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The leading independent newspaper covering news and commentary in pediatrics.

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Fibrosis Risk High in Young Adults With Both Obesity and T2D

Article Type
Changed
Wed, 11/27/2024 - 02:51

TOPLINE:

Up to one in seven young adults with obesity and type 2 diabetes (T2D) have clinically significant hepatic fibrosis, signaling the crucial need for screening in this population to aid early detection and intervention.

METHODOLOGY:

  • Researchers aimed to assess the prevalence of hepatic steatosis and clinically significant fibrosis (stage ≥ 2) in young adults without a history of metabolic dysfunction–associated steatotic liver disease (MASLD), hypothesizing that the rates would be comparable with those in older adults, especially in the presence of cardiometabolic risk factors.
  • Overall, 1420 participants aged 21-79 years with or without T2D (63% or 37%, respectively) were included from outpatient clinics at the University of Florida, Gainesville, Florida, and divided into two age groups: < 45 years (n = 243) and ≥ 45 years (n = 1177).
  • All the participants underwent assessment of liver stiffness via transient elastography, with magnetic resonance elastography (MRE) or liver biopsy recommended when indicated.
  • Participants also underwent a medical history review, physical examination, and fasting blood tests to rule out secondary causes of liver disease.

TAKEAWAY:

  • Overall, 52% of participants had hepatic steatosis, and 9.5% had clinically significant fibrosis.
  • There were no significant differences in the frequencies of hepatic steatosis (50.2% vs 52.7%; P = .6) or clinically significant hepatic fibrosis (7.5% vs 9.9%; P = .2) observed between young and older adults.
  • The presence of either T2D or obesity was linked to an increased prevalence of both hepatic steatosis and fibrosis in both the age groups (P < .01).
  • In young and older adults, the presence of both T2D and obesity led to the highest rates of both hepatic steatosis and clinically significant fibrosis, with the latter rate being statistically similar between the groups (15.7% vs 17.3%; P = .2).
  • The presence of T2D and obesity was the strongest risk factors for hepatic fibrosis in young adults (odds ratios, 4.33 and 1.16, respectively; P < .05 for both).

IN PRACTICE:

“The clinical implication is that young adults with obesity and T2D carry a high risk of future cirrhosis, possibly as high as older adults, and must be aggressively screened at the first visit and carefully followed,” the authors wrote.

SOURCE:

This study, led by Anu Sharma, University of Florida College of Medicine, Gainesville, was published online in Obesity.

LIMITATIONS:

The diagnosis of clinically significant hepatic fibrosis was confirmed via MRE and/or liver biopsy in only 30% of all participants. The study population included a slightly higher proportion of young adults with obesity, T2D, and other cardiometabolic risk factors than that in national averages, which may have limited its generalizability. Genetic variants associated with MASLD were not included in this study.

DISCLOSURES:

This study was funded partly by grants from the National Institutes of Health and Echosens. One author disclosed receiving research support and serving as a consultant for various pharmaceutical companies.

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

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TOPLINE:

Up to one in seven young adults with obesity and type 2 diabetes (T2D) have clinically significant hepatic fibrosis, signaling the crucial need for screening in this population to aid early detection and intervention.

METHODOLOGY:

  • Researchers aimed to assess the prevalence of hepatic steatosis and clinically significant fibrosis (stage ≥ 2) in young adults without a history of metabolic dysfunction–associated steatotic liver disease (MASLD), hypothesizing that the rates would be comparable with those in older adults, especially in the presence of cardiometabolic risk factors.
  • Overall, 1420 participants aged 21-79 years with or without T2D (63% or 37%, respectively) were included from outpatient clinics at the University of Florida, Gainesville, Florida, and divided into two age groups: < 45 years (n = 243) and ≥ 45 years (n = 1177).
  • All the participants underwent assessment of liver stiffness via transient elastography, with magnetic resonance elastography (MRE) or liver biopsy recommended when indicated.
  • Participants also underwent a medical history review, physical examination, and fasting blood tests to rule out secondary causes of liver disease.

TAKEAWAY:

  • Overall, 52% of participants had hepatic steatosis, and 9.5% had clinically significant fibrosis.
  • There were no significant differences in the frequencies of hepatic steatosis (50.2% vs 52.7%; P = .6) or clinically significant hepatic fibrosis (7.5% vs 9.9%; P = .2) observed between young and older adults.
  • The presence of either T2D or obesity was linked to an increased prevalence of both hepatic steatosis and fibrosis in both the age groups (P < .01).
  • In young and older adults, the presence of both T2D and obesity led to the highest rates of both hepatic steatosis and clinically significant fibrosis, with the latter rate being statistically similar between the groups (15.7% vs 17.3%; P = .2).
  • The presence of T2D and obesity was the strongest risk factors for hepatic fibrosis in young adults (odds ratios, 4.33 and 1.16, respectively; P < .05 for both).

IN PRACTICE:

“The clinical implication is that young adults with obesity and T2D carry a high risk of future cirrhosis, possibly as high as older adults, and must be aggressively screened at the first visit and carefully followed,” the authors wrote.

SOURCE:

This study, led by Anu Sharma, University of Florida College of Medicine, Gainesville, was published online in Obesity.

LIMITATIONS:

The diagnosis of clinically significant hepatic fibrosis was confirmed via MRE and/or liver biopsy in only 30% of all participants. The study population included a slightly higher proportion of young adults with obesity, T2D, and other cardiometabolic risk factors than that in national averages, which may have limited its generalizability. Genetic variants associated with MASLD were not included in this study.

DISCLOSURES:

This study was funded partly by grants from the National Institutes of Health and Echosens. One author disclosed receiving research support and serving as a consultant for various pharmaceutical companies.

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

TOPLINE:

Up to one in seven young adults with obesity and type 2 diabetes (T2D) have clinically significant hepatic fibrosis, signaling the crucial need for screening in this population to aid early detection and intervention.

METHODOLOGY:

  • Researchers aimed to assess the prevalence of hepatic steatosis and clinically significant fibrosis (stage ≥ 2) in young adults without a history of metabolic dysfunction–associated steatotic liver disease (MASLD), hypothesizing that the rates would be comparable with those in older adults, especially in the presence of cardiometabolic risk factors.
  • Overall, 1420 participants aged 21-79 years with or without T2D (63% or 37%, respectively) were included from outpatient clinics at the University of Florida, Gainesville, Florida, and divided into two age groups: < 45 years (n = 243) and ≥ 45 years (n = 1177).
  • All the participants underwent assessment of liver stiffness via transient elastography, with magnetic resonance elastography (MRE) or liver biopsy recommended when indicated.
  • Participants also underwent a medical history review, physical examination, and fasting blood tests to rule out secondary causes of liver disease.

TAKEAWAY:

  • Overall, 52% of participants had hepatic steatosis, and 9.5% had clinically significant fibrosis.
  • There were no significant differences in the frequencies of hepatic steatosis (50.2% vs 52.7%; P = .6) or clinically significant hepatic fibrosis (7.5% vs 9.9%; P = .2) observed between young and older adults.
  • The presence of either T2D or obesity was linked to an increased prevalence of both hepatic steatosis and fibrosis in both the age groups (P < .01).
  • In young and older adults, the presence of both T2D and obesity led to the highest rates of both hepatic steatosis and clinically significant fibrosis, with the latter rate being statistically similar between the groups (15.7% vs 17.3%; P = .2).
  • The presence of T2D and obesity was the strongest risk factors for hepatic fibrosis in young adults (odds ratios, 4.33 and 1.16, respectively; P < .05 for both).

IN PRACTICE:

“The clinical implication is that young adults with obesity and T2D carry a high risk of future cirrhosis, possibly as high as older adults, and must be aggressively screened at the first visit and carefully followed,” the authors wrote.

