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TOPLINE:

A case series highlights the features of severe, necrotic skin wounds among hospitalized adults associated with xylazine exposure, including 9% that involved exposed deep structures such as bone or tendon.

METHODOLOGY:

• The alpha-2 agonist xylazine, a veterinary sedative, is increasingly detected in fentanyl used illicitly in the United States and may be causing necrotizing wounds in drug users.
• To characterize specific clinical features of xylazine-associated wounds, researchers conducted a case series at three academic medical hospitals in Philadelphia from April 2022 to February 2023.
• They included 29 patients with confirmed xylazine exposure and a chief complaint that was wound-related, seen as inpatients or in the emergency department.

TAKEAWAY:

• The 29 patients (mean age, 39.4 years; 52% men) had a total of 59 wounds, 90% were located on the arms and legs, and 69% were on the posterior upper or anterior lower extremities. Five wounds (9%) involved exposed deep structures such as the bone or tendon.
• Of the 57 wounds with available photographs, 60% had wound beds with predominantly devitalized tissue (eschar or slough), 11% were blisters, 9% had granulation tissue, and 21% had mixed tissue or other types of wound beds. Devitalized tissue was more commonly observed in medium or large wounds (odds ratio [OR], 5.2; P = .02) than in small wounds.
• As reported by patients, 48% were acute wounds, 20% were subacute, and 29% were chronic (present for 3 months or longer). Subacute and chronic wounds were often medium or large compared with acute wounds (OR, 48.5; P < .001) and contained devitalized tissue (OR, 9.5; P < .001).
• Of the 39 wounds with patient-reported etiology, 34 (87%) occurred at drug injection sites.

IN PRACTICE:

To the best of their knowledge, this is “the largest study of wounds among patients with confirmed exposure to xylazine and the first to systematically describe wound characteristics,” the authors wrote. The results, they concluded, “may help identify xylazine exposure and can guide research on the etiology and management of these wounds.”

SOURCE:

This study was conducted by Lydia Lutz, MD, Johns Hopkins University School of Medicine, Baltimore, Maryland, and coinvestigators and was published online in JAMA Dermatology.

LIMITATIONS:

This single-city, retrospective study limited generalizability, and the selection of the largest wounds may bias results. Additionally, chronicity data relied on patient recall, potentially introducing recall bias.

DISCLOSURES:

Two authors received support from the National Institute on Drug Abuse for the study. The authors declared no competing interests.

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 first appeared on Medscape.com.

TOPLINE:

A case series highlights the features of severe, necrotic skin wounds among hospitalized adults associated with xylazine exposure, including 9% that involved exposed deep structures such as bone or tendon.

METHODOLOGY:

• The alpha-2 agonist xylazine, a veterinary sedative, is increasingly detected in fentanyl used illicitly in the United States and may be causing necrotizing wounds in drug users.
• To characterize specific clinical features of xylazine-associated wounds, researchers conducted a case series at three academic medical hospitals in Philadelphia from April 2022 to February 2023.
• They included 29 patients with confirmed xylazine exposure and a chief complaint that was wound-related, seen as inpatients or in the emergency department.

TAKEAWAY:

• The 29 patients (mean age, 39.4 years; 52% men) had a total of 59 wounds, 90% were located on the arms and legs, and 69% were on the posterior upper or anterior lower extremities. Five wounds (9%) involved exposed deep structures such as the bone or tendon.
• Of the 57 wounds with available photographs, 60% had wound beds with predominantly devitalized tissue (eschar or slough), 11% were blisters, 9% had granulation tissue, and 21% had mixed tissue or other types of wound beds. Devitalized tissue was more commonly observed in medium or large wounds (odds ratio [OR], 5.2; P = .02) than in small wounds.
• As reported by patients, 48% were acute wounds, 20% were subacute, and 29% were chronic (present for 3 months or longer). Subacute and chronic wounds were often medium or large compared with acute wounds (OR, 48.5; P < .001) and contained devitalized tissue (OR, 9.5; P < .001).
• Of the 39 wounds with patient-reported etiology, 34 (87%) occurred at drug injection sites.

IN PRACTICE:

To the best of their knowledge, this is “the largest study of wounds among patients with confirmed exposure to xylazine and the first to systematically describe wound characteristics,” the authors wrote. The results, they concluded, “may help identify xylazine exposure and can guide research on the etiology and management of these wounds.”

SOURCE:

This study was conducted by Lydia Lutz, MD, Johns Hopkins University School of Medicine, Baltimore, Maryland, and coinvestigators and was published online in JAMA Dermatology.

LIMITATIONS:

This single-city, retrospective study limited generalizability, and the selection of the largest wounds may bias results. Additionally, chronicity data relied on patient recall, potentially introducing recall bias.

DISCLOSURES:

Two authors received support from the National Institute on Drug Abuse for the study. The authors declared no competing interests.

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 first appeared on Medscape.com.

TOPLINE:

A case series highlights the features of severe, necrotic skin wounds among hospitalized adults associated with xylazine exposure, including 9% that involved exposed deep structures such as bone or tendon.

METHODOLOGY:

• The alpha-2 agonist xylazine, a veterinary sedative, is increasingly detected in fentanyl used illicitly in the United States and may be causing necrotizing wounds in drug users.
• To characterize specific clinical features of xylazine-associated wounds, researchers conducted a case series at three academic medical hospitals in Philadelphia from April 2022 to February 2023.
• They included 29 patients with confirmed xylazine exposure and a chief complaint that was wound-related, seen as inpatients or in the emergency department.

TAKEAWAY:

• The 29 patients (mean age, 39.4 years; 52% men) had a total of 59 wounds, 90% were located on the arms and legs, and 69% were on the posterior upper or anterior lower extremities. Five wounds (9%) involved exposed deep structures such as the bone or tendon.
• Of the 57 wounds with available photographs, 60% had wound beds with predominantly devitalized tissue (eschar or slough), 11% were blisters, 9% had granulation tissue, and 21% had mixed tissue or other types of wound beds. Devitalized tissue was more commonly observed in medium or large wounds (odds ratio [OR], 5.2; P = .02) than in small wounds.
• As reported by patients, 48% were acute wounds, 20% were subacute, and 29% were chronic (present for 3 months or longer). Subacute and chronic wounds were often medium or large compared with acute wounds (OR, 48.5; P < .001) and contained devitalized tissue (OR, 9.5; P < .001).
• Of the 39 wounds with patient-reported etiology, 34 (87%) occurred at drug injection sites.

IN PRACTICE:

To the best of their knowledge, this is “the largest study of wounds among patients with confirmed exposure to xylazine and the first to systematically describe wound characteristics,” the authors wrote. The results, they concluded, “may help identify xylazine exposure and can guide research on the etiology and management of these wounds.”

SOURCE:

This study was conducted by Lydia Lutz, MD, Johns Hopkins University School of Medicine, Baltimore, Maryland, and coinvestigators and was published online in JAMA Dermatology.

LIMITATIONS:

This single-city, retrospective study limited generalizability, and the selection of the largest wounds may bias results. Additionally, chronicity data relied on patient recall, potentially introducing recall bias.

DISCLOSURES:

Two authors received support from the National Institute on Drug Abuse for the study. The authors declared no competing interests.

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 first appeared on Medscape.com.

TOPLINE:

Combining transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) was associated with a greater reduction in symptoms of major depressive disorder (MDD) than either treatment alone, a new study showed.

 

METHODOLOGY:

• Researchers conducted a double-blind, sham-controlled randomized clinical trial from 2021 to 2023 at three hospitals in China with 240 participants with MDD (mean age, 32.5 years; 58% women).
• Participants received active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, or sham tDCS + sham rTMS with treatments administered five times per week for 2 weeks.
• tDCS was administered in 20-minute sessions using a 2-mA direct current stimulator, whereas rTMS involved 1600 pulses of 10-Hz stimulation targeting the left dorsolateral prefrontal cortex. Sham treatments used a pseudostimulation coil and only emitted sound.
• The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HDRS-24) total score from baseline to week 2.
• Secondary outcomes included HDRS-24 total score change at week 4, remission rate (HDRS-24 total score ≤ 9), response rate (≥ 50% reduction in HDRS-24 total score), and adverse events.

TAKEAWAY:

• The active tDCS + active rTMS group demonstrated the greatest reduction in mean HDRS-24 score (18.33 ± 5.39) at week 2 compared with sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS (P < .001).
• Response rates at week 2 were notably higher in the active tDCS + active rTMS group (85%) than in the active tDCS + sham rTMS (30%) and sham tDCS + sham rTMS groups (32%).
• The remission rate at week 4 reached 83% in the active tDCS + active rTMS group, which was significantly higher than the remission rates with the other interventions (P < .001).
• The treatments were well tolerated, with no serious adverse events, seizures, or manic symptoms reported across all intervention groups.

IN PRACTICE:

This trial “was the first to evaluate the safety, feasibility, and efficacy of combining tDCS and rTMS in treating depression. Future studies should focus on investigating the mechanism of this synergistic effect and improving the stimulation parameters to optimize the therapeutic effect,” the investigators wrote.

 

SOURCE:

This study was led by Dongsheng Zhou, MD, Ningbo Kangning Hospital, Ningbo, China. It was published online in JAMA Network Open.

 

LIMITATIONS:

The brief treatment duration involving 10 sessions may have been insufficient for tDCS and rTMS to demonstrate their full antidepressant potential. The inability to regulate participants’ antidepressant medications throughout the study period presented another limitation. Additionally, the lack of stratified randomization and adjustment for center effects may have introduced variability in the results.

 

DISCLOSURES:

This study received support from multiple grants, including from the Natural Science Foundation of Zhejiang Province, Basic Public Welfare Research Project of Zhejiang Province, Ningbo Medical and Health Brand Discipline, Ningbo Clinical Medical Research Centre for Mental Health, Ningbo Top Medical and Health Research Program, and the Zhejiang Medical and Health Science and Technology Plan Project. The authors reported no conflicts of interest.

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:

Combining transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) was associated with a greater reduction in symptoms of major depressive disorder (MDD) than either treatment alone, a new study showed.

 

METHODOLOGY:

• Researchers conducted a double-blind, sham-controlled randomized clinical trial from 2021 to 2023 at three hospitals in China with 240 participants with MDD (mean age, 32.5 years; 58% women).
• Participants received active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, or sham tDCS + sham rTMS with treatments administered five times per week for 2 weeks.
• tDCS was administered in 20-minute sessions using a 2-mA direct current stimulator, whereas rTMS involved 1600 pulses of 10-Hz stimulation targeting the left dorsolateral prefrontal cortex. Sham treatments used a pseudostimulation coil and only emitted sound.
• The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HDRS-24) total score from baseline to week 2.
• Secondary outcomes included HDRS-24 total score change at week 4, remission rate (HDRS-24 total score ≤ 9), response rate (≥ 50% reduction in HDRS-24 total score), and adverse events.

TAKEAWAY:

• The active tDCS + active rTMS group demonstrated the greatest reduction in mean HDRS-24 score (18.33 ± 5.39) at week 2 compared with sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS (P < .001).
• Response rates at week 2 were notably higher in the active tDCS + active rTMS group (85%) than in the active tDCS + sham rTMS (30%) and sham tDCS + sham rTMS groups (32%).
• The remission rate at week 4 reached 83% in the active tDCS + active rTMS group, which was significantly higher than the remission rates with the other interventions (P < .001).
• The treatments were well tolerated, with no serious adverse events, seizures, or manic symptoms reported across all intervention groups.

IN PRACTICE:

This trial “was the first to evaluate the safety, feasibility, and efficacy of combining tDCS and rTMS in treating depression. Future studies should focus on investigating the mechanism of this synergistic effect and improving the stimulation parameters to optimize the therapeutic effect,” the investigators wrote.

 

SOURCE:

This study was led by Dongsheng Zhou, MD, Ningbo Kangning Hospital, Ningbo, China. It was published online in JAMA Network Open.

 

LIMITATIONS:

The brief treatment duration involving 10 sessions may have been insufficient for tDCS and rTMS to demonstrate their full antidepressant potential. The inability to regulate participants’ antidepressant medications throughout the study period presented another limitation. Additionally, the lack of stratified randomization and adjustment for center effects may have introduced variability in the results.

 

DISCLOSURES:

This study received support from multiple grants, including from the Natural Science Foundation of Zhejiang Province, Basic Public Welfare Research Project of Zhejiang Province, Ningbo Medical and Health Brand Discipline, Ningbo Clinical Medical Research Centre for Mental Health, Ningbo Top Medical and Health Research Program, and the Zhejiang Medical and Health Science and Technology Plan Project. The authors reported no conflicts of interest.

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:

Combining transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) was associated with a greater reduction in symptoms of major depressive disorder (MDD) than either treatment alone, a new study showed.

 

METHODOLOGY:

• Researchers conducted a double-blind, sham-controlled randomized clinical trial from 2021 to 2023 at three hospitals in China with 240 participants with MDD (mean age, 32.5 years; 58% women).
• Participants received active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, or sham tDCS + sham rTMS with treatments administered five times per week for 2 weeks.
• tDCS was administered in 20-minute sessions using a 2-mA direct current stimulator, whereas rTMS involved 1600 pulses of 10-Hz stimulation targeting the left dorsolateral prefrontal cortex. Sham treatments used a pseudostimulation coil and only emitted sound.
• The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HDRS-24) total score from baseline to week 2.
• Secondary outcomes included HDRS-24 total score change at week 4, remission rate (HDRS-24 total score ≤ 9), response rate (≥ 50% reduction in HDRS-24 total score), and adverse events.

TAKEAWAY:

• The active tDCS + active rTMS group demonstrated the greatest reduction in mean HDRS-24 score (18.33 ± 5.39) at week 2 compared with sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS (P < .001).
• Response rates at week 2 were notably higher in the active tDCS + active rTMS group (85%) than in the active tDCS + sham rTMS (30%) and sham tDCS + sham rTMS groups (32%).
• The remission rate at week 4 reached 83% in the active tDCS + active rTMS group, which was significantly higher than the remission rates with the other interventions (P < .001).
• The treatments were well tolerated, with no serious adverse events, seizures, or manic symptoms reported across all intervention groups.

