flu viruses are circulating. 

The timing of the onset and the peak and the end of the flu season vary a bit from year to year. We often start to see generally activity begin to increase in the US in the fall, which is the reason for the end of October recommendation; however, flu activity doesn’t tend to peak in the US until after October. We’re talking December, January, or later, so getting vaccinated after October can still provide important protection during the peak of the season.

There does seem to be a tendency for people to think, OK, I haven’t gotten the vaccine yet, and there probably isn’t a lot of reason to do it now. But really, it’s definitely not too late, and that’s something we like to encourage people to think about, particularly as we move into December and January — it’s not too late if you missed October. 

Influenza vaccination is also available in so many places. You don’t necessarily have to go to a healthcare provider’s office; there are many retail chains which offer influenza vaccines.

 

Is influenza spreading right now? Are activity levels increasing?

Overall influenza activity currently is low nationally, although there’s starting to be some slight increases in the pediatric age groups and, of course, we do anticipate that it will increase in the coming weeks and months.

When we get vaccinated, the protection isn’t instantaneous. The immune system needs a bit of time to react to the vaccine and to develop antibodies. That can take about 2 weeks. Even with that, now is still absolutely not too late to get a vaccine. Neither is December, for that matter. As long as the flu viruses are circulating where you are, it is still worth getting vaccinated.

 

What was influenza vaccination coverage like last season?

It’s a little bit early to tell for the current season, but one of the things that we do know is that since the COVID-19 pandemic, coverage has dropped compared with before the COVID-19 pandemic. Before COVID-19, influenza vaccination coverage had been slowly increasing in most groups, but it has decreased since then, and those downturns in coverage haven’t recovered to prepandemic levels. For example, during 2023-2024, about half of children and adults received a flu vaccine. 

What can providers do to encourage influenza vaccination in their patients?

We know that a healthcare provider’s strong recommendation for flu vaccination is a really major factor in whether or not patients get a flu vaccine, and is more effective in increasing acceptance of vaccination than just about any other factor. 

There’s a method from CDC called SHARE, which is a helpful way to help make a strong recommendation and provide information to help patients make an informed decision about whether or not they want to be vaccinated.

To implement SHARE, it’s an acronym with five parts. S is for Share the reasons why the flu vaccine is right for that patient. H is for Highlight positive experiences with flu vaccination, either personal or in practice. A is for Address patient concerns and questions about the flu vaccine, including things such as side effects, safety, and effectiveness. R is Remind patients that vaccination protects them and their loved ones from serious illness and related complications. E is Explain the potential complications and consequences of getting influenza, including serious health effects, time lost from family, work, and school, and potential financial costs.

Additional resources are accessible on CDC’s influenza resources page, including brochures, posters, and fact sheets that can help providers in encouraging and reminding people to get vaccinated.

A version of this article appeared on Medscape.com.

This news organization recently spoke with the Centers for Disease Control and Prevention’s (CDC) Lisa Grohskopf, MD, MPH, Influenza Division, National Center for Immunization and Respiratory Diseases, about what providers need to know regarding recommendations for influenza vaccination in the United States.

Text has been edited for length. 

 

Are there any updates to this season’s influenza vaccine or vaccine recommendations?

Yes, we have updates to both the vaccine and the vaccine recommendations this year. Typically we have some changes each year, and this year there are two main changes in the recommendations. One relates to the composition of the vaccine for this season, and the other is a new recommendation for adult solid organ transplant recipients. 

We typically have changes in the vaccine composition each season. For most seasons, one or more parts of the vaccine will change, but this year is a little different in that all of the vaccines available in the US for the 2024-2025 season are going to be three-virus, or trivalent, vaccines. They are going to be formulated to protect against three viruses: an influenza A(H1N1) virus, an influenza A(H3N2) virus, and an influenza B/Victoria lineage virus. 

The reason for this change is that since the 2013-2014 season through the 2023-2024 season, we had quadrivalent vaccines that were available in the US that contained four viruses. Those vaccines contained a second influenza B virus from the Yamagata lineage (B viruses come from two main lineages).

The reason for the change to trivalent vaccines this season is that influenza B/Yamagata viruses have not been detected in global surveillance since March 2020, and so their inclusion is no longer warranted. So this season, all of the vaccines available in the US are going to be trivalent.

In addition to that change, we have an update in the influenza A(H3N2) component of the vaccine compared with last season.

The second change concerning adult solid organ transplant recipients is that Advisory Committee on Immunization Practices (ACIP) now recommends that solid organ transplant recipients aged 18-64 years can receive as acceptable options either the high-dose inactivated vaccine or the adjuvanted inactivated vaccine without a preference over other age appropriate, inactivated, or recombinant vaccines.

Those vaccines are both formulated with features intended to make them more immunogenic — ie, promote a stronger immune response — and there are data for immunogenicity that suggest they could be more immunogenic in that population.

 

Who needs an influenza vaccine this season?

That recommendation is the same as it’s been for a number of years, which is that everybody aged 6 months or older is recommended to get a flu vaccine, with some rare exceptions, mainly concerning contraindications to vaccination. 

Contraindications are detailed in the ACIP flu statement each year, and they’re relatively uncommon conditions overall, so most people are recommended, if they’re in that age group 6 months and up, to get an annual flu vaccine.

Are there groups for whom influenza vaccination is especially important?

Yes. While influenza vaccination is recommended for everybody in that age group 6 months and up — and in truth, we can never really predict who’s going to get severely ill — some people are more likely to be at risk of having serious illness or hospitalization. Those people include adults aged 65 years or older; young children; people with certain chronic health conditions such as heart disease, lung disease, and diabetes; and people from some racial and ethnic groups.

 

Are there any specific influenza vaccination recommendations for these groups or others? 

Not for most people. In general, we have a number of different influenza vaccines each season; this year we have a total of nine brands. In general, there’s no preferential recommendation for one vaccine or type of vaccine for specific groups of people, with one exception: For people aged 65 years or older, there’s a preferential recommendation for three specific vaccines — the high-dose inactivated vaccine, Fluzone High-Dose; the recombinant vaccine, Flublok; and the adjuvanted inactivated vaccine, FLUAD. 

Among those three, there’s no preference for any one of them over the other two; they’re all preferred vaccines for this age group, if available. If none of those three vaccines are available at the time that somebody aged 65 or older is there to get vaccinated, people in this age group should get any other age-appropriate influenza vaccine that is available.

 

When should people get vaccinated if they haven’t already?

CDC and ACIP recommend vaccination for most people, ideally by the end of October. But for those who missed the end of October, it is absolutely not too late. Providers should continue to encourage vaccination and people should get their vaccines as long as flu viruses are circulating. 

The timing of the onset and the peak and the end of the flu season vary a bit from year to year. We often start to see generally activity begin to increase in the US in the fall, which is the reason for the end of October recommendation; however, flu activity doesn’t tend to peak in the US until after October. We’re talking December, January, or later, so getting vaccinated after October can still provide important protection during the peak of the season.

There does seem to be a tendency for people to think, OK, I haven’t gotten the vaccine yet, and there probably isn’t a lot of reason to do it now. But really, it’s definitely not too late, and that’s something we like to encourage people to think about, particularly as we move into December and January — it’s not too late if you missed October. 

Influenza vaccination is also available in so many places. You don’t necessarily have to go to a healthcare provider’s office; there are many retail chains which offer influenza vaccines.

 

Is influenza spreading right now? Are activity levels increasing?

Overall influenza activity currently is low nationally, although there’s starting to be some slight increases in the pediatric age groups and, of course, we do anticipate that it will increase in the coming weeks and months.

When we get vaccinated, the protection isn’t instantaneous. The immune system needs a bit of time to react to the vaccine and to develop antibodies. That can take about 2 weeks. Even with that, now is still absolutely not too late to get a vaccine. Neither is December, for that matter. As long as the flu viruses are circulating where you are, it is still worth getting vaccinated.

 

What was influenza vaccination coverage like last season?

It’s a little bit early to tell for the current season, but one of the things that we do know is that since the COVID-19 pandemic, coverage has dropped compared with before the COVID-19 pandemic. Before COVID-19, influenza vaccination coverage had been slowly increasing in most groups, but it has decreased since then, and those downturns in coverage haven’t recovered to prepandemic levels. For example, during 2023-2024, about half of children and adults received a flu vaccine. 

What can providers do to encourage influenza vaccination in their patients?

We know that a healthcare provider’s strong recommendation for flu vaccination is a really major factor in whether or not patients get a flu vaccine, and is more effective in increasing acceptance of vaccination than just about any other factor. 

There’s a method from CDC called SHARE, which is a helpful way to help make a strong recommendation and provide information to help patients make an informed decision about whether or not they want to be vaccinated.

To implement SHARE, it’s an acronym with five parts. S is for Share the reasons why the flu vaccine is right for that patient. H is for Highlight positive experiences with flu vaccination, either personal or in practice. A is for Address patient concerns and questions about the flu vaccine, including things such as side effects, safety, and effectiveness. R is Remind patients that vaccination protects them and their loved ones from serious illness and related complications. E is Explain the potential complications and consequences of getting influenza, including serious health effects, time lost from family, work, and school, and potential financial costs.

Additional resources are accessible on CDC’s influenza resources page, including brochures, posters, and fact sheets that can help providers in encouraging and reminding people to get vaccinated.

A version of this article appeared on Medscape.com.

This news organization recently spoke with the Centers for Disease Control and Prevention’s (CDC) Lisa Grohskopf, MD, MPH, Influenza Division, National Center for Immunization and Respiratory Diseases, about what providers need to know regarding recommendations for influenza vaccination in the United States.

Text has been edited for length. 

 

Are there any updates to this season’s influenza vaccine or vaccine recommendations?

Yes, we have updates to both the vaccine and the vaccine recommendations this year. Typically we have some changes each year, and this year there are two main changes in the recommendations. One relates to the composition of the vaccine for this season, and the other is a new recommendation for adult solid organ transplant recipients. 

We typically have changes in the vaccine composition each season. For most seasons, one or more parts of the vaccine will change, but this year is a little different in that all of the vaccines available in the US for the 2024-2025 season are going to be three-virus, or trivalent, vaccines. They are going to be formulated to protect against three viruses: an influenza A(H1N1) virus, an influenza A(H3N2) virus, and an influenza B/Victoria lineage virus. 

The reason for this change is that since the 2013-2014 season through the 2023-2024 season, we had quadrivalent vaccines that were available in the US that contained four viruses. Those vaccines contained a second influenza B virus from the Yamagata lineage (B viruses come from two main lineages).

The reason for the change to trivalent vaccines this season is that influenza B/Yamagata viruses have not been detected in global surveillance since March 2020, and so their inclusion is no longer warranted. So this season, all of the vaccines available in the US are going to be trivalent.

In addition to that change, we have an update in the influenza A(H3N2) component of the vaccine compared with last season.

The second change concerning adult solid organ transplant recipients is that Advisory Committee on Immunization Practices (ACIP) now recommends that solid organ transplant recipients aged 18-64 years can receive as acceptable options either the high-dose inactivated vaccine or the adjuvanted inactivated vaccine without a preference over other age appropriate, inactivated, or recombinant vaccines.

Those vaccines are both formulated with features intended to make them more immunogenic — ie, promote a stronger immune response — and there are data for immunogenicity that suggest they could be more immunogenic in that population.

 

Who needs an influenza vaccine this season?

That recommendation is the same as it’s been for a number of years, which is that everybody aged 6 months or older is recommended to get a flu vaccine, with some rare exceptions, mainly concerning contraindications to vaccination. 

Contraindications are detailed in the ACIP flu statement each year, and they’re relatively uncommon conditions overall, so most people are recommended, if they’re in that age group 6 months and up, to get an annual flu vaccine.

Are there groups for whom influenza vaccination is especially important?

Yes. While influenza vaccination is recommended for everybody in that age group 6 months and up — and in truth, we can never really predict who’s going to get severely ill — some people are more likely to be at risk of having serious illness or hospitalization. Those people include adults aged 65 years or older; young children; people with certain chronic health conditions such as heart disease, lung disease, and diabetes; and people from some racial and ethnic groups.

 

Are there any specific influenza vaccination recommendations for these groups or others? 

Not for most people. In general, we have a number of different influenza vaccines each season; this year we have a total of nine brands. In general, there’s no preferential recommendation for one vaccine or type of vaccine for specific groups of people, with one exception: For people aged 65 years or older, there’s a preferential recommendation for three specific vaccines — the high-dose inactivated vaccine, Fluzone High-Dose; the recombinant vaccine, Flublok; and the adjuvanted inactivated vaccine, FLUAD. 

Among those three, there’s no preference for any one of them over the other two; they’re all preferred vaccines for this age group, if available. If none of those three vaccines are available at the time that somebody aged 65 or older is there to get vaccinated, people in this age group should get any other age-appropriate influenza vaccine that is available.

