Bright Light Therapy Effective for Nonseasonal Depression

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Thu, 10/17/2024 - 12:30

 

TOPLINE:

Bright light therapy (BLT) is associated with a 41% remission rate in patients with nonseasonal depressive disorders, significantly higher than the remission rates reported with other treatments, a new meta-analysis shows.
 

METHODOLOGY:

  • Researchers conducted a systematic review and meta-analysis of 11 randomized clinical trials with 858 patients with nonseasonal depressive disorders.
  • Included studies compared BLT alone or BLT plus antidepressant with placebo, antidepressant monotherapy, or dim red light.
  • BLT was administered using a fluorescent light box producing white light at 10,000 lux for at least 30 minutes daily.
  • The primary outcomes were the remission of symptoms and response to treatment, assessed using scales such as the Hamilton Rating Scale for Depression (HAM-D).

TAKEAWAY:

  • The estimated remission rate was significantly higher for patients with nonseasonal depressive disorders in the BLT group than for those in the control group (41% vs 23.5%; P < .001).
  • The response rate was also higher for patients in the BLT group than for those in the control group (60% vs 39%; P < .001).
  • In the subgroup analysis on the basis of the duration of follow-up periods, the BLT group had better remission and response rates than the control group for both short-term (< 4 weeks; P < .001) and long-term (> 4 weeks; P = .04) follow-up periods, which suggests that patients achieved remission and responded to treatment more quickly with BLT than with antidepressants alone.
  • The BLT group had a significantly greater reduction in HAM-D scores than the control group (mean difference, −1.44; P = .003).

IN PRACTICE:

“These findings suggest that BLT was an effective adjunctive treatment for nonseasonal depressive disorders, and the response time to the initial treatment may be improved with the addition of BLT,” the study authors wrote.
 

SOURCE:

The study was led by Artur Menegaz de Almeida, MS, Federal University of Mato Grosso, Sinop, Brazil. It was published online on October 2, 2024, in JAMA Psychiatry.
 

LIMITATIONS:

Slight differences were observed in the mean follow-up time between the included trials. The definitions for remission rates and response to treatment varied among the included studies, and they also involved different levels of disorder severity. Additionally, the study did not enable the separate analysis of each included depressive disorder, nor bipolar or unipolar subtypes of major depressive disorder. The moderate number of studies included may have affected the generalizability of the findings.
 

DISCLOSURES:

Study funding was not disclosed. No relevant conflicts of interest were disclosed.

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.

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TOPLINE:

Bright light therapy (BLT) is associated with a 41% remission rate in patients with nonseasonal depressive disorders, significantly higher than the remission rates reported with other treatments, a new meta-analysis shows.
 

METHODOLOGY:

  • Researchers conducted a systematic review and meta-analysis of 11 randomized clinical trials with 858 patients with nonseasonal depressive disorders.
  • Included studies compared BLT alone or BLT plus antidepressant with placebo, antidepressant monotherapy, or dim red light.
  • BLT was administered using a fluorescent light box producing white light at 10,000 lux for at least 30 minutes daily.
  • The primary outcomes were the remission of symptoms and response to treatment, assessed using scales such as the Hamilton Rating Scale for Depression (HAM-D).

TAKEAWAY:

  • The estimated remission rate was significantly higher for patients with nonseasonal depressive disorders in the BLT group than for those in the control group (41% vs 23.5%; P < .001).
  • The response rate was also higher for patients in the BLT group than for those in the control group (60% vs 39%; P < .001).
  • In the subgroup analysis on the basis of the duration of follow-up periods, the BLT group had better remission and response rates than the control group for both short-term (< 4 weeks; P < .001) and long-term (> 4 weeks; P = .04) follow-up periods, which suggests that patients achieved remission and responded to treatment more quickly with BLT than with antidepressants alone.
  • The BLT group had a significantly greater reduction in HAM-D scores than the control group (mean difference, −1.44; P = .003).

IN PRACTICE:

“These findings suggest that BLT was an effective adjunctive treatment for nonseasonal depressive disorders, and the response time to the initial treatment may be improved with the addition of BLT,” the study authors wrote.
 

SOURCE:

The study was led by Artur Menegaz de Almeida, MS, Federal University of Mato Grosso, Sinop, Brazil. It was published online on October 2, 2024, in JAMA Psychiatry.
 

LIMITATIONS:

Slight differences were observed in the mean follow-up time between the included trials. The definitions for remission rates and response to treatment varied among the included studies, and they also involved different levels of disorder severity. Additionally, the study did not enable the separate analysis of each included depressive disorder, nor bipolar or unipolar subtypes of major depressive disorder. The moderate number of studies included may have affected the generalizability of the findings.
 

DISCLOSURES:

Study funding was not disclosed. No relevant conflicts of interest were disclosed.

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:

Bright light therapy (BLT) is associated with a 41% remission rate in patients with nonseasonal depressive disorders, significantly higher than the remission rates reported with other treatments, a new meta-analysis shows.
 

METHODOLOGY:

  • Researchers conducted a systematic review and meta-analysis of 11 randomized clinical trials with 858 patients with nonseasonal depressive disorders.
  • Included studies compared BLT alone or BLT plus antidepressant with placebo, antidepressant monotherapy, or dim red light.
  • BLT was administered using a fluorescent light box producing white light at 10,000 lux for at least 30 minutes daily.
  • The primary outcomes were the remission of symptoms and response to treatment, assessed using scales such as the Hamilton Rating Scale for Depression (HAM-D).

TAKEAWAY:

  • The estimated remission rate was significantly higher for patients with nonseasonal depressive disorders in the BLT group than for those in the control group (41% vs 23.5%; P < .001).
  • The response rate was also higher for patients in the BLT group than for those in the control group (60% vs 39%; P < .001).
  • In the subgroup analysis on the basis of the duration of follow-up periods, the BLT group had better remission and response rates than the control group for both short-term (< 4 weeks; P < .001) and long-term (> 4 weeks; P = .04) follow-up periods, which suggests that patients achieved remission and responded to treatment more quickly with BLT than with antidepressants alone.
  • The BLT group had a significantly greater reduction in HAM-D scores than the control group (mean difference, −1.44; P = .003).

IN PRACTICE:

“These findings suggest that BLT was an effective adjunctive treatment for nonseasonal depressive disorders, and the response time to the initial treatment may be improved with the addition of BLT,” the study authors wrote.
 

SOURCE:

The study was led by Artur Menegaz de Almeida, MS, Federal University of Mato Grosso, Sinop, Brazil. It was published online on October 2, 2024, in JAMA Psychiatry.
 

LIMITATIONS:

Slight differences were observed in the mean follow-up time between the included trials. The definitions for remission rates and response to treatment varied among the included studies, and they also involved different levels of disorder severity. Additionally, the study did not enable the separate analysis of each included depressive disorder, nor bipolar or unipolar subtypes of major depressive disorder. The moderate number of studies included may have affected the generalizability of the findings.
 

DISCLOSURES:

Study funding was not disclosed. No relevant conflicts of interest were disclosed.

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.

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Ultraprocessed Foods and CVD: Myths vs Facts

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Thu, 10/17/2024 - 12:16

I’d like to talk with you about ultraprocessed foods (UPFs) and risk for cardiovascular disease (CVD) and try to separate some of the facts from the myths. I’d like to discuss a recent report in The Lancet Regional Health that looks at this topic comprehensively and in detail.

This report includes three large-scale prospective cohort studies of US female and male health professionals, more than 200,000 participants in total. It also includes a meta-analysis of 22 international cohorts with about 1.2 million participants. I’d like to acknowledge that I’m a co-author of this study.

What are UPFs, and why are they important? Why do we care, and what are the knowledge gaps? UPFs are generally packaged foods that contain ingredients to extend shelf life and improve taste and palatability. It’s important because 60%-70% of the US diet, if not more, is made up of UPFs. So, the relationship between UPFs and CVD and other health outcomes is actually very important. 

And the research to date on this subject has been quite limited. 

Often, UPFs will include additives, such as preservatives, flavor enhancers, colorants, emulsifiers, and sweeteners, and they tend to have an excess amount of calories, added sugars, added salt, sodium, and saturated fat. The packaging can be high in bisphenols, which have also been linked to some health outcomes.

In other studies, these UPFs have been linked to weight gain and dyslipidemia; some tissue glycation has been found, and some changes in the microbiome. Some studies have linked higher UPF intake with type 2 diabetes. A few have looked at certain selected UPF foods and found a higher risk for CVD, but a really comprehensive look at this question hasn’t been done. 

So, that’s what we did in this paper and in the meta-analysis with the 22 cohorts, and we saw a very clear and distinct significant increase in coronary heart disease by 23%, total CVD by 17%, and stroke by 9% when comparing the highest vs the lowest category [of UPF intake]. When we drilled down deeply into the types of UPFs in the US health professional cohorts, we saw that there were some major differences in the relationship with CVD depending on the type of UPF.

In comparing the highest quintile vs the lowest quintile [of total UPF intake], we saw that some of the UPFs were associated with significant elevations in risk for CVD. These included sugar-sweetened beverages and processed meats. But some UPFs were linked with a lower risk for CVD. These included breakfast cereals, yogurt, some dairy desserts, and whole grains.

Overall, it seemed that UPFs are actually quite diverse in their association with health. It’s not one size fits all. They’re not all created equal, and some of these differences matter. Although overall we would recommend that our diets be focused on whole foods, primarily plant based, lots of fruits and vegetables, whole grains, fish, and other whole foods, it seems from this report and the meta-analysis that certain types of UPFs can be incorporated into a healthy diet and don’t need to be avoided entirely. 

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, and Chief of the Division of Preventive Medicine, Brigham and Women’s Hospital, both in Boston, Massachusetts. She reported receiving donations and infrastructure support from Mars Symbioscience.

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

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I’d like to talk with you about ultraprocessed foods (UPFs) and risk for cardiovascular disease (CVD) and try to separate some of the facts from the myths. I’d like to discuss a recent report in The Lancet Regional Health that looks at this topic comprehensively and in detail.

This report includes three large-scale prospective cohort studies of US female and male health professionals, more than 200,000 participants in total. It also includes a meta-analysis of 22 international cohorts with about 1.2 million participants. I’d like to acknowledge that I’m a co-author of this study.

What are UPFs, and why are they important? Why do we care, and what are the knowledge gaps? UPFs are generally packaged foods that contain ingredients to extend shelf life and improve taste and palatability. It’s important because 60%-70% of the US diet, if not more, is made up of UPFs. So, the relationship between UPFs and CVD and other health outcomes is actually very important. 

And the research to date on this subject has been quite limited. 

Often, UPFs will include additives, such as preservatives, flavor enhancers, colorants, emulsifiers, and sweeteners, and they tend to have an excess amount of calories, added sugars, added salt, sodium, and saturated fat. The packaging can be high in bisphenols, which have also been linked to some health outcomes.

In other studies, these UPFs have been linked to weight gain and dyslipidemia; some tissue glycation has been found, and some changes in the microbiome. Some studies have linked higher UPF intake with type 2 diabetes. A few have looked at certain selected UPF foods and found a higher risk for CVD, but a really comprehensive look at this question hasn’t been done. 

So, that’s what we did in this paper and in the meta-analysis with the 22 cohorts, and we saw a very clear and distinct significant increase in coronary heart disease by 23%, total CVD by 17%, and stroke by 9% when comparing the highest vs the lowest category [of UPF intake]. When we drilled down deeply into the types of UPFs in the US health professional cohorts, we saw that there were some major differences in the relationship with CVD depending on the type of UPF.

In comparing the highest quintile vs the lowest quintile [of total UPF intake], we saw that some of the UPFs were associated with significant elevations in risk for CVD. These included sugar-sweetened beverages and processed meats. But some UPFs were linked with a lower risk for CVD. These included breakfast cereals, yogurt, some dairy desserts, and whole grains.

Overall, it seemed that UPFs are actually quite diverse in their association with health. It’s not one size fits all. They’re not all created equal, and some of these differences matter. Although overall we would recommend that our diets be focused on whole foods, primarily plant based, lots of fruits and vegetables, whole grains, fish, and other whole foods, it seems from this report and the meta-analysis that certain types of UPFs can be incorporated into a healthy diet and don’t need to be avoided entirely. 

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, and Chief of the Division of Preventive Medicine, Brigham and Women’s Hospital, both in Boston, Massachusetts. She reported receiving donations and infrastructure support from Mars Symbioscience.

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

I’d like to talk with you about ultraprocessed foods (UPFs) and risk for cardiovascular disease (CVD) and try to separate some of the facts from the myths. I’d like to discuss a recent report in The Lancet Regional Health that looks at this topic comprehensively and in detail.

This report includes three large-scale prospective cohort studies of US female and male health professionals, more than 200,000 participants in total. It also includes a meta-analysis of 22 international cohorts with about 1.2 million participants. I’d like to acknowledge that I’m a co-author of this study.

What are UPFs, and why are they important? Why do we care, and what are the knowledge gaps? UPFs are generally packaged foods that contain ingredients to extend shelf life and improve taste and palatability. It’s important because 60%-70% of the US diet, if not more, is made up of UPFs. So, the relationship between UPFs and CVD and other health outcomes is actually very important. 

And the research to date on this subject has been quite limited. 

Often, UPFs will include additives, such as preservatives, flavor enhancers, colorants, emulsifiers, and sweeteners, and they tend to have an excess amount of calories, added sugars, added salt, sodium, and saturated fat. The packaging can be high in bisphenols, which have also been linked to some health outcomes.

In other studies, these UPFs have been linked to weight gain and dyslipidemia; some tissue glycation has been found, and some changes in the microbiome. Some studies have linked higher UPF intake with type 2 diabetes. A few have looked at certain selected UPF foods and found a higher risk for CVD, but a really comprehensive look at this question hasn’t been done. 

So, that’s what we did in this paper and in the meta-analysis with the 22 cohorts, and we saw a very clear and distinct significant increase in coronary heart disease by 23%, total CVD by 17%, and stroke by 9% when comparing the highest vs the lowest category [of UPF intake]. When we drilled down deeply into the types of UPFs in the US health professional cohorts, we saw that there were some major differences in the relationship with CVD depending on the type of UPF.

In comparing the highest quintile vs the lowest quintile [of total UPF intake], we saw that some of the UPFs were associated with significant elevations in risk for CVD. These included sugar-sweetened beverages and processed meats. But some UPFs were linked with a lower risk for CVD. These included breakfast cereals, yogurt, some dairy desserts, and whole grains.

Overall, it seemed that UPFs are actually quite diverse in their association with health. It’s not one size fits all. They’re not all created equal, and some of these differences matter. Although overall we would recommend that our diets be focused on whole foods, primarily plant based, lots of fruits and vegetables, whole grains, fish, and other whole foods, it seems from this report and the meta-analysis that certain types of UPFs can be incorporated into a healthy diet and don’t need to be avoided entirely. 

