Key clinical point: Among biologic-naive, guselkumab-treated patients with psoriatic arthritis (PsA), enthesitis resolution (ER) was associated with dactylitis resolution (DR), and those achieving ER or DR showed improvements in patient-reported outcomes.

Major finding: At weeks 24, 52, and 100, guselkumab-treated patients who achieved DR were more likely to achieve ER, and vice versa (all P < .05). At week 24, a higher proportion of patients who did vs did not achieve ER reported minimal pain (30%-45% vs 11%-21%; all P < .001), with similar pain outcomes in patients who did vs did not achieve DR.

Study details: This post hoc analysis included 739 biologic-naive patients with PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with crossover to guselkumab (100 mg every 4 weeks) at week 24, of whom 68.6% and 44.9% of patients had enthesitis and dactylitis, respectively.

Disclosures: This study was supported by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owning Johnson and Johnson stock or stock options. The other authors declared receiving consulting fees from or having other ties with various sources, including Janssen.

Source: Rahman P, McInnes IB, Deodhar A, et al. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024;43:1591-1604 (Mar 12). doi: 10.1007/s10067-024-06921-8  Source

Key clinical point: Among biologic-naive, guselkumab-treated patients with psoriatic arthritis (PsA), enthesitis resolution (ER) was associated with dactylitis resolution (DR), and those achieving ER or DR showed improvements in patient-reported outcomes.

Major finding: At weeks 24, 52, and 100, guselkumab-treated patients who achieved DR were more likely to achieve ER, and vice versa (all P < .05). At week 24, a higher proportion of patients who did vs did not achieve ER reported minimal pain (30%-45% vs 11%-21%; all P < .001), with similar pain outcomes in patients who did vs did not achieve DR.

Study details: This post hoc analysis included 739 biologic-naive patients with PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with crossover to guselkumab (100 mg every 4 weeks) at week 24, of whom 68.6% and 44.9% of patients had enthesitis and dactylitis, respectively.

Disclosures: This study was supported by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owning Johnson and Johnson stock or stock options. The other authors declared receiving consulting fees from or having other ties with various sources, including Janssen.

Source: Rahman P, McInnes IB, Deodhar A, et al. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024;43:1591-1604 (Mar 12). doi: 10.1007/s10067-024-06921-8  Source

Key clinical point: Among biologic-naive, guselkumab-treated patients with psoriatic arthritis (PsA), enthesitis resolution (ER) was associated with dactylitis resolution (DR), and those achieving ER or DR showed improvements in patient-reported outcomes.

Major finding: At weeks 24, 52, and 100, guselkumab-treated patients who achieved DR were more likely to achieve ER, and vice versa (all P < .05). At week 24, a higher proportion of patients who did vs did not achieve ER reported minimal pain (30%-45% vs 11%-21%; all P < .001), with similar pain outcomes in patients who did vs did not achieve DR.

Study details: This post hoc analysis included 739 biologic-naive patients with PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with crossover to guselkumab (100 mg every 4 weeks) at week 24, of whom 68.6% and 44.9% of patients had enthesitis and dactylitis, respectively.

Disclosures: This study was supported by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owning Johnson and Johnson stock or stock options. The other authors declared receiving consulting fees from or having other ties with various sources, including Janssen.

Source: Rahman P, McInnes IB, Deodhar A, et al. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024;43:1591-1604 (Mar 12). doi: 10.1007/s10067-024-06921-8  Source

Key clinical point: Guselkumab treatment led to durable improvements in key Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (PsA)-recognized domains through 2 years and showed a consistent safety profile in biologic or Janus kinase inhibitor-naive patients with active PsA.

Major finding: At week 100, more than 50% of patients receiving guselkumab (100 mg every 4 or 8 weeks) achieved  achieved a low PsA Disease Activity Index, had enthesitis resolution, dactylitis resolution, and 100% improvement in Psoriasis Area and Severity Index. No new safety signals were observed.

Study details: This post hoc analysis included 442 biologic or Janus kinase inhibitor-naive patients with active PsA and previous inadequate response or intolerance to standard nonbiologics who received 100 mg guselkumab every 4 or 8 weeks through week 100.