 

When should people get vaccinated if they haven’t already?

CDC and ACIP recommend vaccination for most people, ideally by the end of October. But for those who missed the end of October, it is absolutely not too late. Providers should continue to encourage vaccination and people should get their vaccines as long as flu viruses are circulating. 

The timing of the onset and the peak and the end of the flu season vary a bit from year to year. We often start to see generally activity begin to increase in the US in the fall, which is the reason for the end of October recommendation; however, flu activity doesn’t tend to peak in the US until after October. We’re talking December, January, or later, so getting vaccinated after October can still provide important protection during the peak of the season.

There does seem to be a tendency for people to think, OK, I haven’t gotten the vaccine yet, and there probably isn’t a lot of reason to do it now. But really, it’s definitely not too late, and that’s something we like to encourage people to think about, particularly as we move into December and January — it’s not too late if you missed October. 

Influenza vaccination is also available in so many places. You don’t necessarily have to go to a healthcare provider’s office; there are many retail chains which offer influenza vaccines.

 

Is influenza spreading right now? Are activity levels increasing?

Overall influenza activity currently is low nationally, although there’s starting to be some slight increases in the pediatric age groups and, of course, we do anticipate that it will increase in the coming weeks and months.

When we get vaccinated, the protection isn’t instantaneous. The immune system needs a bit of time to react to the vaccine and to develop antibodies. That can take about 2 weeks. Even with that, now is still absolutely not too late to get a vaccine. Neither is December, for that matter. As long as the flu viruses are circulating where you are, it is still worth getting vaccinated.

 

What was influenza vaccination coverage like last season?

It’s a little bit early to tell for the current season, but one of the things that we do know is that since the COVID-19 pandemic, coverage has dropped compared with before the COVID-19 pandemic. Before COVID-19, influenza vaccination coverage had been slowly increasing in most groups, but it has decreased since then, and those downturns in coverage haven’t recovered to prepandemic levels. For example, during 2023-2024, about half of children and adults received a flu vaccine. 

What can providers do to encourage influenza vaccination in their patients?

We know that a healthcare provider’s strong recommendation for flu vaccination is a really major factor in whether or not patients get a flu vaccine, and is more effective in increasing acceptance of vaccination than just about any other factor. 

There’s a method from CDC called SHARE, which is a helpful way to help make a strong recommendation and provide information to help patients make an informed decision about whether or not they want to be vaccinated.

To implement SHARE, it’s an acronym with five parts. S is for Share the reasons why the flu vaccine is right for that patient. H is for Highlight positive experiences with flu vaccination, either personal or in practice. A is for Address patient concerns and questions about the flu vaccine, including things such as side effects, safety, and effectiveness. R is Remind patients that vaccination protects them and their loved ones from serious illness and related complications. E is Explain the potential complications and consequences of getting influenza, including serious health effects, time lost from family, work, and school, and potential financial costs.

Additional resources are accessible on CDC’s influenza resources page, including brochures, posters, and fact sheets that can help providers in encouraging and reminding people to get vaccinated.

A version of this article appeared on Medscape.com.

Approximately 1 in 20 adults with outpatient respiratory syncytial virus (RSV) infections were readmitted to the hospital within 28 days, based on new data from more than 67,000 cases.

RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.

“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.

The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.

The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).

The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.

Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.

Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.

A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.

The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.

However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.” 

 

Don’t Underestimate RSV Impact

The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.

“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.

The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “

Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.

The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.

The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.

However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.” 

Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.

The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Approximately 1 in 20 adults with outpatient respiratory syncytial virus (RSV) infections were readmitted to the hospital within 28 days, based on new data from more than 67,000 cases.

RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.

“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.

The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.

The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).

The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.

Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.

Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.

A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.

The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.

However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.” 

 

Don’t Underestimate RSV Impact

The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.

“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.

The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “

Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.

The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.

The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.

However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.” 

Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.

The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Approximately 1 in 20 adults with outpatient respiratory syncytial virus (RSV) infections were readmitted to the hospital within 28 days, based on new data from more than 67,000 cases.

RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.

“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.

The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.

The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).

The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.

Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.

Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.

A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.

The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.

However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.” 

 

Don’t Underestimate RSV Impact

The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.

“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.

The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “

Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.

The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.

The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.

However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.” 

Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.

The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

A report published in July 2024 by the US Senate Special Committee on Aging is calling for a national coordinated response to what the authors claim may be an emerging hoarding disorder (HD) crisis.

While millions of US adults are estimated to have HD, it is the disorder’s prevalence and severity among older adults that sounded the alarm for the Committee Chair Sen. Bob Casey (D-PA).

HD affects roughly 2% of the overall population but up to 6% of all people older than 70 years, the report stated. Older adults made up about 16% of the US population in 2019. By 2060, that proportion is projected to soar to 25%.

The country’s aging population alone “could fuel a rise in hoarding in the coming decades,” the report authors noted.

These findings underscore the pressing need for a deeper understanding of HD, particularly as reports of its impact continue to rise. The Senate report also raises critical questions about the nature of HD: What is known about the condition? What evidence-based treatments are currently available, and are there national strategies that will prevent it from becoming a systemic crisis?

 

Why the Urgency?

An increase in anecdotal reports of HD in his home state prompted Casey, chair of the Senate Committee on Aging, to launch the investigation into the incidence and consequences of HD. Soon after the committee began its work, it became evident that the problem was not unique to communities in Pennsylvania. It was a nationwide issue.

“Communities throughout the United States are already grappling with HD,” the report noted.

HD is characterized by persistent difficulty discarding possessions, regardless of their monetary value. For individuals with HD, such items frequently hold meaningful reminders of past events and provide a sense of security. Difficulties with emotional regulation, executive functioning, and impulse control all contribute to the excessive buildup of clutter. Problems with attention, organization, and problem-solving are also common.

As individuals with HD age, physical limitations or disabilities may hinder their ability to discard clutter. As the accumulation increases, it can pose serious risks not only to their safety but also to public health.

Dozens of statements submitted to the Senate committee by those with HD, clinicians and social workers, first responders, social service organizations, state and federal agencies, and professional societies paint a concerning picture about the impact of hoarding on emergency and community services.

Data from the National Fire Incident Reporting System show the number of hoarding-related residential structural fires increased 26% between 2014 and 2022. Some 5242 residential fires connected to cluttered environments during that time resulted in 1367 fire service injuries, 1119 civilian injuries, and over $396 million in damages.

“For older adults, those consequences include health and safety risks, social isolation, eviction, and homelessness,” the report authors noted. “For communities, those consequences include public health concerns, increased risk of fire, and dangers to emergency responders.”

 

What Causes HD?

HD was once classified as a symptom of obsessive-compulsive personality disorder, with extreme causes meeting the diagnostic criteria for obsessive-compulsive disorder. That changed in 2010 when a working group recommended that HD be added to the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition, as a stand-alone disorder. That recommendation was approved in 2012.

However, a decade later, much about HD’s etiology remains unknown.

Often beginning in early adolescence, HD is a chronic and progressive condition, with genetics and trauma playing a role in its onset and course, Sanjaya Saxena, MD, director of Clinical and Research Affairs at the International OCD Foundation, said in an interview.

Between 50% and 85% of people with HD symptoms have family members with similar behavior. HD is often comorbid with other psychiatric and medical disorders, which can complicate treatment.

Results of a 2022 study showed that, compared with healthy control individuals, people with HD had widespread abnormalities in the prefrontal white matter tract which connects cortical regions involved in executive functioning, including working memory, attention, reward processing, and decision-making.

Some research also suggests that dysregulation of serotonin transmission may contribute to compulsive behaviors and the difficulty in letting go of possessions.

“We do know that there are factors that contribute to worsening of hoarding symptoms, but that’s not the same thing as what really causes it. So unfortunately, it’s still very understudied, and we don’t have great knowledge of what causes it,” Saxena said.

 

What Treatments Are Available?

There are currently no Food and Drug Administration–approved medications to treat HD, although some research has shown antidepressants paroxetine and venlafaxine may have some benefit. Methylphenidate and atomoxetine are also under study for HD.

Nonpharmacological therapies have shown more promising results. Among the first was a specialized cognitive-behavioral therapy (CBT) program developed by Randy Frost, PhD, professor emeritus of psychology at Smith College in Northampton, Massachusetts, and Gail Steketee, PhD, dean emerita and professor emerita of social work at Boston University in Massachusetts.

First published in 2007 and the subject of many clinical trials and studies since, the 26-session program has served as a model for psychosocial treatments for HD. The evidence-based therapy addresses various symptoms, including impulse control. One module encourages participants to develop a set of questions to consider before acquiring new items, gradually helping them build resistance to the urge to accumulate more possessions, said Frost, whose early work on HD was cited by those who supported adding the condition to the DSM in 2012.

“There are several features that I think are important including exercises in resisting acquiring and processing information when making decisions about discarding,” Frost said in an interview.

A number of studies have demonstrated the efficacy of CBT for HD, including a 2015 meta-analysis coauthored by Frost. The research showed symptom severity decreased significantly following CBT, with the largest gains in difficulty discarding and moderate improvements in clutter and acquiring.

Responses were better among women and younger patients, and although symptoms improved, posttreatment scores remained closer to the clinical range, researchers noted. It’s possible that more intervention beyond what is usually included in clinical trials — such as more sessions or adding home decluttering visits — could improve treatment response, they added.

A workshop based on the specialized CBT program has expanded the reach of the treatment. The group therapy project, Buried in Treasures (BiT), was developed by Frost, Steketee, and David Tolin, PhD, founder and director of the Anxiety Disorders Center at the Institute of Living, Hartford, and an adjunct professor of psychiatry at Yale School of Medicine, New Haven, Connecticut. The workshop is designed as a facilitated treatment that can be delivered by clinicians or trained nonclinician facilitators.

A study published in May found that more than half the participants with HD responded to the treatment, and of those, 39% reported significant reductions in HD symptoms. BiT sessions were led by trained facilitators, and the study included in-home decluttering sessions, also led by trained volunteers. Researchers said adding the home intervention could increase engagement with the group therapy.

Another study of a modified version of BiT found a 32% decrease in HD symptoms after 15 weeks of treatment delivered via video teleconference.

“The BiT workshop has been expanding around the world and has the advantage of being relatively inexpensive,” Frost said. Another advantage is that it can be run by nonclinicians, which expands treatment options in areas where mental health professionals trained to treat HD are in short supply.

However, the workshop “is not perfect, and clients usually still have symptoms at the end of the workshop,” Frost noted.

“The point is that the BiT workshop is the first step in changing a lifestyle related to possessions,” he continued. “We do certainly need to train more people in how to treat hoarding, and we need to facilitate research to make our treatments more effective.”

 

What’s New in the Field?

One novel program currently under study combines CBT with a cognitive rehabilitation protocol. Called Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST), the program has been shown to help older adults with HD who don’t respond to traditional CBT for HD.

The program, led by Catherine Ayers, PhD, professor of clinical psychiatry at University of California, San Diego, involves memory training and problem-solving combined with exposure therapy to help participants learn how to tolerate distress associated with discarding their possessions.

Early findings pointed to symptom improvement in older adults following 24 sessions with CREST. The program fared better than geriatric case management in a 2018 study — the first randomized controlled trial of a treatment for HD in older adults — and offered additional benefits compared with exposure therapy in a study published in February 2024.

Virtual reality is also helping people with HD. A program developed at Stanford University in California, allows people with HD to work with a therapist as they practice decluttering in a three-dimensional virtual environment created using photographs and videos of actual hoarded objects and cluttered rooms in patients’ homes.

In a small pilot study, nine people older than 55 years with HD attended 16 weeks of online facilitated therapy where they learned to better understand their attachment to those items. They practiced decluttering by selecting virtual items for recycling, donation, or trash. A virtual garbage truck even hauled away the items they had placed in the trash.

Participants were then asked to discard the actual items at home. Most participants reported a decrease in hoarding symptoms, which was confirmed following a home assessment by a clinician.

“When you pick up an object from a loved one, it still maybe has the scent of the loved one. It has these tactile cues, colors. But in the virtual world, you can take a little bit of a step back,” lead researchers Carolyn Rodriguez, MD, PhD, director of Stanford’s Hoarding Disorders Research Program, said in an interview.

“It’s a little ramp to help people practice these skills. And then what we find is that it actually translated really well. They were able to go home and actually do the real uncluttering,” Rodriguez added.

 

What Else Can Be Done?

While researchers like Rodriguez continue studies of new and existing treatments, the Senate report draws attention to other responses that could aid people with HD. Because of its significant impact on emergency responders, adult protective services, aging services, and housing providers, the report recommends a nationwide response to older adults with HD.

Currently, federal agencies in charge of mental and community health are not doing enough to address HD, the report’s authors noted.