IN PRACTICE:

This trial “was the first to evaluate the safety, feasibility, and efficacy of combining tDCS and rTMS in treating depression. Future studies should focus on investigating the mechanism of this synergistic effect and improving the stimulation parameters to optimize the therapeutic effect,” the investigators wrote.

 

SOURCE:

This study was led by Dongsheng Zhou, MD, Ningbo Kangning Hospital, Ningbo, China. It was published online in JAMA Network Open.

 

LIMITATIONS:

The brief treatment duration involving 10 sessions may have been insufficient for tDCS and rTMS to demonstrate their full antidepressant potential. The inability to regulate participants’ antidepressant medications throughout the study period presented another limitation. Additionally, the lack of stratified randomization and adjustment for center effects may have introduced variability in the results.

 

DISCLOSURES:

This study received support from multiple grants, including from the Natural Science Foundation of Zhejiang Province, Basic Public Welfare Research Project of Zhejiang Province, Ningbo Medical and Health Brand Discipline, Ningbo Clinical Medical Research Centre for Mental Health, Ningbo Top Medical and Health Research Program, and the Zhejiang Medical and Health Science and Technology Plan Project. The authors reported no conflicts of interest.

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.

A population-based study has shown a slightly elevated risk for patients’ developing skin disorders, including alopecia areata (AA), alopecia totalis (AT), vitiligo, and bullous pemphigoid (BP), more than 6 months after COVID-19 infection. In addition, the authors reported that COVID-19 vaccination appears to reduce these risks.

The study was published in JAMA Dermatology.

 

‘Compelling Evidence’

“This well-executed study by Heo et al provides compelling evidence to support an association between COVID-19 infection and the development of subsequent autoimmune and autoinflammatory skin diseases,” wrote authors led by Lisa M. Arkin, MD, of the Department of Dermatology, University of Wisconsin School of Medicine and Public Health in Madison, in an accompanying editorial.

Using databases from Korea’s National Health Insurance Service and the Korea Disease Control and Prevention Agency, investigators led by Yeon-Woo Heo, MD, a dermatology resident at Yonsei University Wonju College of Medicine, Wonju, Republic of Korea, compared 3.1 million people who had COVID-19 with 3.8 million controls, all with at least 180 days’ follow-up through December 31, 2022.

At a mean follow-up of 287 days in both cohorts, authors found significantly elevated risks for AA and vitiligo (adjusted hazard ratio [aHR], 1.11 for both), AT (aHR, 1.24), Behçet disease (aHR, 1.45), and BP (aHR, 1.62) in the post–COVID-19 cohort. The infection also raised the risk for other conditions such as systemic lupus erythematosus (aHR, 1.14) and Crohn’s disease (aHR, 1.35).

In subgroup analyses, demographic factors were associated with diverse effects: COVID-19 infection was associated with significantly higher odds of developing AA (for both men and women), vitiligo (men), Behçet disease (men and women), Crohn’s disease (men), ulcerative colitis (men), rheumatoid arthritis (men and women), systemic lupus erythematosus (men), ankylosing spondylitis (men), AT (women), and BP (women) than controls.

Those aged under 40 years were more likely to develop AA, primary cicatricial alopecia, Behçet disease, and ulcerative colitis, while those aged 40 years or older were more likely to develop AA, AT, vitiligo, Behçet disease, Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis, and BP.

Additionally, severe COVID-19 requiring intensive care unit admission was associated with a significantly increased risk for autoimmune diseases, including AA, psoriasis, BP, and sarcoidosis. By timeframe, risks for AA, AT, and psoriasis were significantly higher during the initial Delta-dominant period.

 

Vaccination Effect

Moreover, vaccinated individuals were less likely to develop AA, AT, psoriasis, Behçet disease, and various nondermatologic conditions than were those who were unvaccinated. This finding, wrote Heo and colleagues, “may provide evidence to support the hypothesis that COVID-19 vaccines can help prevent autoimmune diseases.”

“That’s the part we all need to take into our offices tomorrow,” said Brett King, MD, PhD, a Fairfield, Connecticut–based dermatologist in private practice. He was not involved with the study but was asked to comment.

Overall, King said, the study carries two main messages. “The first is that COVID-19 infection increases the likelihood of developing an autoimmune or autoinflammatory disease in a large population.” The second and very important message is that being vaccinated against COVID-19 provides protection against developing an autoimmune or autoinflammatory disease.

“My concern is that the popular media highlights the first part,” said King, “and everybody who develops alopecia areata, vitiligo, or sarcoidosis blames COVID-19. That’s not what this work says.”

The foregoing distinction is especially important during the fall and winter, he added, when people getting influenza vaccines are routinely offered COVID-19 vaccines. “Many patients have said, ‘I got the COVID vaccine and developed alopecia areata 6 months later.’ Nearly everybody who has developed a new or worsening health condition in the last almost 5 years has had the perfect fall guy — the COVID vaccine or infection.”

With virtually all patients asking if they should get an updated COVID-19 vaccine or booster, he added, many report having heard that such vaccines cause AA, vitiligo, or other diseases. “To anchor these conversations in real data and not just anecdotes from a blog or Facebook is very useful,” said King, “and now we have very good data saying that the COVID vaccine is protective against these disorders.”

George Han, MD, PhD, associate professor of dermatology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, applauds investigators’ use of a large, robust database but suggests interpreting results cautiously. He was not involved with the study but was asked to comment.

“You could do a large, well-done study,” Han said, “but it could still not necessarily be generalizable. These autoimmune conditions they’re looking at have clear ethnic and racial biases.” Heo and colleagues acknowledged shortcomings including their study population’s monomorphic nature.

Additional issues that limit the study’s impact, said Han, include the difficulty of conceptualizing a 10%-20% increase in conditions that at baseline are rare. And many of the findings reflected natural patterns, he said. For instance, BP more commonly affects older people, COVID-19 notwithstanding.

Han said that for him, the study’s main value going forward is helping to explain a rash of worsening inflammatory skin disease that many dermatologists saw early in the pandemic. “We would regularly see patients who were well controlled with, for example, psoriasis or eczema. But after COVID-19 infection or a vaccine (usually mRNA-type), in some cases they would come in flaring badly.” This happened at least a dozen times during the first year of post-shutdown appointments, he said.

“We’ve seen patients who have flared multiple times — they get the booster, then flare again,” Han added. Similar patterns occurred with pyoderma gangrenosum and other inflammatory skin diseases, he said.

Given the modest effect sizes of the associations reported in the Korean study, Arkin and colleagues wrote in their JAMA Dermatology editorial that surveillance for autoimmune disease is probably not warranted without new examination findings or symptoms. “For certain,” King said, “we should not go hunting for things that aren’t obviously there.”

Rather, Arkin and colleagues wrote, the higher autoimmunity rates seen among the unvaccinated, as well as during the Delta phase (when patients were sicker and hospitalizations were more likely) and in patients requiring intensive care, suggest that “interventions that reduce disease severity could also potentially reduce long-term risk of subsequent autoimmune sequelae.”

Future research addressing whether people with preexisting autoimmune conditions are at greater risk for flares or developing new autoimmune diseases following COVID-19 infection “would help to frame an evidence-based approach for patients with autoimmune disorders who develop COVID-19 infection, including the role for antiviral treatments,” they added.

The study was supported by grants from the Research Program of the Korea Medical Institute, the Korea Health Industry Development Institute, and the National Research Foundation of Korea. Han and King reported no relevant financial relationships. Arkin disclosed receiving research grants to her institution from Amgen and Eli Lilly, personal fees from Sanofi/Regeneron for consulting, and personal consulting fees from Merck outside the submitted work. Another author reported personal consulting fees from Dexcel Pharma and Honeydew outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

A population-based study has shown a slightly elevated risk for patients’ developing skin disorders, including alopecia areata (AA), alopecia totalis (AT), vitiligo, and bullous pemphigoid (BP), more than 6 months after COVID-19 infection. In addition, the authors reported that COVID-19 vaccination appears to reduce these risks.

The study was published in JAMA Dermatology.

 

‘Compelling Evidence’

“This well-executed study by Heo et al provides compelling evidence to support an association between COVID-19 infection and the development of subsequent autoimmune and autoinflammatory skin diseases,” wrote authors led by Lisa M. Arkin, MD, of the Department of Dermatology, University of Wisconsin School of Medicine and Public Health in Madison, in an accompanying editorial.

Using databases from Korea’s National Health Insurance Service and the Korea Disease Control and Prevention Agency, investigators led by Yeon-Woo Heo, MD, a dermatology resident at Yonsei University Wonju College of Medicine, Wonju, Republic of Korea, compared 3.1 million people who had COVID-19 with 3.8 million controls, all with at least 180 days’ follow-up through December 31, 2022.

At a mean follow-up of 287 days in both cohorts, authors found significantly elevated risks for AA and vitiligo (adjusted hazard ratio [aHR], 1.11 for both), AT (aHR, 1.24), Behçet disease (aHR, 1.45), and BP (aHR, 1.62) in the post–COVID-19 cohort. The infection also raised the risk for other conditions such as systemic lupus erythematosus (aHR, 1.14) and Crohn’s disease (aHR, 1.35).

In subgroup analyses, demographic factors were associated with diverse effects: COVID-19 infection was associated with significantly higher odds of developing AA (for both men and women), vitiligo (men), Behçet disease (men and women), Crohn’s disease (men), ulcerative colitis (men), rheumatoid arthritis (men and women), systemic lupus erythematosus (men), ankylosing spondylitis (men), AT (women), and BP (women) than controls.

Those aged under 40 years were more likely to develop AA, primary cicatricial alopecia, Behçet disease, and ulcerative colitis, while those aged 40 years or older were more likely to develop AA, AT, vitiligo, Behçet disease, Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis, and BP.

Additionally, severe COVID-19 requiring intensive care unit admission was associated with a significantly increased risk for autoimmune diseases, including AA, psoriasis, BP, and sarcoidosis. By timeframe, risks for AA, AT, and psoriasis were significantly higher during the initial Delta-dominant period.

 

Vaccination Effect

Moreover, vaccinated individuals were less likely to develop AA, AT, psoriasis, Behçet disease, and various nondermatologic conditions than were those who were unvaccinated. This finding, wrote Heo and colleagues, “may provide evidence to support the hypothesis that COVID-19 vaccines can help prevent autoimmune diseases.”

“That’s the part we all need to take into our offices tomorrow,” said Brett King, MD, PhD, a Fairfield, Connecticut–based dermatologist in private practice. He was not involved with the study but was asked to comment.

Overall, King said, the study carries two main messages. “The first is that COVID-19 infection increases the likelihood of developing an autoimmune or autoinflammatory disease in a large population.” The second and very important message is that being vaccinated against COVID-19 provides protection against developing an autoimmune or autoinflammatory disease.

“My concern is that the popular media highlights the first part,” said King, “and everybody who develops alopecia areata, vitiligo, or sarcoidosis blames COVID-19. That’s not what this work says.”

The foregoing distinction is especially important during the fall and winter, he added, when people getting influenza vaccines are routinely offered COVID-19 vaccines. “Many patients have said, ‘I got the COVID vaccine and developed alopecia areata 6 months later.’ Nearly everybody who has developed a new or worsening health condition in the last almost 5 years has had the perfect fall guy — the COVID vaccine or infection.”

With virtually all patients asking if they should get an updated COVID-19 vaccine or booster, he added, many report having heard that such vaccines cause AA, vitiligo, or other diseases. “To anchor these conversations in real data and not just anecdotes from a blog or Facebook is very useful,” said King, “and now we have very good data saying that the COVID vaccine is protective against these disorders.”

George Han, MD, PhD, associate professor of dermatology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, applauds investigators’ use of a large, robust database but suggests interpreting results cautiously. He was not involved with the study but was asked to comment.

“You could do a large, well-done study,” Han said, “but it could still not necessarily be generalizable. These autoimmune conditions they’re looking at have clear ethnic and racial biases.” Heo and colleagues acknowledged shortcomings including their study population’s monomorphic nature.

Additional issues that limit the study’s impact, said Han, include the difficulty of conceptualizing a 10%-20% increase in conditions that at baseline are rare. And many of the findings reflected natural patterns, he said. For instance, BP more commonly affects older people, COVID-19 notwithstanding.

Han said that for him, the study’s main value going forward is helping to explain a rash of worsening inflammatory skin disease that many dermatologists saw early in the pandemic. “We would regularly see patients who were well controlled with, for example, psoriasis or eczema. But after COVID-19 infection or a vaccine (usually mRNA-type), in some cases they would come in flaring badly.” This happened at least a dozen times during the first year of post-shutdown appointments, he said.

“We’ve seen patients who have flared multiple times — they get the booster, then flare again,” Han added. Similar patterns occurred with pyoderma gangrenosum and other inflammatory skin diseases, he said.

Given the modest effect sizes of the associations reported in the Korean study, Arkin and colleagues wrote in their JAMA Dermatology editorial that surveillance for autoimmune disease is probably not warranted without new examination findings or symptoms. “For certain,” King said, “we should not go hunting for things that aren’t obviously there.”

Rather, Arkin and colleagues wrote, the higher autoimmunity rates seen among the unvaccinated, as well as during the Delta phase (when patients were sicker and hospitalizations were more likely) and in patients requiring intensive care, suggest that “interventions that reduce disease severity could also potentially reduce long-term risk of subsequent autoimmune sequelae.”

Future research addressing whether people with preexisting autoimmune conditions are at greater risk for flares or developing new autoimmune diseases following COVID-19 infection “would help to frame an evidence-based approach for patients with autoimmune disorders who develop COVID-19 infection, including the role for antiviral treatments,” they added.