SOURCE:

This study, led by Anu Sharma, University of Florida College of Medicine, Gainesville, was published online in Obesity.

LIMITATIONS:

The diagnosis of clinically significant hepatic fibrosis was confirmed via MRE and/or liver biopsy in only 30% of all participants. The study population included a slightly higher proportion of young adults with obesity, T2D, and other cardiometabolic risk factors than that in national averages, which may have limited its generalizability. Genetic variants associated with MASLD were not included in this study.

DISCLOSURES:

This study was funded partly by grants from the National Institutes of Health and Echosens. One author disclosed receiving research support and serving as a consultant for various pharmaceutical companies.

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

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Exposomania

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Changed
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If we’ve learned anything about obesity prevention it’s that if we wait too long the die is cast and our success rate is nil. The GLP-1 antagonists seem to be a workable solution for treating the adult and adolescent population, but I have been afraid that their success will divert too much of our attention away from prevention.

Fortunately, there still seems to be a few researchers committed to the age group in which obesity could be headed off before our only option is treatment. In one recent study, “Neighborhood Food Access in Early Life and Trajectories of Child Body Mass Index and Obesity,” researchers collected data from more than 28,000 children in 55 cohorts during the period from 1994 to 2023). The investigators found that residence in a low–food access, low-income neighborhoods during pregnancy and early childhood was associated with higher BMI “Z” scores, a higher risk of obesity, and severe obesity in childhood. The researchers defined low food access as living greater than 0.5 miles away from a grocery store in an urban setting or greater than 10 minutes away in a rural setting. I don’t think those associations should surprise us, but having some data from a large population may be valuable should we ever find the political will to undertake any steps toward prevention.

I found a Viewpoint article published 2 weeks earlier in the same journal, titled, “The Exposome as a Key to Understanding Pediatric Health Disparities.” I know what the “biome” is and have heard gastroenterologists expound on the power that billions of our little single-celled friends residing in our gut have on seemingly unrelated and spatially distant events in our body. But, “exposome” was a new word for me, although it turns out the concept is simple and one I had harbored since late childhood. 

 

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

The opening sentence of the article reads “One’s environment profoundly changes health outcomes throughout one’s lifespan.” That truism was obvious to my 7-year-old self as I observed my playmates who lived in a poorly kept house in the less desirable area two blocks away and didn’t eat breakfast and were sick more often than the rest of us more-fortunates.

The authors define the exposome as the “totality of an individual’s non-genetic exposures, including psychosocial experiences, structural social determinants, chemical pollution, and neighborhood infrastructure.” This seems to be a pretty complete description of the nurture side of the nature versus nurture conversation. 

I suspect that, like me, most of you through observation and intuition have included your own interpretation of the exposome in your professional activities. However, the authors feel we could be more robust in our efforts and claim that “current pediatric practice largely neglects to characterize health disparities in terms of salient environmental practices.” They go on to call for incorporation of an “exposome lens in pediatric research and healthcare delivery.”

I’m not sure this is a valid criticism. There is certainly more that could be done when it comes to research that examines the effect of environmental stressors. And, I suspect the authors would view this recent paper on the association between neighborhood food access as a step in the right direction. However, when it comes to healthcare delivery, at least at the level where the stethoscope meets the chest, I think, or at least hope, the authors are underestimating the observational skills and sensitivity of primary care providers.

We were all taught to take an appropriate medical history when evaluating a patient. And, through our formal education, our personal observations and through exposure to papers like this one on food access we must be aware of the effect of environmental stressors on our patients’ health. Is there more we could learn about those kind of associations? Certainly. This is where a more broadly focused exposome lens could be most effective. 

The authors of the article observed: “The effect of the exposome is not uniform for all individuals but rather intersects across identities precipitating unique outcomes.” The practical reality is that to generate statistically significant data research must look at identities. This doesn’t mean that large population studies are without value. However, it does obligate investigators to include that caveat about the uniqueness of the individual in their conclusions. And, it is our duty as providers to keep this reality in mind as we interpret studies we read in the context of each individual patient. 

When it comes to healthcare delivery at the structural level, I am concerned that we are moving in a direction that is making it more difficult for the provider to become familiar with the patient’s exposome. I am talking about an over-reliance on the team care delivery model that too often results in the “We never/seldom see the same provider” patient complaint.

I don’t care how slick and user-friendly a practice’s EHR system is; the best way to learn about a patient’s exposome is by repeated exposure (pun unintended) to the same provider. This isn’t always possible, and a well-crafted and conscientiously managed EHR can fill in some of the gaps. But, it is a distant second best. 

Awareness of the importance of the exposome is only the starting point. Finding the political will to make the changes necessary to improve our patients’ outcomes is the bigger challenge. Grocery stores well-stocked with healthy foods don’t just pop up where we want them because we think they may hold answer to preventing pediatric obesity.

 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

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If we’ve learned anything about obesity prevention it’s that if we wait too long the die is cast and our success rate is nil. The GLP-1 antagonists seem to be a workable solution for treating the adult and adolescent population, but I have been afraid that their success will divert too much of our attention away from prevention.

Fortunately, there still seems to be a few researchers committed to the age group in which obesity could be headed off before our only option is treatment. In one recent study, “Neighborhood Food Access in Early Life and Trajectories of Child Body Mass Index and Obesity,” researchers collected data from more than 28,000 children in 55 cohorts during the period from 1994 to 2023). The investigators found that residence in a low–food access, low-income neighborhoods during pregnancy and early childhood was associated with higher BMI “Z” scores, a higher risk of obesity, and severe obesity in childhood. The researchers defined low food access as living greater than 0.5 miles away from a grocery store in an urban setting or greater than 10 minutes away in a rural setting. I don’t think those associations should surprise us, but having some data from a large population may be valuable should we ever find the political will to undertake any steps toward prevention.

I found a Viewpoint article published 2 weeks earlier in the same journal, titled, “The Exposome as a Key to Understanding Pediatric Health Disparities.” I know what the “biome” is and have heard gastroenterologists expound on the power that billions of our little single-celled friends residing in our gut have on seemingly unrelated and spatially distant events in our body. But, “exposome” was a new word for me, although it turns out the concept is simple and one I had harbored since late childhood. 

 

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

The opening sentence of the article reads “One’s environment profoundly changes health outcomes throughout one’s lifespan.” That truism was obvious to my 7-year-old self as I observed my playmates who lived in a poorly kept house in the less desirable area two blocks away and didn’t eat breakfast and were sick more often than the rest of us more-fortunates.

The authors define the exposome as the “totality of an individual’s non-genetic exposures, including psychosocial experiences, structural social determinants, chemical pollution, and neighborhood infrastructure.” This seems to be a pretty complete description of the nurture side of the nature versus nurture conversation. 

I suspect that, like me, most of you through observation and intuition have included your own interpretation of the exposome in your professional activities. However, the authors feel we could be more robust in our efforts and claim that “current pediatric practice largely neglects to characterize health disparities in terms of salient environmental practices.” They go on to call for incorporation of an “exposome lens in pediatric research and healthcare delivery.”

I’m not sure this is a valid criticism. There is certainly more that could be done when it comes to research that examines the effect of environmental stressors. And, I suspect the authors would view this recent paper on the association between neighborhood food access as a step in the right direction. However, when it comes to healthcare delivery, at least at the level where the stethoscope meets the chest, I think, or at least hope, the authors are underestimating the observational skills and sensitivity of primary care providers.

We were all taught to take an appropriate medical history when evaluating a patient. And, through our formal education, our personal observations and through exposure to papers like this one on food access we must be aware of the effect of environmental stressors on our patients’ health. Is there more we could learn about those kind of associations? Certainly. This is where a more broadly focused exposome lens could be most effective. 