The report demonstrates “the scope and severity of these challenges and offers a path forward for how we can help people, communities, and local governments contend with this condition,” Casey said.

Specifically, the document cites a lack of HD services and tracking by the Substance Abuse and Mental Health Services Administration, the Administration for Community Living, and the Centers for Disease Control and Prevention.

The committee recommended these agencies collaborate to improve HD data collection, which will be critical to managing a potential spike in cases as the population ages. The committee also suggested awareness and training campaigns to better educate clinicians, social service providers, court officials, and first responders about HD.

Further, the report’s authors called for the Department of Housing and Urban Development to provide guidance and technical assistance on HD for landlords and housing assistance programs and urged Congress to collaborate with the Centers for Medicare & Medicaid Services to expand coverage for hoarding treatments.

Finally, the committee encouraged policymakers to engage directly with individuals affected by HD and their families to better understand the impact of the disorder and inform policy development.

“I think the Senate report focuses on education, not just for therapists, but other stakeholders too,” Frost said. “There are lots of other professionals who have a stake in this process, housing specialists, elder service folks, health and human services. Awareness of this problem is something that’s important for them as well.”

Rodriguez characterized the report’s recommendations as “potentially lifesaving” for individuals with HD. She added that it represents the first step in an ongoing effort to address an impending public health crisis related to HD in older adults and its broader impact on communities.

A spokesperson with Casey’s office said it’s unclear whether any federal agencies have acted on the report recommendations since it was released in June. It’s also unknown whether the Senate Committee on Aging will pursue any additional work on HD when new committee leaders are appointed in 2025.

“Although some federal agencies have taken steps to address HD, those steps are frequently limited. Other relevant agencies have not addressed HD at all in recent years,” report authors wrote. “The federal government can, and should, do more to bolster the response to HD.”

Frost agreed.

“I think federal agencies can have a positive effect by promoting, supporting, and tracking local efforts in dealing with this problem,” he said.

With reporting from Eve Bender.

A version of this article appeared on Medscape.com.

A report published in July 2024 by the US Senate Special Committee on Aging is calling for a national coordinated response to what the authors claim may be an emerging hoarding disorder (HD) crisis.

While millions of US adults are estimated to have HD, it is the disorder’s prevalence and severity among older adults that sounded the alarm for the Committee Chair Sen. Bob Casey (D-PA).

HD affects roughly 2% of the overall population but up to 6% of all people older than 70 years, the report stated. Older adults made up about 16% of the US population in 2019. By 2060, that proportion is projected to soar to 25%.

The country’s aging population alone “could fuel a rise in hoarding in the coming decades,” the report authors noted.

These findings underscore the pressing need for a deeper understanding of HD, particularly as reports of its impact continue to rise. The Senate report also raises critical questions about the nature of HD: What is known about the condition? What evidence-based treatments are currently available, and are there national strategies that will prevent it from becoming a systemic crisis?

 

Why the Urgency?

An increase in anecdotal reports of HD in his home state prompted Casey, chair of the Senate Committee on Aging, to launch the investigation into the incidence and consequences of HD. Soon after the committee began its work, it became evident that the problem was not unique to communities in Pennsylvania. It was a nationwide issue.

“Communities throughout the United States are already grappling with HD,” the report noted.

HD is characterized by persistent difficulty discarding possessions, regardless of their monetary value. For individuals with HD, such items frequently hold meaningful reminders of past events and provide a sense of security. Difficulties with emotional regulation, executive functioning, and impulse control all contribute to the excessive buildup of clutter. Problems with attention, organization, and problem-solving are also common.

As individuals with HD age, physical limitations or disabilities may hinder their ability to discard clutter. As the accumulation increases, it can pose serious risks not only to their safety but also to public health.

Dozens of statements submitted to the Senate committee by those with HD, clinicians and social workers, first responders, social service organizations, state and federal agencies, and professional societies paint a concerning picture about the impact of hoarding on emergency and community services.

Data from the National Fire Incident Reporting System show the number of hoarding-related residential structural fires increased 26% between 2014 and 2022. Some 5242 residential fires connected to cluttered environments during that time resulted in 1367 fire service injuries, 1119 civilian injuries, and over $396 million in damages.

“For older adults, those consequences include health and safety risks, social isolation, eviction, and homelessness,” the report authors noted. “For communities, those consequences include public health concerns, increased risk of fire, and dangers to emergency responders.”

 

What Causes HD?

HD was once classified as a symptom of obsessive-compulsive personality disorder, with extreme causes meeting the diagnostic criteria for obsessive-compulsive disorder. That changed in 2010 when a working group recommended that HD be added to the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition, as a stand-alone disorder. That recommendation was approved in 2012.

However, a decade later, much about HD’s etiology remains unknown.

Often beginning in early adolescence, HD is a chronic and progressive condition, with genetics and trauma playing a role in its onset and course, Sanjaya Saxena, MD, director of Clinical and Research Affairs at the International OCD Foundation, said in an interview.

Between 50% and 85% of people with HD symptoms have family members with similar behavior. HD is often comorbid with other psychiatric and medical disorders, which can complicate treatment.

Results of a 2022 study showed that, compared with healthy control individuals, people with HD had widespread abnormalities in the prefrontal white matter tract which connects cortical regions involved in executive functioning, including working memory, attention, reward processing, and decision-making.

Some research also suggests that dysregulation of serotonin transmission may contribute to compulsive behaviors and the difficulty in letting go of possessions.

“We do know that there are factors that contribute to worsening of hoarding symptoms, but that’s not the same thing as what really causes it. So unfortunately, it’s still very understudied, and we don’t have great knowledge of what causes it,” Saxena said.

 

What Treatments Are Available?

There are currently no Food and Drug Administration–approved medications to treat HD, although some research has shown antidepressants paroxetine and venlafaxine may have some benefit. Methylphenidate and atomoxetine are also under study for HD.

Nonpharmacological therapies have shown more promising results. Among the first was a specialized cognitive-behavioral therapy (CBT) program developed by Randy Frost, PhD, professor emeritus of psychology at Smith College in Northampton, Massachusetts, and Gail Steketee, PhD, dean emerita and professor emerita of social work at Boston University in Massachusetts.

First published in 2007 and the subject of many clinical trials and studies since, the 26-session program has served as a model for psychosocial treatments for HD. The evidence-based therapy addresses various symptoms, including impulse control. One module encourages participants to develop a set of questions to consider before acquiring new items, gradually helping them build resistance to the urge to accumulate more possessions, said Frost, whose early work on HD was cited by those who supported adding the condition to the DSM in 2012.

“There are several features that I think are important including exercises in resisting acquiring and processing information when making decisions about discarding,” Frost said in an interview.

A number of studies have demonstrated the efficacy of CBT for HD, including a 2015 meta-analysis coauthored by Frost. The research showed symptom severity decreased significantly following CBT, with the largest gains in difficulty discarding and moderate improvements in clutter and acquiring.

Responses were better among women and younger patients, and although symptoms improved, posttreatment scores remained closer to the clinical range, researchers noted. It’s possible that more intervention beyond what is usually included in clinical trials — such as more sessions or adding home decluttering visits — could improve treatment response, they added.

A workshop based on the specialized CBT program has expanded the reach of the treatment. The group therapy project, Buried in Treasures (BiT), was developed by Frost, Steketee, and David Tolin, PhD, founder and director of the Anxiety Disorders Center at the Institute of Living, Hartford, and an adjunct professor of psychiatry at Yale School of Medicine, New Haven, Connecticut. The workshop is designed as a facilitated treatment that can be delivered by clinicians or trained nonclinician facilitators.

A study published in May found that more than half the participants with HD responded to the treatment, and of those, 39% reported significant reductions in HD symptoms. BiT sessions were led by trained facilitators, and the study included in-home decluttering sessions, also led by trained volunteers. Researchers said adding the home intervention could increase engagement with the group therapy.

Another study of a modified version of BiT found a 32% decrease in HD symptoms after 15 weeks of treatment delivered via video teleconference.

“The BiT workshop has been expanding around the world and has the advantage of being relatively inexpensive,” Frost said. Another advantage is that it can be run by nonclinicians, which expands treatment options in areas where mental health professionals trained to treat HD are in short supply.

However, the workshop “is not perfect, and clients usually still have symptoms at the end of the workshop,” Frost noted.

“The point is that the BiT workshop is the first step in changing a lifestyle related to possessions,” he continued. “We do certainly need to train more people in how to treat hoarding, and we need to facilitate research to make our treatments more effective.”

 

What’s New in the Field?

One novel program currently under study combines CBT with a cognitive rehabilitation protocol. Called Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST), the program has been shown to help older adults with HD who don’t respond to traditional CBT for HD.

The program, led by Catherine Ayers, PhD, professor of clinical psychiatry at University of California, San Diego, involves memory training and problem-solving combined with exposure therapy to help participants learn how to tolerate distress associated with discarding their possessions.

Early findings pointed to symptom improvement in older adults following 24 sessions with CREST. The program fared better than geriatric case management in a 2018 study — the first randomized controlled trial of a treatment for HD in older adults — and offered additional benefits compared with exposure therapy in a study published in February 2024.

Virtual reality is also helping people with HD. A program developed at Stanford University in California, allows people with HD to work with a therapist as they practice decluttering in a three-dimensional virtual environment created using photographs and videos of actual hoarded objects and cluttered rooms in patients’ homes.

In a small pilot study, nine people older than 55 years with HD attended 16 weeks of online facilitated therapy where they learned to better understand their attachment to those items. They practiced decluttering by selecting virtual items for recycling, donation, or trash. A virtual garbage truck even hauled away the items they had placed in the trash.

Participants were then asked to discard the actual items at home. Most participants reported a decrease in hoarding symptoms, which was confirmed following a home assessment by a clinician.

“When you pick up an object from a loved one, it still maybe has the scent of the loved one. It has these tactile cues, colors. But in the virtual world, you can take a little bit of a step back,” lead researchers Carolyn Rodriguez, MD, PhD, director of Stanford’s Hoarding Disorders Research Program, said in an interview.

“It’s a little ramp to help people practice these skills. And then what we find is that it actually translated really well. They were able to go home and actually do the real uncluttering,” Rodriguez added.

 

What Else Can Be Done?

While researchers like Rodriguez continue studies of new and existing treatments, the Senate report draws attention to other responses that could aid people with HD. Because of its significant impact on emergency responders, adult protective services, aging services, and housing providers, the report recommends a nationwide response to older adults with HD.

Currently, federal agencies in charge of mental and community health are not doing enough to address HD, the report’s authors noted.

The report demonstrates “the scope and severity of these challenges and offers a path forward for how we can help people, communities, and local governments contend with this condition,” Casey said.

Specifically, the document cites a lack of HD services and tracking by the Substance Abuse and Mental Health Services Administration, the Administration for Community Living, and the Centers for Disease Control and Prevention.

The committee recommended these agencies collaborate to improve HD data collection, which will be critical to managing a potential spike in cases as the population ages. The committee also suggested awareness and training campaigns to better educate clinicians, social service providers, court officials, and first responders about HD.

Further, the report’s authors called for the Department of Housing and Urban Development to provide guidance and technical assistance on HD for landlords and housing assistance programs and urged Congress to collaborate with the Centers for Medicare & Medicaid Services to expand coverage for hoarding treatments.

Finally, the committee encouraged policymakers to engage directly with individuals affected by HD and their families to better understand the impact of the disorder and inform policy development.

“I think the Senate report focuses on education, not just for therapists, but other stakeholders too,” Frost said. “There are lots of other professionals who have a stake in this process, housing specialists, elder service folks, health and human services. Awareness of this problem is something that’s important for them as well.”

Rodriguez characterized the report’s recommendations as “potentially lifesaving” for individuals with HD. She added that it represents the first step in an ongoing effort to address an impending public health crisis related to HD in older adults and its broader impact on communities.

A spokesperson with Casey’s office said it’s unclear whether any federal agencies have acted on the report recommendations since it was released in June. It’s also unknown whether the Senate Committee on Aging will pursue any additional work on HD when new committee leaders are appointed in 2025.

“Although some federal agencies have taken steps to address HD, those steps are frequently limited. Other relevant agencies have not addressed HD at all in recent years,” report authors wrote. “The federal government can, and should, do more to bolster the response to HD.”

Frost agreed.

“I think federal agencies can have a positive effect by promoting, supporting, and tracking local efforts in dealing with this problem,” he said.

With reporting from Eve Bender.

A version of this article appeared on Medscape.com.

A report published in July 2024 by the US Senate Special Committee on Aging is calling for a national coordinated response to what the authors claim may be an emerging hoarding disorder (HD) crisis.

While millions of US adults are estimated to have HD, it is the disorder’s prevalence and severity among older adults that sounded the alarm for the Committee Chair Sen. Bob Casey (D-PA).