Disclosures: This study was supported by Janssen Research & Development (R&D), LLC. Three authors declared being employees of Janssen R&D and owning Johnson and Johnson stocks or stock options. Several authors declared receiving honoraria from or having other ties with various sources, including Janssen.

Source: Coates LC, Gossec L, Zimmermann M, et al. Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2024;10:e003977 (Mar 26). doi: 10.1136/rmdopen-2023-003977 Source

Key clinical point: Guselkumab treatment led to durable improvements in key Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (PsA)-recognized domains through 2 years and showed a consistent safety profile in biologic or Janus kinase inhibitor-naive patients with active PsA.

Major finding: At week 100, more than 50% of patients receiving guselkumab (100 mg every 4 or 8 weeks) achieved  achieved a low PsA Disease Activity Index, had enthesitis resolution, dactylitis resolution, and 100% improvement in Psoriasis Area and Severity Index. No new safety signals were observed.

Study details: This post hoc analysis included 442 biologic or Janus kinase inhibitor-naive patients with active PsA and previous inadequate response or intolerance to standard nonbiologics who received 100 mg guselkumab every 4 or 8 weeks through week 100.

Disclosures: This study was supported by Janssen Research & Development (R&D), LLC. Three authors declared being employees of Janssen R&D and owning Johnson and Johnson stocks or stock options. Several authors declared receiving honoraria from or having other ties with various sources, including Janssen.

Source: Coates LC, Gossec L, Zimmermann M, et al. Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2024;10:e003977 (Mar 26). doi: 10.1136/rmdopen-2023-003977 Source

Key clinical point: Guselkumab treatment led to durable improvements in key Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (PsA)-recognized domains through 2 years and showed a consistent safety profile in biologic or Janus kinase inhibitor-naive patients with active PsA.

Major finding: At week 100, more than 50% of patients receiving guselkumab (100 mg every 4 or 8 weeks) achieved  achieved a low PsA Disease Activity Index, had enthesitis resolution, dactylitis resolution, and 100% improvement in Psoriasis Area and Severity Index. No new safety signals were observed.

Study details: This post hoc analysis included 442 biologic or Janus kinase inhibitor-naive patients with active PsA and previous inadequate response or intolerance to standard nonbiologics who received 100 mg guselkumab every 4 or 8 weeks through week 100.

Disclosures: This study was supported by Janssen Research & Development (R&D), LLC. Three authors declared being employees of Janssen R&D and owning Johnson and Johnson stocks or stock options. Several authors declared receiving honoraria from or having other ties with various sources, including Janssen.

Source: Coates LC, Gossec L, Zimmermann M, et al. Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2024;10:e003977 (Mar 26). doi: 10.1136/rmdopen-2023-003977 Source

Key clinical point: Risankizumab showed long-term efficacy and tolerability in patients having active psoriatic arthritis (PsA) with previous inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).

Major finding: At week 100, more than half the patients who received risankizumab continuously (64.3%) or switched from placebo to risankizumab (62.1%) achieved ≥20% improvement in the American College of Rheumatology criteria (ACR20), with Minimal Disease Activity being reported by nearly 35% of patients in both cohorts. Risankizumab showed a consistent safety profile with no new concerns.

Study details: This long-term efficacy and safety analysis of the KEEPsAKE 1 trial included 828 csDMARD-IR patients with active PsA who received risankizumab or placebo followed by risankizumab till week 100.

Disclosures: This study was funded by AbbVie. Seven authors declared being employees of or holding stocks or stock options in AbbVie. Several authors declared serving as consultants or speakers for or having other ties with various sources, including AbbVie.

Source: Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024 (Mar 18). doi: 10.1007/s40744-024-00654-5 Source

Key clinical point: Risankizumab showed long-term efficacy and tolerability in patients having active psoriatic arthritis (PsA) with previous inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).

Major finding: At week 100, more than half the patients who received risankizumab continuously (64.3%) or switched from placebo to risankizumab (62.1%) achieved ≥20% improvement in the American College of Rheumatology criteria (ACR20), with Minimal Disease Activity being reported by nearly 35% of patients in both cohorts. Risankizumab showed a consistent safety profile with no new concerns.