The authors of the article observed: “The effect of the exposome is not uniform for all individuals but rather intersects across identities precipitating unique outcomes.” The practical reality is that to generate statistically significant data research must look at identities. This doesn’t mean that large population studies are without value. However, it does obligate investigators to include that caveat about the uniqueness of the individual in their conclusions. And, it is our duty as providers to keep this reality in mind as we interpret studies we read in the context of each individual patient. 

When it comes to healthcare delivery at the structural level, I am concerned that we are moving in a direction that is making it more difficult for the provider to become familiar with the patient’s exposome. I am talking about an over-reliance on the team care delivery model that too often results in the “We never/seldom see the same provider” patient complaint.

I don’t care how slick and user-friendly a practice’s EHR system is; the best way to learn about a patient’s exposome is by repeated exposure (pun unintended) to the same provider. This isn’t always possible, and a well-crafted and conscientiously managed EHR can fill in some of the gaps. But, it is a distant second best. 

Awareness of the importance of the exposome is only the starting point. Finding the political will to make the changes necessary to improve our patients’ outcomes is the bigger challenge. Grocery stores well-stocked with healthy foods don’t just pop up where we want them because we think they may hold answer to preventing pediatric obesity.

 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

If we’ve learned anything about obesity prevention it’s that if we wait too long the die is cast and our success rate is nil. The GLP-1 antagonists seem to be a workable solution for treating the adult and adolescent population, but I have been afraid that their success will divert too much of our attention away from prevention.

Fortunately, there still seems to be a few researchers committed to the age group in which obesity could be headed off before our only option is treatment. In one recent study, “Neighborhood Food Access in Early Life and Trajectories of Child Body Mass Index and Obesity,” researchers collected data from more than 28,000 children in 55 cohorts during the period from 1994 to 2023). The investigators found that residence in a low–food access, low-income neighborhoods during pregnancy and early childhood was associated with higher BMI “Z” scores, a higher risk of obesity, and severe obesity in childhood. The researchers defined low food access as living greater than 0.5 miles away from a grocery store in an urban setting or greater than 10 minutes away in a rural setting. I don’t think those associations should surprise us, but having some data from a large population may be valuable should we ever find the political will to undertake any steps toward prevention.

I found a Viewpoint article published 2 weeks earlier in the same journal, titled, “The Exposome as a Key to Understanding Pediatric Health Disparities.” I know what the “biome” is and have heard gastroenterologists expound on the power that billions of our little single-celled friends residing in our gut have on seemingly unrelated and spatially distant events in our body. But, “exposome” was a new word for me, although it turns out the concept is simple and one I had harbored since late childhood. 

 

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

The opening sentence of the article reads “One’s environment profoundly changes health outcomes throughout one’s lifespan.” That truism was obvious to my 7-year-old self as I observed my playmates who lived in a poorly kept house in the less desirable area two blocks away and didn’t eat breakfast and were sick more often than the rest of us more-fortunates.

The authors define the exposome as the “totality of an individual’s non-genetic exposures, including psychosocial experiences, structural social determinants, chemical pollution, and neighborhood infrastructure.” This seems to be a pretty complete description of the nurture side of the nature versus nurture conversation. 

I suspect that, like me, most of you through observation and intuition have included your own interpretation of the exposome in your professional activities. However, the authors feel we could be more robust in our efforts and claim that “current pediatric practice largely neglects to characterize health disparities in terms of salient environmental practices.” They go on to call for incorporation of an “exposome lens in pediatric research and healthcare delivery.”

I’m not sure this is a valid criticism. There is certainly more that could be done when it comes to research that examines the effect of environmental stressors. And, I suspect the authors would view this recent paper on the association between neighborhood food access as a step in the right direction. However, when it comes to healthcare delivery, at least at the level where the stethoscope meets the chest, I think, or at least hope, the authors are underestimating the observational skills and sensitivity of primary care providers.

We were all taught to take an appropriate medical history when evaluating a patient. And, through our formal education, our personal observations and through exposure to papers like this one on food access we must be aware of the effect of environmental stressors on our patients’ health. Is there more we could learn about those kind of associations? Certainly. This is where a more broadly focused exposome lens could be most effective. 

The authors of the article observed: “The effect of the exposome is not uniform for all individuals but rather intersects across identities precipitating unique outcomes.” The practical reality is that to generate statistically significant data research must look at identities. This doesn’t mean that large population studies are without value. However, it does obligate investigators to include that caveat about the uniqueness of the individual in their conclusions. And, it is our duty as providers to keep this reality in mind as we interpret studies we read in the context of each individual patient. 

When it comes to healthcare delivery at the structural level, I am concerned that we are moving in a direction that is making it more difficult for the provider to become familiar with the patient’s exposome. I am talking about an over-reliance on the team care delivery model that too often results in the “We never/seldom see the same provider” patient complaint.

I don’t care how slick and user-friendly a practice’s EHR system is; the best way to learn about a patient’s exposome is by repeated exposure (pun unintended) to the same provider. This isn’t always possible, and a well-crafted and conscientiously managed EHR can fill in some of the gaps. But, it is a distant second best. 

Awareness of the importance of the exposome is only the starting point. Finding the political will to make the changes necessary to improve our patients’ outcomes is the bigger challenge. Grocery stores well-stocked with healthy foods don’t just pop up where we want them because we think they may hold answer to preventing pediatric obesity.

 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

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Recognizing Burnout: Why Physicians Often Miss the Signs in Themselves

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Wed, 11/27/2024 - 01:33

Summary and Key Highlights

Summary: This section explores why physicians often struggle to recognize burnout within themselves, partly due to stigma and a tendency to focus on productivity over well-being. Dr. Tyra Fainstad shares personal experiences of burnout symptoms, emphasizing the importance of awareness and self-reflection. Recognizing and addressing burnout early can help physicians find healthier coping strategies, avoid productivity traps, and seek support.

Key Takeaways:

  • Many physicians struggle to identify burnout due to stigma and self-blame.
  • Awareness of burnout symptoms is essential for early intervention and healthy coping.
  • Seeking support can prevent burnout from worsening and improve quality of life.

Our Editors Also Recommend: 

Medscape Physician Burnout & Depression Report 2024: ‘We Have Much Work to Do’

Medscape Hospitalist Burnout & Depression Report 2024: Seeking Progress, Balance 

Medscape Physician Lifestyle & Happiness Report 2024: The Ongoing Struggle for Balance 

A Transformative Rx for Burnout, Grief, and Illness: Dance 

 

Next Medscape Masters Event:

Stay at the forefront of obesity care. Register for exclusive insights and the latest treatment innovations.

Lotte Dyrbye, has disclosed the following relevant financial relationships: Co-inventor of the Well-being Index and its derivatives, which Mayo Clinic has licensed. Dyrbye receives royalties.

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

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Summary and Key Highlights

Summary: This section explores why physicians often struggle to recognize burnout within themselves, partly due to stigma and a tendency to focus on productivity over well-being. Dr. Tyra Fainstad shares personal experiences of burnout symptoms, emphasizing the importance of awareness and self-reflection. Recognizing and addressing burnout early can help physicians find healthier coping strategies, avoid productivity traps, and seek support.

Key Takeaways:

  • Many physicians struggle to identify burnout due to stigma and self-blame.
  • Awareness of burnout symptoms is essential for early intervention and healthy coping.
  • Seeking support can prevent burnout from worsening and improve quality of life.

Our Editors Also Recommend: 

Medscape Physician Burnout & Depression Report 2024: ‘We Have Much Work to Do’

Medscape Hospitalist Burnout & Depression Report 2024: Seeking Progress, Balance 

Medscape Physician Lifestyle & Happiness Report 2024: The Ongoing Struggle for Balance 

A Transformative Rx for Burnout, Grief, and Illness: Dance 

 

Next Medscape Masters Event:

Stay at the forefront of obesity care. Register for exclusive insights and the latest treatment innovations.