HD affects roughly 2% of the overall population but up to 6% of all people older than 70 years, the report stated. Older adults made up about 16% of the US population in 2019. By 2060, that proportion is projected to soar to 25%.

The country’s aging population alone “could fuel a rise in hoarding in the coming decades,” the report authors noted.

These findings underscore the pressing need for a deeper understanding of HD, particularly as reports of its impact continue to rise. The Senate report also raises critical questions about the nature of HD: What is known about the condition? What evidence-based treatments are currently available, and are there national strategies that will prevent it from becoming a systemic crisis?

 

Why the Urgency?

An increase in anecdotal reports of HD in his home state prompted Casey, chair of the Senate Committee on Aging, to launch the investigation into the incidence and consequences of HD. Soon after the committee began its work, it became evident that the problem was not unique to communities in Pennsylvania. It was a nationwide issue.

“Communities throughout the United States are already grappling with HD,” the report noted.

HD is characterized by persistent difficulty discarding possessions, regardless of their monetary value. For individuals with HD, such items frequently hold meaningful reminders of past events and provide a sense of security. Difficulties with emotional regulation, executive functioning, and impulse control all contribute to the excessive buildup of clutter. Problems with attention, organization, and problem-solving are also common.

As individuals with HD age, physical limitations or disabilities may hinder their ability to discard clutter. As the accumulation increases, it can pose serious risks not only to their safety but also to public health.

Dozens of statements submitted to the Senate committee by those with HD, clinicians and social workers, first responders, social service organizations, state and federal agencies, and professional societies paint a concerning picture about the impact of hoarding on emergency and community services.

Data from the National Fire Incident Reporting System show the number of hoarding-related residential structural fires increased 26% between 2014 and 2022. Some 5242 residential fires connected to cluttered environments during that time resulted in 1367 fire service injuries, 1119 civilian injuries, and over $396 million in damages.

“For older adults, those consequences include health and safety risks, social isolation, eviction, and homelessness,” the report authors noted. “For communities, those consequences include public health concerns, increased risk of fire, and dangers to emergency responders.”

 

What Causes HD?

HD was once classified as a symptom of obsessive-compulsive personality disorder, with extreme causes meeting the diagnostic criteria for obsessive-compulsive disorder. That changed in 2010 when a working group recommended that HD be added to the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition, as a stand-alone disorder. That recommendation was approved in 2012.

However, a decade later, much about HD’s etiology remains unknown.

Often beginning in early adolescence, HD is a chronic and progressive condition, with genetics and trauma playing a role in its onset and course, Sanjaya Saxena, MD, director of Clinical and Research Affairs at the International OCD Foundation, said in an interview.

Between 50% and 85% of people with HD symptoms have family members with similar behavior. HD is often comorbid with other psychiatric and medical disorders, which can complicate treatment.

Results of a 2022 study showed that, compared with healthy control individuals, people with HD had widespread abnormalities in the prefrontal white matter tract which connects cortical regions involved in executive functioning, including working memory, attention, reward processing, and decision-making.

Some research also suggests that dysregulation of serotonin transmission may contribute to compulsive behaviors and the difficulty in letting go of possessions.

“We do know that there are factors that contribute to worsening of hoarding symptoms, but that’s not the same thing as what really causes it. So unfortunately, it’s still very understudied, and we don’t have great knowledge of what causes it,” Saxena said.

 

What Treatments Are Available?

There are currently no Food and Drug Administration–approved medications to treat HD, although some research has shown antidepressants paroxetine and venlafaxine may have some benefit. Methylphenidate and atomoxetine are also under study for HD.

Nonpharmacological therapies have shown more promising results. Among the first was a specialized cognitive-behavioral therapy (CBT) program developed by Randy Frost, PhD, professor emeritus of psychology at Smith College in Northampton, Massachusetts, and Gail Steketee, PhD, dean emerita and professor emerita of social work at Boston University in Massachusetts.

First published in 2007 and the subject of many clinical trials and studies since, the 26-session program has served as a model for psychosocial treatments for HD. The evidence-based therapy addresses various symptoms, including impulse control. One module encourages participants to develop a set of questions to consider before acquiring new items, gradually helping them build resistance to the urge to accumulate more possessions, said Frost, whose early work on HD was cited by those who supported adding the condition to the DSM in 2012.

“There are several features that I think are important including exercises in resisting acquiring and processing information when making decisions about discarding,” Frost said in an interview.

A number of studies have demonstrated the efficacy of CBT for HD, including a 2015 meta-analysis coauthored by Frost. The research showed symptom severity decreased significantly following CBT, with the largest gains in difficulty discarding and moderate improvements in clutter and acquiring.

Responses were better among women and younger patients, and although symptoms improved, posttreatment scores remained closer to the clinical range, researchers noted. It’s possible that more intervention beyond what is usually included in clinical trials — such as more sessions or adding home decluttering visits — could improve treatment response, they added.

A workshop based on the specialized CBT program has expanded the reach of the treatment. The group therapy project, Buried in Treasures (BiT), was developed by Frost, Steketee, and David Tolin, PhD, founder and director of the Anxiety Disorders Center at the Institute of Living, Hartford, and an adjunct professor of psychiatry at Yale School of Medicine, New Haven, Connecticut. The workshop is designed as a facilitated treatment that can be delivered by clinicians or trained nonclinician facilitators.

A study published in May found that more than half the participants with HD responded to the treatment, and of those, 39% reported significant reductions in HD symptoms. BiT sessions were led by trained facilitators, and the study included in-home decluttering sessions, also led by trained volunteers. Researchers said adding the home intervention could increase engagement with the group therapy.

Another study of a modified version of BiT found a 32% decrease in HD symptoms after 15 weeks of treatment delivered via video teleconference.

“The BiT workshop has been expanding around the world and has the advantage of being relatively inexpensive,” Frost said. Another advantage is that it can be run by nonclinicians, which expands treatment options in areas where mental health professionals trained to treat HD are in short supply.

However, the workshop “is not perfect, and clients usually still have symptoms at the end of the workshop,” Frost noted.

“The point is that the BiT workshop is the first step in changing a lifestyle related to possessions,” he continued. “We do certainly need to train more people in how to treat hoarding, and we need to facilitate research to make our treatments more effective.”

 

What’s New in the Field?

One novel program currently under study combines CBT with a cognitive rehabilitation protocol. Called Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST), the program has been shown to help older adults with HD who don’t respond to traditional CBT for HD.

The program, led by Catherine Ayers, PhD, professor of clinical psychiatry at University of California, San Diego, involves memory training and problem-solving combined with exposure therapy to help participants learn how to tolerate distress associated with discarding their possessions.

Early findings pointed to symptom improvement in older adults following 24 sessions with CREST. The program fared better than geriatric case management in a 2018 study — the first randomized controlled trial of a treatment for HD in older adults — and offered additional benefits compared with exposure therapy in a study published in February 2024.

Virtual reality is also helping people with HD. A program developed at Stanford University in California, allows people with HD to work with a therapist as they practice decluttering in a three-dimensional virtual environment created using photographs and videos of actual hoarded objects and cluttered rooms in patients’ homes.

In a small pilot study, nine people older than 55 years with HD attended 16 weeks of online facilitated therapy where they learned to better understand their attachment to those items. They practiced decluttering by selecting virtual items for recycling, donation, or trash. A virtual garbage truck even hauled away the items they had placed in the trash.

Participants were then asked to discard the actual items at home. Most participants reported a decrease in hoarding symptoms, which was confirmed following a home assessment by a clinician.

“When you pick up an object from a loved one, it still maybe has the scent of the loved one. It has these tactile cues, colors. But in the virtual world, you can take a little bit of a step back,” lead researchers Carolyn Rodriguez, MD, PhD, director of Stanford’s Hoarding Disorders Research Program, said in an interview.

“It’s a little ramp to help people practice these skills. And then what we find is that it actually translated really well. They were able to go home and actually do the real uncluttering,” Rodriguez added.

 

What Else Can Be Done?

While researchers like Rodriguez continue studies of new and existing treatments, the Senate report draws attention to other responses that could aid people with HD. Because of its significant impact on emergency responders, adult protective services, aging services, and housing providers, the report recommends a nationwide response to older adults with HD.

Currently, federal agencies in charge of mental and community health are not doing enough to address HD, the report’s authors noted.

The report demonstrates “the scope and severity of these challenges and offers a path forward for how we can help people, communities, and local governments contend with this condition,” Casey said.

Specifically, the document cites a lack of HD services and tracking by the Substance Abuse and Mental Health Services Administration, the Administration for Community Living, and the Centers for Disease Control and Prevention.

The committee recommended these agencies collaborate to improve HD data collection, which will be critical to managing a potential spike in cases as the population ages. The committee also suggested awareness and training campaigns to better educate clinicians, social service providers, court officials, and first responders about HD.

Further, the report’s authors called for the Department of Housing and Urban Development to provide guidance and technical assistance on HD for landlords and housing assistance programs and urged Congress to collaborate with the Centers for Medicare & Medicaid Services to expand coverage for hoarding treatments.

Finally, the committee encouraged policymakers to engage directly with individuals affected by HD and their families to better understand the impact of the disorder and inform policy development.

“I think the Senate report focuses on education, not just for therapists, but other stakeholders too,” Frost said. “There are lots of other professionals who have a stake in this process, housing specialists, elder service folks, health and human services. Awareness of this problem is something that’s important for them as well.”

Rodriguez characterized the report’s recommendations as “potentially lifesaving” for individuals with HD. She added that it represents the first step in an ongoing effort to address an impending public health crisis related to HD in older adults and its broader impact on communities.

A spokesperson with Casey’s office said it’s unclear whether any federal agencies have acted on the report recommendations since it was released in June. It’s also unknown whether the Senate Committee on Aging will pursue any additional work on HD when new committee leaders are appointed in 2025.

“Although some federal agencies have taken steps to address HD, those steps are frequently limited. Other relevant agencies have not addressed HD at all in recent years,” report authors wrote. “The federal government can, and should, do more to bolster the response to HD.”

Frost agreed.

“I think federal agencies can have a positive effect by promoting, supporting, and tracking local efforts in dealing with this problem,” he said.

With reporting from Eve Bender.

A version of this article appeared on Medscape.com.

VANCOUVER, BRITISH COLUMBIA — Family physicians should familiarize themselves with doxycycline post-exposure prophylaxis (doxy PEP) as a prescription for patients who frequently have unprotected sex (including oral, anal, and vaginal) with multiple partners, according to a presentation at the Family Medicine Forum (FMF) 2024. Doxy PEP decreases the risk for bacterial sexually transmitted infections (STIs).

Many family physicians may be unaware of doxy PEP as a means of avoiding STIs. “Doxy PEP is an incredible tool that can be used within 72 hours of unprotected sex to reduce bacterial STI risk,” said James Owen, MD, assistant professor of family and community medicine at the University of Toronto in Ontario, Canada.

The US Centers for Disease Control and Prevention point to data from three randomized, controlled trials that demonstrate the ability of doxy PEP to decrease syphilis and chlamydia infections by more than 70% and decrease gonococcal infections by about 50%, said Jordan Goodridge, MD, assistant professor of family and community medicine at the University of Toronto.

 

Optimizing Doxy PEP

Doxy PEP (200 mg) is most effective when administered in the first 24 hours after unprotected sex, explained Goodridge. It is recommended that patients repeat the 200-mg dose if they are sexually active again within 24 hours.

To ensure optimal absorption of doxy PEP, the drug should not be taken with antacids or multivitamins, said Goodridge. Antacids “can bind to doxycycline and prevent it from being absorbed,” he said.

A key concern about doxy PEP is the development of antimicrobial resistance, noted Goodridge. “We don’t have long-term studies to give us an idea about what this risk is, to quantify it. The studies we have are relatively short, generally less than a year, and didn’t suggest that there was a huge risk [for antimicrobial resistance].”

Moreover, doxycycline is teratogenic, and its use is contraindicated in pregnancy, said Goodridge. If a pregnant patient is being treated for syphilis, then penicillin is the treatment of choice. For pregnant patients with penicillin allergy, Public Health Agency of Canada guidelines call for penicillin desensitization followed by penicillin.

The rate of syphilis has been rising in Canadian women of reproductive age, thus increasing the potential for congenital syphilis, noted Goodridge.

 

Benefits of HPV Vaccine

The 9-valent HPV vaccine is recommended in Canada for patients aged 9-26 years, but those aged 27 years or older at ongoing risk for HPV exposure may receive the 9-valent HPV vaccine after discussion with their healthcare providers, noted Owen.

