The Patient Encounter Is Changing

Article Type
Changed
Mon, 09/30/2024 - 12:05

Over the last few decades the patient encounter has changed dramatically. Most recently fueled by the COVID pandemic, face-to-face events between patients and providers have become less frequent. The shift began years before with the slow acceptance of telemedicine by third-party payers.

As more practices have opened portals, the encounters between providers and patients via the internet have become more common, but received mixed reviews, often leaving both providers and patients with more questions than answers. Even more recently, the explosive arrival of generative artificial intelligence (AI) has promised, some might say threatened, to add a whole new complexity and uncertainty to patient encounters regardless of the venue or platform.

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

Still, among the growing collection of options, I think it is fair to say that a live face-to-face encounter remains the gold standard in the opinions of both patients and providers. Patients may have become increasingly critical and vocal when they feel their provider appears rushed or is over focused on the desktop computer screen. However, given all of the options, I suspect that for the moment patients feel a face-to-face meeting continues to offer them the best chance of being heard and their concerns answered.

Even when the image on the video screen is sharp and the intelligibility of the audio feed is crystal clear, I bet most providers feel they can learn more about the patient during a live face-to-face encounter than a Zoom-style encounter.

Nonetheless, there are hints that face-to-face visits maybe losing their place in the pantheon of patient-provider encounters. A recent study from England found that there were a significant number of patients who were more forthcoming in reporting their preferences for social care-related quality of life when they were surveyed by internet rather than face-to-face. It is unclear what was behind this observation, however it may be that patients were embarrassed and viewed these questions about their social neediness as too sensitive to share face-to-face.

There is ample evidence of situations in which the internet can provide a level of anonymity that emboldens the user to say things that are cruel and hurtful, using words they might be afraid to voice in a live setting. This license to act in an uncivil manner is behind much of the harm generated by chat rooms and other social media sites. While in these cases the ability to hide behind the video screen is a negative, this study from England suggests that we should be looking for more opportunities to use this emboldening feature with certain individuals and populations who may be intimidated during a face-to-face encounter. It is likely a hybrid approach may be the most beneficial strategy tailored to the individual patient.

One advantage of a face-to-face visit is that each participant can read the body language of the other. This, of course, can be a disadvantage for the provider who has failed to master the art of disguising his “I’m running behind” stress level, when he should be replacing it with an “I’m ready to listen” posture.

Portals have opened up a whole other can of worms, particularly when the provider has failed to clearly delineate what sort of questions are appropriate for an online forum, not informed the patient who will be providing the answer, and a rough idea of when this will happen. It may take several trips up the learning curve for patients and providers to develop a style of writing that make optimal use of the portal format and make it fit the needs of the practice and the patients.

Regardless of what kind of visit platform we are talking about, a lot hinges on the providers choice of words. I recently reviewed some of the work of Jeffrey D. Robinson, PhD, a professor of communication at the Portland State University, Portland, Oregon. He offers the example of the difference between “some” and “any.” When the patient was asked “Is there something else you would like to address today” almost 80% of the patient’s unmet questions were addressed. However, when the question was “Is there anything else ...” very few of the patient’s unmet questions were addressed. Dr. Robinson has also found that when the question is posed early in the visit rather than at the end, it improves the chances of having the patient’s unmet concerns addressed.

I suspect that the face-to-face patient encounter will survive, but it will continue to lose its market share as other platforms emerge. We can be sure there will be change. We need look no further than generative AI to look for the next step. A well-crafted question could help the patient and the provider choose the most appropriate patient encounter format given the patient’s demographic, chief complaint, and prior history, and match this with the provider’s background and strengths.
 

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 [email protected].

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Over the last few decades the patient encounter has changed dramatically. Most recently fueled by the COVID pandemic, face-to-face events between patients and providers have become less frequent. The shift began years before with the slow acceptance of telemedicine by third-party payers.

As more practices have opened portals, the encounters between providers and patients via the internet have become more common, but received mixed reviews, often leaving both providers and patients with more questions than answers. Even more recently, the explosive arrival of generative artificial intelligence (AI) has promised, some might say threatened, to add a whole new complexity and uncertainty to patient encounters regardless of the venue or platform.

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

Still, among the growing collection of options, I think it is fair to say that a live face-to-face encounter remains the gold standard in the opinions of both patients and providers. Patients may have become increasingly critical and vocal when they feel their provider appears rushed or is over focused on the desktop computer screen. However, given all of the options, I suspect that for the moment patients feel a face-to-face meeting continues to offer them the best chance of being heard and their concerns answered.

Even when the image on the video screen is sharp and the intelligibility of the audio feed is crystal clear, I bet most providers feel they can learn more about the patient during a live face-to-face encounter than a Zoom-style encounter.

Nonetheless, there are hints that face-to-face visits maybe losing their place in the pantheon of patient-provider encounters. A recent study from England found that there were a significant number of patients who were more forthcoming in reporting their preferences for social care-related quality of life when they were surveyed by internet rather than face-to-face. It is unclear what was behind this observation, however it may be that patients were embarrassed and viewed these questions about their social neediness as too sensitive to share face-to-face.

There is ample evidence of situations in which the internet can provide a level of anonymity that emboldens the user to say things that are cruel and hurtful, using words they might be afraid to voice in a live setting. This license to act in an uncivil manner is behind much of the harm generated by chat rooms and other social media sites. While in these cases the ability to hide behind the video screen is a negative, this study from England suggests that we should be looking for more opportunities to use this emboldening feature with certain individuals and populations who may be intimidated during a face-to-face encounter. It is likely a hybrid approach may be the most beneficial strategy tailored to the individual patient.

One advantage of a face-to-face visit is that each participant can read the body language of the other. This, of course, can be a disadvantage for the provider who has failed to master the art of disguising his “I’m running behind” stress level, when he should be replacing it with an “I’m ready to listen” posture.

Portals have opened up a whole other can of worms, particularly when the provider has failed to clearly delineate what sort of questions are appropriate for an online forum, not informed the patient who will be providing the answer, and a rough idea of when this will happen. It may take several trips up the learning curve for patients and providers to develop a style of writing that make optimal use of the portal format and make it fit the needs of the practice and the patients.

Regardless of what kind of visit platform we are talking about, a lot hinges on the providers choice of words. I recently reviewed some of the work of Jeffrey D. Robinson, PhD, a professor of communication at the Portland State University, Portland, Oregon. He offers the example of the difference between “some” and “any.” When the patient was asked “Is there something else you would like to address today” almost 80% of the patient’s unmet questions were addressed. However, when the question was “Is there anything else ...” very few of the patient’s unmet questions were addressed. Dr. Robinson has also found that when the question is posed early in the visit rather than at the end, it improves the chances of having the patient’s unmet concerns addressed.

I suspect that the face-to-face patient encounter will survive, but it will continue to lose its market share as other platforms emerge. We can be sure there will be change. We need look no further than generative AI to look for the next step. A well-crafted question could help the patient and the provider choose the most appropriate patient encounter format given the patient’s demographic, chief complaint, and prior history, and match this with the provider’s background and strengths.
 

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 [email protected].

Over the last few decades the patient encounter has changed dramatically. Most recently fueled by the COVID pandemic, face-to-face events between patients and providers have become less frequent. The shift began years before with the slow acceptance of telemedicine by third-party payers.

As more practices have opened portals, the encounters between providers and patients via the internet have become more common, but received mixed reviews, often leaving both providers and patients with more questions than answers. Even more recently, the explosive arrival of generative artificial intelligence (AI) has promised, some might say threatened, to add a whole new complexity and uncertainty to patient encounters regardless of the venue or platform.

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

Still, among the growing collection of options, I think it is fair to say that a live face-to-face encounter remains the gold standard in the opinions of both patients and providers. Patients may have become increasingly critical and vocal when they feel their provider appears rushed or is over focused on the desktop computer screen. However, given all of the options, I suspect that for the moment patients feel a face-to-face meeting continues to offer them the best chance of being heard and their concerns answered.

Even when the image on the video screen is sharp and the intelligibility of the audio feed is crystal clear, I bet most providers feel they can learn more about the patient during a live face-to-face encounter than a Zoom-style encounter.

Nonetheless, there are hints that face-to-face visits maybe losing their place in the pantheon of patient-provider encounters. A recent study from England found that there were a significant number of patients who were more forthcoming in reporting their preferences for social care-related quality of life when they were surveyed by internet rather than face-to-face. It is unclear what was behind this observation, however it may be that patients were embarrassed and viewed these questions about their social neediness as too sensitive to share face-to-face.

There is ample evidence of situations in which the internet can provide a level of anonymity that emboldens the user to say things that are cruel and hurtful, using words they might be afraid to voice in a live setting. This license to act in an uncivil manner is behind much of the harm generated by chat rooms and other social media sites. While in these cases the ability to hide behind the video screen is a negative, this study from England suggests that we should be looking for more opportunities to use this emboldening feature with certain individuals and populations who may be intimidated during a face-to-face encounter. It is likely a hybrid approach may be the most beneficial strategy tailored to the individual patient.

One advantage of a face-to-face visit is that each participant can read the body language of the other. This, of course, can be a disadvantage for the provider who has failed to master the art of disguising his “I’m running behind” stress level, when he should be replacing it with an “I’m ready to listen” posture.

Portals have opened up a whole other can of worms, particularly when the provider has failed to clearly delineate what sort of questions are appropriate for an online forum, not informed the patient who will be providing the answer, and a rough idea of when this will happen. It may take several trips up the learning curve for patients and providers to develop a style of writing that make optimal use of the portal format and make it fit the needs of the practice and the patients.

Regardless of what kind of visit platform we are talking about, a lot hinges on the providers choice of words. I recently reviewed some of the work of Jeffrey D. Robinson, PhD, a professor of communication at the Portland State University, Portland, Oregon. He offers the example of the difference between “some” and “any.” When the patient was asked “Is there something else you would like to address today” almost 80% of the patient’s unmet questions were addressed. However, when the question was “Is there anything else ...” very few of the patient’s unmet questions were addressed. Dr. Robinson has also found that when the question is posed early in the visit rather than at the end, it improves the chances of having the patient’s unmet concerns addressed.

I suspect that the face-to-face patient encounter will survive, but it will continue to lose its market share as other platforms emerge. We can be sure there will be change. We need look no further than generative AI to look for the next step. A well-crafted question could help the patient and the provider choose the most appropriate patient encounter format given the patient’s demographic, chief complaint, and prior history, and match this with the provider’s background and strengths.
 

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 [email protected].

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Rheumatologic Disease–Associated Hyperinflammatory Condition Successfully Treated with Emapalumab

Article Type
Changed
Fri, 09/27/2024 - 16:12

 

TOPLINE:

Emapalumab (Gamifant)-containing regimens stabilize key laboratory parameters and show a high 12-month survival probability in patients with rheumatologic disease–associated hemophagocytic lymphohistiocytosis (HLH).