Study details: This long-term efficacy and safety analysis of the KEEPsAKE 1 trial included 828 csDMARD-IR patients with active PsA who received risankizumab or placebo followed by risankizumab till week 100.

Disclosures: This study was funded by AbbVie. Seven authors declared being employees of or holding stocks or stock options in AbbVie. Several authors declared serving as consultants or speakers for or having other ties with various sources, including AbbVie.

Source: Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024 (Mar 18). doi: 10.1007/s40744-024-00654-5 Source

Key clinical point: Risankizumab showed long-term efficacy and tolerability in patients having active psoriatic arthritis (PsA) with previous inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).

Major finding: At week 100, more than half the patients who received risankizumab continuously (64.3%) or switched from placebo to risankizumab (62.1%) achieved ≥20% improvement in the American College of Rheumatology criteria (ACR20), with Minimal Disease Activity being reported by nearly 35% of patients in both cohorts. Risankizumab showed a consistent safety profile with no new concerns.

Study details: This long-term efficacy and safety analysis of the KEEPsAKE 1 trial included 828 csDMARD-IR patients with active PsA who received risankizumab or placebo followed by risankizumab till week 100.

Disclosures: This study was funded by AbbVie. Seven authors declared being employees of or holding stocks or stock options in AbbVie. Several authors declared serving as consultants or speakers for or having other ties with various sources, including AbbVie.

Source: Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024 (Mar 18). doi: 10.1007/s40744-024-00654-5 Source

Key clinical point: The overall risk for serious infections was low in patients with psoriatic arthritis (PsA) who were new users of targeted therapies, with etanercept and ustekinumab being safer treatment options than adalimumab.

Major finding: The incidence of serious infections in new users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93).

Study details: This cohort study included 12,071 patients with PsA (age ≥ 18 years) from the French National Health Insurance Database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib).

Disclosures: This study did not receive any specific funding. Two authors declared receiving meeting support, consulting fees, etc., from or having other ties with various sources. The other authors declared no conflicts of interest.

Source: Bastard L, Claudepierre P, Penso L, et al. Risk of serious infection associated with different classes of targeted therapies used in psoriatic arthritis: A nationwide cohort study from the French Health Insurance Database (SNDS). RMD Open. 2024;10:e003865 (Mar 14). doi: 10.1136/rmdopen-2023-003865 Source

Key clinical point: The overall risk for serious infections was low in patients with psoriatic arthritis (PsA) who were new users of targeted therapies, with etanercept and ustekinumab being safer treatment options than adalimumab.

Major finding: The incidence of serious infections in new users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93).

Study details: This cohort study included 12,071 patients with PsA (age ≥ 18 years) from the French National Health Insurance Database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib).

Disclosures: This study did not receive any specific funding. Two authors declared receiving meeting support, consulting fees, etc., from or having other ties with various sources. The other authors declared no conflicts of interest.

Source: Bastard L, Claudepierre P, Penso L, et al. Risk of serious infection associated with different classes of targeted therapies used in psoriatic arthritis: A nationwide cohort study from the French Health Insurance Database (SNDS). RMD Open. 2024;10:e003865 (Mar 14). doi: 10.1136/rmdopen-2023-003865 Source

Key clinical point: The overall risk for serious infections was low in patients with psoriatic arthritis (PsA) who were new users of targeted therapies, with etanercept and ustekinumab being safer treatment options than adalimumab.

Major finding: The incidence of serious infections in new users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93).

Study details: This cohort study included 12,071 patients with PsA (age ≥ 18 years) from the French National Health Insurance Database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib).

Disclosures: This study did not receive any specific funding. Two authors declared receiving meeting support, consulting fees, etc., from or having other ties with various sources. The other authors declared no conflicts of interest.