High-risk patients can benefit from the vaccine even though they have likely had exposure to HPV, he added. “If someone has multiple sexual partners, they have probably been exposed to HPV at some point,” said Owen. “You still could reduce a patient’s risk for being exposed to certain oncogenic strains [of HPV]. Certainly, within our practices, we’re often giving it [that is, the HPV vaccine] to higher-risk individuals, including men having sex with men.”

 

HIV Prevention

“Condoms are still a mainstay of HIV and STI prevention, but condom use is going down,” said Owen.

In a national survey commissioned by the Toronto-based organization LetsStopAIDS and including more than 1100 Canadians aged 18-24 years, 24% of respondents said they use condoms “all the time.” In 2020, by contrast, more than half (53%) of respondents reported that they use condoms all the time.

Updated Canadian guidelines on the use of HIV pre-exposure prophylaxis (PrEP) are expected to be released in 2025 and will address questions about how frequently individuals taking HIV PrEP should be tested to ensure a negative HIV result. The guidelines will also provide guidance as to whether HIV serology or HIV viral load should be captured, said Owen. Patients in Canada who take HIV PrEP are now generally screened for HIV every 3 months.

A new HIV PrEP tool that has become available to Canadian clinicians is the injectable drug cabotegravir, which is dosed every 2 months.

Owen and Goodridge reported having no relevant financial relationships.

A version of this article appeared on Medscape.com.

VANCOUVER, BRITISH COLUMBIA — Family physicians should familiarize themselves with doxycycline post-exposure prophylaxis (doxy PEP) as a prescription for patients who frequently have unprotected sex (including oral, anal, and vaginal) with multiple partners, according to a presentation at the Family Medicine Forum (FMF) 2024. Doxy PEP decreases the risk for bacterial sexually transmitted infections (STIs).

Many family physicians may be unaware of doxy PEP as a means of avoiding STIs. “Doxy PEP is an incredible tool that can be used within 72 hours of unprotected sex to reduce bacterial STI risk,” said James Owen, MD, assistant professor of family and community medicine at the University of Toronto in Ontario, Canada.

The US Centers for Disease Control and Prevention point to data from three randomized, controlled trials that demonstrate the ability of doxy PEP to decrease syphilis and chlamydia infections by more than 70% and decrease gonococcal infections by about 50%, said Jordan Goodridge, MD, assistant professor of family and community medicine at the University of Toronto.

 

Optimizing Doxy PEP

Doxy PEP (200 mg) is most effective when administered in the first 24 hours after unprotected sex, explained Goodridge. It is recommended that patients repeat the 200-mg dose if they are sexually active again within 24 hours.

To ensure optimal absorption of doxy PEP, the drug should not be taken with antacids or multivitamins, said Goodridge. Antacids “can bind to doxycycline and prevent it from being absorbed,” he said.

A key concern about doxy PEP is the development of antimicrobial resistance, noted Goodridge. “We don’t have long-term studies to give us an idea about what this risk is, to quantify it. The studies we have are relatively short, generally less than a year, and didn’t suggest that there was a huge risk [for antimicrobial resistance].”

Moreover, doxycycline is teratogenic, and its use is contraindicated in pregnancy, said Goodridge. If a pregnant patient is being treated for syphilis, then penicillin is the treatment of choice. For pregnant patients with penicillin allergy, Public Health Agency of Canada guidelines call for penicillin desensitization followed by penicillin.

The rate of syphilis has been rising in Canadian women of reproductive age, thus increasing the potential for congenital syphilis, noted Goodridge.

 

Benefits of HPV Vaccine

The 9-valent HPV vaccine is recommended in Canada for patients aged 9-26 years, but those aged 27 years or older at ongoing risk for HPV exposure may receive the 9-valent HPV vaccine after discussion with their healthcare providers, noted Owen.

High-risk patients can benefit from the vaccine even though they have likely had exposure to HPV, he added. “If someone has multiple sexual partners, they have probably been exposed to HPV at some point,” said Owen. “You still could reduce a patient’s risk for being exposed to certain oncogenic strains [of HPV]. Certainly, within our practices, we’re often giving it [that is, the HPV vaccine] to higher-risk individuals, including men having sex with men.”

 

HIV Prevention

“Condoms are still a mainstay of HIV and STI prevention, but condom use is going down,” said Owen.

In a national survey commissioned by the Toronto-based organization LetsStopAIDS and including more than 1100 Canadians aged 18-24 years, 24% of respondents said they use condoms “all the time.” In 2020, by contrast, more than half (53%) of respondents reported that they use condoms all the time.

Updated Canadian guidelines on the use of HIV pre-exposure prophylaxis (PrEP) are expected to be released in 2025 and will address questions about how frequently individuals taking HIV PrEP should be tested to ensure a negative HIV result. The guidelines will also provide guidance as to whether HIV serology or HIV viral load should be captured, said Owen. Patients in Canada who take HIV PrEP are now generally screened for HIV every 3 months.

A new HIV PrEP tool that has become available to Canadian clinicians is the injectable drug cabotegravir, which is dosed every 2 months.

Owen and Goodridge reported having no relevant financial relationships.

A version of this article appeared on Medscape.com.

VANCOUVER, BRITISH COLUMBIA — Family physicians should familiarize themselves with doxycycline post-exposure prophylaxis (doxy PEP) as a prescription for patients who frequently have unprotected sex (including oral, anal, and vaginal) with multiple partners, according to a presentation at the Family Medicine Forum (FMF) 2024. Doxy PEP decreases the risk for bacterial sexually transmitted infections (STIs).

Many family physicians may be unaware of doxy PEP as a means of avoiding STIs. “Doxy PEP is an incredible tool that can be used within 72 hours of unprotected sex to reduce bacterial STI risk,” said James Owen, MD, assistant professor of family and community medicine at the University of Toronto in Ontario, Canada.

The US Centers for Disease Control and Prevention point to data from three randomized, controlled trials that demonstrate the ability of doxy PEP to decrease syphilis and chlamydia infections by more than 70% and decrease gonococcal infections by about 50%, said Jordan Goodridge, MD, assistant professor of family and community medicine at the University of Toronto.

 

Optimizing Doxy PEP

Doxy PEP (200 mg) is most effective when administered in the first 24 hours after unprotected sex, explained Goodridge. It is recommended that patients repeat the 200-mg dose if they are sexually active again within 24 hours.

To ensure optimal absorption of doxy PEP, the drug should not be taken with antacids or multivitamins, said Goodridge. Antacids “can bind to doxycycline and prevent it from being absorbed,” he said.

A key concern about doxy PEP is the development of antimicrobial resistance, noted Goodridge. “We don’t have long-term studies to give us an idea about what this risk is, to quantify it. The studies we have are relatively short, generally less than a year, and didn’t suggest that there was a huge risk [for antimicrobial resistance].”

Moreover, doxycycline is teratogenic, and its use is contraindicated in pregnancy, said Goodridge. If a pregnant patient is being treated for syphilis, then penicillin is the treatment of choice. For pregnant patients with penicillin allergy, Public Health Agency of Canada guidelines call for penicillin desensitization followed by penicillin.

The rate of syphilis has been rising in Canadian women of reproductive age, thus increasing the potential for congenital syphilis, noted Goodridge.

 

Benefits of HPV Vaccine

The 9-valent HPV vaccine is recommended in Canada for patients aged 9-26 years, but those aged 27 years or older at ongoing risk for HPV exposure may receive the 9-valent HPV vaccine after discussion with their healthcare providers, noted Owen.

High-risk patients can benefit from the vaccine even though they have likely had exposure to HPV, he added. “If someone has multiple sexual partners, they have probably been exposed to HPV at some point,” said Owen. “You still could reduce a patient’s risk for being exposed to certain oncogenic strains [of HPV]. Certainly, within our practices, we’re often giving it [that is, the HPV vaccine] to higher-risk individuals, including men having sex with men.”

 

HIV Prevention

“Condoms are still a mainstay of HIV and STI prevention, but condom use is going down,” said Owen.

In a national survey commissioned by the Toronto-based organization LetsStopAIDS and including more than 1100 Canadians aged 18-24 years, 24% of respondents said they use condoms “all the time.” In 2020, by contrast, more than half (53%) of respondents reported that they use condoms all the time.

Updated Canadian guidelines on the use of HIV pre-exposure prophylaxis (PrEP) are expected to be released in 2025 and will address questions about how frequently individuals taking HIV PrEP should be tested to ensure a negative HIV result. The guidelines will also provide guidance as to whether HIV serology or HIV viral load should be captured, said Owen. Patients in Canada who take HIV PrEP are now generally screened for HIV every 3 months.

A new HIV PrEP tool that has become available to Canadian clinicians is the injectable drug cabotegravir, which is dosed every 2 months.

Owen and Goodridge reported having no relevant financial relationships.

A version of this article appeared on Medscape.com.

The United States Preventive Services Task Force (USPSTF) has issued an updated draft recommendation statement advising early screening for syphilis in all pregnant persons, whether symptomatic or in at-risk groups. Those with abnormal screening results should receive “timely, equitable, and evidence-based evaluation and treatment for syphilis,” it advises.

Reaffirming the task force’s 2018 statement, in which an evidence review found the benefits of screening substantially outweighed the harms, the current draft is based on no substantial new data. It is open for public input until December 23.

“Congenital syphilis infection is still an important health problem, and rates are not decreasing as they should,” said USPSTF panel member Carlos R. Jaén, MD, PhD, MS, Dr. and Mrs. James L. Holly Distinguished Chair in the Department of Family and Community Medicine at the Joe R. and Teresa Lozano Long School of Medicine at the University of Texas Health Science Center at San Antonio. “Cases are 10 times higher today than they were a decade ago, despite the harmful consequences of syphilis infection in mother and baby and despite it being a preventable and easily treated condition.”

The statement notes that untreated syphilis infection in mothers is associated with miscarriage, premature birth, low birth weight, stillbirth, and neonatal death. Syphilis infection is linked to significant abnormalities in infants such as deformed bones, anemia, enlarged liver and spleen, jaundice, meningitis, and brain and nerve problems resulting in permanent vision or hearing loss.

The USPSTF statement aligns with the recommendations of other healthcare organizations, including the American College of Obstetricians and Gynecologists (ACOG), which issued a clinical practice advisory on prenatal syphilis screening in April 2024.

This advisory recommends obstetric care providers screen all pregnant individuals serologically for syphilis at the first prenatal care visit, with universal rescreening during the third trimester and at birth rather than targeted risk-based testing.

The advisory notes that two in five infants with congenital syphilis were born to persons who received no prenatal care. It urges making any healthcare encounter during pregnancy — in emergency departments, jails, syringe service programs, and maternal and child health clinics — an opportunity to screen for syphilis.

So far, there is no official guidance on preconception screening for persons planning a pregnancy, according to Allison Bryant Mantha, MD, MPH, a maternal-fetal medicine specialist at Mass General Brigham health system and an associate professor at Harvard School of Medicine in Boston, Massachusetts, who coauthored the ACOG advisory.

But Lynn M. Yee, MD, MPH, an associate professor of maternal-fetal medicine at Northwestern University Feinberg School of Medicine and director of the Northwestern Medicine Women’s Infectious Disease Program in Chicago, Illinois, said syphilis testing could easily be part of a prepregnancy “bucket” of health checkup items along with other sexually transmitted infections and blood pressure.

 

By the Numbers

In 2022, there were 3761 cases of congenital syphilis in the United States, including 231 stillbirths and 51 infant deaths — the highest number reported in more than 30 years and more than 10 times that reported in 2012.

At play may be social, economic, and immigration status factors creating barriers to prenatal care as well as declines in prevention infrastructure and resources.

Although most syphilis cases occur in men, the increase in incidence rate in women was two to four times higher than that of men from 2017 to 2021.

 

Why Such Persistently High Rates?

Despite a widely available test and cost-effective penicillin treatment covered by most insurance, congenital syphilis remains a challenge. According to Bryant, many mothers are still presenting for care and testing late in pregnancy. “Differential access to care is just one of many reasons,” she said.

Stigma and bias may also play a part, according to Yee. “Some clinicians may think their patient population is not the kind to be at risk and doesn’t need to be screened,” she said. Furthermore, screening is not a one-off test but a two-step process, and serology results can be hard to understand and easy to misinterpret.

In addition, some situations may promote ongoing disease, according to Yee. “Reinfection can occur after treatment if a patient keeps returning to a partner who refuses treatment,” Yee said.

On an optimistic note, however, the Centers for Disease Control and Prevention (CDC) reports that in some areas increases in newborn syphilis cases appear to be slowing — with a 3% increase in 2022 than with a 30% or higher annual increases in previous years. In 2020-2021, for example, congenital cases rose by 32% and resulted in 220 stillbirths and infant deaths.

 

Going Forward

The USPSTF statement identifies knowledge gaps. These include studies to evaluate the benefits and harms of repeat screening later in pregnancy and to evaluate the benefits and harms of such strategies as rapid point-of-care tests. The USPSTF also called for research on disparities in syphilis incidence and screening rates to reduce these disparities in populations.