The study was supported by grants from the Research Program of the Korea Medical Institute, the Korea Health Industry Development Institute, and the National Research Foundation of Korea. Han and King reported no relevant financial relationships. Arkin disclosed receiving research grants to her institution from Amgen and Eli Lilly, personal fees from Sanofi/Regeneron for consulting, and personal consulting fees from Merck outside the submitted work. Another author reported personal consulting fees from Dexcel Pharma and Honeydew outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

A population-based study has shown a slightly elevated risk for patients’ developing skin disorders, including alopecia areata (AA), alopecia totalis (AT), vitiligo, and bullous pemphigoid (BP), more than 6 months after COVID-19 infection. In addition, the authors reported that COVID-19 vaccination appears to reduce these risks.

The study was published in JAMA Dermatology.

 

‘Compelling Evidence’

“This well-executed study by Heo et al provides compelling evidence to support an association between COVID-19 infection and the development of subsequent autoimmune and autoinflammatory skin diseases,” wrote authors led by Lisa M. Arkin, MD, of the Department of Dermatology, University of Wisconsin School of Medicine and Public Health in Madison, in an accompanying editorial.

Using databases from Korea’s National Health Insurance Service and the Korea Disease Control and Prevention Agency, investigators led by Yeon-Woo Heo, MD, a dermatology resident at Yonsei University Wonju College of Medicine, Wonju, Republic of Korea, compared 3.1 million people who had COVID-19 with 3.8 million controls, all with at least 180 days’ follow-up through December 31, 2022.

At a mean follow-up of 287 days in both cohorts, authors found significantly elevated risks for AA and vitiligo (adjusted hazard ratio [aHR], 1.11 for both), AT (aHR, 1.24), Behçet disease (aHR, 1.45), and BP (aHR, 1.62) in the post–COVID-19 cohort. The infection also raised the risk for other conditions such as systemic lupus erythematosus (aHR, 1.14) and Crohn’s disease (aHR, 1.35).

In subgroup analyses, demographic factors were associated with diverse effects: COVID-19 infection was associated with significantly higher odds of developing AA (for both men and women), vitiligo (men), Behçet disease (men and women), Crohn’s disease (men), ulcerative colitis (men), rheumatoid arthritis (men and women), systemic lupus erythematosus (men), ankylosing spondylitis (men), AT (women), and BP (women) than controls.

Those aged under 40 years were more likely to develop AA, primary cicatricial alopecia, Behçet disease, and ulcerative colitis, while those aged 40 years or older were more likely to develop AA, AT, vitiligo, Behçet disease, Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis, and BP.

Additionally, severe COVID-19 requiring intensive care unit admission was associated with a significantly increased risk for autoimmune diseases, including AA, psoriasis, BP, and sarcoidosis. By timeframe, risks for AA, AT, and psoriasis were significantly higher during the initial Delta-dominant period.

 

Vaccination Effect

Moreover, vaccinated individuals were less likely to develop AA, AT, psoriasis, Behçet disease, and various nondermatologic conditions than were those who were unvaccinated. This finding, wrote Heo and colleagues, “may provide evidence to support the hypothesis that COVID-19 vaccines can help prevent autoimmune diseases.”

“That’s the part we all need to take into our offices tomorrow,” said Brett King, MD, PhD, a Fairfield, Connecticut–based dermatologist in private practice. He was not involved with the study but was asked to comment.

Overall, King said, the study carries two main messages. “The first is that COVID-19 infection increases the likelihood of developing an autoimmune or autoinflammatory disease in a large population.” The second and very important message is that being vaccinated against COVID-19 provides protection against developing an autoimmune or autoinflammatory disease.

“My concern is that the popular media highlights the first part,” said King, “and everybody who develops alopecia areata, vitiligo, or sarcoidosis blames COVID-19. That’s not what this work says.”

The foregoing distinction is especially important during the fall and winter, he added, when people getting influenza vaccines are routinely offered COVID-19 vaccines. “Many patients have said, ‘I got the COVID vaccine and developed alopecia areata 6 months later.’ Nearly everybody who has developed a new or worsening health condition in the last almost 5 years has had the perfect fall guy — the COVID vaccine or infection.”

With virtually all patients asking if they should get an updated COVID-19 vaccine or booster, he added, many report having heard that such vaccines cause AA, vitiligo, or other diseases. “To anchor these conversations in real data and not just anecdotes from a blog or Facebook is very useful,” said King, “and now we have very good data saying that the COVID vaccine is protective against these disorders.”

George Han, MD, PhD, associate professor of dermatology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, applauds investigators’ use of a large, robust database but suggests interpreting results cautiously. He was not involved with the study but was asked to comment.

“You could do a large, well-done study,” Han said, “but it could still not necessarily be generalizable. These autoimmune conditions they’re looking at have clear ethnic and racial biases.” Heo and colleagues acknowledged shortcomings including their study population’s monomorphic nature.

Additional issues that limit the study’s impact, said Han, include the difficulty of conceptualizing a 10%-20% increase in conditions that at baseline are rare. And many of the findings reflected natural patterns, he said. For instance, BP more commonly affects older people, COVID-19 notwithstanding.

Han said that for him, the study’s main value going forward is helping to explain a rash of worsening inflammatory skin disease that many dermatologists saw early in the pandemic. “We would regularly see patients who were well controlled with, for example, psoriasis or eczema. But after COVID-19 infection or a vaccine (usually mRNA-type), in some cases they would come in flaring badly.” This happened at least a dozen times during the first year of post-shutdown appointments, he said.

“We’ve seen patients who have flared multiple times — they get the booster, then flare again,” Han added. Similar patterns occurred with pyoderma gangrenosum and other inflammatory skin diseases, he said.

Given the modest effect sizes of the associations reported in the Korean study, Arkin and colleagues wrote in their JAMA Dermatology editorial that surveillance for autoimmune disease is probably not warranted without new examination findings or symptoms. “For certain,” King said, “we should not go hunting for things that aren’t obviously there.”

Rather, Arkin and colleagues wrote, the higher autoimmunity rates seen among the unvaccinated, as well as during the Delta phase (when patients were sicker and hospitalizations were more likely) and in patients requiring intensive care, suggest that “interventions that reduce disease severity could also potentially reduce long-term risk of subsequent autoimmune sequelae.”

Future research addressing whether people with preexisting autoimmune conditions are at greater risk for flares or developing new autoimmune diseases following COVID-19 infection “would help to frame an evidence-based approach for patients with autoimmune disorders who develop COVID-19 infection, including the role for antiviral treatments,” they added.

The study was supported by grants from the Research Program of the Korea Medical Institute, the Korea Health Industry Development Institute, and the National Research Foundation of Korea. Han and King reported no relevant financial relationships. Arkin disclosed receiving research grants to her institution from Amgen and Eli Lilly, personal fees from Sanofi/Regeneron for consulting, and personal consulting fees from Merck outside the submitted work. Another author reported personal consulting fees from Dexcel Pharma and Honeydew outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Early escalation to biologic therapies after failure of treat-to-target with methotrexate in patients with rheumatoid arthritis (RA) does not significantly reduce the risk for the development of difficult-to-treat RA.

METHODOLOGY:

• Researchers conducted a retrospective analysis including 722 patients with new-onset RA (mean age, 60 years; 72% women) who were identified from a cohort at the IRCCS Policlinico San Matteo University Hospital in Italy and followed-up for at least 3 years after diagnosis.
• Patients were initially treated with methotrexate, with escalation to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in case they did not reach the therapeutic target.
• Follow-up for patients who started b/tsDMARDs occurred every 2 months for the first 6 months, then every 4 months, with a target of achieving low disease activity (28-joint disease activity score, < 3.2).
• The effectiveness of each DMARD was evaluated using drug survival rates, and the development of difficult-to-treat RA was assessed using the European Alliance of Associations for Rheumatology criteria.

TAKEAWAY:

• The retention rate of the first b/tsDMARD dropped from 72.3% at 12 months to 41.6% at 60 months, indicating a decline in treatment persistence over time.
• Early escalation to biologic therapies did not significantly reduce the risk for difficult-to-treat RA, with 29% patients meeting the criteria after a median follow-up period of 72.6 months.
• Patients with higher disease activity and a higher number of swollen joints at the start of biologic therapy were more likely to develop treatment resistance.
• Shorter disease duration at the start of treatment with b/tsDMARDs, a greater number of swollen joints, worse pain scores, and autoantibody-negative status were identified as independent predictors of difficult-to-treat RA.

IN PRACTICE:

“Early implementation of treatment after failure of treat-to-target with MTX [methotrexate] may not prevent the development of D2T [difficult-to-treat] in patients with RA,” the authors concluded.

SOURCE:

The study was led by Bernardo D’Onofrio, MD, and Ludovico De Stefano, MD, Department of Internal Medicine and Therapeutics, University of Pavia, in Italy. It was published online November 8, 2024, in Arthritis Research & Therapy.

LIMITATIONS:

The escalation to b/tsDMARDs was not strictly guided by disease activity scores, potentially reflecting clinical practice. Additionally, the study did not account for socioeconomic factors or adherence, which may have influenced treatment outcomes.

DISCLOSURES:

This study was supported by a grant from the IRCCS Policlinico San Matteo Foundation. One author reported receiving grants/research support and personal fees and two authors reported receiving personal fees from various pharmaceutical companies.

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:

Early escalation to biologic therapies after failure of treat-to-target with methotrexate in patients with rheumatoid arthritis (RA) does not significantly reduce the risk for the development of difficult-to-treat RA.

METHODOLOGY:

• Researchers conducted a retrospective analysis including 722 patients with new-onset RA (mean age, 60 years; 72% women) who were identified from a cohort at the IRCCS Policlinico San Matteo University Hospital in Italy and followed-up for at least 3 years after diagnosis.
• Patients were initially treated with methotrexate, with escalation to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in case they did not reach the therapeutic target.
• Follow-up for patients who started b/tsDMARDs occurred every 2 months for the first 6 months, then every 4 months, with a target of achieving low disease activity (28-joint disease activity score, < 3.2).
• The effectiveness of each DMARD was evaluated using drug survival rates, and the development of difficult-to-treat RA was assessed using the European Alliance of Associations for Rheumatology criteria.

TAKEAWAY:

• The retention rate of the first b/tsDMARD dropped from 72.3% at 12 months to 41.6% at 60 months, indicating a decline in treatment persistence over time.
• Early escalation to biologic therapies did not significantly reduce the risk for difficult-to-treat RA, with 29% patients meeting the criteria after a median follow-up period of 72.6 months.
• Patients with higher disease activity and a higher number of swollen joints at the start of biologic therapy were more likely to develop treatment resistance.
• Shorter disease duration at the start of treatment with b/tsDMARDs, a greater number of swollen joints, worse pain scores, and autoantibody-negative status were identified as independent predictors of difficult-to-treat RA.

IN PRACTICE:

“Early implementation of treatment after failure of treat-to-target with MTX [methotrexate] may not prevent the development of D2T [difficult-to-treat] in patients with RA,” the authors concluded.

SOURCE:

The study was led by Bernardo D’Onofrio, MD, and Ludovico De Stefano, MD, Department of Internal Medicine and Therapeutics, University of Pavia, in Italy. It was published online November 8, 2024, in Arthritis Research & Therapy.

LIMITATIONS:

The escalation to b/tsDMARDs was not strictly guided by disease activity scores, potentially reflecting clinical practice. Additionally, the study did not account for socioeconomic factors or adherence, which may have influenced treatment outcomes.

DISCLOSURES:

This study was supported by a grant from the IRCCS Policlinico San Matteo Foundation. One author reported receiving grants/research support and personal fees and two authors reported receiving personal fees from various pharmaceutical companies.

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:

Early escalation to biologic therapies after failure of treat-to-target with methotrexate in patients with rheumatoid arthritis (RA) does not significantly reduce the risk for the development of difficult-to-treat RA.

METHODOLOGY:

• Researchers conducted a retrospective analysis including 722 patients with new-onset RA (mean age, 60 years; 72% women) who were identified from a cohort at the IRCCS Policlinico San Matteo University Hospital in Italy and followed-up for at least 3 years after diagnosis.
• Patients were initially treated with methotrexate, with escalation to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in case they did not reach the therapeutic target.
• Follow-up for patients who started b/tsDMARDs occurred every 2 months for the first 6 months, then every 4 months, with a target of achieving low disease activity (28-joint disease activity score, < 3.2).
• The effectiveness of each DMARD was evaluated using drug survival rates, and the development of difficult-to-treat RA was assessed using the European Alliance of Associations for Rheumatology criteria.

TAKEAWAY:

• The retention rate of the first b/tsDMARD dropped from 72.3% at 12 months to 41.6% at 60 months, indicating a decline in treatment persistence over time.
• Early escalation to biologic therapies did not significantly reduce the risk for difficult-to-treat RA, with 29% patients meeting the criteria after a median follow-up period of 72.6 months.
• Patients with higher disease activity and a higher number of swollen joints at the start of biologic therapy were more likely to develop treatment resistance.
• Shorter disease duration at the start of treatment with b/tsDMARDs, a greater number of swollen joints, worse pain scores, and autoantibody-negative status were identified as independent predictors of difficult-to-treat RA.

IN PRACTICE:

“Early implementation of treatment after failure of treat-to-target with MTX [methotrexate] may not prevent the development of D2T [difficult-to-treat] in patients with RA,” the authors concluded.

SOURCE:

The study was led by Bernardo D’Onofrio, MD, and Ludovico De Stefano, MD, Department of Internal Medicine and Therapeutics, University of Pavia, in Italy. It was published online November 8, 2024, in Arthritis Research & Therapy.

LIMITATIONS:

The escalation to b/tsDMARDs was not strictly guided by disease activity scores, potentially reflecting clinical practice. Additionally, the study did not account for socioeconomic factors or adherence, which may have influenced treatment outcomes.

DISCLOSURES:

This study was supported by a grant from the IRCCS Policlinico San Matteo Foundation. One author reported receiving grants/research support and personal fees and two authors reported receiving personal fees from various pharmaceutical companies.