Lotte Dyrbye, has disclosed the following relevant financial relationships: Co-inventor of the Well-being Index and its derivatives, which Mayo Clinic has licensed. Dyrbye receives royalties.

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

Summary and Key Highlights

Summary: This section explores why physicians often struggle to recognize burnout within themselves, partly due to stigma and a tendency to focus on productivity over well-being. Dr. Tyra Fainstad shares personal experiences of burnout symptoms, emphasizing the importance of awareness and self-reflection. Recognizing and addressing burnout early can help physicians find healthier coping strategies, avoid productivity traps, and seek support.

Key Takeaways:

  • Many physicians struggle to identify burnout due to stigma and self-blame.
  • Awareness of burnout symptoms is essential for early intervention and healthy coping.
  • Seeking support can prevent burnout from worsening and improve quality of life.

Our Editors Also Recommend: 

Medscape Physician Burnout & Depression Report 2024: ‘We Have Much Work to Do’

Medscape Hospitalist Burnout & Depression Report 2024: Seeking Progress, Balance 

Medscape Physician Lifestyle & Happiness Report 2024: The Ongoing Struggle for Balance 

A Transformative Rx for Burnout, Grief, and Illness: Dance 

 

Next Medscape Masters Event:

Stay at the forefront of obesity care. Register for exclusive insights and the latest treatment innovations.

Lotte Dyrbye, has disclosed the following relevant financial relationships: Co-inventor of the Well-being Index and its derivatives, which Mayo Clinic has licensed. Dyrbye receives royalties.

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

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Breaking the Cycle: Why Self-Compassion Is Essential for Today’s Physicians

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Wed, 11/27/2024 - 02:47

Summary and Key Highlights

Summary: Dr Tyra Fainstad explores the ingrained culture in medicine that encourages self-criticism, with many physicians feeling that they must be hard on themselves to succeed. Dr Fainstad challenges this belief, advocating for self-compassion as a healthier alternative. The evolving medical field now includes physicians who prioritize well-being without sacrificing quality of care, underscoring the importance of self-kindness for sustainable practice.

Key Takeaways:

  • Many physicians believe that self-criticism is necessary for success, a mindset rooted in medical culture.
  • Practicing self-compassion can improve long-term resilience and prevent burnout.
  • The changing landscape of healthcare supports a more balanced approach to physician well-being.

Our Editors Also Recommend: 

Medscape Physician Burnout & Depression Report 2024: ‘We Have Much Work to Do’

Medscape Hospitalist Burnout & Depression Report 2024: Seeking Progress, Balance 

Medscape Physician Lifestyle & Happiness Report 2024: The Ongoing Struggle for Balance 

A Transformative Rx for Burnout, Grief, and Illness: Dance 

 

Next Medscape Masters Event:

Stay at the forefront of obesity care. Register for exclusive insights and the latest treatment innovations. 

Lotte Dyrbye, has disclosed the following relevant financial relationships: Co-inventor of the Well-being Index and its derivatives, which Mayo Clinic has licensed. Dyrbye receives royalties.

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

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Summary and Key Highlights

Summary: Dr Tyra Fainstad explores the ingrained culture in medicine that encourages self-criticism, with many physicians feeling that they must be hard on themselves to succeed. Dr Fainstad challenges this belief, advocating for self-compassion as a healthier alternative. The evolving medical field now includes physicians who prioritize well-being without sacrificing quality of care, underscoring the importance of self-kindness for sustainable practice.

Key Takeaways:

  • Many physicians believe that self-criticism is necessary for success, a mindset rooted in medical culture.
  • Practicing self-compassion can improve long-term resilience and prevent burnout.
  • The changing landscape of healthcare supports a more balanced approach to physician well-being.

Our Editors Also Recommend: 

Medscape Physician Burnout & Depression Report 2024: ‘We Have Much Work to Do’

Medscape Hospitalist Burnout & Depression Report 2024: Seeking Progress, Balance 

Medscape Physician Lifestyle & Happiness Report 2024: The Ongoing Struggle for Balance 

A Transformative Rx for Burnout, Grief, and Illness: Dance 

 

Next Medscape Masters Event:

Stay at the forefront of obesity care. Register for exclusive insights and the latest treatment innovations. 

Lotte Dyrbye, has disclosed the following relevant financial relationships: Co-inventor of the Well-being Index and its derivatives, which Mayo Clinic has licensed. Dyrbye receives royalties.

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

Summary and Key Highlights

Summary: Dr Tyra Fainstad explores the ingrained culture in medicine that encourages self-criticism, with many physicians feeling that they must be hard on themselves to succeed. Dr Fainstad challenges this belief, advocating for self-compassion as a healthier alternative. The evolving medical field now includes physicians who prioritize well-being without sacrificing quality of care, underscoring the importance of self-kindness for sustainable practice.

Key Takeaways:

  • Many physicians believe that self-criticism is necessary for success, a mindset rooted in medical culture.
  • Practicing self-compassion can improve long-term resilience and prevent burnout.
  • The changing landscape of healthcare supports a more balanced approach to physician well-being.

Our Editors Also Recommend: 

Medscape Physician Burnout & Depression Report 2024: ‘We Have Much Work to Do’

Medscape Hospitalist Burnout & Depression Report 2024: Seeking Progress, Balance 

Medscape Physician Lifestyle & Happiness Report 2024: The Ongoing Struggle for Balance 

A Transformative Rx for Burnout, Grief, and Illness: Dance 

 

Next Medscape Masters Event:

Stay at the forefront of obesity care. Register for exclusive insights and the latest treatment innovations. 

Lotte Dyrbye, has disclosed the following relevant financial relationships: Co-inventor of the Well-being Index and its derivatives, which Mayo Clinic has licensed. Dyrbye receives royalties.

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

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Thu, 11/21/2024 - 16:38

Finding Fulfillment Beyond Metrics: A Physician’s Path to Lasting Well-Being

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Wed, 11/27/2024 - 02:47

Summary and Key Highlights

Summary: Dr Tyra Fainstad shares her personal experience with burnout and the journey to recovery through coaching and self-compassion. She describes the pressures of seeking validation through external achievements, which ultimately led to a crisis in self-worth after medical training. Through coaching, she learned to cultivate a sense of internal fulfillment, reconnecting with her passion for medicine and achieving a healthier balance.

Key Takeaways:

  • Relying solely on external validation can deepen burnout and affect well-being.
  • Coaching empowers physicians to develop self-compassion and sustainable coping strategies.
  • Shifting from external to internal validation strengthens long-term fulfillment and job satisfaction.

Our Editors Also Recommend: 

Medscape Physician Burnout & Depression Report 2024: ‘We Have Much Work to Do’

Medscape Hospitalist Burnout & Depression Report 2024: Seeking Progress, Balance 

Medscape Physician Lifestyle & Happiness Report 2024: The Ongoing Struggle for Balance 

A Transformative Rx for Burnout, Grief, and Illness: Dance 

 

Next Medscape Masters Event:

Stay at the forefront of obesity care. Register for exclusive insights and the latest treatment innovations.

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

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Summary and Key Highlights

Summary: Dr Tyra Fainstad shares her personal experience with burnout and the journey to recovery through coaching and self-compassion. She describes the pressures of seeking validation through external achievements, which ultimately led to a crisis in self-worth after medical training. Through coaching, she learned to cultivate a sense of internal fulfillment, reconnecting with her passion for medicine and achieving a healthier balance.

Key Takeaways:

  • Relying solely on external validation can deepen burnout and affect well-being.
  • Coaching empowers physicians to develop self-compassion and sustainable coping strategies.
  • Shifting from external to internal validation strengthens long-term fulfillment and job satisfaction.