Within these vulnerable groups, the CDC noted that babies born to Black, Hispanic, or Native American/Alaska Native mothers in 2021 were as much as eight times more likely to have congenital syphilis than those born to their White counterparts.

Jaén, Bryant, and Yee had no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

The United States Preventive Services Task Force (USPSTF) has issued an updated draft recommendation statement advising early screening for syphilis in all pregnant persons, whether symptomatic or in at-risk groups. Those with abnormal screening results should receive “timely, equitable, and evidence-based evaluation and treatment for syphilis,” it advises.

Reaffirming the task force’s 2018 statement, in which an evidence review found the benefits of screening substantially outweighed the harms, the current draft is based on no substantial new data. It is open for public input until December 23.

“Congenital syphilis infection is still an important health problem, and rates are not decreasing as they should,” said USPSTF panel member Carlos R. Jaén, MD, PhD, MS, Dr. and Mrs. James L. Holly Distinguished Chair in the Department of Family and Community Medicine at the Joe R. and Teresa Lozano Long School of Medicine at the University of Texas Health Science Center at San Antonio. “Cases are 10 times higher today than they were a decade ago, despite the harmful consequences of syphilis infection in mother and baby and despite it being a preventable and easily treated condition.”

The statement notes that untreated syphilis infection in mothers is associated with miscarriage, premature birth, low birth weight, stillbirth, and neonatal death. Syphilis infection is linked to significant abnormalities in infants such as deformed bones, anemia, enlarged liver and spleen, jaundice, meningitis, and brain and nerve problems resulting in permanent vision or hearing loss.

The USPSTF statement aligns with the recommendations of other healthcare organizations, including the American College of Obstetricians and Gynecologists (ACOG), which issued a clinical practice advisory on prenatal syphilis screening in April 2024.

This advisory recommends obstetric care providers screen all pregnant individuals serologically for syphilis at the first prenatal care visit, with universal rescreening during the third trimester and at birth rather than targeted risk-based testing.

The advisory notes that two in five infants with congenital syphilis were born to persons who received no prenatal care. It urges making any healthcare encounter during pregnancy — in emergency departments, jails, syringe service programs, and maternal and child health clinics — an opportunity to screen for syphilis.

So far, there is no official guidance on preconception screening for persons planning a pregnancy, according to Allison Bryant Mantha, MD, MPH, a maternal-fetal medicine specialist at Mass General Brigham health system and an associate professor at Harvard School of Medicine in Boston, Massachusetts, who coauthored the ACOG advisory.

But Lynn M. Yee, MD, MPH, an associate professor of maternal-fetal medicine at Northwestern University Feinberg School of Medicine and director of the Northwestern Medicine Women’s Infectious Disease Program in Chicago, Illinois, said syphilis testing could easily be part of a prepregnancy “bucket” of health checkup items along with other sexually transmitted infections and blood pressure.

 

By the Numbers

In 2022, there were 3761 cases of congenital syphilis in the United States, including 231 stillbirths and 51 infant deaths — the highest number reported in more than 30 years and more than 10 times that reported in 2012.

At play may be social, economic, and immigration status factors creating barriers to prenatal care as well as declines in prevention infrastructure and resources.

Although most syphilis cases occur in men, the increase in incidence rate in women was two to four times higher than that of men from 2017 to 2021.

 

Why Such Persistently High Rates?

Despite a widely available test and cost-effective penicillin treatment covered by most insurance, congenital syphilis remains a challenge. According to Bryant, many mothers are still presenting for care and testing late in pregnancy. “Differential access to care is just one of many reasons,” she said.

Stigma and bias may also play a part, according to Yee. “Some clinicians may think their patient population is not the kind to be at risk and doesn’t need to be screened,” she said. Furthermore, screening is not a one-off test but a two-step process, and serology results can be hard to understand and easy to misinterpret.

In addition, some situations may promote ongoing disease, according to Yee. “Reinfection can occur after treatment if a patient keeps returning to a partner who refuses treatment,” Yee said.

On an optimistic note, however, the Centers for Disease Control and Prevention (CDC) reports that in some areas increases in newborn syphilis cases appear to be slowing — with a 3% increase in 2022 than with a 30% or higher annual increases in previous years. In 2020-2021, for example, congenital cases rose by 32% and resulted in 220 stillbirths and infant deaths.

 

Going Forward

The USPSTF statement identifies knowledge gaps. These include studies to evaluate the benefits and harms of repeat screening later in pregnancy and to evaluate the benefits and harms of such strategies as rapid point-of-care tests. The USPSTF also called for research on disparities in syphilis incidence and screening rates to reduce these disparities in populations.

Within these vulnerable groups, the CDC noted that babies born to Black, Hispanic, or Native American/Alaska Native mothers in 2021 were as much as eight times more likely to have congenital syphilis than those born to their White counterparts.

Jaén, Bryant, and Yee had no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

The United States Preventive Services Task Force (USPSTF) has issued an updated draft recommendation statement advising early screening for syphilis in all pregnant persons, whether symptomatic or in at-risk groups. Those with abnormal screening results should receive “timely, equitable, and evidence-based evaluation and treatment for syphilis,” it advises.

Reaffirming the task force’s 2018 statement, in which an evidence review found the benefits of screening substantially outweighed the harms, the current draft is based on no substantial new data. It is open for public input until December 23.

“Congenital syphilis infection is still an important health problem, and rates are not decreasing as they should,” said USPSTF panel member Carlos R. Jaén, MD, PhD, MS, Dr. and Mrs. James L. Holly Distinguished Chair in the Department of Family and Community Medicine at the Joe R. and Teresa Lozano Long School of Medicine at the University of Texas Health Science Center at San Antonio. “Cases are 10 times higher today than they were a decade ago, despite the harmful consequences of syphilis infection in mother and baby and despite it being a preventable and easily treated condition.”

The statement notes that untreated syphilis infection in mothers is associated with miscarriage, premature birth, low birth weight, stillbirth, and neonatal death. Syphilis infection is linked to significant abnormalities in infants such as deformed bones, anemia, enlarged liver and spleen, jaundice, meningitis, and brain and nerve problems resulting in permanent vision or hearing loss.

The USPSTF statement aligns with the recommendations of other healthcare organizations, including the American College of Obstetricians and Gynecologists (ACOG), which issued a clinical practice advisory on prenatal syphilis screening in April 2024.

This advisory recommends obstetric care providers screen all pregnant individuals serologically for syphilis at the first prenatal care visit, with universal rescreening during the third trimester and at birth rather than targeted risk-based testing.

The advisory notes that two in five infants with congenital syphilis were born to persons who received no prenatal care. It urges making any healthcare encounter during pregnancy — in emergency departments, jails, syringe service programs, and maternal and child health clinics — an opportunity to screen for syphilis.

So far, there is no official guidance on preconception screening for persons planning a pregnancy, according to Allison Bryant Mantha, MD, MPH, a maternal-fetal medicine specialist at Mass General Brigham health system and an associate professor at Harvard School of Medicine in Boston, Massachusetts, who coauthored the ACOG advisory.

But Lynn M. Yee, MD, MPH, an associate professor of maternal-fetal medicine at Northwestern University Feinberg School of Medicine and director of the Northwestern Medicine Women’s Infectious Disease Program in Chicago, Illinois, said syphilis testing could easily be part of a prepregnancy “bucket” of health checkup items along with other sexually transmitted infections and blood pressure.

 

By the Numbers

In 2022, there were 3761 cases of congenital syphilis in the United States, including 231 stillbirths and 51 infant deaths — the highest number reported in more than 30 years and more than 10 times that reported in 2012.

At play may be social, economic, and immigration status factors creating barriers to prenatal care as well as declines in prevention infrastructure and resources.

Although most syphilis cases occur in men, the increase in incidence rate in women was two to four times higher than that of men from 2017 to 2021.

 

Why Such Persistently High Rates?

Despite a widely available test and cost-effective penicillin treatment covered by most insurance, congenital syphilis remains a challenge. According to Bryant, many mothers are still presenting for care and testing late in pregnancy. “Differential access to care is just one of many reasons,” she said.

Stigma and bias may also play a part, according to Yee. “Some clinicians may think their patient population is not the kind to be at risk and doesn’t need to be screened,” she said. Furthermore, screening is not a one-off test but a two-step process, and serology results can be hard to understand and easy to misinterpret.

In addition, some situations may promote ongoing disease, according to Yee. “Reinfection can occur after treatment if a patient keeps returning to a partner who refuses treatment,” Yee said.

On an optimistic note, however, the Centers for Disease Control and Prevention (CDC) reports that in some areas increases in newborn syphilis cases appear to be slowing — with a 3% increase in 2022 than with a 30% or higher annual increases in previous years. In 2020-2021, for example, congenital cases rose by 32% and resulted in 220 stillbirths and infant deaths.

 

Going Forward

The USPSTF statement identifies knowledge gaps. These include studies to evaluate the benefits and harms of repeat screening later in pregnancy and to evaluate the benefits and harms of such strategies as rapid point-of-care tests. The USPSTF also called for research on disparities in syphilis incidence and screening rates to reduce these disparities in populations.

Within these vulnerable groups, the CDC noted that babies born to Black, Hispanic, or Native American/Alaska Native mothers in 2021 were as much as eight times more likely to have congenital syphilis than those born to their White counterparts.

Jaén, Bryant, and Yee had no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

Interest is growing in the role of nutrition as means of slowing, or even preventing, neurodegeneration in patients with Parkinson’s disease.

For 15 years, John Duda, MD, national director of the VA Parkinson’s Disease Research, Education and Clinical Centers, has urged his patients to “keep waiting” for effective treatments to manage both motor and nonmotor symptoms of Parkinson’s disease.

However, Duda, who also serves as director of the Brain Wellness Clinic at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, Pennsylvania, recognized the persistent lack of effective drugs to address these symptoms. This prompted him to consider what other evidence-based strategies he could use to support his patients. 

“I recognized that nutritional approaches within a broader program that includes medication review, stress management, social connections, adequate sleep, and physical exercise could make a real difference,” he said.

Observational studies have shown an inverse association between dietary patterns and Parkinson’s disease risk, age of onset, symptom severity, and mortality rates — particularly with the Mediterranean diet (MeDi) and the MIND diet, which combines elements of MeDi and the Dietary Approaches to Stop Hypertension (DASH) diet. Although randomized controlled trials are still limited, the epidemiologic evidence supporting dietary interventions is “compelling,” said Duda. 

For example, a cross-sectional study comparing 167 participants with Parkinson’s disease vs 119 controls showed that later age of Parkinson’s disease onset correlated with adherence to the MIND diet in women, with a difference of up to 17.4 years (P < .001) between low and high dietary tertiles. 

The MeDi was correlated with later onset in men, with differences of up to 8.4 years (P = .002). As previously reported, a healthy diet emphasizing vegetables, fruits, nuts, and grains was inversely associated with prodromal features of Parkinson’s disease, including constipation, excessive daytime sleepiness, and depression. In addition, lower rates of Parkinson’s disease have been shown in populations following vegetarian and vegan dietary patterns. 

 

Does Parkinson’s disease Start in the Gut?

Parkinson’s disease is characterized by decreased short-chain fatty acid–producing bacteria and increased pro-inflammatory species linked to intestinal inflammation and alpha-synuclein aggregation. “There are reasons to believe that a-synuclein accumulation may start in the gut,” Duda noted.

Numerous studies implicate gut microbiome dysbiosis as a pathogenic mechanism in Parkinson’s disease, with gastrointestinal symptoms often predating motor symptoms. Dysbiosis might result in a pro-inflammatory state potentially linked to the recurrent gastrointestinal symptoms. Fecal microbiota transplant may restore a healthier gut environment and beneficially affect Parkinson’s disease symptoms, he said.

Some of the benefits conferred by the MeDi and other healthy diets may be mediated by improving the gut microbiome. Duda cited a study that showed that a 14-day ovo-lacto vegetarian diet intervention and a daily fecal enema for 8 days improved not only the microbiome but also Movement Disorder Society Unified Parkinson’s Disease Rating Scale—part III scores. 

Duda also reviewed the role of dietary interventions in addressing common Parkinson’s disease symptoms, such as orthostatic hypotension. He recommended that Parkinson’s disease patients with this condition should avoid eating large meals, increase dietary salt intake, increase fluid intake, and decrease alcohol intake.

Malnutrition affects close to 25% of those with Parkinson’s disease, which is partially attributable to diminished olfaction. Because the experience of taste is largely driven by a sense of smell, patients may be less interested in eating. Duda recommended increasing herbs, spices, and other flavors in food. High caloric–density foods, including nuts, nut butters, and seeds, can boost weight, he said. However, he added, any patient with significant weight loss should consult a nutritionist.