Source: Bastard L, Claudepierre P, Penso L, et al. Risk of serious infection associated with different classes of targeted therapies used in psoriatic arthritis: A nationwide cohort study from the French Health Insurance Database (SNDS). RMD Open. 2024;10:e003865 (Mar 14). doi: 10.1136/rmdopen-2023-003865 Source

Key clinical point: Bimekizumab showed better long-term efficacy than guselkumab in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD) or had previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: In bDMARD-naive patients, bimekizumab (160 mg every 4 weeks [Q4W]) was associated with a greater likelihood of achievement of ≥70% improvement in the American College of Rheumatology response (odds ratio [OR] > 2.0; P ≤ .001) and minimal disease activity outcome (OR > 1.5; P ≤ .005) at week 52 compared with guselkumab (100 mg Q4W or every 8 weeks). Similar outcomes were observed in the TNFi-IR subgroup.

Study details: This matching-adjusted indirect comparison study included bDMARD-naive and TNFi-IR patients with PsA who received bimekizumab (431 and 267 patients, respectively) and guselkumab (495 and 189 patients, respectively).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees and stockholders of UCB Pharma. The other authors declared receiving consulting fees or honoraria from or having other ties with various sources, including UCB Pharma.

Source: Warren RB, McInnes IB, Nash P, et al. Comparative effectiveness of bimekizumab and guselkumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Mar 15). doi: 10.1007/s40744-024-00659-0 Source

Key clinical point: Bimekizumab showed better long-term efficacy than guselkumab in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD) or had previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: In bDMARD-naive patients, bimekizumab (160 mg every 4 weeks [Q4W]) was associated with a greater likelihood of achievement of ≥70% improvement in the American College of Rheumatology response (odds ratio [OR] > 2.0; P ≤ .001) and minimal disease activity outcome (OR > 1.5; P ≤ .005) at week 52 compared with guselkumab (100 mg Q4W or every 8 weeks). Similar outcomes were observed in the TNFi-IR subgroup.

Study details: This matching-adjusted indirect comparison study included bDMARD-naive and TNFi-IR patients with PsA who received bimekizumab (431 and 267 patients, respectively) and guselkumab (495 and 189 patients, respectively).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees and stockholders of UCB Pharma. The other authors declared receiving consulting fees or honoraria from or having other ties with various sources, including UCB Pharma.

Source: Warren RB, McInnes IB, Nash P, et al. Comparative effectiveness of bimekizumab and guselkumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Mar 15). doi: 10.1007/s40744-024-00659-0 Source

Key clinical point: Bimekizumab showed better long-term efficacy than guselkumab in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD) or had previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: In bDMARD-naive patients, bimekizumab (160 mg every 4 weeks [Q4W]) was associated with a greater likelihood of achievement of ≥70% improvement in the American College of Rheumatology response (odds ratio [OR] > 2.0; P ≤ .001) and minimal disease activity outcome (OR > 1.5; P ≤ .005) at week 52 compared with guselkumab (100 mg Q4W or every 8 weeks). Similar outcomes were observed in the TNFi-IR subgroup.

Study details: This matching-adjusted indirect comparison study included bDMARD-naive and TNFi-IR patients with PsA who received bimekizumab (431 and 267 patients, respectively) and guselkumab (495 and 189 patients, respectively).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees and stockholders of UCB Pharma. The other authors declared receiving consulting fees or honoraria from or having other ties with various sources, including UCB Pharma.

Source: Warren RB, McInnes IB, Nash P, et al. Comparative effectiveness of bimekizumab and guselkumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Mar 15). doi: 10.1007/s40744-024-00659-0 Source

DENVER – Headaches, including tension-type, migraine, and posttraumatic, are robustly associated with both attempted and completed suicide, results of a large study suggest. 

The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.

The retrospective analysis included data on more than 100,000 headache patients from a Danish registry. 

“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
 

Underestimated Problem

Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability. 

Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.

However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.

Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.

Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.

Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.

Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.

Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.

For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
 

Robust Link

The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.

The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.

After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).

“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.

For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).

The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.

The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
 

Ask About Mood

The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.

After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.

Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.

A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.

Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.

Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”

It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.

The study received support from Aarhus University. No relevant conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

DENVER – Headaches, including tension-type, migraine, and posttraumatic, are robustly associated with both attempted and completed suicide, results of a large study suggest. 

The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.