METHODOLOGY:

  • Researchers conducted a retrospective medical chart review study across 33 US hospitals to assess the real-world treatment patterns and outcomes in patients with HLH treated with emapalumab.
  • They included 15 patients with rheumatologic disease–associated HLH (median age at diagnosis, 5 years; 73.3% women) who received at least one dose of emapalumab between November 20, 2018, and October 31, 2021.
  • Most patients with rheumatologic disease–associated HLH had either systemic juvenile idiopathic arthritis (n = 9) or adult-onset Still’s disease (n = 1).
  • Patients received emapalumab for refractory, recurrent, or progressive disease, with an overall treatment duration of 63 days.
  • The primary objective of this study was to describe emapalumab treatment patterns such as time to initiation, treatment duration, dosing patterns, and reasons for initiation.

TAKEAWAY:

  • Most patients (60%) with rheumatologic disease–associated HLH were critically ill and were initiated on emapalumab in an intensive care unit; emapalumab was mostly initiated for treating refractory (33.3%) and recurrent (33.3%) disease.
  • All patients concurrently received emapalumab with other HLH-related therapies, with glucocorticoids (100%) and anakinra (60%) used most frequently.
  • Emapalumab treatment led to achievement of normal fibrinogen levels (> 360 mg/dL), according to defined laboratory criteria in all patients with rheumatologic disease–associated HLH, and an 80.6% reduction in the required glucocorticoid dose.
  • The 12-month survival probability from the initiation of emapalumab was 86.7% in all patients with rheumatologic disease–associated HLH and 90.0% in the subset with systemic juvenile idiopathic arthritis or adult-onset Still’s disease.

IN PRACTICE:

“In this study, emapalumab-containing regimens normalized rheumatologic disease–associated laboratory parameters, substantially reduced glucocorticoid dose, and were associated with low mortality,” the authors wrote.

SOURCE:

The study was led by Shanmuganathan Chandrakasan, MD, Children’s Healthcare of Atlanta, Emory University, Atlanta, Georgia, and was published online on September 8, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

Chart data required for analyses were missing or incomplete in this retrospective study. The sample size of patients with rheumatologic disease–associated HLH was small. No safety data were collected.

DISCLOSURES:

The study was supported by Sobi, which markets emapalumab. Some authors declared receiving grants, consulting fees, or payments or having financial and nonfinancial interests and other ties with several pharmaceutical companies, including Sobi.

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:

Emapalumab (Gamifant)-containing regimens stabilize key laboratory parameters and show a high 12-month survival probability in patients with rheumatologic disease–associated hemophagocytic lymphohistiocytosis (HLH).

METHODOLOGY:

  • Researchers conducted a retrospective medical chart review study across 33 US hospitals to assess the real-world treatment patterns and outcomes in patients with HLH treated with emapalumab.
  • They included 15 patients with rheumatologic disease–associated HLH (median age at diagnosis, 5 years; 73.3% women) who received at least one dose of emapalumab between November 20, 2018, and October 31, 2021.
  • Most patients with rheumatologic disease–associated HLH had either systemic juvenile idiopathic arthritis (n = 9) or adult-onset Still’s disease (n = 1).
  • Patients received emapalumab for refractory, recurrent, or progressive disease, with an overall treatment duration of 63 days.
  • The primary objective of this study was to describe emapalumab treatment patterns such as time to initiation, treatment duration, dosing patterns, and reasons for initiation.

TAKEAWAY:

  • Most patients (60%) with rheumatologic disease–associated HLH were critically ill and were initiated on emapalumab in an intensive care unit; emapalumab was mostly initiated for treating refractory (33.3%) and recurrent (33.3%) disease.
  • All patients concurrently received emapalumab with other HLH-related therapies, with glucocorticoids (100%) and anakinra (60%) used most frequently.
  • Emapalumab treatment led to achievement of normal fibrinogen levels (> 360 mg/dL), according to defined laboratory criteria in all patients with rheumatologic disease–associated HLH, and an 80.6% reduction in the required glucocorticoid dose.
  • The 12-month survival probability from the initiation of emapalumab was 86.7% in all patients with rheumatologic disease–associated HLH and 90.0% in the subset with systemic juvenile idiopathic arthritis or adult-onset Still’s disease.

IN PRACTICE:

“In this study, emapalumab-containing regimens normalized rheumatologic disease–associated laboratory parameters, substantially reduced glucocorticoid dose, and were associated with low mortality,” the authors wrote.

SOURCE:

The study was led by Shanmuganathan Chandrakasan, MD, Children’s Healthcare of Atlanta, Emory University, Atlanta, Georgia, and was published online on September 8, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

Chart data required for analyses were missing or incomplete in this retrospective study. The sample size of patients with rheumatologic disease–associated HLH was small. No safety data were collected.

DISCLOSURES:

The study was supported by Sobi, which markets emapalumab. Some authors declared receiving grants, consulting fees, or payments or having financial and nonfinancial interests and other ties with several pharmaceutical companies, including Sobi.

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:

Emapalumab (Gamifant)-containing regimens stabilize key laboratory parameters and show a high 12-month survival probability in patients with rheumatologic disease–associated hemophagocytic lymphohistiocytosis (HLH).

METHODOLOGY:

  • Researchers conducted a retrospective medical chart review study across 33 US hospitals to assess the real-world treatment patterns and outcomes in patients with HLH treated with emapalumab.
  • They included 15 patients with rheumatologic disease–associated HLH (median age at diagnosis, 5 years; 73.3% women) who received at least one dose of emapalumab between November 20, 2018, and October 31, 2021.
  • Most patients with rheumatologic disease–associated HLH had either systemic juvenile idiopathic arthritis (n = 9) or adult-onset Still’s disease (n = 1).
  • Patients received emapalumab for refractory, recurrent, or progressive disease, with an overall treatment duration of 63 days.
  • The primary objective of this study was to describe emapalumab treatment patterns such as time to initiation, treatment duration, dosing patterns, and reasons for initiation.

TAKEAWAY:

  • Most patients (60%) with rheumatologic disease–associated HLH were critically ill and were initiated on emapalumab in an intensive care unit; emapalumab was mostly initiated for treating refractory (33.3%) and recurrent (33.3%) disease.
  • All patients concurrently received emapalumab with other HLH-related therapies, with glucocorticoids (100%) and anakinra (60%) used most frequently.
  • Emapalumab treatment led to achievement of normal fibrinogen levels (> 360 mg/dL), according to defined laboratory criteria in all patients with rheumatologic disease–associated HLH, and an 80.6% reduction in the required glucocorticoid dose.
  • The 12-month survival probability from the initiation of emapalumab was 86.7% in all patients with rheumatologic disease–associated HLH and 90.0% in the subset with systemic juvenile idiopathic arthritis or adult-onset Still’s disease.

IN PRACTICE:

“In this study, emapalumab-containing regimens normalized rheumatologic disease–associated laboratory parameters, substantially reduced glucocorticoid dose, and were associated with low mortality,” the authors wrote.

SOURCE:

The study was led by Shanmuganathan Chandrakasan, MD, Children’s Healthcare of Atlanta, Emory University, Atlanta, Georgia, and was published online on September 8, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

Chart data required for analyses were missing or incomplete in this retrospective study. The sample size of patients with rheumatologic disease–associated HLH was small. No safety data were collected.

DISCLOSURES:

The study was supported by Sobi, which markets emapalumab. Some authors declared receiving grants, consulting fees, or payments or having financial and nonfinancial interests and other ties with several pharmaceutical companies, including Sobi.

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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Childhood-Onset Atopic Dermatitis Adds Burden in Adulthood

Article Type
Changed
Fri, 09/27/2024 - 10:39

— There is a mountain of evidence that atopic dermatitis (AD) exerts a large negative impact on quality of life, but a unique study with data from more than 30,000 individuals showed that adults whose AD started in childhood carry a far greater psychological and social burden throughout their life relative to AD starting after childhood.

These data, drawn from the ambitious Scars of Life (SOL) project, “suggest that childhood AD persisting into adulthood is its own phenotype,” reported Jonathan I. Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington University, Washington, DC.

Dr. Jonathan I. Silverberg, professor of dermatology at George Washington University, Washington, DC
Dr. Silverberg
Dr. Jonathan I. Silverberg

One reasonable message from these data is that the failure to achieve adequate control of AD in children, whether by a late start of systemic agents or other reasons, results in a greater lifetime burden of disease when the burden beyond physical symptoms is measured, according to Dr. Silverberg.
 

More Than 30,000 From Five Continents Participated

In the SOL project, which was designed to analyze how the age of AD onset affects the severity of symptoms and quality of life, completed questionnaires were collected from 30,801 individuals in 27 countries on five continents. The questions, which elicited data to measure the burden of AD, were developed in association with several professional and patient associations with an interest in AD, including the National Eczema Association.

The SOL project has produced an enormous amount of data in four distinct groups, but Dr. Silverberg, speaking in a late-breaking news session at the annual congress of the European Academy of Dermatology and Venereology, focused on a comparison between the 2875 participants who had AD in childhood that has persisted into adulthood and the 7383 adults with adult-onset AD. Data from the other two subsets in SOL — AD in childhood but not in adulthood and no AD in either phase of life — are expected to fuel an extended series of publications.

In the two groups, baseline characteristics were similar with about 60% reporting moderate to severe symptoms and a median age of about 37 years. The proportion of women was 61% in both groups.

Using the PUSH-D questionnaire, which Dr. Silverberg described as a validated tool for gauging a sense of stigmatization, the greater burden of AD was remarkably consistent for those with childhood-onset AD vs adult-onset AD. With higher scores representing a greater sense of stigmatization, the differences in the overall score (23.0 vs 18.1; P < .0001) were highly significant as was every other domain evaluated.

For all five social behavior domains, such as avoiding contact in public and wariness of approaching people spontaneously, having AD onset in childhood persisting into adulthood produced significantly higher scores than having AD onset in adulthood, with no exceptions (P < .001 for all).
 

AD From Childhood Consistently Results in Worse Outcomes

Providing examples for some of the other 12 domains, Dr. Silverberg maintained that feelings of shame and psychological discomfort were always greater in adults with AD persistent since childhood vs AD starting in adulthood. The P values for these outcomes, such as experiencing bias at work or reporting a sense that others avoided them, were typically highly significant (P < .001).

Compared with those whose AD started in adulthood, “adults with atopic eczema that started during childhood have significantly more difficulties in their life, including occupational relationships, daily life, personal life, and partner or family relationships,” Dr. Silverberg reported.