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.

The addition of dupilumab significantly reduced itching and hives, compared with placebo, in patients with chronic spontaneous urticaria (CSU) that was uncontrolled with H1-antihistamines, based on data from 151 individuals.

“Approximately 50% of patients with chronic spontaneous urticaria do not respond to antihistamines,” said Thomas B. Casale, MD, professor of internal medicine at the University of South Florida, Tampa, in an interview. Omalizumab, the only biologic approved for this condition, is not effective in all patients, and additional treatment options are needed, added Casale, the lead author who presented the new data, at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting.

Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)–4 and IL-13 pathways, is currently approved in the United States for the treatment of several allergy and dermatology indications, including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.

In the study, known as LIBERTY-CSU CUPID Study C, researchers randomized 74 patients with CSU aged 6 years or older to add-on dupilumab subcutaneously every 2 weeks and 77 to placebo. (Patients were omalizumab-naive and had symptomatic CSU, despite treatment with up to four times the approved dose of standard-of-care H1-antihistamines.) Dupilumab doses were 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg.

The primary outcomes were Itch Severity Score over 7 days (ISS7; range, 0-21) and Urticaria Activity Score over 7 days (UAS7; range, 0-42).

Over the 24-week study period, patients in the dupilumab group showed significantly greater change from baseline than those in the placebo group on both measures, with least squares mean changes of 8.6 vs 6.1 for ISS7 and 15.9 vs 11.2 for UAS7 (P = .02 for both).

In addition, at 24 weeks, significantly more patients in the dupilumab group than in the placebo group achieved well-controlled disease based on a UAS of 6 or lower (41% vs 23%; P = .005). Significantly more dupilumab-treated patients also achieved a complete response (defined as a UAS of 0), compared with placebo-treated patients (30% vs 18%; P = .02).

Overall rates of treatment-emergent adverse events were 53% for both groups, and safety data were mainly consistent with dupilumab’s known safety profile, the researchers wrote.

The findings were not surprising, as a previous related study, LIBERTY-CSU CUPID Study A, showed that dupilumab was effective for CSU, Casale told this news organization. “This replicate study confirms the previous study and provides evidence for regulatory approval.”

If approved by the Food and Drug Administration (FDA), “dupilumab will provide another therapeutic option for patients with chronic urticaria unresponsive to antihistamines,” Casale commented.

No new safety signals occurred, and the ability to self-administer the medication at home provides an advantage for patients, he added. As for additional research, “analysis of patient characteristics and potential biomarkers that would predict responsiveness is needed.”

 

More Research Needed to Fine-Tune Management

An unmet need persists for patients with CSU whose disease is not adequately controlled by higher-dose H1-antihistamines, Robert G. Micheletti, MD, associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, said in an interview. “It is important not only to identify effective add-on therapies for these patients but also to generate data to support insurance coverage and drug access,” said Micheletti, who was not involved in the study.

Also referring to the similar findings reported in the LIBERTY-CSU CUPID Study A, Micheletti said, “as in the earlier study, the results demonstrate significantly reduced itch and urticaria in treated patients compared to placebo.”

“While many providers currently prescribe dupilumab off-label for refractory CSU, FDA approval would improve access to the drug for patients who need it and provide an alternative for patients who may not be good candidates for omalizumab,” he added. However, more research is needed to define optimal management of patients with CSU with inadequate response to omalizumab.

“The LIBERTY-CSU CUPID Study B showed a small improvement in itch severity and urticaria activity among such patients receiving dupilumab,” he noted. “Future work should aim to identify biomarkers and other features predictive of response to various therapies.” 

Study B involved patients with CSU who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab, according to Regeneron. 

On November 15, after the ACAAI meeting had ended, the company announced that the FDA had accepted the resubmission of an application for approval of dupilumab for the treatment of CSU in adults and pediatric patients aged 12 years or older not adequately controlled with H1-antihistamines.

The study was supported and sponsored by Sanofi and Regeneron Pharmaceuticals. Casale disclosed serving as a consultant for ALK, ARS Pharma, AstraZeneca, Bryn Pharma, Celgene, Eli Lilly, Genentech, GSK, Jasper, Novartis, Regeneron, and Sanofi and as a speaker for Genentech and Regeneron. Micheletti had no relevant financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

The addition of dupilumab significantly reduced itching and hives, compared with placebo, in patients with chronic spontaneous urticaria (CSU) that was uncontrolled with H1-antihistamines, based on data from 151 individuals.

“Approximately 50% of patients with chronic spontaneous urticaria do not respond to antihistamines,” said Thomas B. Casale, MD, professor of internal medicine at the University of South Florida, Tampa, in an interview. Omalizumab, the only biologic approved for this condition, is not effective in all patients, and additional treatment options are needed, added Casale, the lead author who presented the new data, at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting.

Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)–4 and IL-13 pathways, is currently approved in the United States for the treatment of several allergy and dermatology indications, including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.

In the study, known as LIBERTY-CSU CUPID Study C, researchers randomized 74 patients with CSU aged 6 years or older to add-on dupilumab subcutaneously every 2 weeks and 77 to placebo. (Patients were omalizumab-naive and had symptomatic CSU, despite treatment with up to four times the approved dose of standard-of-care H1-antihistamines.) Dupilumab doses were 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg.

The primary outcomes were Itch Severity Score over 7 days (ISS7; range, 0-21) and Urticaria Activity Score over 7 days (UAS7; range, 0-42).

Over the 24-week study period, patients in the dupilumab group showed significantly greater change from baseline than those in the placebo group on both measures, with least squares mean changes of 8.6 vs 6.1 for ISS7 and 15.9 vs 11.2 for UAS7 (P = .02 for both).

In addition, at 24 weeks, significantly more patients in the dupilumab group than in the placebo group achieved well-controlled disease based on a UAS of 6 or lower (41% vs 23%; P = .005). Significantly more dupilumab-treated patients also achieved a complete response (defined as a UAS of 0), compared with placebo-treated patients (30% vs 18%; P = .02).

Overall rates of treatment-emergent adverse events were 53% for both groups, and safety data were mainly consistent with dupilumab’s known safety profile, the researchers wrote.

The findings were not surprising, as a previous related study, LIBERTY-CSU CUPID Study A, showed that dupilumab was effective for CSU, Casale told this news organization. “This replicate study confirms the previous study and provides evidence for regulatory approval.”

If approved by the Food and Drug Administration (FDA), “dupilumab will provide another therapeutic option for patients with chronic urticaria unresponsive to antihistamines,” Casale commented.

No new safety signals occurred, and the ability to self-administer the medication at home provides an advantage for patients, he added. As for additional research, “analysis of patient characteristics and potential biomarkers that would predict responsiveness is needed.”

 

More Research Needed to Fine-Tune Management

An unmet need persists for patients with CSU whose disease is not adequately controlled by higher-dose H1-antihistamines, Robert G. Micheletti, MD, associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, said in an interview. “It is important not only to identify effective add-on therapies for these patients but also to generate data to support insurance coverage and drug access,” said Micheletti, who was not involved in the study.

Also referring to the similar findings reported in the LIBERTY-CSU CUPID Study A, Micheletti said, “as in the earlier study, the results demonstrate significantly reduced itch and urticaria in treated patients compared to placebo.”

“While many providers currently prescribe dupilumab off-label for refractory CSU, FDA approval would improve access to the drug for patients who need it and provide an alternative for patients who may not be good candidates for omalizumab,” he added. However, more research is needed to define optimal management of patients with CSU with inadequate response to omalizumab.

“The LIBERTY-CSU CUPID Study B showed a small improvement in itch severity and urticaria activity among such patients receiving dupilumab,” he noted. “Future work should aim to identify biomarkers and other features predictive of response to various therapies.” 

Study B involved patients with CSU who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab, according to Regeneron. 

On November 15, after the ACAAI meeting had ended, the company announced that the FDA had accepted the resubmission of an application for approval of dupilumab for the treatment of CSU in adults and pediatric patients aged 12 years or older not adequately controlled with H1-antihistamines.

The study was supported and sponsored by Sanofi and Regeneron Pharmaceuticals. Casale disclosed serving as a consultant for ALK, ARS Pharma, AstraZeneca, Bryn Pharma, Celgene, Eli Lilly, Genentech, GSK, Jasper, Novartis, Regeneron, and Sanofi and as a speaker for Genentech and Regeneron. Micheletti had no relevant financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

The addition of dupilumab significantly reduced itching and hives, compared with placebo, in patients with chronic spontaneous urticaria (CSU) that was uncontrolled with H1-antihistamines, based on data from 151 individuals.

“Approximately 50% of patients with chronic spontaneous urticaria do not respond to antihistamines,” said Thomas B. Casale, MD, professor of internal medicine at the University of South Florida, Tampa, in an interview. Omalizumab, the only biologic approved for this condition, is not effective in all patients, and additional treatment options are needed, added Casale, the lead author who presented the new data, at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting.

Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)–4 and IL-13 pathways, is currently approved in the United States for the treatment of several allergy and dermatology indications, including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.

In the study, known as LIBERTY-CSU CUPID Study C, researchers randomized 74 patients with CSU aged 6 years or older to add-on dupilumab subcutaneously every 2 weeks and 77 to placebo. (Patients were omalizumab-naive and had symptomatic CSU, despite treatment with up to four times the approved dose of standard-of-care H1-antihistamines.) Dupilumab doses were 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg.

The primary outcomes were Itch Severity Score over 7 days (ISS7; range, 0-21) and Urticaria Activity Score over 7 days (UAS7; range, 0-42).

Over the 24-week study period, patients in the dupilumab group showed significantly greater change from baseline than those in the placebo group on both measures, with least squares mean changes of 8.6 vs 6.1 for ISS7 and 15.9 vs 11.2 for UAS7 (P = .02 for both).

In addition, at 24 weeks, significantly more patients in the dupilumab group than in the placebo group achieved well-controlled disease based on a UAS of 6 or lower (41% vs 23%; P = .005). Significantly more dupilumab-treated patients also achieved a complete response (defined as a UAS of 0), compared with placebo-treated patients (30% vs 18%; P = .02).

Overall rates of treatment-emergent adverse events were 53% for both groups, and safety data were mainly consistent with dupilumab’s known safety profile, the researchers wrote.

The findings were not surprising, as a previous related study, LIBERTY-CSU CUPID Study A, showed that dupilumab was effective for CSU, Casale told this news organization. “This replicate study confirms the previous study and provides evidence for regulatory approval.”

If approved by the Food and Drug Administration (FDA), “dupilumab will provide another therapeutic option for patients with chronic urticaria unresponsive to antihistamines,” Casale commented.

No new safety signals occurred, and the ability to self-administer the medication at home provides an advantage for patients, he added. As for additional research, “analysis of patient characteristics and potential biomarkers that would predict responsiveness is needed.”

 

More Research Needed to Fine-Tune Management

An unmet need persists for patients with CSU whose disease is not adequately controlled by higher-dose H1-antihistamines, Robert G. Micheletti, MD, associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, said in an interview. “It is important not only to identify effective add-on therapies for these patients but also to generate data to support insurance coverage and drug access,” said Micheletti, who was not involved in the study.

Also referring to the similar findings reported in the LIBERTY-CSU CUPID Study A, Micheletti said, “as in the earlier study, the results demonstrate significantly reduced itch and urticaria in treated patients compared to placebo.”

“While many providers currently prescribe dupilumab off-label for refractory CSU, FDA approval would improve access to the drug for patients who need it and provide an alternative for patients who may not be good candidates for omalizumab,” he added. However, more research is needed to define optimal management of patients with CSU with inadequate response to omalizumab.

“The LIBERTY-CSU CUPID Study B showed a small improvement in itch severity and urticaria activity among such patients receiving dupilumab,” he noted. “Future work should aim to identify biomarkers and other features predictive of response to various therapies.” 

Study B involved patients with CSU who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab, according to Regeneron. 

On November 15, after the ACAAI meeting had ended, the company announced that the FDA had accepted the resubmission of an application for approval of dupilumab for the treatment of CSU in adults and pediatric patients aged 12 years or older not adequately controlled with H1-antihistamines.

The study was supported and sponsored by Sanofi and Regeneron Pharmaceuticals. Casale disclosed serving as a consultant for ALK, ARS Pharma, AstraZeneca, Bryn Pharma, Celgene, Eli Lilly, Genentech, GSK, Jasper, Novartis, Regeneron, and Sanofi and as a speaker for Genentech and Regeneron. Micheletti had no relevant financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

TOPLINE:

Home spirometry shows potential for early detection of pulmonary function decline in patients with systemic sclerosis–associated interstitial lung disease (SSc-ILD). It shows good cross-sectional correlation with hospital tests, along with 60% sensitivity and 87% specificity for detecting progressive ILD.

METHODOLOGY:

• Researchers conducted a prospective, observational study to examine the validity of home spirometry for detecting a decline in pulmonary function in patients with SSc-ILD.
• They included 43 patients aged 18 years or older with SSc-ILD from two tertiary referral centers in the Netherlands who received treatment with immunosuppressives for a maximum duration of 8 weeks prior to baseline.
• All participants were required to take weekly home spirometry measurements using a handheld spirometer for 1 year, with 35 completing 6 months of follow-up and 31 completing 12 months.
• Pulmonary function tests were conducted in the hospital at baseline and semiannual visits.
• The primary outcome was the κ (kappa statistic) agreement between home and hospital measurements after 1 year to detect a decline in forced vital capacity (FVC) of 5% or more; the sensitivity and specificity of home spirometry were also evaluated to detect an absolute decline in FVC%, using hospital tests as the gold standard.

TAKEAWAY:

• Home spirometry showed a fair agreement with the pulmonary function tests conducted at the hospital (κ, 0.40; 95% CI, 0.01-0.79).
• Home spirometry showed a sensitivity of 60% and specificity of 87% in detecting a decline in FVC% predicted of 5% or more.
• The intraclass correlation coefficient between home and hospital FVC measurements was moderate to high, with values of 0.85 at baseline, 0.84 at 6 months, and 0.72 at 12 months (P < .0001 for all).
• However, the longitudinal agreement between home and hospital measurements was lower with a correlation coefficient of 0.55.