The retrospective analysis included data on more than 100,000 headache patients from a Danish registry. 

“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
 

Underestimated Problem

Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability. 

Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.

However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.

Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.

Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.

Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.

Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.

Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.

For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
 

Robust Link

The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.

The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.

After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).

“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.

For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).

The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.

The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
 

Ask About Mood

The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.

After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.

Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.

A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.

Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.

Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”

It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.

The study received support from Aarhus University. No relevant conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

DENVER – Headaches, including tension-type, migraine, and posttraumatic, are robustly associated with both attempted and completed suicide, results of a large study suggest. 

The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.

The retrospective analysis included data on more than 100,000 headache patients from a Danish registry. 

“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
 

Underestimated Problem

Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability. 

Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.

However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.

Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.

Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.

Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.

Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.

Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.

For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
 

Robust Link

The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.

The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.

After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).

“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.

For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).

The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.

The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
 

Ask About Mood

The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.

After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.

Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.

A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.

Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.

Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”

It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.

The study received support from Aarhus University. No relevant conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

DENVER — Seizure burden, defined by an artificial intelligence (AI) algorithm applied to point-of-care electroencephalography (POC EEG) recordings, can help predict functional outcomes.

After relevant cofactors were controlled for, higher seizure burden correlated with poorer functional outcomes. All of the patients in the study were being monitored as part of their standard of care owing to suspicion of seizures or because they were at risk for seizures, said study investigator Masoom Desai, MD, with the Department of Neurology, University of New Mexico, Albuquerque. The results were “compelling,” she said.

“Our study addresses the critical need for automation in monitoring epileptic activity and seizure burden,” Dr. Desai added during a press briefing at the 2024 annual meeting of the American Academy of Neurology (AAN).
 

A Pivotal Shift 

“Several decades of research have highlighted the significant correlation between seizure burden and unfavorable outcomes both in adult and pediatric populations,” said Dr. Desai. 

However, the traditional method of manually interpreting EEGs to identify seizures and their associated burden is a “complex and time-consuming process that can be subject to human error and variability,” she noted.

POC EEG is a rapid-access, reduced-montage EEG system that, when paired with an automated machine learning tool called Clarity (Ceribell, Inc; Sunnyvale, CA), can monitor and analyze seizure burden in real time.

The algorithm incorporates a comprehensive list of EEG features that have been associated with outcomes. It analyzes EEG activity every 10 seconds from all EEG channels and calculates a seizure burden in the past 5 minutes for the patient. The higher the seizure burden, the more time the patient has spent in seizure activity. 

Among 344 people with POC EEG (mean age, 62 years, 45% women) in the SAFER-EEG trial, 178 (52%) had seizure burden of zero throughout the recording and 41 (12%) had suspected status epilepticus (maximum seizure burden ≥ 90%). 

Before adjustment for clinical covariates, there was a significant association between high seizure burden and unfavorable outcomes. 

Specifically, 76% of patients with a seizure burden of 50% or greater had an unfavorable modified Rankin Scale score of 4 or greater at discharge and a similar proportion was discharged to long-term care facilities, she noted. 

After adjustment for relevant clinical covariants, patients with a high seizure burden (≥ 50 or > 90%) had a fourfold increase in odds of an unfavorable modified Rankin Scale score compared with those with no seizure burden. 

High seizure burden present in the last quarter of the recording was particularly indicative of unfavorable outcomes (fivefold increased odds), “suggesting the critical timing of seizures and its impact on patient prognosis,” Dr. Desai noted. 
 

‘Profound Implications’

“The implications of our research are profound, indicating a pivotal shift towards integrating AI and machine learning-guided automated EEG interpretation in management of critically ill patients with seizures,” she added. 

“As we move forward, our research will concentrate on applying this advanced tool in clinical decision making in clinical practice, examining how it can steer treatment decisions for patients, with the ultimate goal of enhancing patient care and improving outcomes for those affected by these neurological challenges,” Dr. Desai said. 

Briefing moderator Paul M. George, MD, PhD, chair of the AAN science committee, noted that this abstract was one of three featured at the “top science” press briefing themed “advancing the limits of neurologic care,” because it represents an “innovative method” of using new technology to improve understanding of neurologic conditions.