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, and Chief of the Division of Preventive Medicine, Brigham and Women’s Hospital, both in Boston, Massachusetts. She reported receiving donations and infrastructure support from Mars Symbioscience.

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

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How Doctors Use Music to Learn Faster and Perform Better

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Thu, 10/17/2024 - 12:08

“Because you know I’m all about that base, ‘bout that base, no acid.” 

Do those words sound familiar? That’s because they’re the lyrics to Meghan Trainor’s “All About That Bass,” slightly tweaked to function as a medical study tool.

Early in med school, J.C. Sue, DO, now a family medicine physician, refashioned the song’s words to help him prepare for a test on acid extruders and loaders. Sue’s version, “All About That Base,” contained his lecture notes. During the exam, he found himself mentally singing his parody and easily recalling the information. Plus, the approach made cramming a lot more palatable.

Sound silly? It’s not. Sue’s approach is backed up by science. A significant body of research has illuminated the positive association between music and memory. And the benefits last. Recently, a 2024 study from Canada suggested that musical memory doesn’t decrease with age. And a 2023 study revealed music was a better cue than food for helping both young and older adults recall autobiographical memories.

Inspired by his success, Sue gave popular songs a medical spin throughout his medical training. “There’s no rule that says studying must be boring, tedious, or torturous,” Sue said. “If you can make it fun, why not?”

Sue isn’t alone. Many physicians say that writing songs, listening to music, or playing instruments improves their focus, energy, and work performance, along with their confidence and well-being.

Why does music work so well?
 

Tune Your Brain to Work With Tunes

Remember learning your ABCs to the tune of “Twinkle, Twinkle, Little Star?” (Or ask any Gen X person about Schoolhouse Rock.)

In the classroom, music is an established tool for teaching kids, said Ruth Gotian, EdD, MS, chief learning officer and associate professor of education in anesthesiology at Weill Cornell Medicine, New York City. But she said musical strategies make studying easier for adults, too, no matter how complex the material.

Christopher Emdin, PhD, Maxine Greene chair and professor of science education at Teachers College, Columbia University, New York City, shares Gotian’s view. When teaching science, engineering, technology, and mathematics (STEM) subjects to high school kids, he challenged them to write raps about the new concepts.

That’s when he saw visible results: As his students took exams, Emdin noticed them nodding and moving their mouths and heads.

“They were literally performing the songs they’d written for themselves,” Emdin said. “When you write a song to a beat, it’s almost like your heartbeat. You know it so well; you can conjure up your memories by reciting the lyrics.”

If songwriting isn’t in your repertoire, you’ll be glad to hear that just listening to music while studying can help with retention. “Music keeps both sides of the brain stimulated, which has been shown to increase focus and motivation,” explained Anita A. Paschall, MD, PhD, Medical School and Healthcare Admissions expert/director of Medical School and Healthcare Admissions at The Princeton Review.
 

‘Mind on a Permanent Vacation’

Paschall’s enthusiasm comes from personal experience. While preparing for her board exams, Jimmy Buffet’s catalog was her study soundtrack. “His songs stayed in my mind. I could hum along without having to think about it, so my brain was free to focus,” she recalled.

Because Paschall grew up listening to Buffet’s tunes, they also evoked relaxing moments from her earlier life, which she found comforting and uplifting. The combination helped make long, intense study sessions more pleasant. After all, when you’re “wasting away again in Margaritaville,” how can you feel stressed and despondent?

Alexander Remy Bonnel, MD, clinical assistant professor of medicine at the University of Pennsylvania and a physician at Pennsylvania Hospital, both in Philadelphia, found ways to incorporate both auditory and visual stimuli in his med school study routine. He listened to music while color-coding his notes to link both cues to the information. As with Paschall, these tactics helped reduce the monotony of learning reams of material.

That gave Bonnel an easy way to establish an important element for memory: Novelty.

“When you need to memorize so many things in a short amount of time, you’re trying to vary ways of internalizing information,” he observed. “You have a higher chance of retaining information if there’s something unique about it.”
 

Building Team Harmony

“Almost every single OR I rotated through in med school had music playing,” Bonnel also recalled. Furthermore, he noticed a pattern to the chosen songs: Regardless of their age, surgeons selected playlists of tunes that had been popular when they were in their 20s. Those golden oldies, from any era, could turn the OR team into a focused, cohesive unit.

Kyle McCormick, MD, a fifth-year resident in orthopedic surgery at New York–Presbyterian Hospital, Columbia University Irving Medical Center, New York City, has also noticed the ubiquity of background music in ORs. Her observation: Surgeons tend to choose universally popular, inoffensive songs, like tracks from Hall & Oates and Fleetwood Mac.

This meshes with the results of a joint survey of nearly 700 surgeons and other healthcare professionals conducted by Spotify and Figure 1 in 2021; 90% of the surgeons and surgical residents who responded said they listened to music in the OR. Rock and pop were the most popular genres, followed by classical, jazz, and then R&B.

Regardless of genre, music helped the surgical teams focus and feel less tense, the surgeons reported. But when training younger doctors, managing complications, or performing during critical points in surgery, many said they’d lower the volume.

Outside the OR, music can also help foster connection between colleagues. For Lawrence C. Loh, MD, MPH, adjunct professor at Dalla Lana School of Public Health at the University of Toronto in Ontario, Canada, playing guitar and piano has helped him connect with his staff. “I’ve played tunes at staff gatherings and recorded videos as encouragement during the emergency response for COVID-19,” he shared.

In his free time, Loh has also organized outings to his local pub’s weekly karaoke show for more than a decade. His goal: “Promote social cohesion and combat loneliness among my friend and social networks.”
 

Get Your Own Musical Boost

If all this sounds like music to your ears, here are some ways to try it yourself.

Find a study soundtrack. When choosing study music, follow Paschall’s lead and pick songs you know well so they’ll remain in the background. Also, compile a soundtrack you find pleasant and mood-boosting to help relieve the tedium of study and decrease stress.

Keep in mind that we all take in and process information differently, said Gotian. So background music during study sessions might not work for you. According to a 2017 study published in Frontiers in Psychology, it can be a distraction and impair learning for some. Do what works.

Get pumped with a “walkup song.” What songs make you feel like you could conquer the world? asked Emdin. Or what soundtrack would be playing if you were ascending a stage to accept an award or walking out to take the mound in the ninth inning? Those songs should be on what he calls your “superhero” or “walkup” playlist. His prescription: Tune in before you begin your workday or start a challenging procedure.

Paschall agrees and recommends her students and clients listen to music before sitting down for an exam. Forget reviewing flashcards for the nth time, she counseled. Putting on headphones (or earbuds) will put you in a “better headspace.”

Choose work and play playlists. As well as incorporating tunes in your clinic or hospital, music can help relieve stress at the end of the workday. “Medical culture can often be detrimental to doctors’ health,” said Sue, who credits music with helping him maintain equanimity.

Bonnel can relate. Practicing and performing with the Penn Medicine Symphony Orchestra offers him a sense of community and relief from the stress of modern life. “For 2 hours every Tuesday, I put my phone away and just play,” he said. “It’s nice to have those moments when I’m temporarily disconnected and can just focus on one thing: Playing.”
 

 

 

Scale Up Your Career

Years after med school graduation, Sue still recalls many of the tunes he wrote to help him remember information. When he sings a song in his head, he’ll get a refresher on pediatric developmental milestones, medication side effects, anatomical details, and more, which informs the treatment plans he devises for patients. To help other doctors reap these benefits, Sue created the website Tune Rx, a medical music study resource that includes many of the roughly 100 songs he’s written.

Emdin often discusses his musical strategies during talks on STEM education. Initially, people are skeptical, he said. But the idea quickly rings a bell for audience members. “They come up to me afterward to share anecdotes,” Emdin said. “If you have enough anecdotes, there’s a pattern. So let’s create a process. Let’s be intentional about using music as a learning strategy,” he urged.

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

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“Because you know I’m all about that base, ‘bout that base, no acid.” 

Do those words sound familiar? That’s because they’re the lyrics to Meghan Trainor’s “All About That Bass,” slightly tweaked to function as a medical study tool.

Early in med school, J.C. Sue, DO, now a family medicine physician, refashioned the song’s words to help him prepare for a test on acid extruders and loaders. Sue’s version, “All About That Base,” contained his lecture notes. During the exam, he found himself mentally singing his parody and easily recalling the information. Plus, the approach made cramming a lot more palatable.

Sound silly? It’s not. Sue’s approach is backed up by science. A significant body of research has illuminated the positive association between music and memory. And the benefits last. Recently, a 2024 study from Canada suggested that musical memory doesn’t decrease with age. And a 2023 study revealed music was a better cue than food for helping both young and older adults recall autobiographical memories.

Inspired by his success, Sue gave popular songs a medical spin throughout his medical training. “There’s no rule that says studying must be boring, tedious, or torturous,” Sue said. “If you can make it fun, why not?”

Sue isn’t alone. Many physicians say that writing songs, listening to music, or playing instruments improves their focus, energy, and work performance, along with their confidence and well-being.

Why does music work so well?
 

Tune Your Brain to Work With Tunes

Remember learning your ABCs to the tune of “Twinkle, Twinkle, Little Star?” (Or ask any Gen X person about Schoolhouse Rock.)

In the classroom, music is an established tool for teaching kids, said Ruth Gotian, EdD, MS, chief learning officer and associate professor of education in anesthesiology at Weill Cornell Medicine, New York City. But she said musical strategies make studying easier for adults, too, no matter how complex the material.

Christopher Emdin, PhD, Maxine Greene chair and professor of science education at Teachers College, Columbia University, New York City, shares Gotian’s view. When teaching science, engineering, technology, and mathematics (STEM) subjects to high school kids, he challenged them to write raps about the new concepts.

That’s when he saw visible results: As his students took exams, Emdin noticed them nodding and moving their mouths and heads.

“They were literally performing the songs they’d written for themselves,” Emdin said. “When you write a song to a beat, it’s almost like your heartbeat. You know it so well; you can conjure up your memories by reciting the lyrics.”

If songwriting isn’t in your repertoire, you’ll be glad to hear that just listening to music while studying can help with retention. “Music keeps both sides of the brain stimulated, which has been shown to increase focus and motivation,” explained Anita A. Paschall, MD, PhD, Medical School and Healthcare Admissions expert/director of Medical School and Healthcare Admissions at The Princeton Review.
 

‘Mind on a Permanent Vacation’

Paschall’s enthusiasm comes from personal experience. While preparing for her board exams, Jimmy Buffet’s catalog was her study soundtrack. “His songs stayed in my mind. I could hum along without having to think about it, so my brain was free to focus,” she recalled.

Because Paschall grew up listening to Buffet’s tunes, they also evoked relaxing moments from her earlier life, which she found comforting and uplifting. The combination helped make long, intense study sessions more pleasant. After all, when you’re “wasting away again in Margaritaville,” how can you feel stressed and despondent?

Alexander Remy Bonnel, MD, clinical assistant professor of medicine at the University of Pennsylvania and a physician at Pennsylvania Hospital, both in Philadelphia, found ways to incorporate both auditory and visual stimuli in his med school study routine. He listened to music while color-coding his notes to link both cues to the information. As with Paschall, these tactics helped reduce the monotony of learning reams of material.

That gave Bonnel an easy way to establish an important element for memory: Novelty.

“When you need to memorize so many things in a short amount of time, you’re trying to vary ways of internalizing information,” he observed. “You have a higher chance of retaining information if there’s something unique about it.”
 

Building Team Harmony

“Almost every single OR I rotated through in med school had music playing,” Bonnel also recalled. Furthermore, he noticed a pattern to the chosen songs: Regardless of their age, surgeons selected playlists of tunes that had been popular when they were in their 20s. Those golden oldies, from any era, could turn the OR team into a focused, cohesive unit.

Kyle McCormick, MD, a fifth-year resident in orthopedic surgery at New York–Presbyterian Hospital, Columbia University Irving Medical Center, New York City, has also noticed the ubiquity of background music in ORs. Her observation: Surgeons tend to choose universally popular, inoffensive songs, like tracks from Hall & Oates and Fleetwood Mac.

This meshes with the results of a joint survey of nearly 700 surgeons and other healthcare professionals conducted by Spotify and Figure 1 in 2021; 90% of the surgeons and surgical residents who responded said they listened to music in the OR. Rock and pop were the most popular genres, followed by classical, jazz, and then R&B.

Regardless of genre, music helped the surgical teams focus and feel less tense, the surgeons reported. But when training younger doctors, managing complications, or performing during critical points in surgery, many said they’d lower the volume.

Outside the OR, music can also help foster connection between colleagues. For Lawrence C. Loh, MD, MPH, adjunct professor at Dalla Lana School of Public Health at the University of Toronto in Ontario, Canada, playing guitar and piano has helped him connect with his staff. “I’ve played tunes at staff gatherings and recorded videos as encouragement during the emergency response for COVID-19,” he shared.

In his free time, Loh has also organized outings to his local pub’s weekly karaoke show for more than a decade. His goal: “Promote social cohesion and combat loneliness among my friend and social networks.”
 

Get Your Own Musical Boost

If all this sounds like music to your ears, here are some ways to try it yourself.

Find a study soundtrack. When choosing study music, follow Paschall’s lead and pick songs you know well so they’ll remain in the background. Also, compile a soundtrack you find pleasant and mood-boosting to help relieve the tedium of study and decrease stress.

Keep in mind that we all take in and process information differently, said Gotian. So background music during study sessions might not work for you. According to a 2017 study published in Frontiers in Psychology, it can be a distraction and impair learning for some. Do what works.

Get pumped with a “walkup song.” What songs make you feel like you could conquer the world? asked Emdin. Or what soundtrack would be playing if you were ascending a stage to accept an award or walking out to take the mound in the ninth inning? Those songs should be on what he calls your “superhero” or “walkup” playlist. His prescription: Tune in before you begin your workday or start a challenging procedure.

Paschall agrees and recommends her students and clients listen to music before sitting down for an exam. Forget reviewing flashcards for the nth time, she counseled. Putting on headphones (or earbuds) will put you in a “better headspace.”

Choose work and play playlists. As well as incorporating tunes in your clinic or hospital, music can help relieve stress at the end of the workday. “Medical culture can often be detrimental to doctors’ health,” said Sue, who credits music with helping him maintain equanimity.

Bonnel can relate. Practicing and performing with the Penn Medicine Symphony Orchestra offers him a sense of community and relief from the stress of modern life. “For 2 hours every Tuesday, I put my phone away and just play,” he said. “It’s nice to have those moments when I’m temporarily disconnected and can just focus on one thing: Playing.”
 

 

 

Scale Up Your Career

Years after med school graduation, Sue still recalls many of the tunes he wrote to help him remember information. When he sings a song in his head, he’ll get a refresher on pediatric developmental milestones, medication side effects, anatomical details, and more, which informs the treatment plans he devises for patients. To help other doctors reap these benefits, Sue created the website Tune Rx, a medical music study resource that includes many of the roughly 100 songs he’s written.