Our Editors Also Recommend: 

Medscape Physician Burnout & Depression Report 2024: ‘We Have Much Work to Do’

Medscape Hospitalist Burnout & Depression Report 2024: Seeking Progress, Balance 

Medscape Physician Lifestyle & Happiness Report 2024: The Ongoing Struggle for Balance 

A Transformative Rx for Burnout, Grief, and Illness: Dance 

 

Next Medscape Masters Event:

Stay at the forefront of obesity care. Register for exclusive insights and the latest treatment innovations.

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

Summary and Key Highlights

Summary: Dr Tyra Fainstad shares her personal experience with burnout and the journey to recovery through coaching and self-compassion. She describes the pressures of seeking validation through external achievements, which ultimately led to a crisis in self-worth after medical training. Through coaching, she learned to cultivate a sense of internal fulfillment, reconnecting with her passion for medicine and achieving a healthier balance.

Key Takeaways:

  • Relying solely on external validation can deepen burnout and affect well-being.
  • Coaching empowers physicians to develop self-compassion and sustainable coping strategies.
  • Shifting from external to internal validation strengthens long-term fulfillment and job satisfaction.

Our Editors Also Recommend: 

Medscape Physician Burnout & Depression Report 2024: ‘We Have Much Work to Do’

Medscape Hospitalist Burnout & Depression Report 2024: Seeking Progress, Balance 

Medscape Physician Lifestyle & Happiness Report 2024: The Ongoing Struggle for Balance 

A Transformative Rx for Burnout, Grief, and Illness: Dance 

 

Next Medscape Masters Event:

Stay at the forefront of obesity care. Register for exclusive insights and the latest treatment innovations.

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

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Thu, 11/21/2024 - 16:34

Levonorgestrel IUDs Linked to Higher Skin Side Effects

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TOPLINE:

Levonorgestrel intrauterine devices (IUDs) are associated with significantly more reports of acne, alopecia, and hirsutism compared with copper IUDs, with some differences between the available levonorgestrel IUDs.

METHODOLOGY:

  • Researchers reviewed the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) through December 2023 for adverse events associated with levonorgestrel IUDs where IUDs were the only suspected cause, focusing on acne, alopecia, and hirsutism.
  • They included 139,348 reports for the levonorgestrel IUDs (Mirena, Liletta, Kyleena, Skyla) and 50,450 reports for the copper IUD (Paragard).

TAKEAWAY:

  • Levonorgestrel IUD users showed higher odds of reporting acne (odds ratio [OR], 3.21), alopecia (OR, 5.96), and hirsutism (OR, 15.48; all P < .0001) than copper IUD users.
  • The Kyleena 19.5 mg levonorgestrel IUD was associated with the highest odds of acne reports (OR, 3.42), followed by the Mirena 52 mg (OR, 3.40) and Skyla 13.5 mg (OR, 2.30) levonorgestrel IUDs (all P < .0001).
  • The Mirena IUD was associated with the highest odds of alopecia and hirsutism reports (OR, 6.62 and 17.43, respectively), followed by the Kyleena (ORs, 2.90 and 8.17, respectively) and Skyla (ORs, 2.69 and 1.48, respectively) IUDs (all P < .0001).
  • Reports of acne, alopecia, and hirsutism were not significantly different between the Liletta 52 mg levonorgestrel IUD and the copper IUD.

IN PRACTICE:

“Overall, we identified significant associations between levonorgestrel IUDs and androgenic cutaneous adverse events,” the authors wrote. “Counseling prior to initiation of levonorgestrel IUDs should include information on possible cutaneous AEs including acne, alopecia, and hirsutism to guide contraceptive shared decision making,” they added.

 

SOURCE:

The study was led by Lydia Cassard, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, and was published online November 3 in Journal of the American Academy of Dermatology.

LIMITATIONS:

FAERS database reports could not be verified, and differences in FDA approval dates for IUDs could have influenced reporting rates. Moreover, a lack of data on prior medication use limits the ability to determine if these AEs are a result of changes in androgenic or antiandrogenic medication use. Cutaneous adverse events associated with copper IUDs may have been underreported because of assumptions that a nonhormonal device would not cause these adverse events.

DISCLOSURES:

The authors did not report any funding source or conflict of interests.

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

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TOPLINE:

Levonorgestrel intrauterine devices (IUDs) are associated with significantly more reports of acne, alopecia, and hirsutism compared with copper IUDs, with some differences between the available levonorgestrel IUDs.

METHODOLOGY:

  • Researchers reviewed the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) through December 2023 for adverse events associated with levonorgestrel IUDs where IUDs were the only suspected cause, focusing on acne, alopecia, and hirsutism.
  • They included 139,348 reports for the levonorgestrel IUDs (Mirena, Liletta, Kyleena, Skyla) and 50,450 reports for the copper IUD (Paragard).

TAKEAWAY:

  • Levonorgestrel IUD users showed higher odds of reporting acne (odds ratio [OR], 3.21), alopecia (OR, 5.96), and hirsutism (OR, 15.48; all P < .0001) than copper IUD users.
  • The Kyleena 19.5 mg levonorgestrel IUD was associated with the highest odds of acne reports (OR, 3.42), followed by the Mirena 52 mg (OR, 3.40) and Skyla 13.5 mg (OR, 2.30) levonorgestrel IUDs (all P < .0001).
  • The Mirena IUD was associated with the highest odds of alopecia and hirsutism reports (OR, 6.62 and 17.43, respectively), followed by the Kyleena (ORs, 2.90 and 8.17, respectively) and Skyla (ORs, 2.69 and 1.48, respectively) IUDs (all P < .0001).
  • Reports of acne, alopecia, and hirsutism were not significantly different between the Liletta 52 mg levonorgestrel IUD and the copper IUD.

IN PRACTICE:

“Overall, we identified significant associations between levonorgestrel IUDs and androgenic cutaneous adverse events,” the authors wrote. “Counseling prior to initiation of levonorgestrel IUDs should include information on possible cutaneous AEs including acne, alopecia, and hirsutism to guide contraceptive shared decision making,” they added.

 

SOURCE:

The study was led by Lydia Cassard, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, and was published online November 3 in Journal of the American Academy of Dermatology.

LIMITATIONS:

FAERS database reports could not be verified, and differences in FDA approval dates for IUDs could have influenced reporting rates. Moreover, a lack of data on prior medication use limits the ability to determine if these AEs are a result of changes in androgenic or antiandrogenic medication use. Cutaneous adverse events associated with copper IUDs may have been underreported because of assumptions that a nonhormonal device would not cause these adverse events.

DISCLOSURES:

The authors did not report any funding source or conflict of interests.

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

TOPLINE:

Levonorgestrel intrauterine devices (IUDs) are associated with significantly more reports of acne, alopecia, and hirsutism compared with copper IUDs, with some differences between the available levonorgestrel IUDs.

METHODOLOGY:

  • Researchers reviewed the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) through December 2023 for adverse events associated with levonorgestrel IUDs where IUDs were the only suspected cause, focusing on acne, alopecia, and hirsutism.
  • They included 139,348 reports for the levonorgestrel IUDs (Mirena, Liletta, Kyleena, Skyla) and 50,450 reports for the copper IUD (Paragard).

TAKEAWAY:

  • Levonorgestrel IUD users showed higher odds of reporting acne (odds ratio [OR], 3.21), alopecia (OR, 5.96), and hirsutism (OR, 15.48; all P < .0001) than copper IUD users.
  • The Kyleena 19.5 mg levonorgestrel IUD was associated with the highest odds of acne reports (OR, 3.42), followed by the Mirena 52 mg (OR, 3.40) and Skyla 13.5 mg (OR, 2.30) levonorgestrel IUDs (all P < .0001).
  • The Mirena IUD was associated with the highest odds of alopecia and hirsutism reports (OR, 6.62 and 17.43, respectively), followed by the Kyleena (ORs, 2.90 and 8.17, respectively) and Skyla (ORs, 2.69 and 1.48, respectively) IUDs (all P < .0001).
  • Reports of acne, alopecia, and hirsutism were not significantly different between the Liletta 52 mg levonorgestrel IUD and the copper IUD.