IN PRACTICE:

“These findings suggest that home spirometry is both feasible and moderately accurate in patients with systemic sclerosis–associated ILD. However, where home spirometry fell short was the low sensitivity in detecting a decline in FVC% predicted,” experts wrote in an accompanying editorial.

“The results of this study support further evaluation of the implementation of home spirometry in addition to regular healthcare management but do not endorse relying solely on home monitoring to detect a decline in pulmonary function,” study authors wrote.

SOURCE:

The study was led by Arthiha Velauthapillai, MD, Department of Rheumatology, Radboud University Medical Center, Nijmegen, the Netherlands, and was published online November 8, 2024, in The Lancet Rheumatology.

LIMITATIONS:

The study might have been underpowered because of inaccuracies in initial assumptions, with a lower-than-anticipated prevalence of progressive ILD and a higher dropout rate. The study included only Dutch patients, which may have limited the generalizability of its findings to other settings with lower internet access or literacy rates.

DISCLOSURES:

This study was partly supported by grants from Galapagos and Boehringer Ingelheim. Some authors received grants or consulting or speaker fees from Boehringer Ingelheim, AstraZeneca, and other pharmaceutical companies.

 

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:

Home spirometry shows potential for early detection of pulmonary function decline in patients with systemic sclerosis–associated interstitial lung disease (SSc-ILD). It shows good cross-sectional correlation with hospital tests, along with 60% sensitivity and 87% specificity for detecting progressive ILD.

METHODOLOGY:

• Researchers conducted a prospective, observational study to examine the validity of home spirometry for detecting a decline in pulmonary function in patients with SSc-ILD.
• They included 43 patients aged 18 years or older with SSc-ILD from two tertiary referral centers in the Netherlands who received treatment with immunosuppressives for a maximum duration of 8 weeks prior to baseline.
• All participants were required to take weekly home spirometry measurements using a handheld spirometer for 1 year, with 35 completing 6 months of follow-up and 31 completing 12 months.
• Pulmonary function tests were conducted in the hospital at baseline and semiannual visits.
• The primary outcome was the κ (kappa statistic) agreement between home and hospital measurements after 1 year to detect a decline in forced vital capacity (FVC) of 5% or more; the sensitivity and specificity of home spirometry were also evaluated to detect an absolute decline in FVC%, using hospital tests as the gold standard.

TAKEAWAY:

• Home spirometry showed a fair agreement with the pulmonary function tests conducted at the hospital (κ, 0.40; 95% CI, 0.01-0.79).
• Home spirometry showed a sensitivity of 60% and specificity of 87% in detecting a decline in FVC% predicted of 5% or more.
• The intraclass correlation coefficient between home and hospital FVC measurements was moderate to high, with values of 0.85 at baseline, 0.84 at 6 months, and 0.72 at 12 months (P < .0001 for all).
• However, the longitudinal agreement between home and hospital measurements was lower with a correlation coefficient of 0.55.

IN PRACTICE:

“These findings suggest that home spirometry is both feasible and moderately accurate in patients with systemic sclerosis–associated ILD. However, where home spirometry fell short was the low sensitivity in detecting a decline in FVC% predicted,” experts wrote in an accompanying editorial.

“The results of this study support further evaluation of the implementation of home spirometry in addition to regular healthcare management but do not endorse relying solely on home monitoring to detect a decline in pulmonary function,” study authors wrote.

SOURCE:

The study was led by Arthiha Velauthapillai, MD, Department of Rheumatology, Radboud University Medical Center, Nijmegen, the Netherlands, and was published online November 8, 2024, in The Lancet Rheumatology.

LIMITATIONS:

The study might have been underpowered because of inaccuracies in initial assumptions, with a lower-than-anticipated prevalence of progressive ILD and a higher dropout rate. The study included only Dutch patients, which may have limited the generalizability of its findings to other settings with lower internet access or literacy rates.

DISCLOSURES:

This study was partly supported by grants from Galapagos and Boehringer Ingelheim. Some authors received grants or consulting or speaker fees from Boehringer Ingelheim, AstraZeneca, and other pharmaceutical companies.

 

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:

Home spirometry shows potential for early detection of pulmonary function decline in patients with systemic sclerosis–associated interstitial lung disease (SSc-ILD). It shows good cross-sectional correlation with hospital tests, along with 60% sensitivity and 87% specificity for detecting progressive ILD.

METHODOLOGY:

• Researchers conducted a prospective, observational study to examine the validity of home spirometry for detecting a decline in pulmonary function in patients with SSc-ILD.
• They included 43 patients aged 18 years or older with SSc-ILD from two tertiary referral centers in the Netherlands who received treatment with immunosuppressives for a maximum duration of 8 weeks prior to baseline.
• All participants were required to take weekly home spirometry measurements using a handheld spirometer for 1 year, with 35 completing 6 months of follow-up and 31 completing 12 months.
• Pulmonary function tests were conducted in the hospital at baseline and semiannual visits.
• The primary outcome was the κ (kappa statistic) agreement between home and hospital measurements after 1 year to detect a decline in forced vital capacity (FVC) of 5% or more; the sensitivity and specificity of home spirometry were also evaluated to detect an absolute decline in FVC%, using hospital tests as the gold standard.

TAKEAWAY:

• Home spirometry showed a fair agreement with the pulmonary function tests conducted at the hospital (κ, 0.40; 95% CI, 0.01-0.79).
• Home spirometry showed a sensitivity of 60% and specificity of 87% in detecting a decline in FVC% predicted of 5% or more.
• The intraclass correlation coefficient between home and hospital FVC measurements was moderate to high, with values of 0.85 at baseline, 0.84 at 6 months, and 0.72 at 12 months (P < .0001 for all).
• However, the longitudinal agreement between home and hospital measurements was lower with a correlation coefficient of 0.55.

IN PRACTICE:

“These findings suggest that home spirometry is both feasible and moderately accurate in patients with systemic sclerosis–associated ILD. However, where home spirometry fell short was the low sensitivity in detecting a decline in FVC% predicted,” experts wrote in an accompanying editorial.

“The results of this study support further evaluation of the implementation of home spirometry in addition to regular healthcare management but do not endorse relying solely on home monitoring to detect a decline in pulmonary function,” study authors wrote.

SOURCE:

The study was led by Arthiha Velauthapillai, MD, Department of Rheumatology, Radboud University Medical Center, Nijmegen, the Netherlands, and was published online November 8, 2024, in The Lancet Rheumatology.

LIMITATIONS:

The study might have been underpowered because of inaccuracies in initial assumptions, with a lower-than-anticipated prevalence of progressive ILD and a higher dropout rate. The study included only Dutch patients, which may have limited the generalizability of its findings to other settings with lower internet access or literacy rates.

DISCLOSURES:

This study was partly supported by grants from Galapagos and Boehringer Ingelheim. Some authors received grants or consulting or speaker fees from Boehringer Ingelheim, AstraZeneca, and other pharmaceutical companies.

 

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.

Below are some selections from what I am reading in the AGA journals, highlighting clinically applicable and possibly practice-changing expert reviews and studies.

Upper GI

Levinthal DJ et al. AGA Clinical Practice Update on Diagnosis and Management of Cyclic Vomiting Syndrome: Commentary. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.05.031.



Geeratragool T et al. Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.03.036.



Goodoory VC et al. Effect of Brain-Gut Behavioral Treatments on Abdominal Pain in Irritable Bowel Syndrome: Systematic Review and Network Meta-Analysis. Gastroenterology. 2024 Oct. doi: 10.1053/j.gastro.2024.05.010.



Kurlander JE et al; Gastrointestinal Bleeding Working Group. Prescribing of Proton Pump Inhibitors for Prevention of Upper Gastrointestinal Bleeding in US Outpatient Visits. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.01.047.



Oliva S et al. Crafting a Therapeutic Pyramid for Eosinophilic Esophagitis in the Age of Biologics. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.04.020.

Lower GI

Redd WD et al. Follow-Up Colonoscopy for Detection of Missed Colorectal Cancer After Diverticulitis. Clin Gastroenterol Hepatol. 2024 Oct. doi: 10.1016/j.cgh.2024.03.036.



Peyrin-Biroulet L et al. Upadacitinib Achieves Clinical and Endoscopic Outcomes in Crohn’s Disease Regardless of Prior Biologic Exposure. Clin Gastroenterol Hepatol. 2024 Oct. doi: 10.1016/j.cgh.2024.02.026.



Chang PW et al. ChatGPT4 Outperforms Endoscopists for Determination of Postcolonoscopy Rescreening and Surveillance Recommendations. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.04.022.

Liver

Wang L et al. Association of GLP-1 Receptor Agonists and Hepatocellular Carcinoma Incidence and Hepatic Decompensation in Patients With Type 2 Diabetes. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.04.029.



Bajaj JS et al. Serum Ammonia Levels Do Not Correlate With Overt Hepatic Encephalopathy Severity in Hospitalized Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.02.015.

Endoscopy

Steinbrück I, et al. Cold Versus Hot Snare Endoscopic Resection of Large Nonpedunculated Colorectal Polyps: Randomized Controlled German CHRONICLE Trial. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.05.013.

Misc.

Kothari S et al. AGA Clinical Practice Update on Pregnancy-Related Gastrointestinal and Liver Disease: Expert Review. Gastroenterology. 2024 Oct. doi: 10.1053/j.gastro.2024.06.014.



Chavannes M et al. AGA Clinical Practice Update on the Role of Intestinal Ultrasound in Inflammatory Bowel Disease: Commentary. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.04.039.

Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.

Below are some selections from what I am reading in the AGA journals, highlighting clinically applicable and possibly practice-changing expert reviews and studies.

Upper GI

Levinthal DJ et al. AGA Clinical Practice Update on Diagnosis and Management of Cyclic Vomiting Syndrome: Commentary. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.05.031.



Geeratragool T et al. Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.03.036.



Goodoory VC et al. Effect of Brain-Gut Behavioral Treatments on Abdominal Pain in Irritable Bowel Syndrome: Systematic Review and Network Meta-Analysis. Gastroenterology. 2024 Oct. doi: 10.1053/j.gastro.2024.05.010.



Kurlander JE et al; Gastrointestinal Bleeding Working Group. Prescribing of Proton Pump Inhibitors for Prevention of Upper Gastrointestinal Bleeding in US Outpatient Visits. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.01.047.



Oliva S et al. Crafting a Therapeutic Pyramid for Eosinophilic Esophagitis in the Age of Biologics. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.04.020.

Lower GI

Redd WD et al. Follow-Up Colonoscopy for Detection of Missed Colorectal Cancer After Diverticulitis. Clin Gastroenterol Hepatol. 2024 Oct. doi: 10.1016/j.cgh.2024.03.036.



Peyrin-Biroulet L et al. Upadacitinib Achieves Clinical and Endoscopic Outcomes in Crohn’s Disease Regardless of Prior Biologic Exposure. Clin Gastroenterol Hepatol. 2024 Oct. doi: 10.1016/j.cgh.2024.02.026.



Chang PW et al. ChatGPT4 Outperforms Endoscopists for Determination of Postcolonoscopy Rescreening and Surveillance Recommendations. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.04.022.

Liver

Wang L et al. Association of GLP-1 Receptor Agonists and Hepatocellular Carcinoma Incidence and Hepatic Decompensation in Patients With Type 2 Diabetes. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.04.029.



Bajaj JS et al. Serum Ammonia Levels Do Not Correlate With Overt Hepatic Encephalopathy Severity in Hospitalized Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.02.015.

Endoscopy

Steinbrück I, et al. Cold Versus Hot Snare Endoscopic Resection of Large Nonpedunculated Colorectal Polyps: Randomized Controlled German CHRONICLE Trial. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.05.013.

Misc.

Kothari S et al. AGA Clinical Practice Update on Pregnancy-Related Gastrointestinal and Liver Disease: Expert Review. Gastroenterology. 2024 Oct. doi: 10.1053/j.gastro.2024.06.014.



Chavannes M et al. AGA Clinical Practice Update on the Role of Intestinal Ultrasound in Inflammatory Bowel Disease: Commentary. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.04.039.

Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.

Below are some selections from what I am reading in the AGA journals, highlighting clinically applicable and possibly practice-changing expert reviews and studies.

Upper GI

Levinthal DJ et al. AGA Clinical Practice Update on Diagnosis and Management of Cyclic Vomiting Syndrome: Commentary. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.05.031.



Geeratragool T et al. Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.03.036.



Goodoory VC et al. Effect of Brain-Gut Behavioral Treatments on Abdominal Pain in Irritable Bowel Syndrome: Systematic Review and Network Meta-Analysis. Gastroenterology. 2024 Oct. doi: 10.1053/j.gastro.2024.05.010.



Kurlander JE et al; Gastrointestinal Bleeding Working Group. Prescribing of Proton Pump Inhibitors for Prevention of Upper Gastrointestinal Bleeding in US Outpatient Visits. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.01.047.



Oliva S et al. Crafting a Therapeutic Pyramid for Eosinophilic Esophagitis in the Age of Biologics. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.04.020.

Lower GI

Redd WD et al. Follow-Up Colonoscopy for Detection of Missed Colorectal Cancer After Diverticulitis. Clin Gastroenterol Hepatol. 2024 Oct. doi: 10.1016/j.cgh.2024.03.036.



Peyrin-Biroulet L et al. Upadacitinib Achieves Clinical and Endoscopic Outcomes in Crohn’s Disease Regardless of Prior Biologic Exposure. Clin Gastroenterol Hepatol. 2024 Oct. doi: 10.1016/j.cgh.2024.02.026.



Chang PW et al. ChatGPT4 Outperforms Endoscopists for Determination of Postcolonoscopy Rescreening and Surveillance Recommendations. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.04.022.