Emdin often discusses his musical strategies during talks on STEM education. Initially, people are skeptical, he said. But the idea quickly rings a bell for audience members. “They come up to me afterward to share anecdotes,” Emdin said. “If you have enough anecdotes, there’s a pattern. So let’s create a process. Let’s be intentional about using music as a learning strategy,” he urged.

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

“Because you know I’m all about that base, ‘bout that base, no acid.” 

Do those words sound familiar? That’s because they’re the lyrics to Meghan Trainor’s “All About That Bass,” slightly tweaked to function as a medical study tool.

Early in med school, J.C. Sue, DO, now a family medicine physician, refashioned the song’s words to help him prepare for a test on acid extruders and loaders. Sue’s version, “All About That Base,” contained his lecture notes. During the exam, he found himself mentally singing his parody and easily recalling the information. Plus, the approach made cramming a lot more palatable.

Sound silly? It’s not. Sue’s approach is backed up by science. A significant body of research has illuminated the positive association between music and memory. And the benefits last. Recently, a 2024 study from Canada suggested that musical memory doesn’t decrease with age. And a 2023 study revealed music was a better cue than food for helping both young and older adults recall autobiographical memories.

Inspired by his success, Sue gave popular songs a medical spin throughout his medical training. “There’s no rule that says studying must be boring, tedious, or torturous,” Sue said. “If you can make it fun, why not?”

Sue isn’t alone. Many physicians say that writing songs, listening to music, or playing instruments improves their focus, energy, and work performance, along with their confidence and well-being.

Why does music work so well?
 

Tune Your Brain to Work With Tunes

Remember learning your ABCs to the tune of “Twinkle, Twinkle, Little Star?” (Or ask any Gen X person about Schoolhouse Rock.)

In the classroom, music is an established tool for teaching kids, said Ruth Gotian, EdD, MS, chief learning officer and associate professor of education in anesthesiology at Weill Cornell Medicine, New York City. But she said musical strategies make studying easier for adults, too, no matter how complex the material.

Christopher Emdin, PhD, Maxine Greene chair and professor of science education at Teachers College, Columbia University, New York City, shares Gotian’s view. When teaching science, engineering, technology, and mathematics (STEM) subjects to high school kids, he challenged them to write raps about the new concepts.

That’s when he saw visible results: As his students took exams, Emdin noticed them nodding and moving their mouths and heads.

“They were literally performing the songs they’d written for themselves,” Emdin said. “When you write a song to a beat, it’s almost like your heartbeat. You know it so well; you can conjure up your memories by reciting the lyrics.”

If songwriting isn’t in your repertoire, you’ll be glad to hear that just listening to music while studying can help with retention. “Music keeps both sides of the brain stimulated, which has been shown to increase focus and motivation,” explained Anita A. Paschall, MD, PhD, Medical School and Healthcare Admissions expert/director of Medical School and Healthcare Admissions at The Princeton Review.
 

‘Mind on a Permanent Vacation’

Paschall’s enthusiasm comes from personal experience. While preparing for her board exams, Jimmy Buffet’s catalog was her study soundtrack. “His songs stayed in my mind. I could hum along without having to think about it, so my brain was free to focus,” she recalled.

Because Paschall grew up listening to Buffet’s tunes, they also evoked relaxing moments from her earlier life, which she found comforting and uplifting. The combination helped make long, intense study sessions more pleasant. After all, when you’re “wasting away again in Margaritaville,” how can you feel stressed and despondent?

Alexander Remy Bonnel, MD, clinical assistant professor of medicine at the University of Pennsylvania and a physician at Pennsylvania Hospital, both in Philadelphia, found ways to incorporate both auditory and visual stimuli in his med school study routine. He listened to music while color-coding his notes to link both cues to the information. As with Paschall, these tactics helped reduce the monotony of learning reams of material.

That gave Bonnel an easy way to establish an important element for memory: Novelty.

“When you need to memorize so many things in a short amount of time, you’re trying to vary ways of internalizing information,” he observed. “You have a higher chance of retaining information if there’s something unique about it.”
 

Building Team Harmony

“Almost every single OR I rotated through in med school had music playing,” Bonnel also recalled. Furthermore, he noticed a pattern to the chosen songs: Regardless of their age, surgeons selected playlists of tunes that had been popular when they were in their 20s. Those golden oldies, from any era, could turn the OR team into a focused, cohesive unit.

Kyle McCormick, MD, a fifth-year resident in orthopedic surgery at New York–Presbyterian Hospital, Columbia University Irving Medical Center, New York City, has also noticed the ubiquity of background music in ORs. Her observation: Surgeons tend to choose universally popular, inoffensive songs, like tracks from Hall & Oates and Fleetwood Mac.

This meshes with the results of a joint survey of nearly 700 surgeons and other healthcare professionals conducted by Spotify and Figure 1 in 2021; 90% of the surgeons and surgical residents who responded said they listened to music in the OR. Rock and pop were the most popular genres, followed by classical, jazz, and then R&B.

Regardless of genre, music helped the surgical teams focus and feel less tense, the surgeons reported. But when training younger doctors, managing complications, or performing during critical points in surgery, many said they’d lower the volume.

Outside the OR, music can also help foster connection between colleagues. For Lawrence C. Loh, MD, MPH, adjunct professor at Dalla Lana School of Public Health at the University of Toronto in Ontario, Canada, playing guitar and piano has helped him connect with his staff. “I’ve played tunes at staff gatherings and recorded videos as encouragement during the emergency response for COVID-19,” he shared.

In his free time, Loh has also organized outings to his local pub’s weekly karaoke show for more than a decade. His goal: “Promote social cohesion and combat loneliness among my friend and social networks.”
 

Get Your Own Musical Boost

If all this sounds like music to your ears, here are some ways to try it yourself.

Find a study soundtrack. When choosing study music, follow Paschall’s lead and pick songs you know well so they’ll remain in the background. Also, compile a soundtrack you find pleasant and mood-boosting to help relieve the tedium of study and decrease stress.

Keep in mind that we all take in and process information differently, said Gotian. So background music during study sessions might not work for you. According to a 2017 study published in Frontiers in Psychology, it can be a distraction and impair learning for some. Do what works.

Get pumped with a “walkup song.” What songs make you feel like you could conquer the world? asked Emdin. Or what soundtrack would be playing if you were ascending a stage to accept an award or walking out to take the mound in the ninth inning? Those songs should be on what he calls your “superhero” or “walkup” playlist. His prescription: Tune in before you begin your workday or start a challenging procedure.

Paschall agrees and recommends her students and clients listen to music before sitting down for an exam. Forget reviewing flashcards for the nth time, she counseled. Putting on headphones (or earbuds) will put you in a “better headspace.”

Choose work and play playlists. As well as incorporating tunes in your clinic or hospital, music can help relieve stress at the end of the workday. “Medical culture can often be detrimental to doctors’ health,” said Sue, who credits music with helping him maintain equanimity.

Bonnel can relate. Practicing and performing with the Penn Medicine Symphony Orchestra offers him a sense of community and relief from the stress of modern life. “For 2 hours every Tuesday, I put my phone away and just play,” he said. “It’s nice to have those moments when I’m temporarily disconnected and can just focus on one thing: Playing.”
 

 

 

Scale Up Your Career

Years after med school graduation, Sue still recalls many of the tunes he wrote to help him remember information. When he sings a song in his head, he’ll get a refresher on pediatric developmental milestones, medication side effects, anatomical details, and more, which informs the treatment plans he devises for patients. To help other doctors reap these benefits, Sue created the website Tune Rx, a medical music study resource that includes many of the roughly 100 songs he’s written.

Emdin often discusses his musical strategies during talks on STEM education. Initially, people are skeptical, he said. But the idea quickly rings a bell for audience members. “They come up to me afterward to share anecdotes,” Emdin said. “If you have enough anecdotes, there’s a pattern. So let’s create a process. Let’s be intentional about using music as a learning strategy,” he urged.

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

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Automated Insulin Delivery Systems Reduce Burden in Diabetes

Article Type
Changed
Thu, 10/17/2024 - 12:03

 

TOPLINE:

Automated insulin delivery (AID) systems reduce diabetes distress and fear of hypoglycemia, improve quality of life, and increase awareness about hypoglycemia in adults, children, and adolescents with diabetes.

METHODOLOGY:

  • Despite the known benefits of AID systems for glycemic control, conclusive evidence on the impact of these devices on person-reported outcomes (PROs) has been limited.
  • A systematic review and meta-analysis of 62 studies that reported the findings of 45 different quantitative questionnaires analyzed the effects of AID systems on various PROs in patients with diabetes.
  • Studies were included if they reported the results of at least one PRO assessed via a validated questionnaire; no restrictions on populations were applied, such that studies could include individuals of all ages with type 1 diabetes or adults with type 2 diabetes.
  • Intervention groups in the original studies involved an AID system comprising an insulin pump, a continuous glucose monitoring (CGM) system, and an algorithm controlling insulin delivery on the basis of CGM data. The control group, if included, involved non-AID systems such as multiple daily injections of insulin, standalone insulin pump therapy, or others.
  • The main outcomes studied were diabetes distress, fear of hypoglycemia, and quality of life.

TAKEAWAY:

  • Meta-analysis of 13 randomized controlled trials (RCTs) found a significant reduction in diabetes distress with the use of AID systems vs non-AID systems (standardized mean difference [SMD], −0.159; P = .0322).
  • Fear of hypoglycemia, as assessed by the Hypoglycemia Fear Survey-II in up to 16 RCTs, was significantly reduced in participants using AID systems (SMD, −0.339; P = .0005); AID systems also improved awareness about hypoglycemia, as determined from analysis of four RCTs (SMD, −0.231; P = .0193).
  • Quality of life and pediatric quality of life scores at follow-up, as assessed in three and five RCTs, respectively, were higher for patients using AID systems than for those in the control group.
  • The promising effects of AID systems on alleviating disease burden and improving quality of life outcomes were also evident from the observational studies included in this meta-analysis.

IN PRACTICE:

“These findings can be used by health technology assessment bodies and policy makers to inform reimbursement decisions for AID therapy and can also help to widen access to this diabetes technology,” the authors wrote.

SOURCE:

The study was led by Timm Roos, Research Institute of the Diabetes Academy Mergentheim, Bad Mergentheim, Germany. It was published online in eClinicalMedicine.

LIMITATIONS:

A large number of different questionnaires were used to assess PROs, leading to complexity in the analysis. The limited number of studies that could be pooled for some PROs suggests the need for more research with a uniform assessment of PROs. Finally, the inclusion of different generations of AID systems may have introduced bias in the observed effects on PROs.

DISCLOSURES:

This study did not receive any funding. Some authors reported receiving honoraria, consulting fees, travel support, and advisory board member fees as well as other ties with many 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 this article first appeared on Medscape.com.

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TOPLINE:

Automated insulin delivery (AID) systems reduce diabetes distress and fear of hypoglycemia, improve quality of life, and increase awareness about hypoglycemia in adults, children, and adolescents with diabetes.

METHODOLOGY:

  • Despite the known benefits of AID systems for glycemic control, conclusive evidence on the impact of these devices on person-reported outcomes (PROs) has been limited.
  • A systematic review and meta-analysis of 62 studies that reported the findings of 45 different quantitative questionnaires analyzed the effects of AID systems on various PROs in patients with diabetes.
  • Studies were included if they reported the results of at least one PRO assessed via a validated questionnaire; no restrictions on populations were applied, such that studies could include individuals of all ages with type 1 diabetes or adults with type 2 diabetes.
  • Intervention groups in the original studies involved an AID system comprising an insulin pump, a continuous glucose monitoring (CGM) system, and an algorithm controlling insulin delivery on the basis of CGM data. The control group, if included, involved non-AID systems such as multiple daily injections of insulin, standalone insulin pump therapy, or others.
  • The main outcomes studied were diabetes distress, fear of hypoglycemia, and quality of life.

TAKEAWAY:

  • Meta-analysis of 13 randomized controlled trials (RCTs) found a significant reduction in diabetes distress with the use of AID systems vs non-AID systems (standardized mean difference [SMD], −0.159; P = .0322).
  • Fear of hypoglycemia, as assessed by the Hypoglycemia Fear Survey-II in up to 16 RCTs, was significantly reduced in participants using AID systems (SMD, −0.339; P = .0005); AID systems also improved awareness about hypoglycemia, as determined from analysis of four RCTs (SMD, −0.231; P = .0193).
  • Quality of life and pediatric quality of life scores at follow-up, as assessed in three and five RCTs, respectively, were higher for patients using AID systems than for those in the control group.
  • The promising effects of AID systems on alleviating disease burden and improving quality of life outcomes were also evident from the observational studies included in this meta-analysis.

IN PRACTICE:

“These findings can be used by health technology assessment bodies and policy makers to inform reimbursement decisions for AID therapy and can also help to widen access to this diabetes technology,” the authors wrote.

SOURCE:

The study was led by Timm Roos, Research Institute of the Diabetes Academy Mergentheim, Bad Mergentheim, Germany. It was published online in eClinicalMedicine.

LIMITATIONS:

A large number of different questionnaires were used to assess PROs, leading to complexity in the analysis. The limited number of studies that could be pooled for some PROs suggests the need for more research with a uniform assessment of PROs. Finally, the inclusion of different generations of AID systems may have introduced bias in the observed effects on PROs.

DISCLOSURES:

This study did not receive any funding. Some authors reported receiving honoraria, consulting fees, travel support, and advisory board member fees as well as other ties with many 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 this article first appeared on Medscape.com.

 

TOPLINE:

Automated insulin delivery (AID) systems reduce diabetes distress and fear of hypoglycemia, improve quality of life, and increase awareness about hypoglycemia in adults, children, and adolescents with diabetes.

METHODOLOGY:

  • Despite the known benefits of AID systems for glycemic control, conclusive evidence on the impact of these devices on person-reported outcomes (PROs) has been limited.
  • A systematic review and meta-analysis of 62 studies that reported the findings of 45 different quantitative questionnaires analyzed the effects of AID systems on various PROs in patients with diabetes.
  • Studies were included if they reported the results of at least one PRO assessed via a validated questionnaire; no restrictions on populations were applied, such that studies could include individuals of all ages with type 1 diabetes or adults with type 2 diabetes.
  • Intervention groups in the original studies involved an AID system comprising an insulin pump, a continuous glucose monitoring (CGM) system, and an algorithm controlling insulin delivery on the basis of CGM data. The control group, if included, involved non-AID systems such as multiple daily injections of insulin, standalone insulin pump therapy, or others.
  • The main outcomes studied were diabetes distress, fear of hypoglycemia, and quality of life.