IN PRACTICE:

“Overall, we identified significant associations between levonorgestrel IUDs and androgenic cutaneous adverse events,” the authors wrote. “Counseling prior to initiation of levonorgestrel IUDs should include information on possible cutaneous AEs including acne, alopecia, and hirsutism to guide contraceptive shared decision making,” they added.

 

SOURCE:

The study was led by Lydia Cassard, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, and was published online November 3 in Journal of the American Academy of Dermatology.

LIMITATIONS:

FAERS database reports could not be verified, and differences in FDA approval dates for IUDs could have influenced reporting rates. Moreover, a lack of data on prior medication use limits the ability to determine if these AEs are a result of changes in androgenic or antiandrogenic medication use. Cutaneous adverse events associated with copper IUDs may have been underreported because of assumptions that a nonhormonal device would not cause these adverse events.

DISCLOSURES:

The authors did not report any funding source or conflict of interests.

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

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Post COVID-19, Long-term Risk for Autoimmune, Autoinflammatory Skin Disorders Increased, Study Finds

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

The study was published in JAMA Dermatology.

 

‘Compelling Evidence’

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

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

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

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

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

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

 

Vaccination Effect

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A version of this article appeared on Medscape.com.

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

The study was published in JAMA Dermatology.

 

‘Compelling Evidence’

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

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

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

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

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

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

 

Vaccination Effect

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A version of this article appeared on Medscape.com.

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

The study was published in JAMA Dermatology.

 

‘Compelling Evidence’

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

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

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

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

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

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

 

Vaccination Effect

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A version of this article appeared on Medscape.com.

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Dupilumab Beneficial When Antihistamines Fall Short for Chronic Spontaneous Urticaria

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

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

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

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

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

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

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

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

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

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

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

 

More Research Needed to Fine-Tune Management

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

More Research Needed to Fine-Tune Management

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

More Research Needed to Fine-Tune Management

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

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

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

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

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

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

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

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

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Gentle Parenting

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In one my recent Letters, I concluded with the concern that infant-led weaning, which makes some sense, can be confused with child-led family meals, which make none. I referred to an increasingly popular style of parenting overemphasizing child autonomy that seems to be a major contributor to the mealtime chaos that occurs when pleasing every palate at the table becomes the goal.

In the intervening weeks, I have learned that this parenting style is called “gentle parenting.” Despite its growing popularity, possibly fueled by the pandemic, it has not been well-defined nor its effectiveness investigated. In a recent paper published in PLOS ONE, two professors of developmental psychology have attempted correct this deficit in our understanding of this parenting style, which doesn’t appear to make sense to many of us with experience in child behavior and development. 

 

Gentle Parents

By surveying a group of 100 parents of young children, the investigators were able to sort out a group of parents (n = 49) who self-identified as employing gentle parenting. Their responses emphasized a high level of parental affection and emotional regulation by both their children and themselves.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Investigators found that 40% of the self-defined gentle parents “had negative difference scores indicating misbehavior response descriptions that included more child directed responses. I interpret this to mean that almost half of the time the parents failed to evenly include themselves in a solution to a conflict, which indicates incomplete or unsuccessful emotional regulation on their part. The investigators also observed that, like many other parenting styles, gentle parenting includes an emphasis on boundaries “yet, enactment of those boundaries is not uniform.”

More telling was the authors’ observation that “statements of parenting uncertainty and burnout were present in over one third of the gentle of the gentle parenting sample.” While some parents were pleased with their experience, the downside seems unacceptable to me. When asked to explain this finding, Annie Pezalla, PhD, one of the coauthors, has said “gentle parenting practices work best when a parent is emotionally regulated and unconstrained for time — commodities that parents struggle with the most.”

 

Abundance Advice on Parenting Styles

I find this to be a very sad story. Parenting can be difficult. Creating and then gently and effectively policing those boundaries is often the hardest part. There is no shortage of “experts” willing to tell the throngs of anxious parents how to do it. It is not surprising to me that of the four books I have written for parents, the one titled How to Say No to Your Toddler is the only one popular enough to be published in four languages.

Of course I am troubled, as I suspect you may be, with the label “gentle parenting.” It implies that the rest of us are doing something terrible, “harsh” maybe, “cruel” maybe. We can dispense with the “affectionate” descriptor immediately because gentle parenting can’t claim sole ownership to it. Every, behavior management scheme I am aware of touts being caring and loving at its core.

I completely agree that emotional regulation for both parent and child are worthy goals, but I’m not hearing much on how that is to be achieved other than by trying to avoid the inevitable conflict by failing to even say “No” when poorly crafted boundaries are breached. 

There are scores of parenting styles out there. And there should be, because we are all different. Parents have strengths and weaknesses and they have begotten children with different personalities and vulnerabilities. And, families come from different cultures and socioeconomic backgrounds. 

Across all of these differences there are two primary roles for every parent. The first is to lead by example. If a parent wants his/her child to be kind and caring and polite, then the parent has no choice but to behave that way. If the parent can’t always be present, the environment where the child spends most of his/her day should model the desired behavior. I’m not talking about teaching because you can’t preach good behavior. It must be modeled.

The second role for the parent is to keep his/her child safe from dangers that exist in every environment. This can mean accepting vaccines and seeking available medical care. But, it also means creating some limits — the current buzzword is “guardrails” — to keep the child from veering into the ditch.

 

Setting Limits

Limits will, of necessity, vary with the environment. The risks of a child growing on a farm differ from those of child living in the city. And they must be tailored to the personality and developmental stage of the child. A parent may need advice from someone experienced in child behavior to create individualized limits. You may be able to allow your 3-year-old to roam freely in an environment in which I would have to monitor my risk-taking 3-year-old every second. A parent must learn and accept his/her child’s personality and the environment they can provide.

Limits should be inanimate objects whenever possible. Fences, gates, doors with latches, and locked cabinets to keep temptations out of view, etc. Creative environmental manipulations should be employed to keep the annoying verbal warnings, unenforceable threats, and direct child-to-parent confrontations to a minimum.

 

Consequences

Challenges to even the most carefully crafted limits are inevitable, and this is where we get to the third-rail topic of consequences. Yes, when prevention has failed for whatever reason, I believe that an intelligently and affectionately applied time-out is the most efficient and most effective consequence. This is not the place for me to explore or defend the details, but before you write me off as an octogenarian hard-ass (or hard-liner if you prefer) I urge you to read a few chapters in How to Say No to Your Toddler.

Far more important than which consequence a parent chooses are the steps the family has taken to keep both parent and child in a state of balanced emotional regulation. Is everyone well rested and getting enough sleep? Sleep deprivation is one of the most potent triggers of a tantrum; it also leaves parents vulnerable to saying things and making threats they will regret later. Does the child’s schedule leave him or her enough time to decompress? Does the parent’s schedule sync with a developmentally appropriate schedule for the child? Is he/she getting the right kind of attention when it makes the most sense to him/her?

 

Intelligent Parenting

If a family has created an environment in which limits are appropriate for the child’s personality and developmental stage, used physical barriers whenever possible, and kept everyone as well rested as possible, both challenges to the limits and consequences can be kept to a minimum.

But achieving this state requires time as free of constraints as possible. For the few families that have the luxury of meeting these conditions, gentle parenting might be the answer. For the rest of us, intelligent parenting that acknowledges the realities and limits of our own abilities and our children’s vulnerabilities is the better answer.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com

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In one my recent Letters, I concluded with the concern that infant-led weaning, which makes some sense, can be confused with child-led family meals, which make none. I referred to an increasingly popular style of parenting overemphasizing child autonomy that seems to be a major contributor to the mealtime chaos that occurs when pleasing every palate at the table becomes the goal.