Constipation is one of the most debilitating symptoms of Parkinson’s disease, affecting up to 66% of patients. Duda advised increasing fluid intake, exercise, and dietary fiber and use of stool softeners and laxatives. The MeDi may reduce symptoms of constipation and have a beneficial effect on gut microbiota. 

Coffee may be helpful for sleepiness in Parkinson’s disease and may also confer neuroprotective, motor, and cognitive benefits. As an adjuvant treatment, caffeine may alter levodopa pharmacokinetics, reduce dyskinesia, improve gait in patients with freezing and may even reduce the risk of developing Parkinson’s disease, with a maximum benefit reached at approximately three cups of coffee daily.

 

Problematic Foods

There is also a growing body of evidence regarding the deleterious effects of ultraprocessed foods (UPFs), Duda said. He noted that a recent systematic review and meta-analysis of 28 studies showed that higher UPF intake was significantly associated with an enhanced risk for Parkinson’s disease (relative risk, 1.56; 95% CI, 1.21-2.02). As previously reported, UPFs have been tied to a host of adverse neurologic outcomes, including cognitive decline and stroke. 

Although protein is a necessary nutrient, incorporating it into the diet of Parkinson’s disease patients taking levodopa is complicated. Levodopa, a large neutral amino acid (LNAA), competes with other LNAAs for transport to the brain from the small intestine, Duda explained. 

“Some people notice that carbidopa-levodopa doesn’t work as well if taken with a high-protein meal.” He recommended taking carbidopa-levodopa 30 minutes before or 60 minutes after meals.

Rebecca Gilbert, MD, PhD, chief mission officer of the American Parkinson’s Disease Association, said that patients with Parkinson’s disease might want to avoid eating protein during the day, concentrating instead on carbohydrates and vegetables and saving the protein for the evening, which is closer to bedtime. Some evidence also supports the use of protein redistribution diets to enhance the clinical response to levodopa and reduce motor fluctuations. 

 

What About Supplements? 

It’s “hard to prove that one specific supplement can be protective against Parkinson’s disease because diet consists of many different components and the whole diet may be worth more than the sum of its parts,” Gilbert said. The evidence for individual supplements “isn’t robust enough to say they prevent or treat Parkinson’s disease.”

Research on the role of specific nutrients in Parkinson’s disease is conflicting, with no clear evidence supporting or refuting their benefits. For example, a study that followed participants for about 30 years showed no link between reduced Parkinson’s disease risk and vitamin B or folate intake. 

On the other hand, there is research suggesting that certain vitamins may help reduce Parkinson’s disease risk, although these nutrients do not operate in isolation. For instance, one recent study showed a connection between vitamins C and E and reduced Parkinson’s disease risk, but factors such as body mass index and coffee consumption appeared to influence the strength of this association.

Consuming polyunsaturated fatty acids along with reducing saturated fatty acid intake has been tied to a reduced risk for Parkinson’s disease. 

Additionally, certain foods may offer protective effects, including green and black tea, with consumption of three or more cups per day associated with a delay in motor symptom onset by 7.7 years. Foods high in nicotine content, such as those from the Solanaceae family — including peppers, tomatoes, tomato juice, and potatoes — have also been linked to potential protective benefits.

Diets rich in antioxidants, including carotenoids, lutein, and vitamins E and C, have been robustly linked to a reduced risk for parkinsonism and progression of parkinsonian symptoms in older adults.

Increasing the intake of dietary flavonoids, particularly tea, berry fruits, apples, red wine, and oranges or orange juice, can reduce Parkinson’s disease risk. One study showed that male participants in the highest quintile of total flavonoid consumption had a 40% lower Parkinson’s disease risk compared with those in the lowest quintile. Another study showed that flavonoid-rich foods were also associated with a lower risk for death in patients with Parkinson’s disease. 

 

Food as Medicine 

Although recent research shows that the drug development pipeline for Parkinson’s disease is robust, with a wide variety of approaches being developed and evaluated in phase 1 and 2, investigators note that only a limited number of disease-modifying treatments are transitioning to phase 3.

Duda noted that phytochemicals incorporated into the diet might target some of the same mechanisms that are targets of these drugs in development. 

“Flavonoids have been shown to stabilize alpha-synuclein in vitro,” he said. “Caffeine, curcumin, resveratrol, and eliminating meat and dairy inhibit mTOR [mammalian target of rapamycin], and mTOR inhibition results in increased autophagy that may help clear alpha-synuclein. Genestein, an isoflavone in soybeans, protects dopaminergic neurons by inhibiting microglia activation. Flavonoids inhibit inflammation by inhibiting release of NO [nitric oxide] and pro-inflammatory cytokines,” he noted. 

Ongoing studies of dietary interventions for Parkinson’s disease are exploring various areas, including the potential role of the ketogenic diet in protecting the gut microbiome, optimizing protein intake for muscle preservation and sleep, the effects of psyllium and wheat bran on weight and constipation, and the impact of a gluten-free diet.

 

Practical Tips for Healthy Eating 

Gilbert emphasized that there are no medications or interventions currently available that can delay a Parkinson’s disease diagnosis by up to 17 years, as some dietary patterns have been shown to do, and she noted that it’s not possible to replicate the MeDi diet in a pill. However, she recommended a practical approach to eating that includes a diet low in ultraprocessed foods and high in beneficial nutrients. She encouraged people to shop for “real food” and enjoy a variety of colorful fruits and vegetables.

Duda acknowledged that motivating patients to follow a healthy diet can be difficult. As a result, the focus often shifts to making small adjustments and modifications. For example, he suggested that instead of pairing meat with French fries, people could opt for vegetables or add greens to their meals. Similarly, instead of having eggs and bacon for breakfast, they might choose oatmeal.

Preparing whole-food, plant-based meals may take more time than patients are accustomed to, so Duda suggests that, if possible, patients involve loved ones in both the meal preparation and the meal itself. He explained that a healthy meal can become an opportunity for bonding and that the key is educating them about new meal-related concepts. 

Duda reported no relevant financial relationships with the pharmaceutical or food industries. He has received compensation from the Physicians Committee for Responsible Medicine for his lecture delivered at the conference and research grant support from the VA, the National Institutes of Health, the Michael J. Fox Foundation, and the Department of Defense unrelated to this topic. Gilbert reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Interest is growing in the role of nutrition as means of slowing, or even preventing, neurodegeneration in patients with Parkinson’s disease.

For 15 years, John Duda, MD, national director of the VA Parkinson’s Disease Research, Education and Clinical Centers, has urged his patients to “keep waiting” for effective treatments to manage both motor and nonmotor symptoms of Parkinson’s disease.

However, Duda, who also serves as director of the Brain Wellness Clinic at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, Pennsylvania, recognized the persistent lack of effective drugs to address these symptoms. This prompted him to consider what other evidence-based strategies he could use to support his patients. 

“I recognized that nutritional approaches within a broader program that includes medication review, stress management, social connections, adequate sleep, and physical exercise could make a real difference,” he said.

Observational studies have shown an inverse association between dietary patterns and Parkinson’s disease risk, age of onset, symptom severity, and mortality rates — particularly with the Mediterranean diet (MeDi) and the MIND diet, which combines elements of MeDi and the Dietary Approaches to Stop Hypertension (DASH) diet. Although randomized controlled trials are still limited, the epidemiologic evidence supporting dietary interventions is “compelling,” said Duda. 

For example, a cross-sectional study comparing 167 participants with Parkinson’s disease vs 119 controls showed that later age of Parkinson’s disease onset correlated with adherence to the MIND diet in women, with a difference of up to 17.4 years (P < .001) between low and high dietary tertiles. 

The MeDi was correlated with later onset in men, with differences of up to 8.4 years (P = .002). As previously reported, a healthy diet emphasizing vegetables, fruits, nuts, and grains was inversely associated with prodromal features of Parkinson’s disease, including constipation, excessive daytime sleepiness, and depression. In addition, lower rates of Parkinson’s disease have been shown in populations following vegetarian and vegan dietary patterns. 

 

Does Parkinson’s disease Start in the Gut?

Parkinson’s disease is characterized by decreased short-chain fatty acid–producing bacteria and increased pro-inflammatory species linked to intestinal inflammation and alpha-synuclein aggregation. “There are reasons to believe that a-synuclein accumulation may start in the gut,” Duda noted.

Numerous studies implicate gut microbiome dysbiosis as a pathogenic mechanism in Parkinson’s disease, with gastrointestinal symptoms often predating motor symptoms. Dysbiosis might result in a pro-inflammatory state potentially linked to the recurrent gastrointestinal symptoms. Fecal microbiota transplant may restore a healthier gut environment and beneficially affect Parkinson’s disease symptoms, he said.

Some of the benefits conferred by the MeDi and other healthy diets may be mediated by improving the gut microbiome. Duda cited a study that showed that a 14-day ovo-lacto vegetarian diet intervention and a daily fecal enema for 8 days improved not only the microbiome but also Movement Disorder Society Unified Parkinson’s Disease Rating Scale—part III scores. 

Duda also reviewed the role of dietary interventions in addressing common Parkinson’s disease symptoms, such as orthostatic hypotension. He recommended that Parkinson’s disease patients with this condition should avoid eating large meals, increase dietary salt intake, increase fluid intake, and decrease alcohol intake.

Malnutrition affects close to 25% of those with Parkinson’s disease, which is partially attributable to diminished olfaction. Because the experience of taste is largely driven by a sense of smell, patients may be less interested in eating. Duda recommended increasing herbs, spices, and other flavors in food. High caloric–density foods, including nuts, nut butters, and seeds, can boost weight, he said. However, he added, any patient with significant weight loss should consult a nutritionist.

Constipation is one of the most debilitating symptoms of Parkinson’s disease, affecting up to 66% of patients. Duda advised increasing fluid intake, exercise, and dietary fiber and use of stool softeners and laxatives. The MeDi may reduce symptoms of constipation and have a beneficial effect on gut microbiota. 

Coffee may be helpful for sleepiness in Parkinson’s disease and may also confer neuroprotective, motor, and cognitive benefits. As an adjuvant treatment, caffeine may alter levodopa pharmacokinetics, reduce dyskinesia, improve gait in patients with freezing and may even reduce the risk of developing Parkinson’s disease, with a maximum benefit reached at approximately three cups of coffee daily.

 

Problematic Foods

There is also a growing body of evidence regarding the deleterious effects of ultraprocessed foods (UPFs), Duda said. He noted that a recent systematic review and meta-analysis of 28 studies showed that higher UPF intake was significantly associated with an enhanced risk for Parkinson’s disease (relative risk, 1.56; 95% CI, 1.21-2.02). As previously reported, UPFs have been tied to a host of adverse neurologic outcomes, including cognitive decline and stroke. 

Although protein is a necessary nutrient, incorporating it into the diet of Parkinson’s disease patients taking levodopa is complicated. Levodopa, a large neutral amino acid (LNAA), competes with other LNAAs for transport to the brain from the small intestine, Duda explained. 

“Some people notice that carbidopa-levodopa doesn’t work as well if taken with a high-protein meal.” He recommended taking carbidopa-levodopa 30 minutes before or 60 minutes after meals.

Rebecca Gilbert, MD, PhD, chief mission officer of the American Parkinson’s Disease Association, said that patients with Parkinson’s disease might want to avoid eating protein during the day, concentrating instead on carbohydrates and vegetables and saving the protein for the evening, which is closer to bedtime. Some evidence also supports the use of protein redistribution diets to enhance the clinical response to levodopa and reduce motor fluctuations. 

 

What About Supplements? 

It’s “hard to prove that one specific supplement can be protective against Parkinson’s disease because diet consists of many different components and the whole diet may be worth more than the sum of its parts,” Gilbert said. The evidence for individual supplements “isn’t robust enough to say they prevent or treat Parkinson’s disease.”

Research on the role of specific nutrients in Parkinson’s disease is conflicting, with no clear evidence supporting or refuting their benefits. For example, a study that followed participants for about 30 years showed no link between reduced Parkinson’s disease risk and vitamin B or folate intake. 

On the other hand, there is research suggesting that certain vitamins may help reduce Parkinson’s disease risk, although these nutrients do not operate in isolation. For instance, one recent study showed a connection between vitamins C and E and reduced Parkinson’s disease risk, but factors such as body mass index and coffee consumption appeared to influence the strength of this association.

Consuming polyunsaturated fatty acids along with reducing saturated fatty acid intake has been tied to a reduced risk for Parkinson’s disease. 

Additionally, certain foods may offer protective effects, including green and black tea, with consumption of three or more cups per day associated with a delay in motor symptom onset by 7.7 years. Foods high in nicotine content, such as those from the Solanaceae family — including peppers, tomatoes, tomato juice, and potatoes — have also been linked to potential protective benefits.