Liver

Wang L et al. Association of GLP-1 Receptor Agonists and Hepatocellular Carcinoma Incidence and Hepatic Decompensation in Patients With Type 2 Diabetes. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.04.029.



Bajaj JS et al. Serum Ammonia Levels Do Not Correlate With Overt Hepatic Encephalopathy Severity in Hospitalized Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.02.015.

Endoscopy

Steinbrück I, et al. Cold Versus Hot Snare Endoscopic Resection of Large Nonpedunculated Colorectal Polyps: Randomized Controlled German CHRONICLE Trial. Gastroenterology. 2024 Sep. doi: 10.1053/j.gastro.2024.05.013.

Misc.

Kothari S et al. AGA Clinical Practice Update on Pregnancy-Related Gastrointestinal and Liver Disease: Expert Review. Gastroenterology. 2024 Oct. doi: 10.1053/j.gastro.2024.06.014.



Chavannes M et al. AGA Clinical Practice Update on the Role of Intestinal Ultrasound in Inflammatory Bowel Disease: Commentary. Clin Gastroenterol Hepatol. 2024 Sep. doi: 10.1016/j.cgh.2024.04.039.

Dr. Trieu is assistant professor of medicine, interventional endoscopy, in the Division of Gastroenterology at Washington University in St. Louis School of Medicine, Missouri.

Adults with diabetes who participated in telehealth visits reported similar levels of care, trust in the healthcare system, and patient-centered communication compared to those who had in-person visits, a cross-sectional study suggested. 

The authors urged continued integration of telehealth into diabetes care beyond December 31, 2024, when the pandemic public health emergency ends, potentially limiting such services.

The study “provides population-level evidence that telehealth can deliver care quality comparable to in-person visits in diabetes management,” lead author Young-Rock Hong, PhD, MPH, an assistant professor in the University of Florida, Gainesville, told this news organization.

“Perhaps the most meaningful finding was the high utilization of telephone-only visits among older adults,” he said. “This has important policy implications, particularly as some insurers and healthcare systems have pushed to restrict telehealth coverage to video-only visits.”

“Maintaining telephone visit coverage is crucial for equitable access, especially for older adults who may be less comfortable with video technology; those with limited internet access; or patients facing other barriers to video visits,” he explained. 

The study was published online in BMJ Open.

 

Video-only, Voice-only, Both

The researchers did a secondary analysis of data from the 2022 Health Information National Trends Survey, a nationally representative survey that includes information on health communication and knowledge and perceptions about all health conditions among US adults aged ≥ 18 years.

Participants had a self-reported diagnosis of type 1 or type 2 diabetes. The mean age was 59.4 years; 50% were women; and 53% were non-Hispanic White individuals.

Primary and secondary outcomes were use of telehealth in the last 12-months; telehealth modality; overall perception of quality of care; perceived trust in the healthcare system; and patient-centered communication score.

In the analysis of 1116 participants representing 33.6 million individuals, 48.1% reported telehealth use in the past 12 months.

Telehealth users were more likely to be younger and women with higher household incomes and health insurance coverage; live in metropolitan areas; and have multiple chronic conditions, poorer perceived health status, and more frequent physician visits than nonusers.

After adjustment, adults aged ≥ 65 years had a significantly lower likelihood of telehealth use than those ages 18-49 years (odds ratio [OR], 0.43).

Higher income and more frequent healthcare visits were predictors of telehealth usage, with no significant differences across race, education, or location. 

Those with a household income between $35,000 and $74,999 had more than double the likelihood of telehealth use (OR, 2.14) than those with incomes below $35,000.

Among telehealth users, 39.3% reported having video-only; 35%, phone (voice)-only; and 25.7%, both modalities. Among those aged ≥ 65 years, 55.5% used phone calls only and 25.5% used video only. In contrast, those aged 18-49 years had higher rates of video-only use (36.1%) and combined video/phone use (31.2%).

Healthcare provider recommendation (68.1%) was the most common reason for telehealth use, followed by convenience (57.7%), avoiding potential COVID-19 exposure (48.1%), and obtaining advice about the need for in-person care (23.6%).

Nonusers said they preferred in-person visits and also cited privacy concerns and technology challenges.

Patient-reported quality-of-care outcomes were comparable between telehealth users and nonusers, with no significant differences by telehealth modality or area of residence (urban or rural).

Around 70% of individuals with diabetes in both groups rated their quality of care as “excellent” and “very good;” fewer than 10% rated their care as “fair” and “poor.” 

Similarly, trust in the healthcare system was comparable between users and nonusers: 41.3% of telehealth users 41% of nonusers reported trusting the healthcare system “very much.” Patient-centered communication scores were also similar between users and nonusers.

Telehealth appears to be a good option from the providers’ perspective as well, according to the authors. A previous study by the team found more than 80% of US physicians intended to continue telehealth beyond the pandemic.

“The recent unanimous bipartisan passage of the Telehealth Modernization Act by the House Energy & Commerce Committee signals strong political support for extending telehealth flexibilities through 2026,” Hong said. “The bill addresses key access issues by permanently removing geographic restrictions, expanding eligible providers, and maintaining audio-only coverage — provisions that align with our study’s findings about the importance of telephone visits, particularly for older adults and underserved populations.”

There is concern that extending telehealth services might increase Medicare spending by over $2 billion, he added. “While this may be a valid concern, there is a need for more robust evidence regarding the overall value of telehealth services — ie, the ‘benefits’ they provide relative to their costs and outcomes.”

 

Reassuring, but More Research Needed

COVID prompted “dramatic shifts” in care delivery from in-person to telehealth, Kevin Peterson, MD, MPH, American Diabetes Association vice president of primary care told this news organization. “The authors’ findings provide reassurance that these changes provided for additional convenience in care delivery without being associated with compromises in patient-reported care quality.”

However, he said, “the study does not necessarily capture representative samples of rural and underserved populations, making the impact of telehealth on health equity difficult to determine.” In addition, although patient-perceived care quality did not change with telehealth delivery, the study “does not address impacts on safety, clinical outcomes, equity, costs, or other important measures.”

Furthermore, he noted, “this is an association study that occurred during the dramatic changes brought about by COVID. It may not represent provider or patient preferences that characterize the role of telehealth under more normal circumstances.”

For now, clinicians should be aware that “initial evidence suggests that telehealth can be integrated into care without significantly compromising the patient’s perception of the quality of care,” he concluded.

No funding was declared. Hong and Peterson reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

Adults with diabetes who participated in telehealth visits reported similar levels of care, trust in the healthcare system, and patient-centered communication compared to those who had in-person visits, a cross-sectional study suggested. 

The authors urged continued integration of telehealth into diabetes care beyond December 31, 2024, when the pandemic public health emergency ends, potentially limiting such services.

The study “provides population-level evidence that telehealth can deliver care quality comparable to in-person visits in diabetes management,” lead author Young-Rock Hong, PhD, MPH, an assistant professor in the University of Florida, Gainesville, told this news organization.

“Perhaps the most meaningful finding was the high utilization of telephone-only visits among older adults,” he said. “This has important policy implications, particularly as some insurers and healthcare systems have pushed to restrict telehealth coverage to video-only visits.”

“Maintaining telephone visit coverage is crucial for equitable access, especially for older adults who may be less comfortable with video technology; those with limited internet access; or patients facing other barriers to video visits,” he explained. 

The study was published online in BMJ Open.

 

Video-only, Voice-only, Both

The researchers did a secondary analysis of data from the 2022 Health Information National Trends Survey, a nationally representative survey that includes information on health communication and knowledge and perceptions about all health conditions among US adults aged ≥ 18 years.

Participants had a self-reported diagnosis of type 1 or type 2 diabetes. The mean age was 59.4 years; 50% were women; and 53% were non-Hispanic White individuals.

Primary and secondary outcomes were use of telehealth in the last 12-months; telehealth modality; overall perception of quality of care; perceived trust in the healthcare system; and patient-centered communication score.

In the analysis of 1116 participants representing 33.6 million individuals, 48.1% reported telehealth use in the past 12 months.

Telehealth users were more likely to be younger and women with higher household incomes and health insurance coverage; live in metropolitan areas; and have multiple chronic conditions, poorer perceived health status, and more frequent physician visits than nonusers.

After adjustment, adults aged ≥ 65 years had a significantly lower likelihood of telehealth use than those ages 18-49 years (odds ratio [OR], 0.43).

Higher income and more frequent healthcare visits were predictors of telehealth usage, with no significant differences across race, education, or location. 

Those with a household income between $35,000 and $74,999 had more than double the likelihood of telehealth use (OR, 2.14) than those with incomes below $35,000.

Among telehealth users, 39.3% reported having video-only; 35%, phone (voice)-only; and 25.7%, both modalities. Among those aged ≥ 65 years, 55.5% used phone calls only and 25.5% used video only. In contrast, those aged 18-49 years had higher rates of video-only use (36.1%) and combined video/phone use (31.2%).

Healthcare provider recommendation (68.1%) was the most common reason for telehealth use, followed by convenience (57.7%), avoiding potential COVID-19 exposure (48.1%), and obtaining advice about the need for in-person care (23.6%).

Nonusers said they preferred in-person visits and also cited privacy concerns and technology challenges.

Patient-reported quality-of-care outcomes were comparable between telehealth users and nonusers, with no significant differences by telehealth modality or area of residence (urban or rural).

Around 70% of individuals with diabetes in both groups rated their quality of care as “excellent” and “very good;” fewer than 10% rated their care as “fair” and “poor.” 

Similarly, trust in the healthcare system was comparable between users and nonusers: 41.3% of telehealth users 41% of nonusers reported trusting the healthcare system “very much.” Patient-centered communication scores were also similar between users and nonusers.

Telehealth appears to be a good option from the providers’ perspective as well, according to the authors. A previous study by the team found more than 80% of US physicians intended to continue telehealth beyond the pandemic.

“The recent unanimous bipartisan passage of the Telehealth Modernization Act by the House Energy & Commerce Committee signals strong political support for extending telehealth flexibilities through 2026,” Hong said. “The bill addresses key access issues by permanently removing geographic restrictions, expanding eligible providers, and maintaining audio-only coverage — provisions that align with our study’s findings about the importance of telephone visits, particularly for older adults and underserved populations.”

There is concern that extending telehealth services might increase Medicare spending by over $2 billion, he added. “While this may be a valid concern, there is a need for more robust evidence regarding the overall value of telehealth services — ie, the ‘benefits’ they provide relative to their costs and outcomes.”

 

Reassuring, but More Research Needed

COVID prompted “dramatic shifts” in care delivery from in-person to telehealth, Kevin Peterson, MD, MPH, American Diabetes Association vice president of primary care told this news organization. “The authors’ findings provide reassurance that these changes provided for additional convenience in care delivery without being associated with compromises in patient-reported care quality.”

However, he said, “the study does not necessarily capture representative samples of rural and underserved populations, making the impact of telehealth on health equity difficult to determine.” In addition, although patient-perceived care quality did not change with telehealth delivery, the study “does not address impacts on safety, clinical outcomes, equity, costs, or other important measures.”

Furthermore, he noted, “this is an association study that occurred during the dramatic changes brought about by COVID. It may not represent provider or patient preferences that characterize the role of telehealth under more normal circumstances.”

For now, clinicians should be aware that “initial evidence suggests that telehealth can be integrated into care without significantly compromising the patient’s perception of the quality of care,” he concluded.

No funding was declared. Hong and Peterson reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

Adults with diabetes who participated in telehealth visits reported similar levels of care, trust in the healthcare system, and patient-centered communication compared to those who had in-person visits, a cross-sectional study suggested. 

The authors urged continued integration of telehealth into diabetes care beyond December 31, 2024, when the pandemic public health emergency ends, potentially limiting such services.

The study “provides population-level evidence that telehealth can deliver care quality comparable to in-person visits in diabetes management,” lead author Young-Rock Hong, PhD, MPH, an assistant professor in the University of Florida, Gainesville, told this news organization.

“Perhaps the most meaningful finding was the high utilization of telephone-only visits among older adults,” he said. “This has important policy implications, particularly as some insurers and healthcare systems have pushed to restrict telehealth coverage to video-only visits.”

“Maintaining telephone visit coverage is crucial for equitable access, especially for older adults who may be less comfortable with video technology; those with limited internet access; or patients facing other barriers to video visits,” he explained. 

The study was published online in BMJ Open.

 

Video-only, Voice-only, Both

The researchers did a secondary analysis of data from the 2022 Health Information National Trends Survey, a nationally representative survey that includes information on health communication and knowledge and perceptions about all health conditions among US adults aged ≥ 18 years.

Participants had a self-reported diagnosis of type 1 or type 2 diabetes. The mean age was 59.4 years; 50% were women; and 53% were non-Hispanic White individuals.

Primary and secondary outcomes were use of telehealth in the last 12-months; telehealth modality; overall perception of quality of care; perceived trust in the healthcare system; and patient-centered communication score.

In the analysis of 1116 participants representing 33.6 million individuals, 48.1% reported telehealth use in the past 12 months.

Telehealth users were more likely to be younger and women with higher household incomes and health insurance coverage; live in metropolitan areas; and have multiple chronic conditions, poorer perceived health status, and more frequent physician visits than nonusers.

After adjustment, adults aged ≥ 65 years had a significantly lower likelihood of telehealth use than those ages 18-49 years (odds ratio [OR], 0.43).

Higher income and more frequent healthcare visits were predictors of telehealth usage, with no significant differences across race, education, or location. 

Those with a household income between $35,000 and $74,999 had more than double the likelihood of telehealth use (OR, 2.14) than those with incomes below $35,000.

Among telehealth users, 39.3% reported having video-only; 35%, phone (voice)-only; and 25.7%, both modalities. Among those aged ≥ 65 years, 55.5% used phone calls only and 25.5% used video only. In contrast, those aged 18-49 years had higher rates of video-only use (36.1%) and combined video/phone use (31.2%).