In the intervening weeks, I have learned that this parenting style is called “gentle parenting.” Despite its growing popularity, possibly fueled by the pandemic, it has not been well-defined nor its effectiveness investigated. In a recent paper published in PLOS ONE, two professors of developmental psychology have attempted correct this deficit in our understanding of this parenting style, which doesn’t appear to make sense to many of us with experience in child behavior and development. 

 

Gentle Parents

By surveying a group of 100 parents of young children, the investigators were able to sort out a group of parents (n = 49) who self-identified as employing gentle parenting. Their responses emphasized a high level of parental affection and emotional regulation by both their children and themselves.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Investigators found that 40% of the self-defined gentle parents “had negative difference scores indicating misbehavior response descriptions that included more child directed responses. I interpret this to mean that almost half of the time the parents failed to evenly include themselves in a solution to a conflict, which indicates incomplete or unsuccessful emotional regulation on their part. The investigators also observed that, like many other parenting styles, gentle parenting includes an emphasis on boundaries “yet, enactment of those boundaries is not uniform.”

More telling was the authors’ observation that “statements of parenting uncertainty and burnout were present in over one third of the gentle of the gentle parenting sample.” While some parents were pleased with their experience, the downside seems unacceptable to me. When asked to explain this finding, Annie Pezalla, PhD, one of the coauthors, has said “gentle parenting practices work best when a parent is emotionally regulated and unconstrained for time — commodities that parents struggle with the most.”

 

Abundance Advice on Parenting Styles

I find this to be a very sad story. Parenting can be difficult. Creating and then gently and effectively policing those boundaries is often the hardest part. There is no shortage of “experts” willing to tell the throngs of anxious parents how to do it. It is not surprising to me that of the four books I have written for parents, the one titled How to Say No to Your Toddler is the only one popular enough to be published in four languages.

Of course I am troubled, as I suspect you may be, with the label “gentle parenting.” It implies that the rest of us are doing something terrible, “harsh” maybe, “cruel” maybe. We can dispense with the “affectionate” descriptor immediately because gentle parenting can’t claim sole ownership to it. Every, behavior management scheme I am aware of touts being caring and loving at its core.

I completely agree that emotional regulation for both parent and child are worthy goals, but I’m not hearing much on how that is to be achieved other than by trying to avoid the inevitable conflict by failing to even say “No” when poorly crafted boundaries are breached. 

There are scores of parenting styles out there. And there should be, because we are all different. Parents have strengths and weaknesses and they have begotten children with different personalities and vulnerabilities. And, families come from different cultures and socioeconomic backgrounds. 

Across all of these differences there are two primary roles for every parent. The first is to lead by example. If a parent wants his/her child to be kind and caring and polite, then the parent has no choice but to behave that way. If the parent can’t always be present, the environment where the child spends most of his/her day should model the desired behavior. I’m not talking about teaching because you can’t preach good behavior. It must be modeled.

The second role for the parent is to keep his/her child safe from dangers that exist in every environment. This can mean accepting vaccines and seeking available medical care. But, it also means creating some limits — the current buzzword is “guardrails” — to keep the child from veering into the ditch.

 

Setting Limits

Limits will, of necessity, vary with the environment. The risks of a child growing on a farm differ from those of child living in the city. And they must be tailored to the personality and developmental stage of the child. A parent may need advice from someone experienced in child behavior to create individualized limits. You may be able to allow your 3-year-old to roam freely in an environment in which I would have to monitor my risk-taking 3-year-old every second. A parent must learn and accept his/her child’s personality and the environment they can provide.

Limits should be inanimate objects whenever possible. Fences, gates, doors with latches, and locked cabinets to keep temptations out of view, etc. Creative environmental manipulations should be employed to keep the annoying verbal warnings, unenforceable threats, and direct child-to-parent confrontations to a minimum.

 

Consequences

Challenges to even the most carefully crafted limits are inevitable, and this is where we get to the third-rail topic of consequences. Yes, when prevention has failed for whatever reason, I believe that an intelligently and affectionately applied time-out is the most efficient and most effective consequence. This is not the place for me to explore or defend the details, but before you write me off as an octogenarian hard-ass (or hard-liner if you prefer) I urge you to read a few chapters in How to Say No to Your Toddler.

Far more important than which consequence a parent chooses are the steps the family has taken to keep both parent and child in a state of balanced emotional regulation. Is everyone well rested and getting enough sleep? Sleep deprivation is one of the most potent triggers of a tantrum; it also leaves parents vulnerable to saying things and making threats they will regret later. Does the child’s schedule leave him or her enough time to decompress? Does the parent’s schedule sync with a developmentally appropriate schedule for the child? Is he/she getting the right kind of attention when it makes the most sense to him/her?

 

Intelligent Parenting

If a family has created an environment in which limits are appropriate for the child’s personality and developmental stage, used physical barriers whenever possible, and kept everyone as well rested as possible, both challenges to the limits and consequences can be kept to a minimum.

But achieving this state requires time as free of constraints as possible. For the few families that have the luxury of meeting these conditions, gentle parenting might be the answer. For the rest of us, intelligent parenting that acknowledges the realities and limits of our own abilities and our children’s vulnerabilities is the better answer.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com

In one my recent Letters, I concluded with the concern that infant-led weaning, which makes some sense, can be confused with child-led family meals, which make none. I referred to an increasingly popular style of parenting overemphasizing child autonomy that seems to be a major contributor to the mealtime chaos that occurs when pleasing every palate at the table becomes the goal.

In the intervening weeks, I have learned that this parenting style is called “gentle parenting.” Despite its growing popularity, possibly fueled by the pandemic, it has not been well-defined nor its effectiveness investigated. In a recent paper published in PLOS ONE, two professors of developmental psychology have attempted correct this deficit in our understanding of this parenting style, which doesn’t appear to make sense to many of us with experience in child behavior and development. 

 

Gentle Parents

By surveying a group of 100 parents of young children, the investigators were able to sort out a group of parents (n = 49) who self-identified as employing gentle parenting. Their responses emphasized a high level of parental affection and emotional regulation by both their children and themselves.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Investigators found that 40% of the self-defined gentle parents “had negative difference scores indicating misbehavior response descriptions that included more child directed responses. I interpret this to mean that almost half of the time the parents failed to evenly include themselves in a solution to a conflict, which indicates incomplete or unsuccessful emotional regulation on their part. The investigators also observed that, like many other parenting styles, gentle parenting includes an emphasis on boundaries “yet, enactment of those boundaries is not uniform.”

More telling was the authors’ observation that “statements of parenting uncertainty and burnout were present in over one third of the gentle of the gentle parenting sample.” While some parents were pleased with their experience, the downside seems unacceptable to me. When asked to explain this finding, Annie Pezalla, PhD, one of the coauthors, has said “gentle parenting practices work best when a parent is emotionally regulated and unconstrained for time — commodities that parents struggle with the most.”

 

Abundance Advice on Parenting Styles

I find this to be a very sad story. Parenting can be difficult. Creating and then gently and effectively policing those boundaries is often the hardest part. There is no shortage of “experts” willing to tell the throngs of anxious parents how to do it. It is not surprising to me that of the four books I have written for parents, the one titled How to Say No to Your Toddler is the only one popular enough to be published in four languages.

Of course I am troubled, as I suspect you may be, with the label “gentle parenting.” It implies that the rest of us are doing something terrible, “harsh” maybe, “cruel” maybe. We can dispense with the “affectionate” descriptor immediately because gentle parenting can’t claim sole ownership to it. Every, behavior management scheme I am aware of touts being caring and loving at its core.