Dr. George said this technology “could be particularly useful in settings with few clinical specialists. It will be exciting to see as this unfolds, where it can guide maybe the ED doctor or primary care physician to help improve patient care.”

On that note, Dr. George cautioned that it’s still “early in the field” of using AI to guide decision-making and it will be important to gather more information to confirm that “machine learning algorithms can help guide physicians in treating patients with neurologic conditions.”

Funding for the study was provided by the University of Wisconsin-Madison and Ceribell, Inc. Dr. Desai received funding from Ceribell for this project. Dr. George has no relevant disclosures.

A version of this article appeared on Medscape.com.

DENVER — Seizure burden, defined by an artificial intelligence (AI) algorithm applied to point-of-care electroencephalography (POC EEG) recordings, can help predict functional outcomes.

After relevant cofactors were controlled for, higher seizure burden correlated with poorer functional outcomes. All of the patients in the study were being monitored as part of their standard of care owing to suspicion of seizures or because they were at risk for seizures, said study investigator Masoom Desai, MD, with the Department of Neurology, University of New Mexico, Albuquerque. The results were “compelling,” she said.

“Our study addresses the critical need for automation in monitoring epileptic activity and seizure burden,” Dr. Desai added during a press briefing at the 2024 annual meeting of the American Academy of Neurology (AAN).
 

A Pivotal Shift 

“Several decades of research have highlighted the significant correlation between seizure burden and unfavorable outcomes both in adult and pediatric populations,” said Dr. Desai. 

However, the traditional method of manually interpreting EEGs to identify seizures and their associated burden is a “complex and time-consuming process that can be subject to human error and variability,” she noted.

POC EEG is a rapid-access, reduced-montage EEG system that, when paired with an automated machine learning tool called Clarity (Ceribell, Inc; Sunnyvale, CA), can monitor and analyze seizure burden in real time.

The algorithm incorporates a comprehensive list of EEG features that have been associated with outcomes. It analyzes EEG activity every 10 seconds from all EEG channels and calculates a seizure burden in the past 5 minutes for the patient. The higher the seizure burden, the more time the patient has spent in seizure activity. 

Among 344 people with POC EEG (mean age, 62 years, 45% women) in the SAFER-EEG trial, 178 (52%) had seizure burden of zero throughout the recording and 41 (12%) had suspected status epilepticus (maximum seizure burden ≥ 90%). 

Before adjustment for clinical covariates, there was a significant association between high seizure burden and unfavorable outcomes. 

Specifically, 76% of patients with a seizure burden of 50% or greater had an unfavorable modified Rankin Scale score of 4 or greater at discharge and a similar proportion was discharged to long-term care facilities, she noted. 

After adjustment for relevant clinical covariants, patients with a high seizure burden (≥ 50 or > 90%) had a fourfold increase in odds of an unfavorable modified Rankin Scale score compared with those with no seizure burden. 

High seizure burden present in the last quarter of the recording was particularly indicative of unfavorable outcomes (fivefold increased odds), “suggesting the critical timing of seizures and its impact on patient prognosis,” Dr. Desai noted. 
 

‘Profound Implications’

“The implications of our research are profound, indicating a pivotal shift towards integrating AI and machine learning-guided automated EEG interpretation in management of critically ill patients with seizures,” she added. 

“As we move forward, our research will concentrate on applying this advanced tool in clinical decision making in clinical practice, examining how it can steer treatment decisions for patients, with the ultimate goal of enhancing patient care and improving outcomes for those affected by these neurological challenges,” Dr. Desai said. 

Briefing moderator Paul M. George, MD, PhD, chair of the AAN science committee, noted that this abstract was one of three featured at the “top science” press briefing themed “advancing the limits of neurologic care,” because it represents an “innovative method” of using new technology to improve understanding of neurologic conditions.

Dr. George said this technology “could be particularly useful in settings with few clinical specialists. It will be exciting to see as this unfolds, where it can guide maybe the ED doctor or primary care physician to help improve patient care.”