He said that the data were controlled for multiple confounders, particularly greater severity of AD. He acknowledged that childhood onset might be considered a surrogate for more severe disease, but the data were controlled for this possibility.

Despite the fact that there are “thousands of studies across all age groups showing the burden of AD,” Dr. Silverberg considers these data to be unique by emphasizing the burden of chronicity rather than the impact of AD in any single moment in time.

For those with chronic AD from childhood, “the effect is not just on physical health but a deep negative influence on psychological and social aspects of life,” Dr. Silverberg said, suggesting that the independent effects of chronicity might be worth studying across other dermatologic diseases.

“Regulatory agencies focus on what you can do in that moment of time, losing the bigger picture of how patients are affected chronically,” he said, adding that this is an area of clinical research that should be further explored.

What the data further suggest “is that the earlier we intervene, the more likely patients will do better long term,” he said.
 

Data Provide Evidence of Systemic Therapy in Kids

For Gudrun Ratzinger, MD, of the Department of Dermatology and Venerology at the Medical University of Innsbruck in Austria, these are valuable data.

“When I prescribe systemic therapies to children, I often get resistance from the healthcare system and even other colleagues,” said Dr. Ratzinger, who was asked to comment on the results. “We are at a teaching hospital, but I often find that when patients return to their home physician, the systemic therapies are stopped.”

In her own practice, she believes the most effective therapies should be introduced in children and adults when complete control is not achieved on first-line drugs. “These data are very helpful for me in explaining to others the importance of effective treatment of atopic dermatitis in children,” she said.

Dr. Silverberg reported financial relationships with more than 40 pharmaceutical companies, including those that make drugs for AD. Dr. Ratzinger reported financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pelpharma, Pfizer, and UCB.

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

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— There is a mountain of evidence that atopic dermatitis (AD) exerts a large negative impact on quality of life, but a unique study with data from more than 30,000 individuals showed that adults whose AD started in childhood carry a far greater psychological and social burden throughout their life relative to AD starting after childhood.

These data, drawn from the ambitious Scars of Life (SOL) project, “suggest that childhood AD persisting into adulthood is its own phenotype,” reported Jonathan I. Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington University, Washington, DC.

Dr. Jonathan I. Silverberg, professor of dermatology at George Washington University, Washington, DC
Dr. Silverberg
Dr. Jonathan I. Silverberg

One reasonable message from these data is that the failure to achieve adequate control of AD in children, whether by a late start of systemic agents or other reasons, results in a greater lifetime burden of disease when the burden beyond physical symptoms is measured, according to Dr. Silverberg.
 

More Than 30,000 From Five Continents Participated

In the SOL project, which was designed to analyze how the age of AD onset affects the severity of symptoms and quality of life, completed questionnaires were collected from 30,801 individuals in 27 countries on five continents. The questions, which elicited data to measure the burden of AD, were developed in association with several professional and patient associations with an interest in AD, including the National Eczema Association.

The SOL project has produced an enormous amount of data in four distinct groups, but Dr. Silverberg, speaking in a late-breaking news session at the annual congress of the European Academy of Dermatology and Venereology, focused on a comparison between the 2875 participants who had AD in childhood that has persisted into adulthood and the 7383 adults with adult-onset AD. Data from the other two subsets in SOL — AD in childhood but not in adulthood and no AD in either phase of life — are expected to fuel an extended series of publications.

In the two groups, baseline characteristics were similar with about 60% reporting moderate to severe symptoms and a median age of about 37 years. The proportion of women was 61% in both groups.

Using the PUSH-D questionnaire, which Dr. Silverberg described as a validated tool for gauging a sense of stigmatization, the greater burden of AD was remarkably consistent for those with childhood-onset AD vs adult-onset AD. With higher scores representing a greater sense of stigmatization, the differences in the overall score (23.0 vs 18.1; P < .0001) were highly significant as was every other domain evaluated.

For all five social behavior domains, such as avoiding contact in public and wariness of approaching people spontaneously, having AD onset in childhood persisting into adulthood produced significantly higher scores than having AD onset in adulthood, with no exceptions (P < .001 for all).
 

AD From Childhood Consistently Results in Worse Outcomes

Providing examples for some of the other 12 domains, Dr. Silverberg maintained that feelings of shame and psychological discomfort were always greater in adults with AD persistent since childhood vs AD starting in adulthood. The P values for these outcomes, such as experiencing bias at work or reporting a sense that others avoided them, were typically highly significant (P < .001).

Compared with those whose AD started in adulthood, “adults with atopic eczema that started during childhood have significantly more difficulties in their life, including occupational relationships, daily life, personal life, and partner or family relationships,” Dr. Silverberg reported.

He said that the data were controlled for multiple confounders, particularly greater severity of AD. He acknowledged that childhood onset might be considered a surrogate for more severe disease, but the data were controlled for this possibility.

Despite the fact that there are “thousands of studies across all age groups showing the burden of AD,” Dr. Silverberg considers these data to be unique by emphasizing the burden of chronicity rather than the impact of AD in any single moment in time.

For those with chronic AD from childhood, “the effect is not just on physical health but a deep negative influence on psychological and social aspects of life,” Dr. Silverberg said, suggesting that the independent effects of chronicity might be worth studying across other dermatologic diseases.

“Regulatory agencies focus on what you can do in that moment of time, losing the bigger picture of how patients are affected chronically,” he said, adding that this is an area of clinical research that should be further explored.

What the data further suggest “is that the earlier we intervene, the more likely patients will do better long term,” he said.
 

Data Provide Evidence of Systemic Therapy in Kids

For Gudrun Ratzinger, MD, of the Department of Dermatology and Venerology at the Medical University of Innsbruck in Austria, these are valuable data.

“When I prescribe systemic therapies to children, I often get resistance from the healthcare system and even other colleagues,” said Dr. Ratzinger, who was asked to comment on the results. “We are at a teaching hospital, but I often find that when patients return to their home physician, the systemic therapies are stopped.”

In her own practice, she believes the most effective therapies should be introduced in children and adults when complete control is not achieved on first-line drugs. “These data are very helpful for me in explaining to others the importance of effective treatment of atopic dermatitis in children,” she said.

Dr. Silverberg reported financial relationships with more than 40 pharmaceutical companies, including those that make drugs for AD. Dr. Ratzinger reported financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pelpharma, Pfizer, and UCB.

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

— There is a mountain of evidence that atopic dermatitis (AD) exerts a large negative impact on quality of life, but a unique study with data from more than 30,000 individuals showed that adults whose AD started in childhood carry a far greater psychological and social burden throughout their life relative to AD starting after childhood.

These data, drawn from the ambitious Scars of Life (SOL) project, “suggest that childhood AD persisting into adulthood is its own phenotype,” reported Jonathan I. Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington University, Washington, DC.

Dr. Jonathan I. Silverberg, professor of dermatology at George Washington University, Washington, DC
Dr. Silverberg
Dr. Jonathan I. Silverberg

One reasonable message from these data is that the failure to achieve adequate control of AD in children, whether by a late start of systemic agents or other reasons, results in a greater lifetime burden of disease when the burden beyond physical symptoms is measured, according to Dr. Silverberg.
 

More Than 30,000 From Five Continents Participated

In the SOL project, which was designed to analyze how the age of AD onset affects the severity of symptoms and quality of life, completed questionnaires were collected from 30,801 individuals in 27 countries on five continents. The questions, which elicited data to measure the burden of AD, were developed in association with several professional and patient associations with an interest in AD, including the National Eczema Association.

The SOL project has produced an enormous amount of data in four distinct groups, but Dr. Silverberg, speaking in a late-breaking news session at the annual congress of the European Academy of Dermatology and Venereology, focused on a comparison between the 2875 participants who had AD in childhood that has persisted into adulthood and the 7383 adults with adult-onset AD. Data from the other two subsets in SOL — AD in childhood but not in adulthood and no AD in either phase of life — are expected to fuel an extended series of publications.

In the two groups, baseline characteristics were similar with about 60% reporting moderate to severe symptoms and a median age of about 37 years. The proportion of women was 61% in both groups.

Using the PUSH-D questionnaire, which Dr. Silverberg described as a validated tool for gauging a sense of stigmatization, the greater burden of AD was remarkably consistent for those with childhood-onset AD vs adult-onset AD. With higher scores representing a greater sense of stigmatization, the differences in the overall score (23.0 vs 18.1; P < .0001) were highly significant as was every other domain evaluated.

For all five social behavior domains, such as avoiding contact in public and wariness of approaching people spontaneously, having AD onset in childhood persisting into adulthood produced significantly higher scores than having AD onset in adulthood, with no exceptions (P < .001 for all).
 

AD From Childhood Consistently Results in Worse Outcomes

Providing examples for some of the other 12 domains, Dr. Silverberg maintained that feelings of shame and psychological discomfort were always greater in adults with AD persistent since childhood vs AD starting in adulthood. The P values for these outcomes, such as experiencing bias at work or reporting a sense that others avoided them, were typically highly significant (P < .001).

Compared with those whose AD started in adulthood, “adults with atopic eczema that started during childhood have significantly more difficulties in their life, including occupational relationships, daily life, personal life, and partner or family relationships,” Dr. Silverberg reported.

He said that the data were controlled for multiple confounders, particularly greater severity of AD. He acknowledged that childhood onset might be considered a surrogate for more severe disease, but the data were controlled for this possibility.

Despite the fact that there are “thousands of studies across all age groups showing the burden of AD,” Dr. Silverberg considers these data to be unique by emphasizing the burden of chronicity rather than the impact of AD in any single moment in time.

For those with chronic AD from childhood, “the effect is not just on physical health but a deep negative influence on psychological and social aspects of life,” Dr. Silverberg said, suggesting that the independent effects of chronicity might be worth studying across other dermatologic diseases.

“Regulatory agencies focus on what you can do in that moment of time, losing the bigger picture of how patients are affected chronically,” he said, adding that this is an area of clinical research that should be further explored.

What the data further suggest “is that the earlier we intervene, the more likely patients will do better long term,” he said.
 

Data Provide Evidence of Systemic Therapy in Kids

For Gudrun Ratzinger, MD, of the Department of Dermatology and Venerology at the Medical University of Innsbruck in Austria, these are valuable data.

“When I prescribe systemic therapies to children, I often get resistance from the healthcare system and even other colleagues,” said Dr. Ratzinger, who was asked to comment on the results. “We are at a teaching hospital, but I often find that when patients return to their home physician, the systemic therapies are stopped.”

In her own practice, she believes the most effective therapies should be introduced in children and adults when complete control is not achieved on first-line drugs. “These data are very helpful for me in explaining to others the importance of effective treatment of atopic dermatitis in children,” she said.