Healthcare provider recommendation (68.1%) was the most common reason for telehealth use, followed by convenience (57.7%), avoiding potential COVID-19 exposure (48.1%), and obtaining advice about the need for in-person care (23.6%).

Nonusers said they preferred in-person visits and also cited privacy concerns and technology challenges.

Patient-reported quality-of-care outcomes were comparable between telehealth users and nonusers, with no significant differences by telehealth modality or area of residence (urban or rural).

Around 70% of individuals with diabetes in both groups rated their quality of care as “excellent” and “very good;” fewer than 10% rated their care as “fair” and “poor.” 

Similarly, trust in the healthcare system was comparable between users and nonusers: 41.3% of telehealth users 41% of nonusers reported trusting the healthcare system “very much.” Patient-centered communication scores were also similar between users and nonusers.

Telehealth appears to be a good option from the providers’ perspective as well, according to the authors. A previous study by the team found more than 80% of US physicians intended to continue telehealth beyond the pandemic.

“The recent unanimous bipartisan passage of the Telehealth Modernization Act by the House Energy & Commerce Committee signals strong political support for extending telehealth flexibilities through 2026,” Hong said. “The bill addresses key access issues by permanently removing geographic restrictions, expanding eligible providers, and maintaining audio-only coverage — provisions that align with our study’s findings about the importance of telephone visits, particularly for older adults and underserved populations.”

There is concern that extending telehealth services might increase Medicare spending by over $2 billion, he added. “While this may be a valid concern, there is a need for more robust evidence regarding the overall value of telehealth services — ie, the ‘benefits’ they provide relative to their costs and outcomes.”

 

Reassuring, but More Research Needed

COVID prompted “dramatic shifts” in care delivery from in-person to telehealth, Kevin Peterson, MD, MPH, American Diabetes Association vice president of primary care told this news organization. “The authors’ findings provide reassurance that these changes provided for additional convenience in care delivery without being associated with compromises in patient-reported care quality.”

However, he said, “the study does not necessarily capture representative samples of rural and underserved populations, making the impact of telehealth on health equity difficult to determine.” In addition, although patient-perceived care quality did not change with telehealth delivery, the study “does not address impacts on safety, clinical outcomes, equity, costs, or other important measures.”

Furthermore, he noted, “this is an association study that occurred during the dramatic changes brought about by COVID. It may not represent provider or patient preferences that characterize the role of telehealth under more normal circumstances.”

For now, clinicians should be aware that “initial evidence suggests that telehealth can be integrated into care without significantly compromising the patient’s perception of the quality of care,” he concluded.

No funding was declared. Hong and Peterson reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

Nursing is a competitive field. In 2022, nursing schools rejected more than 78,000 qualified applications, and the students whose applications were accepted faced demanding schedules and rigorous academics and clinical rotations. Is this a recipe for depression?

In 2024, 38% of nursing students experienced depression — a 9.3% increase over 2019, according to research from higher education research group Degreechoices. Catherine A. Stubin, PhD, RN, assistant professor of nursing at Rutgers University–Camden in New Jersey, calls it “a mental health crisis in nursing.”

“Nursing is a very rigorous, difficult, psychologically and physically demanding profession,” she said. “If students don’t have the tools and resources to adequately deal with these stressors in nursing school, it’s going to carry over to their professional practice.”

A growing recognition of the toll that nursing programs may have on students’ mental health has led schools to launch initiatives to better support the next generation of nurses.

 

Diagnosing the Problem

Higher than average rates of depression among nursing students are not new. Nursing students often work long shifts with limited breaks. The academic rigors and clinical demands of caring for patients with acute and chronic conditions while instructors evaluate and watch for mistakes can cause high levels of stress, Stubin told this news organization. “Eventually, something has to give, and it’s usually their mental health.”

Clinical practicums often start when nursing students are still freshmen, and asking 18-year-old students to provide patient care in often-chaotic clinical environments is “overwhelming,” according to Stubin. The COVID-19 pandemic further exacerbated the issue.

During lockdown, more than half the nursing students reported moderate to severe symptoms of anxiety and depression, which was attributed to the transition to online learning, fear of infection, burnout, and the psychological distress of lockdown.

“The pandemic exacerbated existing mental health problems in undergraduate nursing students,” said Stubin. “In the wake of it ... a lot of [registered nurses] have mental health issues and are leaving the profession.”

 

Helping Nurses Heal

A significant shift in the willingness to talk about mental health and seek treatment could help. In 2011, just one third of students participated in the treatment for a mental health disorder. The latest data show that 61% of students experiencing symptoms of depression or anxiety take medication or seek therapy or counseling.

Incoming health sciences students at Ohio State University (OSU), Columbus, are screened for depression, anxiety, and suicidal ideation and directed to campus health services as needed. Bernadette Mazurek Melnyk, PhD, APRN-CNP, OSU’s chief wellness officer and former dean in the College of Nursing, believes it’s an essential step in supporting students, adding, “If you don’t screen, you don’t know the students are suffering, and we’re able to get help to the students who need it quickly.”

 

Prioritizing Solutions

Counseling services available through campus health centers are just one part of a multipronged approach that nursing schools have taken to improve the health and well-being of students. Nursing programs have also introduced initiatives to lower stress, prevent burnout, and relieve emotional trauma.

“In nursing education, we have to lay the groundwork for the self-care, wellness, and resilience practices that can, hopefully, be carried over into their professional practices,” Stubin said.

At Rutgers University–Camden, the wellness center provides counseling services, and the Student Nursing Association offers a pet therapy program. Stubin also incorporates self-care, resilience-building strategies, and wellness programming into the curriculum.

During the pandemic, the University of Colorado College of Nursing, Aurora, created a class called Stress Impact and Care for COVID-19 to provide content, exercises, and support groups for nursing students. The class was so popular that it was adapted and integrated into the curriculum.

The University of Vermont, Burlington, introduced the Benson-Henry Institute Stress Management and Resiliency Training program in 2021. The 8-week program was designed to teach nursing students coping strategies to reduce stress.

Offering stress management programs to first-year nursing students has been linked to improved problem-solving skills and fewer emotional and social behavioral symptoms. However, for programs to be effective, Melnyk believes that they need to be integrated into the curriculum, not offered as electives.

“We know mindfulness works, we know cognitive behavior skills-building works, and these types of evidence-based programs with such efficacy behind them should not be optional,” she said. “Students are overwhelmed just with their coursework, so if these programs exist for extra credit, students won’t take them.”

 

Creating a Culture of Wellness

Teaching nursing students how to manage stress and providing the resources to combat depression and anxiety is just the first step in building a healthy, resilient nursing workforce.

Prioritizing wellness in nursing isn’t just essential for addressing the nationwide nursing shortage. Burnout in the medical field costs the United States healthcare system $4.6 billion per year, and preventable medical errors are the third leading cause of death in the United States.

“There is a nice movement across the United States to reduce these mental health issues because they’re so costly,” Melnyk said.

There are also national efforts to address the issue. The National Academy of Medicine introduced the Action Collaborative on Clinician Well-Being and Resilience, which has grown to include more than 200 organizations committed to reversing burnout and improving mental health in the clinical workforce. The American Nurses Foundation created The Nurse Well-Being: Building Peer and Leadership Support Program to provide resources and peer support to help nurses manage stress.

Health systems and hospitals also need to prioritize clinical well-being to reduce stress and burnout — and these efforts must be ongoing.

“These resources have to be extended into the working world ... and not just once a year for Nurses Week in May, but on a regular continued basis,” said Stubin. “Healthcare corporations and hospitals have to continue these resources and this help; it has to be a priority.”

Until the culture changes, Stubin fears that nursing students will continue facing barriers to completing their programs and maintaining nursing careers. Currently, 43% of college students considered leaving their program for mental health reasons, and 21.7% of nurses reported suicidal ideation.

“There’s a nursing shortage, and the acuity of patient care is increasing, so the stressors in the clinical area aren’t going to decrease,” Stubin said. “We as nursing faculty must teach our students how to manage these stressors to build a resilient, mentally and physically healthy workforce.”

A version of this article first appeared on Medscape.com.

Nursing is a competitive field. In 2022, nursing schools rejected more than 78,000 qualified applications, and the students whose applications were accepted faced demanding schedules and rigorous academics and clinical rotations. Is this a recipe for depression?

In 2024, 38% of nursing students experienced depression — a 9.3% increase over 2019, according to research from higher education research group Degreechoices. Catherine A. Stubin, PhD, RN, assistant professor of nursing at Rutgers University–Camden in New Jersey, calls it “a mental health crisis in nursing.”

“Nursing is a very rigorous, difficult, psychologically and physically demanding profession,” she said. “If students don’t have the tools and resources to adequately deal with these stressors in nursing school, it’s going to carry over to their professional practice.”

A growing recognition of the toll that nursing programs may have on students’ mental health has led schools to launch initiatives to better support the next generation of nurses.

 

Diagnosing the Problem

Higher than average rates of depression among nursing students are not new. Nursing students often work long shifts with limited breaks. The academic rigors and clinical demands of caring for patients with acute and chronic conditions while instructors evaluate and watch for mistakes can cause high levels of stress, Stubin told this news organization. “Eventually, something has to give, and it’s usually their mental health.”

Clinical practicums often start when nursing students are still freshmen, and asking 18-year-old students to provide patient care in often-chaotic clinical environments is “overwhelming,” according to Stubin. The COVID-19 pandemic further exacerbated the issue.

During lockdown, more than half the nursing students reported moderate to severe symptoms of anxiety and depression, which was attributed to the transition to online learning, fear of infection, burnout, and the psychological distress of lockdown.

“The pandemic exacerbated existing mental health problems in undergraduate nursing students,” said Stubin. “In the wake of it ... a lot of [registered nurses] have mental health issues and are leaving the profession.”

 

Helping Nurses Heal

A significant shift in the willingness to talk about mental health and seek treatment could help. In 2011, just one third of students participated in the treatment for a mental health disorder. The latest data show that 61% of students experiencing symptoms of depression or anxiety take medication or seek therapy or counseling.

Incoming health sciences students at Ohio State University (OSU), Columbus, are screened for depression, anxiety, and suicidal ideation and directed to campus health services as needed. Bernadette Mazurek Melnyk, PhD, APRN-CNP, OSU’s chief wellness officer and former dean in the College of Nursing, believes it’s an essential step in supporting students, adding, “If you don’t screen, you don’t know the students are suffering, and we’re able to get help to the students who need it quickly.”

 

Prioritizing Solutions

Counseling services available through campus health centers are just one part of a multipronged approach that nursing schools have taken to improve the health and well-being of students. Nursing programs have also introduced initiatives to lower stress, prevent burnout, and relieve emotional trauma.

“In nursing education, we have to lay the groundwork for the self-care, wellness, and resilience practices that can, hopefully, be carried over into their professional practices,” Stubin said.

At Rutgers University–Camden, the wellness center provides counseling services, and the Student Nursing Association offers a pet therapy program. Stubin also incorporates self-care, resilience-building strategies, and wellness programming into the curriculum.

During the pandemic, the University of Colorado College of Nursing, Aurora, created a class called Stress Impact and Care for COVID-19 to provide content, exercises, and support groups for nursing students. The class was so popular that it was adapted and integrated into the curriculum.

The University of Vermont, Burlington, introduced the Benson-Henry Institute Stress Management and Resiliency Training program in 2021. The 8-week program was designed to teach nursing students coping strategies to reduce stress.

Offering stress management programs to first-year nursing students has been linked to improved problem-solving skills and fewer emotional and social behavioral symptoms. However, for programs to be effective, Melnyk believes that they need to be integrated into the curriculum, not offered as electives.

“We know mindfulness works, we know cognitive behavior skills-building works, and these types of evidence-based programs with such efficacy behind them should not be optional,” she said. “Students are overwhelmed just with their coursework, so if these programs exist for extra credit, students won’t take them.”

 

Creating a Culture of Wellness

Teaching nursing students how to manage stress and providing the resources to combat depression and anxiety is just the first step in building a healthy, resilient nursing workforce.

Prioritizing wellness in nursing isn’t just essential for addressing the nationwide nursing shortage. Burnout in the medical field costs the United States healthcare system $4.6 billion per year, and preventable medical errors are the third leading cause of death in the United States.

“There is a nice movement across the United States to reduce these mental health issues because they’re so costly,” Melnyk said.

There are also national efforts to address the issue. The National Academy of Medicine introduced the Action Collaborative on Clinician Well-Being and Resilience, which has grown to include more than 200 organizations committed to reversing burnout and improving mental health in the clinical workforce. The American Nurses Foundation created The Nurse Well-Being: Building Peer and Leadership Support Program to provide resources and peer support to help nurses manage stress.

Health systems and hospitals also need to prioritize clinical well-being to reduce stress and burnout — and these efforts must be ongoing.

“These resources have to be extended into the working world ... and not just once a year for Nurses Week in May, but on a regular continued basis,” said Stubin. “Healthcare corporations and hospitals have to continue these resources and this help; it has to be a priority.”

Until the culture changes, Stubin fears that nursing students will continue facing barriers to completing their programs and maintaining nursing careers. Currently, 43% of college students considered leaving their program for mental health reasons, and 21.7% of nurses reported suicidal ideation.

“There’s a nursing shortage, and the acuity of patient care is increasing, so the stressors in the clinical area aren’t going to decrease,” Stubin said. “We as nursing faculty must teach our students how to manage these stressors to build a resilient, mentally and physically healthy workforce.”

A version of this article first appeared on Medscape.com.

Nursing is a competitive field. In 2022, nursing schools rejected more than 78,000 qualified applications, and the students whose applications were accepted faced demanding schedules and rigorous academics and clinical rotations. Is this a recipe for depression?

In 2024, 38% of nursing students experienced depression — a 9.3% increase over 2019, according to research from higher education research group Degreechoices. Catherine A. Stubin, PhD, RN, assistant professor of nursing at Rutgers University–Camden in New Jersey, calls it “a mental health crisis in nursing.”