TAKEAWAY:

  • Meta-analysis of 13 randomized controlled trials (RCTs) found a significant reduction in diabetes distress with the use of AID systems vs non-AID systems (standardized mean difference [SMD], −0.159; P = .0322).
  • Fear of hypoglycemia, as assessed by the Hypoglycemia Fear Survey-II in up to 16 RCTs, was significantly reduced in participants using AID systems (SMD, −0.339; P = .0005); AID systems also improved awareness about hypoglycemia, as determined from analysis of four RCTs (SMD, −0.231; P = .0193).
  • Quality of life and pediatric quality of life scores at follow-up, as assessed in three and five RCTs, respectively, were higher for patients using AID systems than for those in the control group.
  • The promising effects of AID systems on alleviating disease burden and improving quality of life outcomes were also evident from the observational studies included in this meta-analysis.

IN PRACTICE:

“These findings can be used by health technology assessment bodies and policy makers to inform reimbursement decisions for AID therapy and can also help to widen access to this diabetes technology,” the authors wrote.

SOURCE:

The study was led by Timm Roos, Research Institute of the Diabetes Academy Mergentheim, Bad Mergentheim, Germany. It was published online in eClinicalMedicine.

LIMITATIONS:

A large number of different questionnaires were used to assess PROs, leading to complexity in the analysis. The limited number of studies that could be pooled for some PROs suggests the need for more research with a uniform assessment of PROs. Finally, the inclusion of different generations of AID systems may have introduced bias in the observed effects on PROs.

DISCLOSURES:

This study did not receive any funding. Some authors reported receiving honoraria, consulting fees, travel support, and advisory board member fees as well as other ties with many 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 this article first appeared on Medscape.com.

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Sustained Control with Investigational Monoclonal Antibody for Myasthenia Gravis

Article Type
Changed
Thu, 10/17/2024 - 11:58

The investigational monoclonal antibody nipocalimab (Johnson & Johnson) is associated with significant improvement in patients with generalized myasthenia gravis (gMG) over a 24-week period, according to topline results from the phase 3 VIVACITY-MG3 study.

The VIVACITY-MG3 trial is the first registrational study of a neonatal fragment crystallizable receptor (FcRn) blocker to show sustained efficacy through 6 months of fixed schedule dosing.

Lead investigator Tuan Vu, MD, professor of neurology at the University of South Florida in Tampa, presented the findings at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2024
 

Autoantibody Depletion

FcRN plays a crucial role in the transport of immunoglobulin G. Blocking it can reduce circulating immunoglobulin G antibodies, including pathogenic gMG autoantibodies. 

The double-blind, placebo-controlled trial included 196 adults with a broad range of seropositive gMG – who account for approximately 95% of the gMG patient population – and 42 seronegative patients.

The mean age was 52 years, 92% were female, and 63% were White. The mean disease duration was about 8 years. Among seropositive patients, 87.6% were acetylcholine receptor autoantibody-positive (AChR+), 10.5% were muscle-specific kinase autoantibody-positive (MuSK+), and 2% were low-density lipoprotein receptor-related protein 4 antibody positive.

They were randomly assigned 1:1 to receive either nipocalimab IV plus standard of care, or placebo plus standard of care for 24 weeks. A total of 87 patients in the nipocalimab arm and 82 in the placebo arm completed the study.

The primary efficacy endpoint was the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Participants treated with nipocalimab demonstrated a statistically significant improvement of 4.70 points from baseline, compared to the 3.25-point improvement in those treated with placebo (P =.002). 
 

Clinically Meaningful Changes?

“For someone living with gMG, a 1 to 2-point improvement on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator,” the drug’s manufacturer noted in a release. 

Secondary endpoints were also better in the nipocalimab group, compared with participants on placebo. Specifically, on the 13-item clinician assessed Quantitative Myasthenia Gravis disease severity score, patients who received nipocalimab had an average reduction of 4.86 points from baseline compared to a reduction of 2.05 points in the placebo arm (P <.001). 

Similarly, MG-ADL response (defined as ≥ 2-point improvement from baseline) was significantly greater in the nipocalimab versus placebo arms (68.8% vs 52.6%; P =.021).

Subgroup analysis revealed similar results for the different types of seropositive patients, but there was no statistically significant difference in results for seronegative patients treated with nipocalimab versus placebo.

“The drug was pretty well tolerated and there was little difference, other than more patients with muscle spasm in the nipocalimab group (12.2% vs 3.1%),” said Vu. 

In addition, peripheral edema occurred in 11.2% of the nipocalimab group and none of the placebo-treated patients. Cholesterol levels were also higher in the nipocalimab arm, but there were no cardiac side effects, he added.
 

Encouraging Findings

Commenting on the findings, Neelam Goyal, MD, clinical professor of neurology and neurological sciences at Stanford University School of Medicine in Palo Alto, California, was encouraged.

“It’s a phase 3 trial, it’s positive, which is great, so it’ll be another drug on the market, another option for our patients,” she said. However, she cautioned, “their placebo arm did better than most placebos, so I think the delta is not as robust, but it was still statistically significant.” 

Goyal noted that, if approved, nipocalimab will be the third FcRn inhibitor in the MG field, preceded by efgartigimod (Vyvgart), which is approved for AChR antibody-positive disease, and rozanolixizumab-noli (Rystiggo) which is approved for both for AChR and MUSK antibody positive disease. 

“Its target of action is similar to the two drugs that are already on the market, but one thing that is unique about nipocalimab is that it is continuous dosing versus the other two medications that are given cyclically,” she said. 

“The reason that’s an upside, is that with cyclical dosing, patients have a return of symptoms. We treat, they get better, and then they get worse. That’s very disconcerting to patients. So, they want to be treated continuously.”

Additionally, she said there are some early data suggesting its safety in pregnancy.

Vu disclosed he is the USF Site Principal Investigator for MG clinical trials sponsored by Alexion/ AstraZeneca Rare Disease, Amgen, argenx, Cartesian Therapeutics, COUR Pharmaceuticals, Dianthus Therapeutics, Immunovant, Johnson & Johnson, NMD Pharmaceuticals, Regeneron Pharmaceuticals, and UCB, and has served as a speaker for Alexion/AstraZeneca Rare Disease, argenx, and CSL Behring. He performs consulting work for Alexion/AstraZeneca Rare Disease, argenx, Dianthus Therapeutics, ImmunAbs, and UCB. Goyal disclosed consultant, advisory or grant support from argenx, UCB, Alexion, and Janssen. The study was funded by Janssen. 
 

A version of this article appeared on Medscape.com.

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The investigational monoclonal antibody nipocalimab (Johnson & Johnson) is associated with significant improvement in patients with generalized myasthenia gravis (gMG) over a 24-week period, according to topline results from the phase 3 VIVACITY-MG3 study.

The VIVACITY-MG3 trial is the first registrational study of a neonatal fragment crystallizable receptor (FcRn) blocker to show sustained efficacy through 6 months of fixed schedule dosing.

Lead investigator Tuan Vu, MD, professor of neurology at the University of South Florida in Tampa, presented the findings at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2024
 

Autoantibody Depletion

FcRN plays a crucial role in the transport of immunoglobulin G. Blocking it can reduce circulating immunoglobulin G antibodies, including pathogenic gMG autoantibodies. 

The double-blind, placebo-controlled trial included 196 adults with a broad range of seropositive gMG – who account for approximately 95% of the gMG patient population – and 42 seronegative patients.

The mean age was 52 years, 92% were female, and 63% were White. The mean disease duration was about 8 years. Among seropositive patients, 87.6% were acetylcholine receptor autoantibody-positive (AChR+), 10.5% were muscle-specific kinase autoantibody-positive (MuSK+), and 2% were low-density lipoprotein receptor-related protein 4 antibody positive.

They were randomly assigned 1:1 to receive either nipocalimab IV plus standard of care, or placebo plus standard of care for 24 weeks. A total of 87 patients in the nipocalimab arm and 82 in the placebo arm completed the study.

The primary efficacy endpoint was the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Participants treated with nipocalimab demonstrated a statistically significant improvement of 4.70 points from baseline, compared to the 3.25-point improvement in those treated with placebo (P =.002). 
 

Clinically Meaningful Changes?

“For someone living with gMG, a 1 to 2-point improvement on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator,” the drug’s manufacturer noted in a release. 

Secondary endpoints were also better in the nipocalimab group, compared with participants on placebo. Specifically, on the 13-item clinician assessed Quantitative Myasthenia Gravis disease severity score, patients who received nipocalimab had an average reduction of 4.86 points from baseline compared to a reduction of 2.05 points in the placebo arm (P <.001). 

Similarly, MG-ADL response (defined as ≥ 2-point improvement from baseline) was significantly greater in the nipocalimab versus placebo arms (68.8% vs 52.6%; P =.021).

Subgroup analysis revealed similar results for the different types of seropositive patients, but there was no statistically significant difference in results for seronegative patients treated with nipocalimab versus placebo.

“The drug was pretty well tolerated and there was little difference, other than more patients with muscle spasm in the nipocalimab group (12.2% vs 3.1%),” said Vu. 

In addition, peripheral edema occurred in 11.2% of the nipocalimab group and none of the placebo-treated patients. Cholesterol levels were also higher in the nipocalimab arm, but there were no cardiac side effects, he added.
 

Encouraging Findings

Commenting on the findings, Neelam Goyal, MD, clinical professor of neurology and neurological sciences at Stanford University School of Medicine in Palo Alto, California, was encouraged.

“It’s a phase 3 trial, it’s positive, which is great, so it’ll be another drug on the market, another option for our patients,” she said. However, she cautioned, “their placebo arm did better than most placebos, so I think the delta is not as robust, but it was still statistically significant.” 

Goyal noted that, if approved, nipocalimab will be the third FcRn inhibitor in the MG field, preceded by efgartigimod (Vyvgart), which is approved for AChR antibody-positive disease, and rozanolixizumab-noli (Rystiggo) which is approved for both for AChR and MUSK antibody positive disease. 

“Its target of action is similar to the two drugs that are already on the market, but one thing that is unique about nipocalimab is that it is continuous dosing versus the other two medications that are given cyclically,” she said. 

“The reason that’s an upside, is that with cyclical dosing, patients have a return of symptoms. We treat, they get better, and then they get worse. That’s very disconcerting to patients. So, they want to be treated continuously.”

Additionally, she said there are some early data suggesting its safety in pregnancy.

Vu disclosed he is the USF Site Principal Investigator for MG clinical trials sponsored by Alexion/ AstraZeneca Rare Disease, Amgen, argenx, Cartesian Therapeutics, COUR Pharmaceuticals, Dianthus Therapeutics, Immunovant, Johnson & Johnson, NMD Pharmaceuticals, Regeneron Pharmaceuticals, and UCB, and has served as a speaker for Alexion/AstraZeneca Rare Disease, argenx, and CSL Behring. He performs consulting work for Alexion/AstraZeneca Rare Disease, argenx, Dianthus Therapeutics, ImmunAbs, and UCB. Goyal disclosed consultant, advisory or grant support from argenx, UCB, Alexion, and Janssen. The study was funded by Janssen. 
 

A version of this article appeared on Medscape.com.

The investigational monoclonal antibody nipocalimab (Johnson & Johnson) is associated with significant improvement in patients with generalized myasthenia gravis (gMG) over a 24-week period, according to topline results from the phase 3 VIVACITY-MG3 study.

The VIVACITY-MG3 trial is the first registrational study of a neonatal fragment crystallizable receptor (FcRn) blocker to show sustained efficacy through 6 months of fixed schedule dosing.

Lead investigator Tuan Vu, MD, professor of neurology at the University of South Florida in Tampa, presented the findings at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2024
 

Autoantibody Depletion

FcRN plays a crucial role in the transport of immunoglobulin G. Blocking it can reduce circulating immunoglobulin G antibodies, including pathogenic gMG autoantibodies. 

The double-blind, placebo-controlled trial included 196 adults with a broad range of seropositive gMG – who account for approximately 95% of the gMG patient population – and 42 seronegative patients.

The mean age was 52 years, 92% were female, and 63% were White. The mean disease duration was about 8 years. Among seropositive patients, 87.6% were acetylcholine receptor autoantibody-positive (AChR+), 10.5% were muscle-specific kinase autoantibody-positive (MuSK+), and 2% were low-density lipoprotein receptor-related protein 4 antibody positive.

They were randomly assigned 1:1 to receive either nipocalimab IV plus standard of care, or placebo plus standard of care for 24 weeks. A total of 87 patients in the nipocalimab arm and 82 in the placebo arm completed the study.

The primary efficacy endpoint was the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Participants treated with nipocalimab demonstrated a statistically significant improvement of 4.70 points from baseline, compared to the 3.25-point improvement in those treated with placebo (P =.002). 
 

Clinically Meaningful Changes?

“For someone living with gMG, a 1 to 2-point improvement on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator,” the drug’s manufacturer noted in a release. 

Secondary endpoints were also better in the nipocalimab group, compared with participants on placebo. Specifically, on the 13-item clinician assessed Quantitative Myasthenia Gravis disease severity score, patients who received nipocalimab had an average reduction of 4.86 points from baseline compared to a reduction of 2.05 points in the placebo arm (P <.001). 

Similarly, MG-ADL response (defined as ≥ 2-point improvement from baseline) was significantly greater in the nipocalimab versus placebo arms (68.8% vs 52.6%; P =.021).

Subgroup analysis revealed similar results for the different types of seropositive patients, but there was no statistically significant difference in results for seronegative patients treated with nipocalimab versus placebo.

“The drug was pretty well tolerated and there was little difference, other than more patients with muscle spasm in the nipocalimab group (12.2% vs 3.1%),” said Vu. 

In addition, peripheral edema occurred in 11.2% of the nipocalimab group and none of the placebo-treated patients. Cholesterol levels were also higher in the nipocalimab arm, but there were no cardiac side effects, he added.
 

Encouraging Findings

Commenting on the findings, Neelam Goyal, MD, clinical professor of neurology and neurological sciences at Stanford University School of Medicine in Palo Alto, California, was encouraged.

“It’s a phase 3 trial, it’s positive, which is great, so it’ll be another drug on the market, another option for our patients,” she said. However, she cautioned, “their placebo arm did better than most placebos, so I think the delta is not as robust, but it was still statistically significant.” 

Goyal noted that, if approved, nipocalimab will be the third FcRn inhibitor in the MG field, preceded by efgartigimod (Vyvgart), which is approved for AChR antibody-positive disease, and rozanolixizumab-noli (Rystiggo) which is approved for both for AChR and MUSK antibody positive disease. 

“Its target of action is similar to the two drugs that are already on the market, but one thing that is unique about nipocalimab is that it is continuous dosing versus the other two medications that are given cyclically,” she said. 

“The reason that’s an upside, is that with cyclical dosing, patients have a return of symptoms. We treat, they get better, and then they get worse. That’s very disconcerting to patients. So, they want to be treated continuously.”