Dr. Silverberg reported financial relationships with more than 40 pharmaceutical companies, including those that make drugs for AD. Dr. Ratzinger reported financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pelpharma, Pfizer, and UCB.

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

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AACR Cancer Progress Report: Big Strides and Big Gaps

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Despite the “remarkable progress” in cancer research and care, cancer remains “an ongoing public health challenge,” which requires significant attention and funding, according to the Cancer Progress Report 2024 from the American Association for Cancer Research (AACR).

The AACR’s 216-page report — an annual endeavor now in its 14th year — focused on the “tremendous” strides made in cancer care, prevention, and early detection and highlighted areas where more research and attention are warranted. 

One key area is funding. For the first time since 2016, federal funding for the National Institutes of Health (NIH) and National Cancer Institute (NCI) decreased in the past year. The cuts followed nearly a decade of funding increases that saw the NIH budget expand by nearly $15 billion, and that allowed for a “rapid pace and broad scope” of advances in cancer, AACR’s chief executive officer Margaret Foti, MD, PhD, said during a press briefing.

These recent cuts “threaten to curtail the medical progress seen in recent years and stymie future advancements,” said Dr. Foti, who called on Congress to commit to funding cancer research at significant and consistent levels to “maintain the momentum of progress against cancer.”
 

Inside the Report: Big Progress

Overall, advances in prevention, early detection, and treatment have helped catch more cancers earlier and save lives. 

According to the AACR report, the age-adjusted overall cancer death rate in the United States fell by 33% between 1991 and 2021, meaning about 4.1 million cancer deaths were averted. The overall cancer death rate for children and adolescents has declined by 24% in the past 2 decades. The 5-year relative survival rate for children diagnosed with cancer in the US has improved from 58% for those diagnosed in the mid-1970s to 85% for those diagnosed between 2013 and 2019.

The past fiscal year has seen many new approvals for cancer drugs, diagnostics, and screening tests. From July 1, 2023, to June 30, 2024, the Food and Drug Administration (FDA) approved 15 new anticancer therapeutics, as well as 15 new indications for previously approved agents, one new imaging agent, several artificial intelligence (AI) tools to improve early cancer detection and diagnosis, and two minimally invasive tests for assessing inherited cancer risk or early cancer detection, according to the report.

“Cancer diagnostics are becoming more sophisticated,” AACR president Patricia M. LoRusso, DO, PhD, said during the briefing. “New technologies, such as spatial transcriptomics, are helping us study tumors at a cellular level, and helping to unveil things that we did not initially even begin to understand or think of. AI-based approaches are beginning to transform cancer detection, diagnosis, clinical decision-making, and treatment response monitoring.” 

The report also highlights the significant progress in many childhood and adolescent/young adult cancers, Dr. LoRusso noted. These include FDA approvals for two new molecularly targeted therapeutics: tovorafenib for children with certain types of brain tumor and repotrectinib for children with a wide array of cancer types that have a specific genetic alteration known as NTRK gene fusion. It also includes an expanded approval for eflornithine to reduce the risk for relapse in children with high-risk neuroblastoma.

“Decades — decades — of basic research discoveries, have led to these clinical breakthroughs,” she stressed. “These gains against cancer are because of the rapid progress in our ability to decode the cancer genome, which has opened new and innovative avenues for drug development.”
 

 

 

The Gaps

Even with progress in cancer prevention, early detection, and treatment, cancer remains a significant issue.

“In 2024, it is estimated that more than 2 million new cases of cancer will be diagnosed in the United States. More than 611,000 people will die from the disease,” according to the report.

The 2024 report shows that incidence rates for some cancers are increasing in the United States, including vaccine-preventable cancers such as human papillomavirus (HPV)–associated oral cancers and, in young adults, cervical cancers. A recent analysis also found that overall cervical cancer incidence among women aged 30-34 years increased by 2.5% a year between 2012 and 2019.

Furthermore, despite clear evidence demonstrating that the HPV vaccine reduces cervical cancer incidence, uptake has remained poor, with only 38.6% of US children and adolescents aged 9-17 years receiving at least one dose of the vaccine in 2022.

Early-onset cancers are also increasing. Rates of breast, colorectal, and other cancers are on the rise in adults younger than 50 years, the report noted.

The report also pointed to data that 40% of all cancer cases in the United States can be attributed to preventable factors, such as smoking, excess body weight, and alcohol. However, our understanding of these risk factors has improved. Excessive levels of alcohol consumption have, for instance, been shown to increase the risk for six different types of cancer: certain types of head and neck cancer, esophageal squamous cell carcinoma, and breast, colorectal, liver, and stomach cancers.

Financial toxicity remains prevalent as well.

The report explains that financial hardship following a cancer diagnosis is widespread, and the effects can last for years. In fact, more than 40% of patients can spend their entire life savings within the first 2 years of cancer treatment. Among adult survivors of childhood cancers, 20.7% had trouble paying their medical bills, 29.9% said they had been sent to debt collection for unpaid bills, 14.1% had forgone medical care, and 26.8% could not afford nutritious meals.

For young cancer survivors, the lifetime costs associated with a diagnosis of cancer are substantial, reaching an average of $259,324 per person.

On a global level, it is estimated that from 2020 to 2050, the cumulative economic burden of cancer will be $25.2 trillion.
 

The Path Forward

Despite these challenges, Dr. LoRusso said, “it is unquestionable that we are in a time of unparalleled opportunities in cancer research.

“I am excited about what the future holds for cancer research, and especially for patient care,” she said. 

However, funding commitments are needed to avoid impeding this momentum and losing a “talented and creative young workforce” that has brought new ideas and new technologies to the table.

Continued robust funding will help “to markedly improve cancer care, increase cancer survivorship, spur economic growth, and maintain the United States’ position as the global leader in science and medical research,” she added.

The AACR report specifically calls on Congress to:

  • Appropriate at least $51.3 billion in fiscal year 2025 for the base budget of the NIH and at least $7.934 billion for the NCI.
  • Provide $3.6 billion in dedicated funding for Cancer Moonshot activities through fiscal year 2026 in addition to other funding, consistent with the President’s fiscal year 2025 budget.
  • Appropriate at least $472.4 million in fiscal year 2025 for the CDC’s Division of Cancer Prevention to support comprehensive cancer control, central cancer registries, and screening and awareness programs for specific cancers.
  • Allocate $55 million in funding for the Oncology Center of Excellence at FDA in fiscal year 2025 to provide regulators with the staff and tools necessary to conduct expedited review of cancer-related medical products.

By working together with Congress and other stakeholders, “we will be able to accelerate the pace of progress and make major strides toward the lifesaving goal of preventing and curing all cancers at the earliest possible time,” Dr. Foti said. “I believe if we do that ... one day we will win this war on cancer.”

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

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Despite the “remarkable progress” in cancer research and care, cancer remains “an ongoing public health challenge,” which requires significant attention and funding, according to the Cancer Progress Report 2024 from the American Association for Cancer Research (AACR).

The AACR’s 216-page report — an annual endeavor now in its 14th year — focused on the “tremendous” strides made in cancer care, prevention, and early detection and highlighted areas where more research and attention are warranted. 

One key area is funding. For the first time since 2016, federal funding for the National Institutes of Health (NIH) and National Cancer Institute (NCI) decreased in the past year. The cuts followed nearly a decade of funding increases that saw the NIH budget expand by nearly $15 billion, and that allowed for a “rapid pace and broad scope” of advances in cancer, AACR’s chief executive officer Margaret Foti, MD, PhD, said during a press briefing.

These recent cuts “threaten to curtail the medical progress seen in recent years and stymie future advancements,” said Dr. Foti, who called on Congress to commit to funding cancer research at significant and consistent levels to “maintain the momentum of progress against cancer.”
 

Inside the Report: Big Progress

Overall, advances in prevention, early detection, and treatment have helped catch more cancers earlier and save lives. 

According to the AACR report, the age-adjusted overall cancer death rate in the United States fell by 33% between 1991 and 2021, meaning about 4.1 million cancer deaths were averted. The overall cancer death rate for children and adolescents has declined by 24% in the past 2 decades. The 5-year relative survival rate for children diagnosed with cancer in the US has improved from 58% for those diagnosed in the mid-1970s to 85% for those diagnosed between 2013 and 2019.

The past fiscal year has seen many new approvals for cancer drugs, diagnostics, and screening tests. From July 1, 2023, to June 30, 2024, the Food and Drug Administration (FDA) approved 15 new anticancer therapeutics, as well as 15 new indications for previously approved agents, one new imaging agent, several artificial intelligence (AI) tools to improve early cancer detection and diagnosis, and two minimally invasive tests for assessing inherited cancer risk or early cancer detection, according to the report.

“Cancer diagnostics are becoming more sophisticated,” AACR president Patricia M. LoRusso, DO, PhD, said during the briefing. “New technologies, such as spatial transcriptomics, are helping us study tumors at a cellular level, and helping to unveil things that we did not initially even begin to understand or think of. AI-based approaches are beginning to transform cancer detection, diagnosis, clinical decision-making, and treatment response monitoring.” 

The report also highlights the significant progress in many childhood and adolescent/young adult cancers, Dr. LoRusso noted. These include FDA approvals for two new molecularly targeted therapeutics: tovorafenib for children with certain types of brain tumor and repotrectinib for children with a wide array of cancer types that have a specific genetic alteration known as NTRK gene fusion. It also includes an expanded approval for eflornithine to reduce the risk for relapse in children with high-risk neuroblastoma.

“Decades — decades — of basic research discoveries, have led to these clinical breakthroughs,” she stressed. “These gains against cancer are because of the rapid progress in our ability to decode the cancer genome, which has opened new and innovative avenues for drug development.”
 

 

 

The Gaps

Even with progress in cancer prevention, early detection, and treatment, cancer remains a significant issue.

“In 2024, it is estimated that more than 2 million new cases of cancer will be diagnosed in the United States. More than 611,000 people will die from the disease,” according to the report.

The 2024 report shows that incidence rates for some cancers are increasing in the United States, including vaccine-preventable cancers such as human papillomavirus (HPV)–associated oral cancers and, in young adults, cervical cancers. A recent analysis also found that overall cervical cancer incidence among women aged 30-34 years increased by 2.5% a year between 2012 and 2019.

Furthermore, despite clear evidence demonstrating that the HPV vaccine reduces cervical cancer incidence, uptake has remained poor, with only 38.6% of US children and adolescents aged 9-17 years receiving at least one dose of the vaccine in 2022.

Early-onset cancers are also increasing. Rates of breast, colorectal, and other cancers are on the rise in adults younger than 50 years, the report noted.

The report also pointed to data that 40% of all cancer cases in the United States can be attributed to preventable factors, such as smoking, excess body weight, and alcohol. However, our understanding of these risk factors has improved. Excessive levels of alcohol consumption have, for instance, been shown to increase the risk for six different types of cancer: certain types of head and neck cancer, esophageal squamous cell carcinoma, and breast, colorectal, liver, and stomach cancers.