“Nursing is a very rigorous, difficult, psychologically and physically demanding profession,” she said. “If students don’t have the tools and resources to adequately deal with these stressors in nursing school, it’s going to carry over to their professional practice.”

A growing recognition of the toll that nursing programs may have on students’ mental health has led schools to launch initiatives to better support the next generation of nurses.

 

Diagnosing the Problem

Higher than average rates of depression among nursing students are not new. Nursing students often work long shifts with limited breaks. The academic rigors and clinical demands of caring for patients with acute and chronic conditions while instructors evaluate and watch for mistakes can cause high levels of stress, Stubin told this news organization. “Eventually, something has to give, and it’s usually their mental health.”

Clinical practicums often start when nursing students are still freshmen, and asking 18-year-old students to provide patient care in often-chaotic clinical environments is “overwhelming,” according to Stubin. The COVID-19 pandemic further exacerbated the issue.

During lockdown, more than half the nursing students reported moderate to severe symptoms of anxiety and depression, which was attributed to the transition to online learning, fear of infection, burnout, and the psychological distress of lockdown.

“The pandemic exacerbated existing mental health problems in undergraduate nursing students,” said Stubin. “In the wake of it ... a lot of [registered nurses] have mental health issues and are leaving the profession.”

 

Helping Nurses Heal

A significant shift in the willingness to talk about mental health and seek treatment could help. In 2011, just one third of students participated in the treatment for a mental health disorder. The latest data show that 61% of students experiencing symptoms of depression or anxiety take medication or seek therapy or counseling.

Incoming health sciences students at Ohio State University (OSU), Columbus, are screened for depression, anxiety, and suicidal ideation and directed to campus health services as needed. Bernadette Mazurek Melnyk, PhD, APRN-CNP, OSU’s chief wellness officer and former dean in the College of Nursing, believes it’s an essential step in supporting students, adding, “If you don’t screen, you don’t know the students are suffering, and we’re able to get help to the students who need it quickly.”

 

Prioritizing Solutions

Counseling services available through campus health centers are just one part of a multipronged approach that nursing schools have taken to improve the health and well-being of students. Nursing programs have also introduced initiatives to lower stress, prevent burnout, and relieve emotional trauma.

“In nursing education, we have to lay the groundwork for the self-care, wellness, and resilience practices that can, hopefully, be carried over into their professional practices,” Stubin said.

At Rutgers University–Camden, the wellness center provides counseling services, and the Student Nursing Association offers a pet therapy program. Stubin also incorporates self-care, resilience-building strategies, and wellness programming into the curriculum.

During the pandemic, the University of Colorado College of Nursing, Aurora, created a class called Stress Impact and Care for COVID-19 to provide content, exercises, and support groups for nursing students. The class was so popular that it was adapted and integrated into the curriculum.

The University of Vermont, Burlington, introduced the Benson-Henry Institute Stress Management and Resiliency Training program in 2021. The 8-week program was designed to teach nursing students coping strategies to reduce stress.

Offering stress management programs to first-year nursing students has been linked to improved problem-solving skills and fewer emotional and social behavioral symptoms. However, for programs to be effective, Melnyk believes that they need to be integrated into the curriculum, not offered as electives.

“We know mindfulness works, we know cognitive behavior skills-building works, and these types of evidence-based programs with such efficacy behind them should not be optional,” she said. “Students are overwhelmed just with their coursework, so if these programs exist for extra credit, students won’t take them.”

 

Creating a Culture of Wellness

Teaching nursing students how to manage stress and providing the resources to combat depression and anxiety is just the first step in building a healthy, resilient nursing workforce.

Prioritizing wellness in nursing isn’t just essential for addressing the nationwide nursing shortage. Burnout in the medical field costs the United States healthcare system $4.6 billion per year, and preventable medical errors are the third leading cause of death in the United States.

“There is a nice movement across the United States to reduce these mental health issues because they’re so costly,” Melnyk said.

There are also national efforts to address the issue. The National Academy of Medicine introduced the Action Collaborative on Clinician Well-Being and Resilience, which has grown to include more than 200 organizations committed to reversing burnout and improving mental health in the clinical workforce. The American Nurses Foundation created The Nurse Well-Being: Building Peer and Leadership Support Program to provide resources and peer support to help nurses manage stress.

Health systems and hospitals also need to prioritize clinical well-being to reduce stress and burnout — and these efforts must be ongoing.

“These resources have to be extended into the working world ... and not just once a year for Nurses Week in May, but on a regular continued basis,” said Stubin. “Healthcare corporations and hospitals have to continue these resources and this help; it has to be a priority.”

Until the culture changes, Stubin fears that nursing students will continue facing barriers to completing their programs and maintaining nursing careers. Currently, 43% of college students considered leaving their program for mental health reasons, and 21.7% of nurses reported suicidal ideation.

“There’s a nursing shortage, and the acuity of patient care is increasing, so the stressors in the clinical area aren’t going to decrease,” Stubin said. “We as nursing faculty must teach our students how to manage these stressors to build a resilient, mentally and physically healthy workforce.”

A version of this article first appeared on Medscape.com.

TOPLINE:

Intermittent calorie restriction (CR) diet is more effective in reducing liver fat content than a standard-of-care diet in patients with metabolic dysfunction–associated steatotic liver disease (MASLD), especially in those with obesity.

METHODOLOGY:

• Intermittent CR, which involves alternating periods of energy restriction and regular energy intake, has been proposed as a dietary intervention for MASLD.
• Researchers conducted a 12-week randomized controlled trial to compare the effects of a 5:2 intermittent CR and standard-of-care diet in nondiabetic patients with MASLD with or without obesity at an outpatient clinic in Korea.
• Intermittent CR comprised a reduced calorie consumption (500 kcal/d for women and 600 kcal/d for men) on 2 nonconsecutive days a week and, on the remaining 5 days/wk, following the Korean Dietary Reference Intakes (2000 kcal/d for women and 2500 kcal/d for men).
• The standard diet involved the consumption of 80% of the recommended calories (1200-1500 kcal/d for women and 1500-1800 kcal/d for men, or reducing 500-1000 kcal/d).
• The primary outcome was a relative reduction of ≥ 30% in the liver fat content measured by MRI-proton density fat fraction after 12 weeks.
• The secondary outcomes included changes in liver fibrosis, body weight, and body composition from baseline to week 12.

TAKEAWAY:

• Researchers enrolled 72 participants (36 patients with obesity and 36 without), with 63 completing the trial; of these, 32 received an intermittent CR diet (median age, 47.0 years; 58.8% men) and 31 received a standard-of-care diet (median age, 53.0 years; 36.4% men).
• A higher proportion of patients in the intermittent CR group achieved a relative reduction of ≥ 30% in the liver fat content at 12 weeks than the standard-of-care group (72.2% vs 44.4%; P = .033).
• These findings were even more prominent among those with obesity (61.1% in the intermittent CR group vs 27.7% in the standard-of-care group; P = .030).
• Patients with obesity in the intermittent CR group also showed a greater relative reduction in body weight than those in the standard-of-care group (–5.5% vs –2.9%; P = .022).
• Intermittent CR had no apparent effects on body composition, liver enzymes, or the lipid and glucose profiles of those with or without obesity.

IN PRACTICE:

“These results support the recommendation of a 5:2 [intermittent CR] diet as a useful dietary strategy for patients with MASLD,” the authors wrote.

SOURCE:

The study, led by Han Ah Lee, PhD, Department of Internal Medicine, College of Medicine, Chung-Ang University, Seoul, South Korea, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The intervention period of 12 weeks was relatively short, limiting the ability to observe long-term effects. The study did not reveal the effects of intermittent CR on histologic metabolic dysfunction–associated steatohepatitis or significantly advanced fibrosis. The study was conducted at a single center located in an urban, metropolitan area in Korea, which may limit the applicability of the findings to other populations.

DISCLOSURES:

This study was supported in part by a grant from the National Research Foundation of Korea funded by the Ministry of Science and ICT. The authors declared no conflicts of interest.

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 first appeared on Medscape.com.

TOPLINE:

Intermittent calorie restriction (CR) diet is more effective in reducing liver fat content than a standard-of-care diet in patients with metabolic dysfunction–associated steatotic liver disease (MASLD), especially in those with obesity.

METHODOLOGY:

• Intermittent CR, which involves alternating periods of energy restriction and regular energy intake, has been proposed as a dietary intervention for MASLD.
• Researchers conducted a 12-week randomized controlled trial to compare the effects of a 5:2 intermittent CR and standard-of-care diet in nondiabetic patients with MASLD with or without obesity at an outpatient clinic in Korea.
• Intermittent CR comprised a reduced calorie consumption (500 kcal/d for women and 600 kcal/d for men) on 2 nonconsecutive days a week and, on the remaining 5 days/wk, following the Korean Dietary Reference Intakes (2000 kcal/d for women and 2500 kcal/d for men).
• The standard diet involved the consumption of 80% of the recommended calories (1200-1500 kcal/d for women and 1500-1800 kcal/d for men, or reducing 500-1000 kcal/d).
• The primary outcome was a relative reduction of ≥ 30% in the liver fat content measured by MRI-proton density fat fraction after 12 weeks.
• The secondary outcomes included changes in liver fibrosis, body weight, and body composition from baseline to week 12.

TAKEAWAY:

• Researchers enrolled 72 participants (36 patients with obesity and 36 without), with 63 completing the trial; of these, 32 received an intermittent CR diet (median age, 47.0 years; 58.8% men) and 31 received a standard-of-care diet (median age, 53.0 years; 36.4% men).
• A higher proportion of patients in the intermittent CR group achieved a relative reduction of ≥ 30% in the liver fat content at 12 weeks than the standard-of-care group (72.2% vs 44.4%; P = .033).
• These findings were even more prominent among those with obesity (61.1% in the intermittent CR group vs 27.7% in the standard-of-care group; P = .030).
• Patients with obesity in the intermittent CR group also showed a greater relative reduction in body weight than those in the standard-of-care group (–5.5% vs –2.9%; P = .022).
• Intermittent CR had no apparent effects on body composition, liver enzymes, or the lipid and glucose profiles of those with or without obesity.

IN PRACTICE:

“These results support the recommendation of a 5:2 [intermittent CR] diet as a useful dietary strategy for patients with MASLD,” the authors wrote.

SOURCE:

The study, led by Han Ah Lee, PhD, Department of Internal Medicine, College of Medicine, Chung-Ang University, Seoul, South Korea, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The intervention period of 12 weeks was relatively short, limiting the ability to observe long-term effects. The study did not reveal the effects of intermittent CR on histologic metabolic dysfunction–associated steatohepatitis or significantly advanced fibrosis. The study was conducted at a single center located in an urban, metropolitan area in Korea, which may limit the applicability of the findings to other populations.

DISCLOSURES:

This study was supported in part by a grant from the National Research Foundation of Korea funded by the Ministry of Science and ICT. The authors declared no conflicts of interest.

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 first appeared on Medscape.com.

TOPLINE:

Intermittent calorie restriction (CR) diet is more effective in reducing liver fat content than a standard-of-care diet in patients with metabolic dysfunction–associated steatotic liver disease (MASLD), especially in those with obesity.

METHODOLOGY:

• Intermittent CR, which involves alternating periods of energy restriction and regular energy intake, has been proposed as a dietary intervention for MASLD.
• Researchers conducted a 12-week randomized controlled trial to compare the effects of a 5:2 intermittent CR and standard-of-care diet in nondiabetic patients with MASLD with or without obesity at an outpatient clinic in Korea.
• Intermittent CR comprised a reduced calorie consumption (500 kcal/d for women and 600 kcal/d for men) on 2 nonconsecutive days a week and, on the remaining 5 days/wk, following the Korean Dietary Reference Intakes (2000 kcal/d for women and 2500 kcal/d for men).
• The standard diet involved the consumption of 80% of the recommended calories (1200-1500 kcal/d for women and 1500-1800 kcal/d for men, or reducing 500-1000 kcal/d).
• The primary outcome was a relative reduction of ≥ 30% in the liver fat content measured by MRI-proton density fat fraction after 12 weeks.
• The secondary outcomes included changes in liver fibrosis, body weight, and body composition from baseline to week 12.

TAKEAWAY:

• Researchers enrolled 72 participants (36 patients with obesity and 36 without), with 63 completing the trial; of these, 32 received an intermittent CR diet (median age, 47.0 years; 58.8% men) and 31 received a standard-of-care diet (median age, 53.0 years; 36.4% men).
• A higher proportion of patients in the intermittent CR group achieved a relative reduction of ≥ 30% in the liver fat content at 12 weeks than the standard-of-care group (72.2% vs 44.4%; P = .033).
• These findings were even more prominent among those with obesity (61.1% in the intermittent CR group vs 27.7% in the standard-of-care group; P = .030).
• Patients with obesity in the intermittent CR group also showed a greater relative reduction in body weight than those in the standard-of-care group (–5.5% vs –2.9%; P = .022).
• Intermittent CR had no apparent effects on body composition, liver enzymes, or the lipid and glucose profiles of those with or without obesity.

IN PRACTICE:

“These results support the recommendation of a 5:2 [intermittent CR] diet as a useful dietary strategy for patients with MASLD,” the authors wrote.

SOURCE:

The study, led by Han Ah Lee, PhD, Department of Internal Medicine, College of Medicine, Chung-Ang University, Seoul, South Korea, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The intervention period of 12 weeks was relatively short, limiting the ability to observe long-term effects. The study did not reveal the effects of intermittent CR on histologic metabolic dysfunction–associated steatohepatitis or significantly advanced fibrosis. The study was conducted at a single center located in an urban, metropolitan area in Korea, which may limit the applicability of the findings to other populations.

DISCLOSURES:

This study was supported in part by a grant from the National Research Foundation of Korea funded by the Ministry of Science and ICT. The authors declared no conflicts of interest.

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 first appeared on Medscape.com.