On that note, Dr. George cautioned that it’s still “early in the field” of using AI to guide decision-making and it will be important to gather more information to confirm that “machine learning algorithms can help guide physicians in treating patients with neurologic conditions.”

Funding for the study was provided by the University of Wisconsin-Madison and Ceribell, Inc. Dr. Desai received funding from Ceribell for this project. Dr. George has no relevant disclosures.

A version of this article appeared on Medscape.com.

DENVER — Seizure burden, defined by an artificial intelligence (AI) algorithm applied to point-of-care electroencephalography (POC EEG) recordings, can help predict functional outcomes.

After relevant cofactors were controlled for, higher seizure burden correlated with poorer functional outcomes. All of the patients in the study were being monitored as part of their standard of care owing to suspicion of seizures or because they were at risk for seizures, said study investigator Masoom Desai, MD, with the Department of Neurology, University of New Mexico, Albuquerque. The results were “compelling,” she said.

“Our study addresses the critical need for automation in monitoring epileptic activity and seizure burden,” Dr. Desai added during a press briefing at the 2024 annual meeting of the American Academy of Neurology (AAN).
 

A Pivotal Shift 

“Several decades of research have highlighted the significant correlation between seizure burden and unfavorable outcomes both in adult and pediatric populations,” said Dr. Desai. 

However, the traditional method of manually interpreting EEGs to identify seizures and their associated burden is a “complex and time-consuming process that can be subject to human error and variability,” she noted.

POC EEG is a rapid-access, reduced-montage EEG system that, when paired with an automated machine learning tool called Clarity (Ceribell, Inc; Sunnyvale, CA), can monitor and analyze seizure burden in real time.

The algorithm incorporates a comprehensive list of EEG features that have been associated with outcomes. It analyzes EEG activity every 10 seconds from all EEG channels and calculates a seizure burden in the past 5 minutes for the patient. The higher the seizure burden, the more time the patient has spent in seizure activity. 

Among 344 people with POC EEG (mean age, 62 years, 45% women) in the SAFER-EEG trial, 178 (52%) had seizure burden of zero throughout the recording and 41 (12%) had suspected status epilepticus (maximum seizure burden ≥ 90%). 

Before adjustment for clinical covariates, there was a significant association between high seizure burden and unfavorable outcomes. 

Specifically, 76% of patients with a seizure burden of 50% or greater had an unfavorable modified Rankin Scale score of 4 or greater at discharge and a similar proportion was discharged to long-term care facilities, she noted. 

After adjustment for relevant clinical covariants, patients with a high seizure burden (≥ 50 or > 90%) had a fourfold increase in odds of an unfavorable modified Rankin Scale score compared with those with no seizure burden. 

High seizure burden present in the last quarter of the recording was particularly indicative of unfavorable outcomes (fivefold increased odds), “suggesting the critical timing of seizures and its impact on patient prognosis,” Dr. Desai noted. 
 

‘Profound Implications’

“The implications of our research are profound, indicating a pivotal shift towards integrating AI and machine learning-guided automated EEG interpretation in management of critically ill patients with seizures,” she added. 

“As we move forward, our research will concentrate on applying this advanced tool in clinical decision making in clinical practice, examining how it can steer treatment decisions for patients, with the ultimate goal of enhancing patient care and improving outcomes for those affected by these neurological challenges,” Dr. Desai said. 

Briefing moderator Paul M. George, MD, PhD, chair of the AAN science committee, noted that this abstract was one of three featured at the “top science” press briefing themed “advancing the limits of neurologic care,” because it represents an “innovative method” of using new technology to improve understanding of neurologic conditions.

Dr. George said this technology “could be particularly useful in settings with few clinical specialists. It will be exciting to see as this unfolds, where it can guide maybe the ED doctor or primary care physician to help improve patient care.”

On that note, Dr. George cautioned that it’s still “early in the field” of using AI to guide decision-making and it will be important to gather more information to confirm that “machine learning algorithms can help guide physicians in treating patients with neurologic conditions.”

Funding for the study was provided by the University of Wisconsin-Madison and Ceribell, Inc. Dr. Desai received funding from Ceribell for this project. Dr. George has no relevant disclosures.

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source