Financial toxicity remains prevalent as well.

The report explains that financial hardship following a cancer diagnosis is widespread, and the effects can last for years. In fact, more than 40% of patients can spend their entire life savings within the first 2 years of cancer treatment. Among adult survivors of childhood cancers, 20.7% had trouble paying their medical bills, 29.9% said they had been sent to debt collection for unpaid bills, 14.1% had forgone medical care, and 26.8% could not afford nutritious meals.

For young cancer survivors, the lifetime costs associated with a diagnosis of cancer are substantial, reaching an average of $259,324 per person.

On a global level, it is estimated that from 2020 to 2050, the cumulative economic burden of cancer will be $25.2 trillion.
 

The Path Forward

Despite these challenges, Dr. LoRusso said, “it is unquestionable that we are in a time of unparalleled opportunities in cancer research.

“I am excited about what the future holds for cancer research, and especially for patient care,” she said. 

However, funding commitments are needed to avoid impeding this momentum and losing a “talented and creative young workforce” that has brought new ideas and new technologies to the table.

Continued robust funding will help “to markedly improve cancer care, increase cancer survivorship, spur economic growth, and maintain the United States’ position as the global leader in science and medical research,” she added.

The AACR report specifically calls on Congress to:

  • Appropriate at least $51.3 billion in fiscal year 2025 for the base budget of the NIH and at least $7.934 billion for the NCI.
  • Provide $3.6 billion in dedicated funding for Cancer Moonshot activities through fiscal year 2026 in addition to other funding, consistent with the President’s fiscal year 2025 budget.
  • Appropriate at least $472.4 million in fiscal year 2025 for the CDC’s Division of Cancer Prevention to support comprehensive cancer control, central cancer registries, and screening and awareness programs for specific cancers.
  • Allocate $55 million in funding for the Oncology Center of Excellence at FDA in fiscal year 2025 to provide regulators with the staff and tools necessary to conduct expedited review of cancer-related medical products.

By working together with Congress and other stakeholders, “we will be able to accelerate the pace of progress and make major strides toward the lifesaving goal of preventing and curing all cancers at the earliest possible time,” Dr. Foti said. “I believe if we do that ... one day we will win this war on cancer.”

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

Despite the “remarkable progress” in cancer research and care, cancer remains “an ongoing public health challenge,” which requires significant attention and funding, according to the Cancer Progress Report 2024 from the American Association for Cancer Research (AACR).

The AACR’s 216-page report — an annual endeavor now in its 14th year — focused on the “tremendous” strides made in cancer care, prevention, and early detection and highlighted areas where more research and attention are warranted. 

One key area is funding. For the first time since 2016, federal funding for the National Institutes of Health (NIH) and National Cancer Institute (NCI) decreased in the past year. The cuts followed nearly a decade of funding increases that saw the NIH budget expand by nearly $15 billion, and that allowed for a “rapid pace and broad scope” of advances in cancer, AACR’s chief executive officer Margaret Foti, MD, PhD, said during a press briefing.

These recent cuts “threaten to curtail the medical progress seen in recent years and stymie future advancements,” said Dr. Foti, who called on Congress to commit to funding cancer research at significant and consistent levels to “maintain the momentum of progress against cancer.”
 

Inside the Report: Big Progress

Overall, advances in prevention, early detection, and treatment have helped catch more cancers earlier and save lives. 

According to the AACR report, the age-adjusted overall cancer death rate in the United States fell by 33% between 1991 and 2021, meaning about 4.1 million cancer deaths were averted. The overall cancer death rate for children and adolescents has declined by 24% in the past 2 decades. The 5-year relative survival rate for children diagnosed with cancer in the US has improved from 58% for those diagnosed in the mid-1970s to 85% for those diagnosed between 2013 and 2019.

The past fiscal year has seen many new approvals for cancer drugs, diagnostics, and screening tests. From July 1, 2023, to June 30, 2024, the Food and Drug Administration (FDA) approved 15 new anticancer therapeutics, as well as 15 new indications for previously approved agents, one new imaging agent, several artificial intelligence (AI) tools to improve early cancer detection and diagnosis, and two minimally invasive tests for assessing inherited cancer risk or early cancer detection, according to the report.

“Cancer diagnostics are becoming more sophisticated,” AACR president Patricia M. LoRusso, DO, PhD, said during the briefing. “New technologies, such as spatial transcriptomics, are helping us study tumors at a cellular level, and helping to unveil things that we did not initially even begin to understand or think of. AI-based approaches are beginning to transform cancer detection, diagnosis, clinical decision-making, and treatment response monitoring.” 

The report also highlights the significant progress in many childhood and adolescent/young adult cancers, Dr. LoRusso noted. These include FDA approvals for two new molecularly targeted therapeutics: tovorafenib for children with certain types of brain tumor and repotrectinib for children with a wide array of cancer types that have a specific genetic alteration known as NTRK gene fusion. It also includes an expanded approval for eflornithine to reduce the risk for relapse in children with high-risk neuroblastoma.

“Decades — decades — of basic research discoveries, have led to these clinical breakthroughs,” she stressed. “These gains against cancer are because of the rapid progress in our ability to decode the cancer genome, which has opened new and innovative avenues for drug development.”
 

 

 

The Gaps

Even with progress in cancer prevention, early detection, and treatment, cancer remains a significant issue.

“In 2024, it is estimated that more than 2 million new cases of cancer will be diagnosed in the United States. More than 611,000 people will die from the disease,” according to the report.

The 2024 report shows that incidence rates for some cancers are increasing in the United States, including vaccine-preventable cancers such as human papillomavirus (HPV)–associated oral cancers and, in young adults, cervical cancers. A recent analysis also found that overall cervical cancer incidence among women aged 30-34 years increased by 2.5% a year between 2012 and 2019.

Furthermore, despite clear evidence demonstrating that the HPV vaccine reduces cervical cancer incidence, uptake has remained poor, with only 38.6% of US children and adolescents aged 9-17 years receiving at least one dose of the vaccine in 2022.

Early-onset cancers are also increasing. Rates of breast, colorectal, and other cancers are on the rise in adults younger than 50 years, the report noted.

The report also pointed to data that 40% of all cancer cases in the United States can be attributed to preventable factors, such as smoking, excess body weight, and alcohol. However, our understanding of these risk factors has improved. Excessive levels of alcohol consumption have, for instance, been shown to increase the risk for six different types of cancer: certain types of head and neck cancer, esophageal squamous cell carcinoma, and breast, colorectal, liver, and stomach cancers.

Financial toxicity remains prevalent as well.

The report explains that financial hardship following a cancer diagnosis is widespread, and the effects can last for years. In fact, more than 40% of patients can spend their entire life savings within the first 2 years of cancer treatment. Among adult survivors of childhood cancers, 20.7% had trouble paying their medical bills, 29.9% said they had been sent to debt collection for unpaid bills, 14.1% had forgone medical care, and 26.8% could not afford nutritious meals.

For young cancer survivors, the lifetime costs associated with a diagnosis of cancer are substantial, reaching an average of $259,324 per person.

On a global level, it is estimated that from 2020 to 2050, the cumulative economic burden of cancer will be $25.2 trillion.
 

The Path Forward

Despite these challenges, Dr. LoRusso said, “it is unquestionable that we are in a time of unparalleled opportunities in cancer research.

“I am excited about what the future holds for cancer research, and especially for patient care,” she said. 

However, funding commitments are needed to avoid impeding this momentum and losing a “talented and creative young workforce” that has brought new ideas and new technologies to the table.

Continued robust funding will help “to markedly improve cancer care, increase cancer survivorship, spur economic growth, and maintain the United States’ position as the global leader in science and medical research,” she added.

The AACR report specifically calls on Congress to:

  • Appropriate at least $51.3 billion in fiscal year 2025 for the base budget of the NIH and at least $7.934 billion for the NCI.
  • Provide $3.6 billion in dedicated funding for Cancer Moonshot activities through fiscal year 2026 in addition to other funding, consistent with the President’s fiscal year 2025 budget.
  • Appropriate at least $472.4 million in fiscal year 2025 for the CDC’s Division of Cancer Prevention to support comprehensive cancer control, central cancer registries, and screening and awareness programs for specific cancers.
  • Allocate $55 million in funding for the Oncology Center of Excellence at FDA in fiscal year 2025 to provide regulators with the staff and tools necessary to conduct expedited review of cancer-related medical products.

By working together with Congress and other stakeholders, “we will be able to accelerate the pace of progress and make major strides toward the lifesaving goal of preventing and curing all cancers at the earliest possible time,” Dr. Foti said. “I believe if we do that ... one day we will win this war on cancer.”

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

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Burnout and Vacations

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How many weeks of vacation do you take each year? Does it feel like enough? What prevents you from taking more time off? Is it a contractual obligation to your employer? Or a concern about the lack of income while your are away? Is it the difficulty of finding coverage for your patient care responsibilities? How much of it is the dread of facing your unattended or poorly attended EHR box when you return?

A recent survey of more than 3000 US physicians found that almost 60% took 3 weeks or less vacation per year? The investigators also learned that 70% of the respondents did patient-related tasks while they were on vacation and less than half had full EHR coverage while they were away. Not surprisingly, providers who expressed concerns about finding someone to cover clinical responsibilities and financial concerns were less likely to take more than 3 weeks’ vacation.

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

As one might hope, taking more than 3 weeks’ vacation and having full EHR coverage were associated with decreased rates of burnout. On the other hand, spending more than 30 minutes per day doing patient-related work while on vacation was associated with higher rates of burnout.

In their conclusion, the authors suggest that if we hope to reduce physician burnout, employers should introduce system-level initiatives to ensure that physicians take adequate vacation and have adequate coverage for their clinical responsibilities — including EHR inbox management.

I will readily admit that I was one of those physicians who took less than 3 weeks of vacation and can’t recall ever taking more than 2 weeks. Since most of our vacations were staycations, I would usually round on the newborns first thing in the morning when I was in town to keep the flow of new patients coming into the practice.

I’m sure there was some collateral damage to my family, but our children continue to reassure me that they weren’t envious of their peers who went away on “real” vacations. As adults two of them take their families on the kind of vacations that make me envious. The third has married someone who shares, what I might call, a “robust commitment” to showing up in the office. But they seem to be a happy couple.

At the root of my vacation style was an egotistical delusion that there weren’t any clinicians in the community who could look after my patients as well as I did. Unfortunately, I had done little to discourage those patients who shared my distorted view.