Additionally, she said there are some early data suggesting its safety in pregnancy.

Vu disclosed he is the USF Site Principal Investigator for MG clinical trials sponsored by Alexion/ AstraZeneca Rare Disease, Amgen, argenx, Cartesian Therapeutics, COUR Pharmaceuticals, Dianthus Therapeutics, Immunovant, Johnson & Johnson, NMD Pharmaceuticals, Regeneron Pharmaceuticals, and UCB, and has served as a speaker for Alexion/AstraZeneca Rare Disease, argenx, and CSL Behring. He performs consulting work for Alexion/AstraZeneca Rare Disease, argenx, Dianthus Therapeutics, ImmunAbs, and UCB. Goyal disclosed consultant, advisory or grant support from argenx, UCB, Alexion, and Janssen. The study was funded by Janssen. 
 

A version of this article appeared on Medscape.com.

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First-in-Class B-Cell Depleting Agent Promising for Myasthenia Gravis

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Thu, 10/17/2024 - 11:55

— Inebilizumab, a first-in-class anti-CD19 B-cell depleting agent, demonstrated both safety and superior efficacy compared with placebo in patients with seropositive generalized myasthenia gravis (gMG), new phase 3 data showed.

“Based on these results, we have demonstrated that targeting B cells, including the antibody-secreting cells, is beneficial, and there is likely a role for this kind of therapeutic strategy for patients with myasthenia gravis,” said senior investigator Richard Nowak, MD.

The findings were published and presented at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2024.
 

Largest Cohort of Muscle-Specific Kinase (MuSK) Antibody–Positive Disease

The Myasthenia Gravis INebilizumab Trial study enrolled 238 participants, 60.8% women, mean age 47.5 years, from 79 sites in 18 countries. The participants were divided into two cohorts: 190 acetylcholine receptor (AChR) autoantibody–positive patients and 48 MuSK autoantibody–positive patients.

“This is the largest enrolled cohort of MuSK antibody–positive disease in a placebo-controlled trial to date,” said Nowak, director of the Yale Myasthenia Gravis Clinic and associate professor of neurology at Yale School of Medicine, in New Haven, Connecticut.

Both groups had similar gMG duration (mean 6.7 and 5.2 years for AChR+ and MuSK+ patients, respectively) and disease severity based on Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) baseline score. In addition, more than 80% of participants were on a prednisone equivalent dose greater than 5 mg daily at study entry.

Participants were randomly assigned to receive intravenous (IV) inebilizumab or IV placebo for 52 weeks (AChR+ group) or 26 weeks (MuSK+ group). In addition, study participants who were taking corticosteroids were tapered down starting at week 4 to prednisone 5 mg per day by week 24.

The trial met its primary endpoint, with a statistically significant change from baseline in MG-ADL and with a reduction of 4.2 points for inebilizumab versus 2.2 for placebo (P < .0001) at week 26 for the combined study population.

“You can see that the trend is actually going toward separation of the two groups after week 8 in the combined population,” said Nowak. Key secondary endpoints also showed statistically significant and clinically meaningful change from baseline compared with placebo.

This included a statistically significant change in QMG score inebilizumab compared with placebo for the combined population, a reduction of 4.8 versus 2.3 points, respectively, at week 26 (P = .0002).

In addition, both MG-ADL and QMG scores in the AChR+ subgroup were superior for inebilizumab versus placebo at week 26, with reductions of 4.2 versus 2.4, and 4.4 versus 2.0; P = .0015 and P = .0011, respectively.

In the MuSK+ subgroup, inebilizumab-treated patients had better MG-ADL scores than placebo-treated patients, with reductions of 3.9 versus 1.7 points, respectively, at week 26, although this difference did not meet statistical significance.

“There were no increased safety incidents in the inebilizumab-treated patients versus placebo, and a similar percentage of safety incidents in the AChR–positive and MuSK–positive groups. There were three deaths reported, all likely related to myasthenic crisis,” he said.

Nowak said that inebilizumab is “unique from the other currently FDA-approved medications for myasthenia gravis in that it’s targeting the upstream immunopathogenic mechanism of disease, specifically B cells — and B cells that are actually antibody-secreting cells.”

“It is targeting the factories of autoantibody production, whereas an FcRn antagonist, for example, is not targeting those factories but rather targeting what’s being produced — the immunoglobulins, IgGs in general,” he added.

Nowak said that what is particularly exciting about the drug is that the schedule is not very frequent. It begins with an initial IV infusion, followed by a second infusion 2 weeks later and a third infusion 6 months after that, so that patients are treated approximately every 6 months. This is in contrast to some other targeted therapies, where failing to address the underlying factors driving immunopathogenesis necessitates more regular and frequent medication administration.
 

 

 

New, Novel, Exciting

Commenting on the research, Neelam Goyal, MD, who chaired the session, said, “It’s definitely new, novel, interesting, exciting.”

Goyal, clinical professor of neurology and neurological sciences at Stanford University School of Medicine in Palo Alto, California, also noted that while B-cell depletion has shown some previous success in MG, it was with rituximab, a CD20 B-cell depleting agent.

She noted that unlike rituximab, which targets CD20, inebilizumab targets CD19, although both medications lead to B-cell depletion. Rituximab has proven effective for MUSK–positive MG, which accounts for approximately 5% of cases.

However, Goyal noted that the results for AChR–positive MG have been mixed — “the BeatMG trial was negative and the RINOMAX trial was positive. So, I think this is really interesting. It is exciting, and this drug is already on the market.”

She added that although inebilizumab is already US Food and Drug Administration–approved for the treatment of neuromyelitis optica, it still faces approval and indication hurdles for MG.

The future of this drug in the management algorithm for MG remains uncertain. Goyal noted that it’s “quite costly,” and although its benefits are evident — particularly for FcRn and complement inhibitors — some early data from chimeric antigen receptor T-cell therapy studies appear significantly more impressive.

Nowak disclosed research support from the National Institutes of Health, Genentech, Alexion Pharmaceuticals, argenx, Annexon Biosciences, Ra Pharmaceuticals (now UCB S.A.), the Myasthenia Gravis Foundation of America, Momenta Pharmaceuticals (now Janssen), Immunovant, Grifols, S.A., and Viela Bio, Horizon Therapeutics (now Amgen). Served as a consultant and advisor for Alexion Pharmaceuticals, argenx, Cabaletta Bio, Cour Pharmaceuticals, Ra Pharmaceuticals (now UCB S.A.), Immunovant, Momenta Pharmaceuticals (now Janssen), and Viela Bio (Horizon Therapeutics, now Amgen).

Goyal disclosed consultant, advisory, or grant support from argenx, UCB, Alexion, and Janssen. The study was funded by Amgen.
 

A version of this article appeared on Medscape.com.

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— Inebilizumab, a first-in-class anti-CD19 B-cell depleting agent, demonstrated both safety and superior efficacy compared with placebo in patients with seropositive generalized myasthenia gravis (gMG), new phase 3 data showed.

“Based on these results, we have demonstrated that targeting B cells, including the antibody-secreting cells, is beneficial, and there is likely a role for this kind of therapeutic strategy for patients with myasthenia gravis,” said senior investigator Richard Nowak, MD.

The findings were published and presented at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2024.
 

Largest Cohort of Muscle-Specific Kinase (MuSK) Antibody–Positive Disease

The Myasthenia Gravis INebilizumab Trial study enrolled 238 participants, 60.8% women, mean age 47.5 years, from 79 sites in 18 countries. The participants were divided into two cohorts: 190 acetylcholine receptor (AChR) autoantibody–positive patients and 48 MuSK autoantibody–positive patients.

“This is the largest enrolled cohort of MuSK antibody–positive disease in a placebo-controlled trial to date,” said Nowak, director of the Yale Myasthenia Gravis Clinic and associate professor of neurology at Yale School of Medicine, in New Haven, Connecticut.

Both groups had similar gMG duration (mean 6.7 and 5.2 years for AChR+ and MuSK+ patients, respectively) and disease severity based on Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) baseline score. In addition, more than 80% of participants were on a prednisone equivalent dose greater than 5 mg daily at study entry.

Participants were randomly assigned to receive intravenous (IV) inebilizumab or IV placebo for 52 weeks (AChR+ group) or 26 weeks (MuSK+ group). In addition, study participants who were taking corticosteroids were tapered down starting at week 4 to prednisone 5 mg per day by week 24.

The trial met its primary endpoint, with a statistically significant change from baseline in MG-ADL and with a reduction of 4.2 points for inebilizumab versus 2.2 for placebo (P < .0001) at week 26 for the combined study population.

“You can see that the trend is actually going toward separation of the two groups after week 8 in the combined population,” said Nowak. Key secondary endpoints also showed statistically significant and clinically meaningful change from baseline compared with placebo.

This included a statistically significant change in QMG score inebilizumab compared with placebo for the combined population, a reduction of 4.8 versus 2.3 points, respectively, at week 26 (P = .0002).

In addition, both MG-ADL and QMG scores in the AChR+ subgroup were superior for inebilizumab versus placebo at week 26, with reductions of 4.2 versus 2.4, and 4.4 versus 2.0; P = .0015 and P = .0011, respectively.

In the MuSK+ subgroup, inebilizumab-treated patients had better MG-ADL scores than placebo-treated patients, with reductions of 3.9 versus 1.7 points, respectively, at week 26, although this difference did not meet statistical significance.

“There were no increased safety incidents in the inebilizumab-treated patients versus placebo, and a similar percentage of safety incidents in the AChR–positive and MuSK–positive groups. There were three deaths reported, all likely related to myasthenic crisis,” he said.

Nowak said that inebilizumab is “unique from the other currently FDA-approved medications for myasthenia gravis in that it’s targeting the upstream immunopathogenic mechanism of disease, specifically B cells — and B cells that are actually antibody-secreting cells.”

“It is targeting the factories of autoantibody production, whereas an FcRn antagonist, for example, is not targeting those factories but rather targeting what’s being produced — the immunoglobulins, IgGs in general,” he added.

Nowak said that what is particularly exciting about the drug is that the schedule is not very frequent. It begins with an initial IV infusion, followed by a second infusion 2 weeks later and a third infusion 6 months after that, so that patients are treated approximately every 6 months. This is in contrast to some other targeted therapies, where failing to address the underlying factors driving immunopathogenesis necessitates more regular and frequent medication administration.
 

 

 

New, Novel, Exciting

Commenting on the research, Neelam Goyal, MD, who chaired the session, said, “It’s definitely new, novel, interesting, exciting.”

Goyal, clinical professor of neurology and neurological sciences at Stanford University School of Medicine in Palo Alto, California, also noted that while B-cell depletion has shown some previous success in MG, it was with rituximab, a CD20 B-cell depleting agent.

She noted that unlike rituximab, which targets CD20, inebilizumab targets CD19, although both medications lead to B-cell depletion. Rituximab has proven effective for MUSK–positive MG, which accounts for approximately 5% of cases.

However, Goyal noted that the results for AChR–positive MG have been mixed — “the BeatMG trial was negative and the RINOMAX trial was positive. So, I think this is really interesting. It is exciting, and this drug is already on the market.”

She added that although inebilizumab is already US Food and Drug Administration–approved for the treatment of neuromyelitis optica, it still faces approval and indication hurdles for MG.

The future of this drug in the management algorithm for MG remains uncertain. Goyal noted that it’s “quite costly,” and although its benefits are evident — particularly for FcRn and complement inhibitors — some early data from chimeric antigen receptor T-cell therapy studies appear significantly more impressive.

Nowak disclosed research support from the National Institutes of Health, Genentech, Alexion Pharmaceuticals, argenx, Annexon Biosciences, Ra Pharmaceuticals (now UCB S.A.), the Myasthenia Gravis Foundation of America, Momenta Pharmaceuticals (now Janssen), Immunovant, Grifols, S.A., and Viela Bio, Horizon Therapeutics (now Amgen). Served as a consultant and advisor for Alexion Pharmaceuticals, argenx, Cabaletta Bio, Cour Pharmaceuticals, Ra Pharmaceuticals (now UCB S.A.), Immunovant, Momenta Pharmaceuticals (now Janssen), and Viela Bio (Horizon Therapeutics, now Amgen).

Goyal disclosed consultant, advisory, or grant support from argenx, UCB, Alexion, and Janssen. The study was funded by Amgen.
 

A version of this article appeared on Medscape.com.

— Inebilizumab, a first-in-class anti-CD19 B-cell depleting agent, demonstrated both safety and superior efficacy compared with placebo in patients with seropositive generalized myasthenia gravis (gMG), new phase 3 data showed.

“Based on these results, we have demonstrated that targeting B cells, including the antibody-secreting cells, is beneficial, and there is likely a role for this kind of therapeutic strategy for patients with myasthenia gravis,” said senior investigator Richard Nowak, MD.

The findings were published and presented at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2024.
 

Largest Cohort of Muscle-Specific Kinase (MuSK) Antibody–Positive Disease

The Myasthenia Gravis INebilizumab Trial study enrolled 238 participants, 60.8% women, mean age 47.5 years, from 79 sites in 18 countries. The participants were divided into two cohorts: 190 acetylcholine receptor (AChR) autoantibody–positive patients and 48 MuSK autoantibody–positive patients.

“This is the largest enrolled cohort of MuSK antibody–positive disease in a placebo-controlled trial to date,” said Nowak, director of the Yale Myasthenia Gravis Clinic and associate professor of neurology at Yale School of Medicine, in New Haven, Connecticut.

Both groups had similar gMG duration (mean 6.7 and 5.2 years for AChR+ and MuSK+ patients, respectively) and disease severity based on Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) baseline score. In addition, more than 80% of participants were on a prednisone equivalent dose greater than 5 mg daily at study entry.

Participants were randomly assigned to receive intravenous (IV) inebilizumab or IV placebo for 52 weeks (AChR+ group) or 26 weeks (MuSK+ group). In addition, study participants who were taking corticosteroids were tapered down starting at week 4 to prednisone 5 mg per day by week 24.

The trial met its primary endpoint, with a statistically significant change from baseline in MG-ADL and with a reduction of 4.2 points for inebilizumab versus 2.2 for placebo (P < .0001) at week 26 for the combined study population.

“You can see that the trend is actually going toward separation of the two groups after week 8 in the combined population,” said Nowak. Key secondary endpoints also showed statistically significant and clinically meaningful change from baseline compared with placebo.

This included a statistically significant change in QMG score inebilizumab compared with placebo for the combined population, a reduction of 4.8 versus 2.3 points, respectively, at week 26 (P = .0002).

In addition, both MG-ADL and QMG scores in the AChR+ subgroup were superior for inebilizumab versus placebo at week 26, with reductions of 4.2 versus 2.4, and 4.4 versus 2.0; P = .0015 and P = .0011, respectively.

In the MuSK+ subgroup, inebilizumab-treated patients had better MG-ADL scores than placebo-treated patients, with reductions of 3.9 versus 1.7 points, respectively, at week 26, although this difference did not meet statistical significance.