Diets rich in antioxidants, including carotenoids, lutein, and vitamins E and C, have been robustly linked to a reduced risk for parkinsonism and progression of parkinsonian symptoms in older adults.

Increasing the intake of dietary flavonoids, particularly tea, berry fruits, apples, red wine, and oranges or orange juice, can reduce Parkinson’s disease risk. One study showed that male participants in the highest quintile of total flavonoid consumption had a 40% lower Parkinson’s disease risk compared with those in the lowest quintile. Another study showed that flavonoid-rich foods were also associated with a lower risk for death in patients with Parkinson’s disease. 

 

Food as Medicine 

Although recent research shows that the drug development pipeline for Parkinson’s disease is robust, with a wide variety of approaches being developed and evaluated in phase 1 and 2, investigators note that only a limited number of disease-modifying treatments are transitioning to phase 3.

Duda noted that phytochemicals incorporated into the diet might target some of the same mechanisms that are targets of these drugs in development. 

“Flavonoids have been shown to stabilize alpha-synuclein in vitro,” he said. “Caffeine, curcumin, resveratrol, and eliminating meat and dairy inhibit mTOR [mammalian target of rapamycin], and mTOR inhibition results in increased autophagy that may help clear alpha-synuclein. Genestein, an isoflavone in soybeans, protects dopaminergic neurons by inhibiting microglia activation. Flavonoids inhibit inflammation by inhibiting release of NO [nitric oxide] and pro-inflammatory cytokines,” he noted. 

Ongoing studies of dietary interventions for Parkinson’s disease are exploring various areas, including the potential role of the ketogenic diet in protecting the gut microbiome, optimizing protein intake for muscle preservation and sleep, the effects of psyllium and wheat bran on weight and constipation, and the impact of a gluten-free diet.

 

Practical Tips for Healthy Eating 

Gilbert emphasized that there are no medications or interventions currently available that can delay a Parkinson’s disease diagnosis by up to 17 years, as some dietary patterns have been shown to do, and she noted that it’s not possible to replicate the MeDi diet in a pill. However, she recommended a practical approach to eating that includes a diet low in ultraprocessed foods and high in beneficial nutrients. She encouraged people to shop for “real food” and enjoy a variety of colorful fruits and vegetables.

Duda acknowledged that motivating patients to follow a healthy diet can be difficult. As a result, the focus often shifts to making small adjustments and modifications. For example, he suggested that instead of pairing meat with French fries, people could opt for vegetables or add greens to their meals. Similarly, instead of having eggs and bacon for breakfast, they might choose oatmeal.

Preparing whole-food, plant-based meals may take more time than patients are accustomed to, so Duda suggests that, if possible, patients involve loved ones in both the meal preparation and the meal itself. He explained that a healthy meal can become an opportunity for bonding and that the key is educating them about new meal-related concepts. 

Duda reported no relevant financial relationships with the pharmaceutical or food industries. He has received compensation from the Physicians Committee for Responsible Medicine for his lecture delivered at the conference and research grant support from the VA, the National Institutes of Health, the Michael J. Fox Foundation, and the Department of Defense unrelated to this topic. Gilbert reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Interest is growing in the role of nutrition as means of slowing, or even preventing, neurodegeneration in patients with Parkinson’s disease.

For 15 years, John Duda, MD, national director of the VA Parkinson’s Disease Research, Education and Clinical Centers, has urged his patients to “keep waiting” for effective treatments to manage both motor and nonmotor symptoms of Parkinson’s disease.

However, Duda, who also serves as director of the Brain Wellness Clinic at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, Pennsylvania, recognized the persistent lack of effective drugs to address these symptoms. This prompted him to consider what other evidence-based strategies he could use to support his patients. 

“I recognized that nutritional approaches within a broader program that includes medication review, stress management, social connections, adequate sleep, and physical exercise could make a real difference,” he said.

Observational studies have shown an inverse association between dietary patterns and Parkinson’s disease risk, age of onset, symptom severity, and mortality rates — particularly with the Mediterranean diet (MeDi) and the MIND diet, which combines elements of MeDi and the Dietary Approaches to Stop Hypertension (DASH) diet. Although randomized controlled trials are still limited, the epidemiologic evidence supporting dietary interventions is “compelling,” said Duda. 

For example, a cross-sectional study comparing 167 participants with Parkinson’s disease vs 119 controls showed that later age of Parkinson’s disease onset correlated with adherence to the MIND diet in women, with a difference of up to 17.4 years (P < .001) between low and high dietary tertiles. 

The MeDi was correlated with later onset in men, with differences of up to 8.4 years (P = .002). As previously reported, a healthy diet emphasizing vegetables, fruits, nuts, and grains was inversely associated with prodromal features of Parkinson’s disease, including constipation, excessive daytime sleepiness, and depression. In addition, lower rates of Parkinson’s disease have been shown in populations following vegetarian and vegan dietary patterns. 

 

Does Parkinson’s disease Start in the Gut?

Parkinson’s disease is characterized by decreased short-chain fatty acid–producing bacteria and increased pro-inflammatory species linked to intestinal inflammation and alpha-synuclein aggregation. “There are reasons to believe that a-synuclein accumulation may start in the gut,” Duda noted.

Numerous studies implicate gut microbiome dysbiosis as a pathogenic mechanism in Parkinson’s disease, with gastrointestinal symptoms often predating motor symptoms. Dysbiosis might result in a pro-inflammatory state potentially linked to the recurrent gastrointestinal symptoms. Fecal microbiota transplant may restore a healthier gut environment and beneficially affect Parkinson’s disease symptoms, he said.

Some of the benefits conferred by the MeDi and other healthy diets may be mediated by improving the gut microbiome. Duda cited a study that showed that a 14-day ovo-lacto vegetarian diet intervention and a daily fecal enema for 8 days improved not only the microbiome but also Movement Disorder Society Unified Parkinson’s Disease Rating Scale—part III scores. 

Duda also reviewed the role of dietary interventions in addressing common Parkinson’s disease symptoms, such as orthostatic hypotension. He recommended that Parkinson’s disease patients with this condition should avoid eating large meals, increase dietary salt intake, increase fluid intake, and decrease alcohol intake.

Malnutrition affects close to 25% of those with Parkinson’s disease, which is partially attributable to diminished olfaction. Because the experience of taste is largely driven by a sense of smell, patients may be less interested in eating. Duda recommended increasing herbs, spices, and other flavors in food. High caloric–density foods, including nuts, nut butters, and seeds, can boost weight, he said. However, he added, any patient with significant weight loss should consult a nutritionist.

Constipation is one of the most debilitating symptoms of Parkinson’s disease, affecting up to 66% of patients. Duda advised increasing fluid intake, exercise, and dietary fiber and use of stool softeners and laxatives. The MeDi may reduce symptoms of constipation and have a beneficial effect on gut microbiota. 

Coffee may be helpful for sleepiness in Parkinson’s disease and may also confer neuroprotective, motor, and cognitive benefits. As an adjuvant treatment, caffeine may alter levodopa pharmacokinetics, reduce dyskinesia, improve gait in patients with freezing and may even reduce the risk of developing Parkinson’s disease, with a maximum benefit reached at approximately three cups of coffee daily.

 

Problematic Foods

There is also a growing body of evidence regarding the deleterious effects of ultraprocessed foods (UPFs), Duda said. He noted that a recent systematic review and meta-analysis of 28 studies showed that higher UPF intake was significantly associated with an enhanced risk for Parkinson’s disease (relative risk, 1.56; 95% CI, 1.21-2.02). As previously reported, UPFs have been tied to a host of adverse neurologic outcomes, including cognitive decline and stroke. 

Although protein is a necessary nutrient, incorporating it into the diet of Parkinson’s disease patients taking levodopa is complicated. Levodopa, a large neutral amino acid (LNAA), competes with other LNAAs for transport to the brain from the small intestine, Duda explained. 

“Some people notice that carbidopa-levodopa doesn’t work as well if taken with a high-protein meal.” He recommended taking carbidopa-levodopa 30 minutes before or 60 minutes after meals.

Rebecca Gilbert, MD, PhD, chief mission officer of the American Parkinson’s Disease Association, said that patients with Parkinson’s disease might want to avoid eating protein during the day, concentrating instead on carbohydrates and vegetables and saving the protein for the evening, which is closer to bedtime. Some evidence also supports the use of protein redistribution diets to enhance the clinical response to levodopa and reduce motor fluctuations. 

 

What About Supplements? 

It’s “hard to prove that one specific supplement can be protective against Parkinson’s disease because diet consists of many different components and the whole diet may be worth more than the sum of its parts,” Gilbert said. The evidence for individual supplements “isn’t robust enough to say they prevent or treat Parkinson’s disease.”

Research on the role of specific nutrients in Parkinson’s disease is conflicting, with no clear evidence supporting or refuting their benefits. For example, a study that followed participants for about 30 years showed no link between reduced Parkinson’s disease risk and vitamin B or folate intake. 

On the other hand, there is research suggesting that certain vitamins may help reduce Parkinson’s disease risk, although these nutrients do not operate in isolation. For instance, one recent study showed a connection between vitamins C and E and reduced Parkinson’s disease risk, but factors such as body mass index and coffee consumption appeared to influence the strength of this association.

Consuming polyunsaturated fatty acids along with reducing saturated fatty acid intake has been tied to a reduced risk for Parkinson’s disease. 

Additionally, certain foods may offer protective effects, including green and black tea, with consumption of three or more cups per day associated with a delay in motor symptom onset by 7.7 years. Foods high in nicotine content, such as those from the Solanaceae family — including peppers, tomatoes, tomato juice, and potatoes — have also been linked to potential protective benefits.

Diets rich in antioxidants, including carotenoids, lutein, and vitamins E and C, have been robustly linked to a reduced risk for parkinsonism and progression of parkinsonian symptoms in older adults.

Increasing the intake of dietary flavonoids, particularly tea, berry fruits, apples, red wine, and oranges or orange juice, can reduce Parkinson’s disease risk. One study showed that male participants in the highest quintile of total flavonoid consumption had a 40% lower Parkinson’s disease risk compared with those in the lowest quintile. Another study showed that flavonoid-rich foods were also associated with a lower risk for death in patients with Parkinson’s disease. 

 

Food as Medicine 

Although recent research shows that the drug development pipeline for Parkinson’s disease is robust, with a wide variety of approaches being developed and evaluated in phase 1 and 2, investigators note that only a limited number of disease-modifying treatments are transitioning to phase 3.

Duda noted that phytochemicals incorporated into the diet might target some of the same mechanisms that are targets of these drugs in development. 

“Flavonoids have been shown to stabilize alpha-synuclein in vitro,” he said. “Caffeine, curcumin, resveratrol, and eliminating meat and dairy inhibit mTOR [mammalian target of rapamycin], and mTOR inhibition results in increased autophagy that may help clear alpha-synuclein. Genestein, an isoflavone in soybeans, protects dopaminergic neurons by inhibiting microglia activation. Flavonoids inhibit inflammation by inhibiting release of NO [nitric oxide] and pro-inflammatory cytokines,” he noted. 

Ongoing studies of dietary interventions for Parkinson’s disease are exploring various areas, including the potential role of the ketogenic diet in protecting the gut microbiome, optimizing protein intake for muscle preservation and sleep, the effects of psyllium and wheat bran on weight and constipation, and the impact of a gluten-free diet.

 

Practical Tips for Healthy Eating 

Gilbert emphasized that there are no medications or interventions currently available that can delay a Parkinson’s disease diagnosis by up to 17 years, as some dietary patterns have been shown to do, and she noted that it’s not possible to replicate the MeDi diet in a pill. However, she recommended a practical approach to eating that includes a diet low in ultraprocessed foods and high in beneficial nutrients. She encouraged people to shop for “real food” and enjoy a variety of colorful fruits and vegetables.

Duda acknowledged that motivating patients to follow a healthy diet can be difficult. As a result, the focus often shifts to making small adjustments and modifications. For example, he suggested that instead of pairing meat with French fries, people could opt for vegetables or add greens to their meals. Similarly, instead of having eggs and bacon for breakfast, they might choose oatmeal.

Preparing whole-food, plant-based meals may take more time than patients are accustomed to, so Duda suggests that, if possible, patients involve loved ones in both the meal preparation and the meal itself. He explained that a healthy meal can become an opportunity for bonding and that the key is educating them about new meal-related concepts. 

Duda reported no relevant financial relationships with the pharmaceutical or food industries. He has received compensation from the Physicians Committee for Responsible Medicine for his lecture delivered at the conference and research grant support from the VA, the National Institutes of Health, the Michael J. Fox Foundation, and the Department of Defense unrelated to this topic. Gilbert reported no relevant financial relationships.

A version of this article appeared on Medscape.com.