I was lucky to have spent nearly all my career without the added burden of an EHR inbox. However, in the lead up to our infrequent vacations, the rush to tie up the loose ends of those patients for whom we had not achieved diagnostic closure was stressful and time consuming. Luckily, as a primary care pediatrician most of their problems were short lived. But, leaving the ship battened down could be exhausting.

I can fully understand why the physicians who are taking less than 3 weeks’ vacation and continue to be burdened by patient-related tasks while they are “away” are more likely to experience burnout. However, I wonder why I seemed to have been resistant considering my vacation style, which the authors of the above-mentioned article feel would have placed me at high risk.

I think the answer may lie in my commitment to making decisions that allowed me to maintain equilibrium in my life. In other words, if there were things in my day-to-day activities that were so taxing or distasteful that I am counting the hours and days until I can escape them, then I needed to make the necessary changes promptly and not count on a vacation to repair the accumulating damage. That may have required cutting back some responsibilities or it may have meant that I needed to be in better mental and physical shape to be able to maintain that equilibrium. Maybe it was more sleep, more exercise, less television, not investing as much in time-wasting meetings. This doesn’t mean that I didn’t have bad days. Stuff happens. But if I was putting together two or three bad days a week, something had to change. A vacation wasn’t going solve the inherent or systemic problems that are making day-to-day life so intolerable that I needed to escape for some respite.

In full disclosure, I will share that at age 55 I took a leave of 2 1/2 months and with my wife and another couple bicycled across America. This was a goal I had harbored since childhood and in anticipation over several decades had banked considerable coverage equity by doing extra coverage for other providers to minimize my guilt feelings at being away. This was not an escape from I job I didn’t enjoy going to everyday. It was an exercise in goal fulfillment.

I think the authors of this recent study should be applauded for providing some numbers to support the obvious. However, if we are looking for ways to minimize physician burnout, we should be giving more attention to the factors in clinical practice that are making it so intolerable. More vacation time is just one strategy.

Encouraging a clinician to take a bit more vacation may help. But, having someone to properly manage the EHR inbox would do a lot more. If your coverage is telling everyone to “Wait until Dr. Away has returned” it is only going to make things worse.

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 [email protected].

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How many weeks of vacation do you take each year? Does it feel like enough? What prevents you from taking more time off? Is it a contractual obligation to your employer? Or a concern about the lack of income while your are away? Is it the difficulty of finding coverage for your patient care responsibilities? How much of it is the dread of facing your unattended or poorly attended EHR box when you return?

A recent survey of more than 3000 US physicians found that almost 60% took 3 weeks or less vacation per year? The investigators also learned that 70% of the respondents did patient-related tasks while they were on vacation and less than half had full EHR coverage while they were away. Not surprisingly, providers who expressed concerns about finding someone to cover clinical responsibilities and financial concerns were less likely to take more than 3 weeks’ vacation.

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

As one might hope, taking more than 3 weeks’ vacation and having full EHR coverage were associated with decreased rates of burnout. On the other hand, spending more than 30 minutes per day doing patient-related work while on vacation was associated with higher rates of burnout.

In their conclusion, the authors suggest that if we hope to reduce physician burnout, employers should introduce system-level initiatives to ensure that physicians take adequate vacation and have adequate coverage for their clinical responsibilities — including EHR inbox management.

I will readily admit that I was one of those physicians who took less than 3 weeks of vacation and can’t recall ever taking more than 2 weeks. Since most of our vacations were staycations, I would usually round on the newborns first thing in the morning when I was in town to keep the flow of new patients coming into the practice.

I’m sure there was some collateral damage to my family, but our children continue to reassure me that they weren’t envious of their peers who went away on “real” vacations. As adults two of them take their families on the kind of vacations that make me envious. The third has married someone who shares, what I might call, a “robust commitment” to showing up in the office. But they seem to be a happy couple.

At the root of my vacation style was an egotistical delusion that there weren’t any clinicians in the community who could look after my patients as well as I did. Unfortunately, I had done little to discourage those patients who shared my distorted view.

I was lucky to have spent nearly all my career without the added burden of an EHR inbox. However, in the lead up to our infrequent vacations, the rush to tie up the loose ends of those patients for whom we had not achieved diagnostic closure was stressful and time consuming. Luckily, as a primary care pediatrician most of their problems were short lived. But, leaving the ship battened down could be exhausting.

I can fully understand why the physicians who are taking less than 3 weeks’ vacation and continue to be burdened by patient-related tasks while they are “away” are more likely to experience burnout. However, I wonder why I seemed to have been resistant considering my vacation style, which the authors of the above-mentioned article feel would have placed me at high risk.

I think the answer may lie in my commitment to making decisions that allowed me to maintain equilibrium in my life. In other words, if there were things in my day-to-day activities that were so taxing or distasteful that I am counting the hours and days until I can escape them, then I needed to make the necessary changes promptly and not count on a vacation to repair the accumulating damage. That may have required cutting back some responsibilities or it may have meant that I needed to be in better mental and physical shape to be able to maintain that equilibrium. Maybe it was more sleep, more exercise, less television, not investing as much in time-wasting meetings. This doesn’t mean that I didn’t have bad days. Stuff happens. But if I was putting together two or three bad days a week, something had to change. A vacation wasn’t going solve the inherent or systemic problems that are making day-to-day life so intolerable that I needed to escape for some respite.

In full disclosure, I will share that at age 55 I took a leave of 2 1/2 months and with my wife and another couple bicycled across America. This was a goal I had harbored since childhood and in anticipation over several decades had banked considerable coverage equity by doing extra coverage for other providers to minimize my guilt feelings at being away. This was not an escape from I job I didn’t enjoy going to everyday. It was an exercise in goal fulfillment.

I think the authors of this recent study should be applauded for providing some numbers to support the obvious. However, if we are looking for ways to minimize physician burnout, we should be giving more attention to the factors in clinical practice that are making it so intolerable. More vacation time is just one strategy.

Encouraging a clinician to take a bit more vacation may help. But, having someone to properly manage the EHR inbox would do a lot more. If your coverage is telling everyone to “Wait until Dr. Away has returned” it is only going to make things worse.

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 [email protected].

How many weeks of vacation do you take each year? Does it feel like enough? What prevents you from taking more time off? Is it a contractual obligation to your employer? Or a concern about the lack of income while your are away? Is it the difficulty of finding coverage for your patient care responsibilities? How much of it is the dread of facing your unattended or poorly attended EHR box when you return?

A recent survey of more than 3000 US physicians found that almost 60% took 3 weeks or less vacation per year? The investigators also learned that 70% of the respondents did patient-related tasks while they were on vacation and less than half had full EHR coverage while they were away. Not surprisingly, providers who expressed concerns about finding someone to cover clinical responsibilities and financial concerns were less likely to take more than 3 weeks’ vacation.

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

As one might hope, taking more than 3 weeks’ vacation and having full EHR coverage were associated with decreased rates of burnout. On the other hand, spending more than 30 minutes per day doing patient-related work while on vacation was associated with higher rates of burnout.

In their conclusion, the authors suggest that if we hope to reduce physician burnout, employers should introduce system-level initiatives to ensure that physicians take adequate vacation and have adequate coverage for their clinical responsibilities — including EHR inbox management.

I will readily admit that I was one of those physicians who took less than 3 weeks of vacation and can’t recall ever taking more than 2 weeks. Since most of our vacations were staycations, I would usually round on the newborns first thing in the morning when I was in town to keep the flow of new patients coming into the practice.

I’m sure there was some collateral damage to my family, but our children continue to reassure me that they weren’t envious of their peers who went away on “real” vacations. As adults two of them take their families on the kind of vacations that make me envious. The third has married someone who shares, what I might call, a “robust commitment” to showing up in the office. But they seem to be a happy couple.

At the root of my vacation style was an egotistical delusion that there weren’t any clinicians in the community who could look after my patients as well as I did. Unfortunately, I had done little to discourage those patients who shared my distorted view.

I was lucky to have spent nearly all my career without the added burden of an EHR inbox. However, in the lead up to our infrequent vacations, the rush to tie up the loose ends of those patients for whom we had not achieved diagnostic closure was stressful and time consuming. Luckily, as a primary care pediatrician most of their problems were short lived. But, leaving the ship battened down could be exhausting.

I can fully understand why the physicians who are taking less than 3 weeks’ vacation and continue to be burdened by patient-related tasks while they are “away” are more likely to experience burnout. However, I wonder why I seemed to have been resistant considering my vacation style, which the authors of the above-mentioned article feel would have placed me at high risk.

I think the answer may lie in my commitment to making decisions that allowed me to maintain equilibrium in my life. In other words, if there were things in my day-to-day activities that were so taxing or distasteful that I am counting the hours and days until I can escape them, then I needed to make the necessary changes promptly and not count on a vacation to repair the accumulating damage. That may have required cutting back some responsibilities or it may have meant that I needed to be in better mental and physical shape to be able to maintain that equilibrium. Maybe it was more sleep, more exercise, less television, not investing as much in time-wasting meetings. This doesn’t mean that I didn’t have bad days. Stuff happens. But if I was putting together two or three bad days a week, something had to change. A vacation wasn’t going solve the inherent or systemic problems that are making day-to-day life so intolerable that I needed to escape for some respite.

In full disclosure, I will share that at age 55 I took a leave of 2 1/2 months and with my wife and another couple bicycled across America. This was a goal I had harbored since childhood and in anticipation over several decades had banked considerable coverage equity by doing extra coverage for other providers to minimize my guilt feelings at being away. This was not an escape from I job I didn’t enjoy going to everyday. It was an exercise in goal fulfillment.

I think the authors of this recent study should be applauded for providing some numbers to support the obvious. However, if we are looking for ways to minimize physician burnout, we should be giving more attention to the factors in clinical practice that are making it so intolerable. More vacation time is just one strategy.

Encouraging a clinician to take a bit more vacation may help. But, having someone to properly manage the EHR inbox would do a lot more. If your coverage is telling everyone to “Wait until Dr. Away has returned” it is only going to make things worse.

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 [email protected].

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Phase3 Data: Atopic Dermatitis Symptoms Improved with Topical Roflumilast

Article Type
Changed
Thu, 09/26/2024 - 10:36

 

TOPLINE:

Roflumilast cream 0.15% was well tolerated and significantly improved symptoms in adults and children with mild to moderate atopic dermatitis (AD) in two phase 3 trials.