“There were no increased safety incidents in the inebilizumab-treated patients versus placebo, and a similar percentage of safety incidents in the AChR–positive and MuSK–positive groups. There were three deaths reported, all likely related to myasthenic crisis,” he said.

Nowak said that inebilizumab is “unique from the other currently FDA-approved medications for myasthenia gravis in that it’s targeting the upstream immunopathogenic mechanism of disease, specifically B cells — and B cells that are actually antibody-secreting cells.”

“It is targeting the factories of autoantibody production, whereas an FcRn antagonist, for example, is not targeting those factories but rather targeting what’s being produced — the immunoglobulins, IgGs in general,” he added.

Nowak said that what is particularly exciting about the drug is that the schedule is not very frequent. It begins with an initial IV infusion, followed by a second infusion 2 weeks later and a third infusion 6 months after that, so that patients are treated approximately every 6 months. This is in contrast to some other targeted therapies, where failing to address the underlying factors driving immunopathogenesis necessitates more regular and frequent medication administration.
 

 

 

New, Novel, Exciting

Commenting on the research, Neelam Goyal, MD, who chaired the session, said, “It’s definitely new, novel, interesting, exciting.”

Goyal, clinical professor of neurology and neurological sciences at Stanford University School of Medicine in Palo Alto, California, also noted that while B-cell depletion has shown some previous success in MG, it was with rituximab, a CD20 B-cell depleting agent.

She noted that unlike rituximab, which targets CD20, inebilizumab targets CD19, although both medications lead to B-cell depletion. Rituximab has proven effective for MUSK–positive MG, which accounts for approximately 5% of cases.

However, Goyal noted that the results for AChR–positive MG have been mixed — “the BeatMG trial was negative and the RINOMAX trial was positive. So, I think this is really interesting. It is exciting, and this drug is already on the market.”

She added that although inebilizumab is already US Food and Drug Administration–approved for the treatment of neuromyelitis optica, it still faces approval and indication hurdles for MG.

The future of this drug in the management algorithm for MG remains uncertain. Goyal noted that it’s “quite costly,” and although its benefits are evident — particularly for FcRn and complement inhibitors — some early data from chimeric antigen receptor T-cell therapy studies appear significantly more impressive.

Nowak disclosed research support from the National Institutes of Health, Genentech, Alexion Pharmaceuticals, argenx, Annexon Biosciences, Ra Pharmaceuticals (now UCB S.A.), the Myasthenia Gravis Foundation of America, Momenta Pharmaceuticals (now Janssen), Immunovant, Grifols, S.A., and Viela Bio, Horizon Therapeutics (now Amgen). Served as a consultant and advisor for Alexion Pharmaceuticals, argenx, Cabaletta Bio, Cour Pharmaceuticals, Ra Pharmaceuticals (now UCB S.A.), Immunovant, Momenta Pharmaceuticals (now Janssen), and Viela Bio (Horizon Therapeutics, now Amgen).

Goyal disclosed consultant, advisory, or grant support from argenx, UCB, Alexion, and Janssen. The study was funded by Amgen.
 

A version of this article appeared on Medscape.com.

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Is BMI Underestimating Breast Cancer Risk in Postmenopausal Women?

Article Type
Changed
Wed, 10/16/2024 - 12:40

 

TOPLINE:

Excess body fat in postmenopausal women is linked to a higher risk for breast cancer, with the Clínica Universidad de Navarra-Body Adiposity Estimator (CUN-BAE) showing a stronger association than body mass index (BMI). Accurate body fat measures are crucial for effective cancer prevention.

METHODOLOGY:

  • Researchers conducted a case-control study including 1033 breast cancer cases and 1143 postmenopausal population controls from the MCC-Spain study.
  • Participants were aged 20-85 years. BMI was calculated as the ratio of weight to height squared and categorized using World Health Organization standards: < 25, 25-29.9, 30-34.9, and ≥ 35.
  • CUN-BAE was calculated using a specific equation and categorized according to the estimated percentage of body fat: < 35%, 35%-39.9%, 40%-44.9%, and ≥ 45%.
  • Odds ratios (ORs) were estimated with 95% CIs for both measures (BMI and CUN-BAE) for breast cancer cases using unconditional logistic regression.

TAKEAWAY:

  • Excess body weight attributable to the risk for breast cancer was 23% when assessed using a BMI value > 30 and 38% when assessed using a CUN-BAE value > 40% body fat.
  • Hormone receptor stratification showed that these differences in population-attributable fractions were only observed in hormone receptor–positive cases, with an estimated burden of 19.9% for BMI and 41.9% for CUN-BAE.
  • The highest categories of CUN-BAE showed an increase in the risk for postmenopausal breast cancer (OR, 2.13 for body fat ≥ 45% compared with the reference category < 35%).
  • No similar trend was observed for BMI, as the gradient declined after a BMI ≥ 35.

IN PRACTICE:

“The results of our study indicate that excess body fat is a significant risk factor for hormone receptor–positive breast cancer in postmenopausal women. Our findings suggest that the population impact could be underestimated when using traditional BMI estimates, and that more accurate measures of body fat, such as CUN-BAE, should be considered,” the authors of the study wrote.

SOURCE:

This study was led by Verónica Dávila-Batista, University of Las Palmas de Gran Canaria in Las Palmas de Gran Canaria, Spain. It was published online in Journal of Epidemiology and Community Health.

LIMITATIONS:

The case-control design of the study may have limited the ability to establish causal relationships. BMI was self-reported at the time of the interview for controls and 1 year before diagnosis for cancer cases, which may have introduced recall bias. The formula for CUN-BAE was calculated from a sedentary convenience sample, which may not have been representative of the general population. The small sample size of cases that did not express hormone receptors was another limitation. The study’s findings may not be generalizable to non-White populations as non-White participants were excluded.

DISCLOSURES:

Dávila-Batista disclosed receiving grants from the Carlos III Health Institute. Additional disclosures are noted in the original article.

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.

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TOPLINE:

Excess body fat in postmenopausal women is linked to a higher risk for breast cancer, with the Clínica Universidad de Navarra-Body Adiposity Estimator (CUN-BAE) showing a stronger association than body mass index (BMI). Accurate body fat measures are crucial for effective cancer prevention.

METHODOLOGY:

  • Researchers conducted a case-control study including 1033 breast cancer cases and 1143 postmenopausal population controls from the MCC-Spain study.
  • Participants were aged 20-85 years. BMI was calculated as the ratio of weight to height squared and categorized using World Health Organization standards: < 25, 25-29.9, 30-34.9, and ≥ 35.
  • CUN-BAE was calculated using a specific equation and categorized according to the estimated percentage of body fat: < 35%, 35%-39.9%, 40%-44.9%, and ≥ 45%.
  • Odds ratios (ORs) were estimated with 95% CIs for both measures (BMI and CUN-BAE) for breast cancer cases using unconditional logistic regression.

TAKEAWAY:

  • Excess body weight attributable to the risk for breast cancer was 23% when assessed using a BMI value > 30 and 38% when assessed using a CUN-BAE value > 40% body fat.
  • Hormone receptor stratification showed that these differences in population-attributable fractions were only observed in hormone receptor–positive cases, with an estimated burden of 19.9% for BMI and 41.9% for CUN-BAE.
  • The highest categories of CUN-BAE showed an increase in the risk for postmenopausal breast cancer (OR, 2.13 for body fat ≥ 45% compared with the reference category < 35%).
  • No similar trend was observed for BMI, as the gradient declined after a BMI ≥ 35.

IN PRACTICE:

“The results of our study indicate that excess body fat is a significant risk factor for hormone receptor–positive breast cancer in postmenopausal women. Our findings suggest that the population impact could be underestimated when using traditional BMI estimates, and that more accurate measures of body fat, such as CUN-BAE, should be considered,” the authors of the study wrote.

SOURCE:

This study was led by Verónica Dávila-Batista, University of Las Palmas de Gran Canaria in Las Palmas de Gran Canaria, Spain. It was published online in Journal of Epidemiology and Community Health.

LIMITATIONS:

The case-control design of the study may have limited the ability to establish causal relationships. BMI was self-reported at the time of the interview for controls and 1 year before diagnosis for cancer cases, which may have introduced recall bias. The formula for CUN-BAE was calculated from a sedentary convenience sample, which may not have been representative of the general population. The small sample size of cases that did not express hormone receptors was another limitation. The study’s findings may not be generalizable to non-White populations as non-White participants were excluded.

DISCLOSURES:

Dávila-Batista disclosed receiving grants from the Carlos III Health Institute. Additional disclosures are noted in the original article.

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:

Excess body fat in postmenopausal women is linked to a higher risk for breast cancer, with the Clínica Universidad de Navarra-Body Adiposity Estimator (CUN-BAE) showing a stronger association than body mass index (BMI). Accurate body fat measures are crucial for effective cancer prevention.

METHODOLOGY:

  • Researchers conducted a case-control study including 1033 breast cancer cases and 1143 postmenopausal population controls from the MCC-Spain study.
  • Participants were aged 20-85 years. BMI was calculated as the ratio of weight to height squared and categorized using World Health Organization standards: < 25, 25-29.9, 30-34.9, and ≥ 35.
  • CUN-BAE was calculated using a specific equation and categorized according to the estimated percentage of body fat: < 35%, 35%-39.9%, 40%-44.9%, and ≥ 45%.
  • Odds ratios (ORs) were estimated with 95% CIs for both measures (BMI and CUN-BAE) for breast cancer cases using unconditional logistic regression.

TAKEAWAY:

  • Excess body weight attributable to the risk for breast cancer was 23% when assessed using a BMI value > 30 and 38% when assessed using a CUN-BAE value > 40% body fat.
  • Hormone receptor stratification showed that these differences in population-attributable fractions were only observed in hormone receptor–positive cases, with an estimated burden of 19.9% for BMI and 41.9% for CUN-BAE.
  • The highest categories of CUN-BAE showed an increase in the risk for postmenopausal breast cancer (OR, 2.13 for body fat ≥ 45% compared with the reference category < 35%).
  • No similar trend was observed for BMI, as the gradient declined after a BMI ≥ 35.

IN PRACTICE:

“The results of our study indicate that excess body fat is a significant risk factor for hormone receptor–positive breast cancer in postmenopausal women. Our findings suggest that the population impact could be underestimated when using traditional BMI estimates, and that more accurate measures of body fat, such as CUN-BAE, should be considered,” the authors of the study wrote.

SOURCE:

This study was led by Verónica Dávila-Batista, University of Las Palmas de Gran Canaria in Las Palmas de Gran Canaria, Spain. It was published online in Journal of Epidemiology and Community Health.

LIMITATIONS:

The case-control design of the study may have limited the ability to establish causal relationships. BMI was self-reported at the time of the interview for controls and 1 year before diagnosis for cancer cases, which may have introduced recall bias. The formula for CUN-BAE was calculated from a sedentary convenience sample, which may not have been representative of the general population. The small sample size of cases that did not express hormone receptors was another limitation. The study’s findings may not be generalizable to non-White populations as non-White participants were excluded.

DISCLOSURES:

Dávila-Batista disclosed receiving grants from the Carlos III Health Institute. Additional disclosures are noted in the original article.

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.

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GLP-1 Receptor Agonists Reduce Suicidal Behavior in Adolescents With Obesity

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Wed, 10/16/2024 - 11:32

Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) given to adolescents with obesity was associated with a one-third decreased risk for suicidal ideation and suicide attempts compared with lifestyle intervention alone, a large international retrospective study found.

A study published in JAMA Pediatrics suggested that GLP-1 RAs such as semaglutide, liraglutide, and tirzepatide, which are widely used to treat type 2 diabetes (T2D), have a favorable psychiatric safety profile and open up potential avenues for prospective studies of psychiatric outcomes in adolescents with obesity.

Investigators Liya Kerem, MD, MSc, and Joshua Stokar, MD, of Hadassah University Medical Center in Jerusalem, Israel, reported that the reduced risk in GLP-1 RA recipients was maintained up to 3 years follow-up compared with propensity score–matched controls treated with behavioral interventions alone.

“These findings support the notion that childhood obesity does not result from lack of willpower and shed light on underlying mechanisms that can be targeted by pharmacotherapy.” Kerem and Stokar wrote.

Other research has suggested these agents have neurobiologic effects unrelated to weight loss that positively affect mood and mental health.
 

Study Details

The analysis included data from December 2019 to June 2024, drawn from 120 international healthcare organizations, mainly in the United States. A total of 4052 racially and ethnically diverse adolescents with obesity (aged 12-18 years [mean age, about 15.5 years]) being treated with an anti-obesity intervention were identified for the GLP-1 RA cohort and 50,112 for the control cohort. The arms were balanced for baseline demographic characteristics, psychiatric medications and comorbidities, and diagnoses associated with socioeconomic status and healthcare access.

Propensity score matching (PSM) resulted in 3456 participants in each of two balanced cohorts.

Before PSM, intervention patients were older (mean age, 15.5 vs 14.7 years), were more likely to be female (59% vs 49%), and had a higher body mass index (41.9 vs 33.8). They also had a higher prevalence of diabetes (40% vs 4%) and treatment with antidiabetic medications.

GLP-1 RA recipients also had a history of psychiatric diagnoses (17% vs 9% for mood disorders) and psychiatric medications (18% vs 7% for antidepressants). Previous use of non–GLP-1 RA anti-obesity medications was uncommon in the cohort overall, although more common in the GLP-1 RA cohort (2.5% vs 0.2% for phentermine).

Prescription of GLP-1 RA was associated with a 33% reduced risk for suicidal ideation or attempts over 12 months of follow-up: 1.45% vs 2.26% (hazard ratio [HR], 0.67; 95% CI, 0.47-0.95; P = .02). It was also associated with a higher rate of gastrointestinal symptoms: 6.9% vs 5.4% (HR, 1.41; 95% CI, 1.12-1.78; P = .003). There was no difference in rates of upper respiratory tract infections (URTIs), although some research suggests these agents reduce URTIs.
 

Mechanisms

The etiology of childhood obesity is complex and multifactorial, the authors wrote, and genetic predisposition to adiposity, an obesogenic environment, and a sedentary lifestyle synergistically contribute to its development. Variants in genes active in the hypothalamic appetite-regulation neurocircuitry appear to be associated with the development of childhood and adolescent obesity.

The authors noted that adolescence carries an increased risk for psychiatric disorders and suicidal ideation. “The amelioration of obesity could indirectly improve these psychiatric comorbidities,” they wrote. In addition, preclinical studies suggested that GLP-1 RA may improve depression-related neuropathology, including neuroinflammation and neurotransmitter imbalance, and may promote neurogenesis.

recent meta-analysis found that adults with T2D treated with GLP-1 RA showed significant reduction in depression scale scores compared with those treated with non-GLP-1 RA antidiabetic medications.