I completely agree that emotional regulation for both parent and child are worthy goals, but I’m not hearing much on how that is to be achieved other than by trying to avoid the inevitable conflict by failing to even say “No” when poorly crafted boundaries are breached. 

There are scores of parenting styles out there. And there should be, because we are all different. Parents have strengths and weaknesses and they have begotten children with different personalities and vulnerabilities. And, families come from different cultures and socioeconomic backgrounds. 

Across all of these differences there are two primary roles for every parent. The first is to lead by example. If a parent wants his/her child to be kind and caring and polite, then the parent has no choice but to behave that way. If the parent can’t always be present, the environment where the child spends most of his/her day should model the desired behavior. I’m not talking about teaching because you can’t preach good behavior. It must be modeled.

The second role for the parent is to keep his/her child safe from dangers that exist in every environment. This can mean accepting vaccines and seeking available medical care. But, it also means creating some limits — the current buzzword is “guardrails” — to keep the child from veering into the ditch.

 

Setting Limits

Limits will, of necessity, vary with the environment. The risks of a child growing on a farm differ from those of child living in the city. And they must be tailored to the personality and developmental stage of the child. A parent may need advice from someone experienced in child behavior to create individualized limits. You may be able to allow your 3-year-old to roam freely in an environment in which I would have to monitor my risk-taking 3-year-old every second. A parent must learn and accept his/her child’s personality and the environment they can provide.

Limits should be inanimate objects whenever possible. Fences, gates, doors with latches, and locked cabinets to keep temptations out of view, etc. Creative environmental manipulations should be employed to keep the annoying verbal warnings, unenforceable threats, and direct child-to-parent confrontations to a minimum.

 

Consequences

Challenges to even the most carefully crafted limits are inevitable, and this is where we get to the third-rail topic of consequences. Yes, when prevention has failed for whatever reason, I believe that an intelligently and affectionately applied time-out is the most efficient and most effective consequence. This is not the place for me to explore or defend the details, but before you write me off as an octogenarian hard-ass (or hard-liner if you prefer) I urge you to read a few chapters in How to Say No to Your Toddler.

Far more important than which consequence a parent chooses are the steps the family has taken to keep both parent and child in a state of balanced emotional regulation. Is everyone well rested and getting enough sleep? Sleep deprivation is one of the most potent triggers of a tantrum; it also leaves parents vulnerable to saying things and making threats they will regret later. Does the child’s schedule leave him or her enough time to decompress? Does the parent’s schedule sync with a developmentally appropriate schedule for the child? Is he/she getting the right kind of attention when it makes the most sense to him/her?

 

Intelligent Parenting

If a family has created an environment in which limits are appropriate for the child’s personality and developmental stage, used physical barriers whenever possible, and kept everyone as well rested as possible, both challenges to the limits and consequences can be kept to a minimum.

But achieving this state requires time as free of constraints as possible. For the few families that have the luxury of meeting these conditions, gentle parenting might be the answer. For the rest of us, intelligent parenting that acknowledges the realities and limits of our own abilities and our children’s vulnerabilities is the better answer.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com

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First Brain-Injected Gene Therapy Approved by FDA

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The US Food and Drug Administration (FDA) has granted fast-track approval for a groundbreaking gene therapy indicated for a rare genetic disorder called aromatic L-amino acid decarboxylase (AADC) deficiency. The gene therapy, marketed under the brand name Kebilidi, is the first in the United States to be injected directly into the brain. It is approved for children with fully developed skulls and for adults.

AADC is an enzyme that helps the body make dopamine. AADC deficiency affects patients’ physical, mental, and behavioral health from infancy, leading to severe disabilities and shorter lifespan. Children with AADC may also experience painful seizure-like episodes called oculogyric crises. 

Kebilidi (generic name: eladocagene exuparvovec) is injected into a specific area of the brain where it boosts AADC, restoring dopamine production and gradually improving movement-related symptoms. This surgery is to be performed only by brain surgeons in specialized centers.

The FDA approval was based on the therapy’s safety and effectiveness as shown in an ongoing clinical trial involving 13 children diagnosed with AADC deficiency. According to PTC Therapeutics, the maker of Kebilidi, long-term follow-up studies of the participants are still needed, and additional proof of the therapy’s benefits are required for full FDA approval.

Common side effects of Kebilidi therapy may include involuntary movements (dyskinesia), anemia, fever, low blood pressure, excessive salivation, problems sleeping, low blood levels of certain minerals, and complications after the injection, including breathing or heart problems. The surgical procedure for injecting Kebilidi also carries certain risks, such as cerebrospinal fluid leaks, bleeding in the brain, inflammation, strokes, and infections. 

 

A version of this article appeared on WebMD.com.

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The US Food and Drug Administration (FDA) has granted fast-track approval for a groundbreaking gene therapy indicated for a rare genetic disorder called aromatic L-amino acid decarboxylase (AADC) deficiency. The gene therapy, marketed under the brand name Kebilidi, is the first in the United States to be injected directly into the brain. It is approved for children with fully developed skulls and for adults.

AADC is an enzyme that helps the body make dopamine. AADC deficiency affects patients’ physical, mental, and behavioral health from infancy, leading to severe disabilities and shorter lifespan. Children with AADC may also experience painful seizure-like episodes called oculogyric crises. 

Kebilidi (generic name: eladocagene exuparvovec) is injected into a specific area of the brain where it boosts AADC, restoring dopamine production and gradually improving movement-related symptoms. This surgery is to be performed only by brain surgeons in specialized centers.

The FDA approval was based on the therapy’s safety and effectiveness as shown in an ongoing clinical trial involving 13 children diagnosed with AADC deficiency. According to PTC Therapeutics, the maker of Kebilidi, long-term follow-up studies of the participants are still needed, and additional proof of the therapy’s benefits are required for full FDA approval.

Common side effects of Kebilidi therapy may include involuntary movements (dyskinesia), anemia, fever, low blood pressure, excessive salivation, problems sleeping, low blood levels of certain minerals, and complications after the injection, including breathing or heart problems. The surgical procedure for injecting Kebilidi also carries certain risks, such as cerebrospinal fluid leaks, bleeding in the brain, inflammation, strokes, and infections. 

 

A version of this article appeared on WebMD.com.

The US Food and Drug Administration (FDA) has granted fast-track approval for a groundbreaking gene therapy indicated for a rare genetic disorder called aromatic L-amino acid decarboxylase (AADC) deficiency. The gene therapy, marketed under the brand name Kebilidi, is the first in the United States to be injected directly into the brain. It is approved for children with fully developed skulls and for adults.

AADC is an enzyme that helps the body make dopamine. AADC deficiency affects patients’ physical, mental, and behavioral health from infancy, leading to severe disabilities and shorter lifespan. Children with AADC may also experience painful seizure-like episodes called oculogyric crises. 

Kebilidi (generic name: eladocagene exuparvovec) is injected into a specific area of the brain where it boosts AADC, restoring dopamine production and gradually improving movement-related symptoms. This surgery is to be performed only by brain surgeons in specialized centers.

The FDA approval was based on the therapy’s safety and effectiveness as shown in an ongoing clinical trial involving 13 children diagnosed with AADC deficiency. According to PTC Therapeutics, the maker of Kebilidi, long-term follow-up studies of the participants are still needed, and additional proof of the therapy’s benefits are required for full FDA approval.

Common side effects of Kebilidi therapy may include involuntary movements (dyskinesia), anemia, fever, low blood pressure, excessive salivation, problems sleeping, low blood levels of certain minerals, and complications after the injection, including breathing or heart problems. The surgical procedure for injecting Kebilidi also carries certain risks, such as cerebrospinal fluid leaks, bleeding in the brain, inflammation, strokes, and infections. 

 

A version of this article appeared on WebMD.com.

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