METHODOLOGY:

  • Two randomized, parallel-group, double-blind, vehicle-controlled phase 3 trials, INTEGUMENT-1 (n = 654) and INTEGUMENT-2 (n = 683), enrolled patients aged ≥ 6 years with mild to moderate AD who were randomly assigned in a 2:1 ratio to roflumilast cream 0.15%, a phosphodiesterase 4 inhibitor, or vehicle cream once daily for 4 weeks.
  • The primary efficacy endpoint was the Validated Investigator Global Assessment for AD (vIGA-AD) success at week 4, defined as a score of 0 (clear) or 1 (almost clear) plus improvement of at least two grades from baseline.
  • Secondary endpoints included vIGA-AD success at week 4 in patients with a baseline score of 3, at least a four-point reduction in the Worst Itch Numeric Rating Scale (WI-NRS), and at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at weeks 1, 2, and 4.

TAKEAWAY:

  • Significantly more patients receiving roflumilast achieved vIGA-AD success at week 4 vs those in the vehicle group in INTEGUMENT-1 (32.0% vs 15.2%; P < .001) and INTEGUMENT-2 (28.9% vs 12.0%; P < .001), which was consistent across all age groups and in those with a baseline score of 3.
  • Similarly, a greater proportion of patients treated with roflumilast vs vehicle achieved at least a four-point reduction in WI-NRS at weeks 1, 2, and 4, with improvements noted as early as 24 hours after the first application (P < .05 at all subsequent timepoints).
  • The number of patients achieving EASI-75 and vIGA-AD scores of 0 or 1 was significantly higher with roflumilast than with vehicle at weeks 1, 2, and 4.
  • Most treatment-emergent adverse events (TEAEs) were mild to moderate, with only 0.9% of the patients experiencing serious TEAEs in each trial. More than 95% of the patients showed no signs of irritation, and over 90% reported no or mild sensation at the application site.

IN PRACTICE:

The two phase 3 randomized clinical trials of patients with AD treated with roflumilast cream 0.15% “demonstrated improvement across multiple efficacy endpoints, including reducing pruritus within 24 hours after application, with favorable safety and tolerability,” the authors wrote. “Additional research, including subgroup analyses, will provide more data regarding the efficacy and safety of roflumilast cream 0.15%, in patients with AD,” they added.

SOURCE:

The study was led by Eric L. Simpson, MD, of the Department of Dermatology, Oregon Health & Science University, Portland, Oregon, and was published online on September 18 in JAMA Dermatology.

LIMITATIONS:

A short duration, a minimum age limit of 6 years, and the lack of an active comparator may influence the interpretation and generalizability of the results.

DISCLOSURES:

The study was sponsored by Arcutis Biotherapeutics. Simpson received grants and personal fees from Arcutis during this study. Three authors reported being employees and/or stockholders of Arcutis, two other authors reported patents for Arcutis, and several authors declared having various ties with various sources, including Arcutis.

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:

Roflumilast cream 0.15% was well tolerated and significantly improved symptoms in adults and children with mild to moderate atopic dermatitis (AD) in two phase 3 trials.

METHODOLOGY:

  • Two randomized, parallel-group, double-blind, vehicle-controlled phase 3 trials, INTEGUMENT-1 (n = 654) and INTEGUMENT-2 (n = 683), enrolled patients aged ≥ 6 years with mild to moderate AD who were randomly assigned in a 2:1 ratio to roflumilast cream 0.15%, a phosphodiesterase 4 inhibitor, or vehicle cream once daily for 4 weeks.
  • The primary efficacy endpoint was the Validated Investigator Global Assessment for AD (vIGA-AD) success at week 4, defined as a score of 0 (clear) or 1 (almost clear) plus improvement of at least two grades from baseline.
  • Secondary endpoints included vIGA-AD success at week 4 in patients with a baseline score of 3, at least a four-point reduction in the Worst Itch Numeric Rating Scale (WI-NRS), and at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at weeks 1, 2, and 4.

TAKEAWAY:

  • Significantly more patients receiving roflumilast achieved vIGA-AD success at week 4 vs those in the vehicle group in INTEGUMENT-1 (32.0% vs 15.2%; P < .001) and INTEGUMENT-2 (28.9% vs 12.0%; P < .001), which was consistent across all age groups and in those with a baseline score of 3.
  • Similarly, a greater proportion of patients treated with roflumilast vs vehicle achieved at least a four-point reduction in WI-NRS at weeks 1, 2, and 4, with improvements noted as early as 24 hours after the first application (P < .05 at all subsequent timepoints).
  • The number of patients achieving EASI-75 and vIGA-AD scores of 0 or 1 was significantly higher with roflumilast than with vehicle at weeks 1, 2, and 4.
  • Most treatment-emergent adverse events (TEAEs) were mild to moderate, with only 0.9% of the patients experiencing serious TEAEs in each trial. More than 95% of the patients showed no signs of irritation, and over 90% reported no or mild sensation at the application site.

IN PRACTICE:

The two phase 3 randomized clinical trials of patients with AD treated with roflumilast cream 0.15% “demonstrated improvement across multiple efficacy endpoints, including reducing pruritus within 24 hours after application, with favorable safety and tolerability,” the authors wrote. “Additional research, including subgroup analyses, will provide more data regarding the efficacy and safety of roflumilast cream 0.15%, in patients with AD,” they added.

SOURCE:

The study was led by Eric L. Simpson, MD, of the Department of Dermatology, Oregon Health & Science University, Portland, Oregon, and was published online on September 18 in JAMA Dermatology.

LIMITATIONS:

A short duration, a minimum age limit of 6 years, and the lack of an active comparator may influence the interpretation and generalizability of the results.

DISCLOSURES:

The study was sponsored by Arcutis Biotherapeutics. Simpson received grants and personal fees from Arcutis during this study. Three authors reported being employees and/or stockholders of Arcutis, two other authors reported patents for Arcutis, and several authors declared having various ties with various sources, including Arcutis.

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:

Roflumilast cream 0.15% was well tolerated and significantly improved symptoms in adults and children with mild to moderate atopic dermatitis (AD) in two phase 3 trials.

METHODOLOGY:

  • Two randomized, parallel-group, double-blind, vehicle-controlled phase 3 trials, INTEGUMENT-1 (n = 654) and INTEGUMENT-2 (n = 683), enrolled patients aged ≥ 6 years with mild to moderate AD who were randomly assigned in a 2:1 ratio to roflumilast cream 0.15%, a phosphodiesterase 4 inhibitor, or vehicle cream once daily for 4 weeks.
  • The primary efficacy endpoint was the Validated Investigator Global Assessment for AD (vIGA-AD) success at week 4, defined as a score of 0 (clear) or 1 (almost clear) plus improvement of at least two grades from baseline.
  • Secondary endpoints included vIGA-AD success at week 4 in patients with a baseline score of 3, at least a four-point reduction in the Worst Itch Numeric Rating Scale (WI-NRS), and at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at weeks 1, 2, and 4.

TAKEAWAY:

  • Significantly more patients receiving roflumilast achieved vIGA-AD success at week 4 vs those in the vehicle group in INTEGUMENT-1 (32.0% vs 15.2%; P < .001) and INTEGUMENT-2 (28.9% vs 12.0%; P < .001), which was consistent across all age groups and in those with a baseline score of 3.
  • Similarly, a greater proportion of patients treated with roflumilast vs vehicle achieved at least a four-point reduction in WI-NRS at weeks 1, 2, and 4, with improvements noted as early as 24 hours after the first application (P < .05 at all subsequent timepoints).
  • The number of patients achieving EASI-75 and vIGA-AD scores of 0 or 1 was significantly higher with roflumilast than with vehicle at weeks 1, 2, and 4.
  • Most treatment-emergent adverse events (TEAEs) were mild to moderate, with only 0.9% of the patients experiencing serious TEAEs in each trial. More than 95% of the patients showed no signs of irritation, and over 90% reported no or mild sensation at the application site.

IN PRACTICE:

The two phase 3 randomized clinical trials of patients with AD treated with roflumilast cream 0.15% “demonstrated improvement across multiple efficacy endpoints, including reducing pruritus within 24 hours after application, with favorable safety and tolerability,” the authors wrote. “Additional research, including subgroup analyses, will provide more data regarding the efficacy and safety of roflumilast cream 0.15%, in patients with AD,” they added.

SOURCE:

The study was led by Eric L. Simpson, MD, of the Department of Dermatology, Oregon Health & Science University, Portland, Oregon, and was published online on September 18 in JAMA Dermatology.

LIMITATIONS:

A short duration, a minimum age limit of 6 years, and the lack of an active comparator may influence the interpretation and generalizability of the results.

DISCLOSURES:

The study was sponsored by Arcutis Biotherapeutics. Simpson received grants and personal fees from Arcutis during this study. Three authors reported being employees and/or stockholders of Arcutis, two other authors reported patents for Arcutis, and several authors declared having various ties with various sources, including Arcutis.

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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Considering Eating Disorder Potential When Prescribing Weight Loss Drugs to Teens

Article Type
Changed
Wed, 09/25/2024 - 12:04

As a psychiatrist specializing in eating disorders, Kim Dennis, MD, has seen firsthand the complex relationship between obesity treatment and mental health in adolescents.

Now, with the rising popularity of medications like Ozempic for weight loss, she fears she will care for more teens with eating disorders who are seeking glucagon-like peptide 1 (GLP-1) agonists or who have developed a disorder while taking them.

“We haven’t seen patients yet, but I’m sure they are on their way,” said Dr. Dennis, a clinical assistant professor in the Department of Psychiatry at the University of Illinois College of Medicine in Chicago. She is also the cofounder and chief medical officer of SunCloud Health, an outpatient eating disorder treatment center in Illinois.

Dr. Dennis’ concerns reflect a growing unease among eating disorder specialists as obesity medications gain traction for adolescent use. A recent study published in JAMA Pediatrics showed nearly 80% of teens in treatment for obesity reported symptoms of disordered eating at the outset of an intervention. These included signs of binge eating and loss of control.

The randomized clinical trial, conducted from 2018 to 2023, examined 141 adolescents with obesity undergoing interventions like low-energy diets or intermittent energy restriction. Almost half scored as having risk for an undiagnosed eating disorder, as defined by the Eating Disorder Examination Questionnaire (EDE-Q).

At the end of the intervention, many teens continued to have symptoms of disordered eating, while a smaller group was newly scored as having a risk for an eating disorder.
 

Weight Loss and Eating Disorders: A Balancing Act

The findings illuminate a significant challenge for pediatricians and primary care clinicians: Balancing effective weight management with the risk of exacerbating or triggering eating disorders, said Hiba Jebeile, PhD, a research dietitian at The Children’s Hospital at Westmead in Australia, and the study’s lead author. Adding weight loss medication on top of the equation can further complicate care.

“It is helpful for obesity and eating disorder services to work together, with clear referral pathways, to manage these adolescents,” Dr. Jebeile said.

The US Food and Drug Administration approved semaglutide for weight loss in adolescents aged 12-17 years in December 2020. One study found that the number of adolescents prescribed GLP-1 receptor agonists (GLP-1 RAs) for type 2 diabetes and weight management rose from 8722 to 60,567 between 2020 and 2023 — a nearly sevenfold increase.