Commenting on the study but not involved in it, psychiatrist Robert H. Dicker, MD, associate director of child and adolescent psychiatry at Northwell Zucker Hillside Hospital in Glen Oaks, New York, cautioned that these are preliminary data limited by a retrospective review, not a prospective double-blind, placebo-controlled study.

“The mechanism is unknown — is it a direct effect on weight loss with an improvement of quality of life, more positive feedback by the community, enhanced ability to exercise, and a decrease in depressive symptoms?” he asked.

Dicker suggested an alternative hypothesis: Does the GLP-1 RA have a direct effect on neurotransmitters and inflammation and, thus, an impact on mood, emotional regulation, impulse control, and suicide?

“To further answer these questions, prospective studies must be conducted. It is far too early to conclude that these medications are effective in treating mood disorders in our youth,” Dicker said. “But it is promising that these treatments do not appear to increase suicidal ideas and behavior.”

Adding another outsider’s perspective on the study, Suzanne E. Cuda, MD, FOMA, FAAP, a pediatrician who treats childhood obesity in San Antonio, said that while there was no risk for increased psychiatric disease and a suggestion that GLP-1 RAs may reduce suicidal ideation or attempts, “I don’t think this translates to a treatment for depression in adolescents. Nor does this study indicate there could be a decrease in depression due specifically to the use of GLP1Rs. If the results in this study are replicated, however, it would be reassuring to know that adolescents would not be at risk for an increase in suicidal ideation or attempts.”

This study had no external funding. Kerem reported receiving personal fees from Novo Nordisk for lectures on childhood obesity outside of the submitted work. No other disclosures were reported. Dicker and Cuda had no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

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Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) given to adolescents with obesity was associated with a one-third decreased risk for suicidal ideation and suicide attempts compared with lifestyle intervention alone, a large international retrospective study found.

A study published in JAMA Pediatrics suggested that GLP-1 RAs such as semaglutide, liraglutide, and tirzepatide, which are widely used to treat type 2 diabetes (T2D), have a favorable psychiatric safety profile and open up potential avenues for prospective studies of psychiatric outcomes in adolescents with obesity.

Investigators Liya Kerem, MD, MSc, and Joshua Stokar, MD, of Hadassah University Medical Center in Jerusalem, Israel, reported that the reduced risk in GLP-1 RA recipients was maintained up to 3 years follow-up compared with propensity score–matched controls treated with behavioral interventions alone.

“These findings support the notion that childhood obesity does not result from lack of willpower and shed light on underlying mechanisms that can be targeted by pharmacotherapy.” Kerem and Stokar wrote.

Other research has suggested these agents have neurobiologic effects unrelated to weight loss that positively affect mood and mental health.
 

Study Details

The analysis included data from December 2019 to June 2024, drawn from 120 international healthcare organizations, mainly in the United States. A total of 4052 racially and ethnically diverse adolescents with obesity (aged 12-18 years [mean age, about 15.5 years]) being treated with an anti-obesity intervention were identified for the GLP-1 RA cohort and 50,112 for the control cohort. The arms were balanced for baseline demographic characteristics, psychiatric medications and comorbidities, and diagnoses associated with socioeconomic status and healthcare access.

Propensity score matching (PSM) resulted in 3456 participants in each of two balanced cohorts.

Before PSM, intervention patients were older (mean age, 15.5 vs 14.7 years), were more likely to be female (59% vs 49%), and had a higher body mass index (41.9 vs 33.8). They also had a higher prevalence of diabetes (40% vs 4%) and treatment with antidiabetic medications.

GLP-1 RA recipients also had a history of psychiatric diagnoses (17% vs 9% for mood disorders) and psychiatric medications (18% vs 7% for antidepressants). Previous use of non–GLP-1 RA anti-obesity medications was uncommon in the cohort overall, although more common in the GLP-1 RA cohort (2.5% vs 0.2% for phentermine).

Prescription of GLP-1 RA was associated with a 33% reduced risk for suicidal ideation or attempts over 12 months of follow-up: 1.45% vs 2.26% (hazard ratio [HR], 0.67; 95% CI, 0.47-0.95; P = .02). It was also associated with a higher rate of gastrointestinal symptoms: 6.9% vs 5.4% (HR, 1.41; 95% CI, 1.12-1.78; P = .003). There was no difference in rates of upper respiratory tract infections (URTIs), although some research suggests these agents reduce URTIs.
 

Mechanisms

The etiology of childhood obesity is complex and multifactorial, the authors wrote, and genetic predisposition to adiposity, an obesogenic environment, and a sedentary lifestyle synergistically contribute to its development. Variants in genes active in the hypothalamic appetite-regulation neurocircuitry appear to be associated with the development of childhood and adolescent obesity.

The authors noted that adolescence carries an increased risk for psychiatric disorders and suicidal ideation. “The amelioration of obesity could indirectly improve these psychiatric comorbidities,” they wrote. In addition, preclinical studies suggested that GLP-1 RA may improve depression-related neuropathology, including neuroinflammation and neurotransmitter imbalance, and may promote neurogenesis.

recent meta-analysis found that adults with T2D treated with GLP-1 RA showed significant reduction in depression scale scores compared with those treated with non-GLP-1 RA antidiabetic medications.

Commenting on the study but not involved in it, psychiatrist Robert H. Dicker, MD, associate director of child and adolescent psychiatry at Northwell Zucker Hillside Hospital in Glen Oaks, New York, cautioned that these are preliminary data limited by a retrospective review, not a prospective double-blind, placebo-controlled study.

“The mechanism is unknown — is it a direct effect on weight loss with an improvement of quality of life, more positive feedback by the community, enhanced ability to exercise, and a decrease in depressive symptoms?” he asked.

Dicker suggested an alternative hypothesis: Does the GLP-1 RA have a direct effect on neurotransmitters and inflammation and, thus, an impact on mood, emotional regulation, impulse control, and suicide?

“To further answer these questions, prospective studies must be conducted. It is far too early to conclude that these medications are effective in treating mood disorders in our youth,” Dicker said. “But it is promising that these treatments do not appear to increase suicidal ideas and behavior.”

Adding another outsider’s perspective on the study, Suzanne E. Cuda, MD, FOMA, FAAP, a pediatrician who treats childhood obesity in San Antonio, said that while there was no risk for increased psychiatric disease and a suggestion that GLP-1 RAs may reduce suicidal ideation or attempts, “I don’t think this translates to a treatment for depression in adolescents. Nor does this study indicate there could be a decrease in depression due specifically to the use of GLP1Rs. If the results in this study are replicated, however, it would be reassuring to know that adolescents would not be at risk for an increase in suicidal ideation or attempts.”

This study had no external funding. Kerem reported receiving personal fees from Novo Nordisk for lectures on childhood obesity outside of the submitted work. No other disclosures were reported. Dicker and Cuda had no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) given to adolescents with obesity was associated with a one-third decreased risk for suicidal ideation and suicide attempts compared with lifestyle intervention alone, a large international retrospective study found.

A study published in JAMA Pediatrics suggested that GLP-1 RAs such as semaglutide, liraglutide, and tirzepatide, which are widely used to treat type 2 diabetes (T2D), have a favorable psychiatric safety profile and open up potential avenues for prospective studies of psychiatric outcomes in adolescents with obesity.

Investigators Liya Kerem, MD, MSc, and Joshua Stokar, MD, of Hadassah University Medical Center in Jerusalem, Israel, reported that the reduced risk in GLP-1 RA recipients was maintained up to 3 years follow-up compared with propensity score–matched controls treated with behavioral interventions alone.

“These findings support the notion that childhood obesity does not result from lack of willpower and shed light on underlying mechanisms that can be targeted by pharmacotherapy.” Kerem and Stokar wrote.

Other research has suggested these agents have neurobiologic effects unrelated to weight loss that positively affect mood and mental health.
 

Study Details

The analysis included data from December 2019 to June 2024, drawn from 120 international healthcare organizations, mainly in the United States. A total of 4052 racially and ethnically diverse adolescents with obesity (aged 12-18 years [mean age, about 15.5 years]) being treated with an anti-obesity intervention were identified for the GLP-1 RA cohort and 50,112 for the control cohort. The arms were balanced for baseline demographic characteristics, psychiatric medications and comorbidities, and diagnoses associated with socioeconomic status and healthcare access.

Propensity score matching (PSM) resulted in 3456 participants in each of two balanced cohorts.

Before PSM, intervention patients were older (mean age, 15.5 vs 14.7 years), were more likely to be female (59% vs 49%), and had a higher body mass index (41.9 vs 33.8). They also had a higher prevalence of diabetes (40% vs 4%) and treatment with antidiabetic medications.

GLP-1 RA recipients also had a history of psychiatric diagnoses (17% vs 9% for mood disorders) and psychiatric medications (18% vs 7% for antidepressants). Previous use of non–GLP-1 RA anti-obesity medications was uncommon in the cohort overall, although more common in the GLP-1 RA cohort (2.5% vs 0.2% for phentermine).

Prescription of GLP-1 RA was associated with a 33% reduced risk for suicidal ideation or attempts over 12 months of follow-up: 1.45% vs 2.26% (hazard ratio [HR], 0.67; 95% CI, 0.47-0.95; P = .02). It was also associated with a higher rate of gastrointestinal symptoms: 6.9% vs 5.4% (HR, 1.41; 95% CI, 1.12-1.78; P = .003). There was no difference in rates of upper respiratory tract infections (URTIs), although some research suggests these agents reduce URTIs.
 

Mechanisms

The etiology of childhood obesity is complex and multifactorial, the authors wrote, and genetic predisposition to adiposity, an obesogenic environment, and a sedentary lifestyle synergistically contribute to its development. Variants in genes active in the hypothalamic appetite-regulation neurocircuitry appear to be associated with the development of childhood and adolescent obesity.

The authors noted that adolescence carries an increased risk for psychiatric disorders and suicidal ideation. “The amelioration of obesity could indirectly improve these psychiatric comorbidities,” they wrote. In addition, preclinical studies suggested that GLP-1 RA may improve depression-related neuropathology, including neuroinflammation and neurotransmitter imbalance, and may promote neurogenesis.

recent meta-analysis found that adults with T2D treated with GLP-1 RA showed significant reduction in depression scale scores compared with those treated with non-GLP-1 RA antidiabetic medications.

Commenting on the study but not involved in it, psychiatrist Robert H. Dicker, MD, associate director of child and adolescent psychiatry at Northwell Zucker Hillside Hospital in Glen Oaks, New York, cautioned that these are preliminary data limited by a retrospective review, not a prospective double-blind, placebo-controlled study.

“The mechanism is unknown — is it a direct effect on weight loss with an improvement of quality of life, more positive feedback by the community, enhanced ability to exercise, and a decrease in depressive symptoms?” he asked.

Dicker suggested an alternative hypothesis: Does the GLP-1 RA have a direct effect on neurotransmitters and inflammation and, thus, an impact on mood, emotional regulation, impulse control, and suicide?

“To further answer these questions, prospective studies must be conducted. It is far too early to conclude that these medications are effective in treating mood disorders in our youth,” Dicker said. “But it is promising that these treatments do not appear to increase suicidal ideas and behavior.”

Adding another outsider’s perspective on the study, Suzanne E. Cuda, MD, FOMA, FAAP, a pediatrician who treats childhood obesity in San Antonio, said that while there was no risk for increased psychiatric disease and a suggestion that GLP-1 RAs may reduce suicidal ideation or attempts, “I don’t think this translates to a treatment for depression in adolescents. Nor does this study indicate there could be a decrease in depression due specifically to the use of GLP1Rs. If the results in this study are replicated, however, it would be reassuring to know that adolescents would not be at risk for an increase in suicidal ideation or attempts.”

This study had no external funding. Kerem reported receiving personal fees from Novo Nordisk for lectures on childhood obesity outside of the submitted work. No other disclosures were reported. Dicker and Cuda had no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

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Unseen Cost of Weight Loss and Aging: Tackling Sarcopenia

Article Type
Changed
Wed, 10/16/2024 - 11:25

Losses of muscle and strength are inescapable effects of the aging process. Left unchecked, these progressive losses will start to impair physical function. 

Once a certain level of impairment occurs, an individual can be diagnosed with sarcopenia, which comes from the Greek words “sarco” (flesh) and “penia” (poverty). Individuals with sarcopenia have a significant increase in the risk for falls and death, as well as diminished quality of life.

Muscle mass losses generally occur with weight loss, and the increasing use of glucagon-like peptide 1 (GLP-1) medications may lead to greater incidence and prevalence of sarcopenia in the years to come.

A recent meta-analysis of 56 studies (mean participant age, 50 years) found a twofold greater risk for mortality in those with sarcopenia vs those without. Despite its health consequences, sarcopenia tends to be underdiagnosed and, consequently, undertreated at a population and individual level. Part of the reason probably stems from the lack of health insurance reimbursement for individual clinicians and hospital systems to perform sarcopenia screening assessments. 

In aging and obesity, it appears justified to include and emphasize a recommendation for sarcopenia screening in medical society guidelines; however, individual patients and clinicians do not need to wait for updated guidelines to implement sarcopenia screening, treatment, and prevention strategies in their own lives and/or clinical practice. 
 

Simple Prevention and Treatment Strategy

Much can be done to help prevent sarcopenia. The primary strategy, unsurprisingly, is engaging in frequent strength training. But that doesn’t mean hours in the gym every week. 

With just one session per week over 10 weeks, lean body mass (LBM), a common proxy for muscle mass, increased by 0.33 kg, according to a study which evaluated LBM improvements across different strength training frequencies. Adding a second weekly session was significantly better. In the twice-weekly group, LBM increased by 1.4 kg over 10 weeks, resulting in an increase in LBM more than four times greater than the once-a-week group. (There was no greater improvement in LBM by adding a third weekly session vs two weekly sessions.) 

Although that particular study didn’t identify greater benefit at three times a week, compared with twice a week, the specific training routines and lack of a protein consumption assessment may have played a role in that finding. 

Underlying the diminishing benefits, a different study found a marginally greater benefit in favor of performing ≥ five sets per major muscle group per week, compared with < five sets per week for increasing muscle in the legs, arms, back, chest, and shoulders. 

Expensive gym memberships and fancy equipment are not necessary. While the use of strength training machines and free weights have been viewed by many as the optimal approach, a recent systematic review and meta-analysis found that comparable improvements to strength can be achieved with workouts using resistance bands. For those who struggle to find the time to go to a gym, or for whom gym fees are not financially affordable, resistance bands are a cheaper and more convenient alternative. 

Lucas, Assistant Professor of Clinical Medicine, Comprehensive Weight Control Center, Weill Cornell Medicine, New York City, disclosed ties with Measured (Better Health Labs).

A version of this article appeared on Medscape.com.

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Losses of muscle and strength are inescapable effects of the aging process. Left unchecked, these progressive losses will start to impair physical function. 

Once a certain level of impairment occurs, an individual can be diagnosed with sarcopenia, which comes from the Greek words “sarco” (flesh) and “penia” (poverty). Individuals with sarcopenia have a significant increase in the risk for falls and death, as well as diminished quality of life.

Muscle mass losses generally occur with weight loss, and the increasing use of glucagon-like peptide 1 (GLP-1) medications may lead to greater incidence and prevalence of sarcopenia in the years to come.

A recent meta-analysis of 56 studies (mean participant age, 50 years) found a twofold greater risk for mortality in those with sarcopenia vs those without. Despite its health consequences, sarcopenia tends to be underdiagnosed and, consequently, undertreated at a population and individual level. Part of the reason probably stems from the lack of health insurance reimbursement for individual clinicians and hospital systems to perform sarcopenia screening assessments. 

In aging and obesity, it appears justified to include and emphasize a recommendation for sarcopenia screening in medical society guidelines; however, individual patients and clinicians do not need to wait for updated guidelines to implement sarcopenia screening, treatment, and prevention strategies in their own lives and/or clinical practice. 
 

Simple Prevention and Treatment Strategy

Much can be done to help prevent sarcopenia. The primary strategy, unsurprisingly, is engaging in frequent strength training. But that doesn’t mean hours in the gym every week. 

With just one session per week over 10 weeks, lean body mass (LBM), a common proxy for muscle mass, increased by 0.33 kg, according to a study which evaluated LBM improvements across different strength training frequencies. Adding a second weekly session was significantly better. In the twice-weekly group, LBM increased by 1.4 kg over 10 weeks, resulting in an increase in LBM more than four times greater than the once-a-week group. (There was no greater improvement in LBM by adding a third weekly session vs two weekly sessions.) 

Although that particular study didn’t identify greater benefit at three times a week, compared with twice a week, the specific training routines and lack of a protein consumption assessment may have played a role in that finding. 

Underlying the diminishing benefits, a different study found a marginally greater benefit in favor of performing ≥ five sets per major muscle group per week, compared with < five sets per week for increasing muscle in the legs, arms, back, chest, and shoulders. 

Expensive gym memberships and fancy equipment are not necessary. While the use of strength training machines and free weights have been viewed by many as the optimal approach, a recent systematic review and meta-analysis found that comparable improvements to strength can be achieved with workouts using resistance bands. For those who struggle to find the time to go to a gym, or for whom gym fees are not financially affordable, resistance bands are a cheaper and more convenient alternative. 

Lucas, Assistant Professor of Clinical Medicine, Comprehensive Weight Control Center, Weill Cornell Medicine, New York City, disclosed ties with Measured (Better Health Labs).

A version of this article appeared on Medscape.com.

Losses of muscle and strength are inescapable effects of the aging process. Left unchecked, these progressive losses will start to impair physical function. 

Once a certain level of impairment occurs, an individual can be diagnosed with sarcopenia, which comes from the Greek words “sarco” (flesh) and “penia” (poverty). Individuals with sarcopenia have a significant increase in the risk for falls and death, as well as diminished quality of life.

Muscle mass losses generally occur with weight loss, and the increasing use of glucagon-like peptide 1 (GLP-1) medications may lead to greater incidence and prevalence of sarcopenia in the years to come.

A recent meta-analysis of 56 studies (mean participant age, 50 years) found a twofold greater risk for mortality in those with sarcopenia vs those without. Despite its health consequences, sarcopenia tends to be underdiagnosed and, consequently, undertreated at a population and individual level. Part of the reason probably stems from the lack of health insurance reimbursement for individual clinicians and hospital systems to perform sarcopenia screening assessments. 

In aging and obesity, it appears justified to include and emphasize a recommendation for sarcopenia screening in medical society guidelines; however, individual patients and clinicians do not need to wait for updated guidelines to implement sarcopenia screening, treatment, and prevention strategies in their own lives and/or clinical practice. 
 

Simple Prevention and Treatment Strategy

Much can be done to help prevent sarcopenia. The primary strategy, unsurprisingly, is engaging in frequent strength training. But that doesn’t mean hours in the gym every week. 

With just one session per week over 10 weeks, lean body mass (LBM), a common proxy for muscle mass, increased by 0.33 kg, according to a study which evaluated LBM improvements across different strength training frequencies. Adding a second weekly session was significantly better. In the twice-weekly group, LBM increased by 1.4 kg over 10 weeks, resulting in an increase in LBM more than four times greater than the once-a-week group. (There was no greater improvement in LBM by adding a third weekly session vs two weekly sessions.) 

Although that particular study didn’t identify greater benefit at three times a week, compared with twice a week, the specific training routines and lack of a protein consumption assessment may have played a role in that finding. 

Underlying the diminishing benefits, a different study found a marginally greater benefit in favor of performing ≥ five sets per major muscle group per week, compared with < five sets per week for increasing muscle in the legs, arms, back, chest, and shoulders. 

Expensive gym memberships and fancy equipment are not necessary. While the use of strength training machines and free weights have been viewed by many as the optimal approach, a recent systematic review and meta-analysis found that comparable improvements to strength can be achieved with workouts using resistance bands. For those who struggle to find the time to go to a gym, or for whom gym fees are not financially affordable, resistance bands are a cheaper and more convenient alternative. 

Lucas, Assistant Professor of Clinical Medicine, Comprehensive Weight Control Center, Weill Cornell Medicine, New York City, disclosed ties with Measured (Better Health Labs).

A version of this article appeared on Medscape.com.

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Fear of Cancer Recurrence Can Persist for Childhood Survivors

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TOPLINE:

About one third of adult survivors of childhood cancer experience a clinically significant or high fear that their primary cancer may recur or that they will develop a subsequent malignancy, according to a recent analysis. The study finds that several factors are associated with a higher risk of experiencing a clinically significant fear of recurrence, including being unemployed or having elevated anxiety or depression.

METHODOLOGY:

  • Adult survivors of childhood cancer face a high risk of developing subsequent malignant neoplasms — about a sixfold greater risk than in the general population — and studies indicate that these cancer survivors also fear their cancer will recur. However, data on the prevalence of and risk factors associated with clinically significant fear of recurrence in this population remain limited.
  • This cross-sectional study included 229 adult survivors of childhood cancer (mean age at study completion, 39.6 years), recruited from the Childhood Cancer Survivor Study, who completed online surveys between October 2018 and April 2019.
  • Fear of cancer recurrence was assessed using the 9-item Fear of Cancer Recurrence Inventory–Short Form, which defines recurrence as the possibility that cancer might return to the same or a different part of the body.
  • Chronic pain, symptoms of depression and anxiety, self-perceived health, and intolerance of uncertainty were also evaluated.
  • Among the participants, 21 experienced a recurrence of their primary cancer and 17 were diagnosed with a subsequent malignant neoplasm.
  •  

TAKEAWAY:

  • Overall, 38 (16.6%) adult survivors of childhood cancer reported clinically significant fear that their cancer would recur, and an additional 36 (15.7%) survivors experienced high levels of fear; the remaining 67.7% of participants reported minimal levels of fear.
  • Survivors who were unemployed (prevalence ratio [PR], 2.5) were more likely to experience a clinically significant fear of recurrence, as were survivors who had undergone pelvic radiation (PR, 2.9) or limb-sparing or amputation surgery (PR, 2.4).
  • Survivors who had elevated anxiety or depression (PR, 2.6) or both (PR, 3.2) were more likely to experience a clinically significant fear of recurrence, as were survivors who had a chronic neurologic health condition (PR, 3.3) or who perceived their health status to be poor or fair vs good to excellent (PR, 3.0).
  • Among 94 participants with chronic pain, 25.5% reported clinically significant fear and 13.8% reported high levels of fear. But chronic pain (PR, 1.2; 95% CI, 0.6-2.4) was not significantly associated with a clinically significant fear of recurrence in a multivariable model.
  •  

IN PRACTICE:

“These findings underscore the substantial psychological and functional burden of FCR [fear of cancer recurrence] and suggest healthcare professionals should routinely assess FCR as a part of providing comprehensive care to long-term survivors,” the authors wrote.

SOURCE:

The study, led by Alex Pizzo, MSc, Concordia University, Montréal, Québec, Canada, was published online in JAMA Network Open.

 

 

LIMITATIONS:

The cross-sectional design limited causal inference. Self-perceived health was assessed with a single item, limiting its measurement. Internet and smartphone access eligibility could have introduced bias. The study also lacked racial and ethnic diversity.

DISCLOSURES:

The study was supported by the Childhood Cancer Survivor Study Career Development Award and a grant from the National Cancer Institute. Additional funding was provided by the Canada Research Chairs Program. Three authors reported receiving grants from various sources.

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.

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TOPLINE:

About one third of adult survivors of childhood cancer experience a clinically significant or high fear that their primary cancer may recur or that they will develop a subsequent malignancy, according to a recent analysis. The study finds that several factors are associated with a higher risk of experiencing a clinically significant fear of recurrence, including being unemployed or having elevated anxiety or depression.

METHODOLOGY:

  • Adult survivors of childhood cancer face a high risk of developing subsequent malignant neoplasms — about a sixfold greater risk than in the general population — and studies indicate that these cancer survivors also fear their cancer will recur. However, data on the prevalence of and risk factors associated with clinically significant fear of recurrence in this population remain limited.
  • This cross-sectional study included 229 adult survivors of childhood cancer (mean age at study completion, 39.6 years), recruited from the Childhood Cancer Survivor Study, who completed online surveys between October 2018 and April 2019.
  • Fear of cancer recurrence was assessed using the 9-item Fear of Cancer Recurrence Inventory–Short Form, which defines recurrence as the possibility that cancer might return to the same or a different part of the body.
  • Chronic pain, symptoms of depression and anxiety, self-perceived health, and intolerance of uncertainty were also evaluated.
  • Among the participants, 21 experienced a recurrence of their primary cancer and 17 were diagnosed with a subsequent malignant neoplasm.
  •  

TAKEAWAY:

  • Overall, 38 (16.6%) adult survivors of childhood cancer reported clinically significant fear that their cancer would recur, and an additional 36 (15.7%) survivors experienced high levels of fear; the remaining 67.7% of participants reported minimal levels of fear.
  • Survivors who were unemployed (prevalence ratio [PR], 2.5) were more likely to experience a clinically significant fear of recurrence, as were survivors who had undergone pelvic radiation (PR, 2.9) or limb-sparing or amputation surgery (PR, 2.4).
  • Survivors who had elevated anxiety or depression (PR, 2.6) or both (PR, 3.2) were more likely to experience a clinically significant fear of recurrence, as were survivors who had a chronic neurologic health condition (PR, 3.3) or who perceived their health status to be poor or fair vs good to excellent (PR, 3.0).
  • Among 94 participants with chronic pain, 25.5% reported clinically significant fear and 13.8% reported high levels of fear. But chronic pain (PR, 1.2; 95% CI, 0.6-2.4) was not significantly associated with a clinically significant fear of recurrence in a multivariable model.
  •  

IN PRACTICE:

“These findings underscore the substantial psychological and functional burden of FCR [fear of cancer recurrence] and suggest healthcare professionals should routinely assess FCR as a part of providing comprehensive care to long-term survivors,” the authors wrote.

SOURCE:

The study, led by Alex Pizzo, MSc, Concordia University, Montréal, Québec, Canada, was published online in JAMA Network Open.

 

 

LIMITATIONS:

The cross-sectional design limited causal inference. Self-perceived health was assessed with a single item, limiting its measurement. Internet and smartphone access eligibility could have introduced bias. The study also lacked racial and ethnic diversity.

DISCLOSURES:

The study was supported by the Childhood Cancer Survivor Study Career Development Award and a grant from the National Cancer Institute. Additional funding was provided by the Canada Research Chairs Program. Three authors reported receiving grants from various sources.

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:

About one third of adult survivors of childhood cancer experience a clinically significant or high fear that their primary cancer may recur or that they will develop a subsequent malignancy, according to a recent analysis. The study finds that several factors are associated with a higher risk of experiencing a clinically significant fear of recurrence, including being unemployed or having elevated anxiety or depression.

METHODOLOGY:

  • Adult survivors of childhood cancer face a high risk of developing subsequent malignant neoplasms — about a sixfold greater risk than in the general population — and studies indicate that these cancer survivors also fear their cancer will recur. However, data on the prevalence of and risk factors associated with clinically significant fear of recurrence in this population remain limited.
  • This cross-sectional study included 229 adult survivors of childhood cancer (mean age at study completion, 39.6 years), recruited from the Childhood Cancer Survivor Study, who completed online surveys between October 2018 and April 2019.
  • Fear of cancer recurrence was assessed using the 9-item Fear of Cancer Recurrence Inventory–Short Form, which defines recurrence as the possibility that cancer might return to the same or a different part of the body.
  • Chronic pain, symptoms of depression and anxiety, self-perceived health, and intolerance of uncertainty were also evaluated.
  • Among the participants, 21 experienced a recurrence of their primary cancer and 17 were diagnosed with a subsequent malignant neoplasm.
  •  

TAKEAWAY:

  • Overall, 38 (16.6%) adult survivors of childhood cancer reported clinically significant fear that their cancer would recur, and an additional 36 (15.7%) survivors experienced high levels of fear; the remaining 67.7% of participants reported minimal levels of fear.
  • Survivors who were unemployed (prevalence ratio [PR], 2.5) were more likely to experience a clinically significant fear of recurrence, as were survivors who had undergone pelvic radiation (PR, 2.9) or limb-sparing or amputation surgery (PR, 2.4).
  • Survivors who had elevated anxiety or depression (PR, 2.6) or both (PR, 3.2) were more likely to experience a clinically significant fear of recurrence, as were survivors who had a chronic neurologic health condition (PR, 3.3) or who perceived their health status to be poor or fair vs good to excellent (PR, 3.0).
  • Among 94 participants with chronic pain, 25.5% reported clinically significant fear and 13.8% reported high levels of fear. But chronic pain (PR, 1.2; 95% CI, 0.6-2.4) was not significantly associated with a clinically significant fear of recurrence in a multivariable model.
  •  

IN PRACTICE:

“These findings underscore the substantial psychological and functional burden of FCR [fear of cancer recurrence] and suggest healthcare professionals should routinely assess FCR as a part of providing comprehensive care to long-term survivors,” the authors wrote.

SOURCE:

The study, led by Alex Pizzo, MSc, Concordia University, Montréal, Québec, Canada, was published online in JAMA Network Open.

 

 

LIMITATIONS:

The cross-sectional design limited causal inference. Self-perceived health was assessed with a single item, limiting its measurement. Internet and smartphone access eligibility could have introduced bias. The study also lacked racial and ethnic diversity.

DISCLOSURES:

The study was supported by the Childhood Cancer Survivor Study Career Development Award and a grant from the National Cancer Institute. Additional funding was provided by the Canada Research Chairs Program. Three authors reported receiving grants from various sources.

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.

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