“The number of adolescents taking these medications is going up because they work,” said Suzanne Cuda, MD, medical director of Alamo City Healthy Kids and Families, a medical weight management clinic in San Antonio. The medications have been shown to treat type 2 diabetes, lower blood pressure, and reduce the risk for cardiovascular diseases.

“The younger you are, the better the outcome,” Dr. Cuda said.

How GLP-1 agonists may affect adolescents in the long run is not yet clear. Existing studies on GLP-1 medications in patients with eating disorders have shown mixed results. Some studies indicate that the drugs decrease binge episodes for those with binge eating disorder or bulimia nervosa. However, these studies had small sample sizes and measured only short-term effects, leaving long-term outcomes and risks unknown.

Traditional treatments for eating disorders emphasize regular eating patterns, body acceptance, addressing weight stigma, and improving attunement to hunger and fullness cues — approaches that may conflict with the effects of GLP-1 agonists. These drugs suppress appetite, alter metabolic signals, and may unintentionally reinforce weight loss as a primary goal, creating a potential disconnect between the aims of recovery from eating disorders and the biologic effects of the medication, experts said.

Dr. Cuda said she has cared for adolescents with diagnosed eating disorders in her practice who are seeking GLP-1 agonists. She said she first works with patients to treat the underlying disorder before prescribing medication.

“One of the concerns is the extreme reductions in calories that could be induced by GLP-1 RA in children and adolescents,” she said. Unlike adults, adolescents use caloric energy not just for physical activity but also for growing and developing, she said.

“They can’t catch up on that growth and development,” she added.
 

 

 

Advice for Screening and Monitoring

The National Eating Disorders Association raised concerns about the potential misuse of these medications and their potential to exacerbate eating disorder behaviors in people who are already at a higher risk of developing one of the conditions, including those with existing mental health disorders, stress, who have already dieted, and who have experienced weight-centric bullying.

Clinicians should be on the lookout for patients seeking GLP-1s who present with symptoms of an eating disorder that may be less apparent, such as picky eating, insomnia or difficulty sleeping, or, for girls, irregular menstrual periods, Dr. Dennis said. These patients may be more likely to go undiagnosed or misdiagnosed. Research also suggests that people of color are less likely to be diagnosed or receive specialty care for eating disorders.

Discussions between patients and clinicians about obesity treatment prior to prescribing provide a crucial opportunity to screen and monitor for disordered eating, which Dr. Dennis said does not universally occur currently.

Dr. Dennis recommended initial assessments using validated screening tools like the EDE-Q and the Center for Epidemiologic Studies Depression Scale Revised, 10-Item Version.

Ongoing monitoring throughout treatment is essential, with initial monthly check-ins that include dietary counseling to detect subtle changes in eating behaviors or attitudes toward food and body image, Dr. Cuda said.

The Obesity Medicine Association (OMA) has stressed the importance of a collaborative approach involving connections with mental health professionals specializing in eating disorders and dietitians.

“If you have a chance to send them to an obesity medicine specialist, you should do that,” said Dr. Cuda, who coauthored the OMA statement. “It’s impractical to expect a primary care physician to do everything: Screen for dietary disorders, do a full dietary counseling, follow up on their activity.”

For patients showing signs of disordered eating, clinicians should avoid recommending restrictive dietary approaches, like cutting out food groups such as carbohydrates or a restricted calorie goal. Instead, they can suggest focusing on healthier lifestyle habits and referring to a psychotherapist, the experts said. Clinicians also should be prepared to adjust or pause GLP-1 agonists if disordered eating disorder symptoms worsen.

“I think a weight-agnostic approach where the focus of care is not weight loss but increase in health protective behaviors and nutritional intake is safest for all kids, especially those with eating disorders or eating disorder risk factors,” Dr. Dennis said.

Various authors of the eating disorder study reported receiving grants, advisory board fees, and speaker fees from entities including the National Health and Medical Research Council of Australia, Eli Lilly, Novo Nordisk, Nu-Mega Ingredients, and the National Institutes of Health, among others.
 

A version of this article appeared on Medscape.com.

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As a psychiatrist specializing in eating disorders, Kim Dennis, MD, has seen firsthand the complex relationship between obesity treatment and mental health in adolescents.

Now, with the rising popularity of medications like Ozempic for weight loss, she fears she will care for more teens with eating disorders who are seeking glucagon-like peptide 1 (GLP-1) agonists or who have developed a disorder while taking them.

“We haven’t seen patients yet, but I’m sure they are on their way,” said Dr. Dennis, a clinical assistant professor in the Department of Psychiatry at the University of Illinois College of Medicine in Chicago. She is also the cofounder and chief medical officer of SunCloud Health, an outpatient eating disorder treatment center in Illinois.

Dr. Dennis’ concerns reflect a growing unease among eating disorder specialists as obesity medications gain traction for adolescent use. A recent study published in JAMA Pediatrics showed nearly 80% of teens in treatment for obesity reported symptoms of disordered eating at the outset of an intervention. These included signs of binge eating and loss of control.

The randomized clinical trial, conducted from 2018 to 2023, examined 141 adolescents with obesity undergoing interventions like low-energy diets or intermittent energy restriction. Almost half scored as having risk for an undiagnosed eating disorder, as defined by the Eating Disorder Examination Questionnaire (EDE-Q).

At the end of the intervention, many teens continued to have symptoms of disordered eating, while a smaller group was newly scored as having a risk for an eating disorder.
 

Weight Loss and Eating Disorders: A Balancing Act

The findings illuminate a significant challenge for pediatricians and primary care clinicians: Balancing effective weight management with the risk of exacerbating or triggering eating disorders, said Hiba Jebeile, PhD, a research dietitian at The Children’s Hospital at Westmead in Australia, and the study’s lead author. Adding weight loss medication on top of the equation can further complicate care.

“It is helpful for obesity and eating disorder services to work together, with clear referral pathways, to manage these adolescents,” Dr. Jebeile said.

The US Food and Drug Administration approved semaglutide for weight loss in adolescents aged 12-17 years in December 2020. One study found that the number of adolescents prescribed GLP-1 receptor agonists (GLP-1 RAs) for type 2 diabetes and weight management rose from 8722 to 60,567 between 2020 and 2023 — a nearly sevenfold increase.

“The number of adolescents taking these medications is going up because they work,” said Suzanne Cuda, MD, medical director of Alamo City Healthy Kids and Families, a medical weight management clinic in San Antonio. The medications have been shown to treat type 2 diabetes, lower blood pressure, and reduce the risk for cardiovascular diseases.

“The younger you are, the better the outcome,” Dr. Cuda said.

How GLP-1 agonists may affect adolescents in the long run is not yet clear. Existing studies on GLP-1 medications in patients with eating disorders have shown mixed results. Some studies indicate that the drugs decrease binge episodes for those with binge eating disorder or bulimia nervosa. However, these studies had small sample sizes and measured only short-term effects, leaving long-term outcomes and risks unknown.

Traditional treatments for eating disorders emphasize regular eating patterns, body acceptance, addressing weight stigma, and improving attunement to hunger and fullness cues — approaches that may conflict with the effects of GLP-1 agonists. These drugs suppress appetite, alter metabolic signals, and may unintentionally reinforce weight loss as a primary goal, creating a potential disconnect between the aims of recovery from eating disorders and the biologic effects of the medication, experts said.

Dr. Cuda said she has cared for adolescents with diagnosed eating disorders in her practice who are seeking GLP-1 agonists. She said she first works with patients to treat the underlying disorder before prescribing medication.

“One of the concerns is the extreme reductions in calories that could be induced by GLP-1 RA in children and adolescents,” she said. Unlike adults, adolescents use caloric energy not just for physical activity but also for growing and developing, she said.

“They can’t catch up on that growth and development,” she added.
 

 

 

Advice for Screening and Monitoring

The National Eating Disorders Association raised concerns about the potential misuse of these medications and their potential to exacerbate eating disorder behaviors in people who are already at a higher risk of developing one of the conditions, including those with existing mental health disorders, stress, who have already dieted, and who have experienced weight-centric bullying.

Clinicians should be on the lookout for patients seeking GLP-1s who present with symptoms of an eating disorder that may be less apparent, such as picky eating, insomnia or difficulty sleeping, or, for girls, irregular menstrual periods, Dr. Dennis said. These patients may be more likely to go undiagnosed or misdiagnosed. Research also suggests that people of color are less likely to be diagnosed or receive specialty care for eating disorders.

Discussions between patients and clinicians about obesity treatment prior to prescribing provide a crucial opportunity to screen and monitor for disordered eating, which Dr. Dennis said does not universally occur currently.

Dr. Dennis recommended initial assessments using validated screening tools like the EDE-Q and the Center for Epidemiologic Studies Depression Scale Revised, 10-Item Version.

Ongoing monitoring throughout treatment is essential, with initial monthly check-ins that include dietary counseling to detect subtle changes in eating behaviors or attitudes toward food and body image, Dr. Cuda said.

The Obesity Medicine Association (OMA) has stressed the importance of a collaborative approach involving connections with mental health professionals specializing in eating disorders and dietitians.

“If you have a chance to send them to an obesity medicine specialist, you should do that,” said Dr. Cuda, who coauthored the OMA statement. “It’s impractical to expect a primary care physician to do everything: Screen for dietary disorders, do a full dietary counseling, follow up on their activity.”

For patients showing signs of disordered eating, clinicians should avoid recommending restrictive dietary approaches, like cutting out food groups such as carbohydrates or a restricted calorie goal. Instead, they can suggest focusing on healthier lifestyle habits and referring to a psychotherapist, the experts said. Clinicians also should be prepared to adjust or pause GLP-1 agonists if disordered eating disorder symptoms worsen.

“I think a weight-agnostic approach where the focus of care is not weight loss but increase in health protective behaviors and nutritional intake is safest for all kids, especially those with eating disorders or eating disorder risk factors,” Dr. Dennis said.

Various authors of the eating disorder study reported receiving grants, advisory board fees, and speaker fees from entities including the National Health and Medical Research Council of Australia, Eli Lilly, Novo Nordisk, Nu-Mega Ingredients, and the National Institutes of Health, among others.
 

A version of this article appeared on Medscape.com.

As a psychiatrist specializing in eating disorders, Kim Dennis, MD, has seen firsthand the complex relationship between obesity treatment and mental health in adolescents.

Now, with the rising popularity of medications like Ozempic for weight loss, she fears she will care for more teens with eating disorders who are seeking glucagon-like peptide 1 (GLP-1) agonists or who have developed a disorder while taking them.

“We haven’t seen patients yet, but I’m sure they are on their way,” said Dr. Dennis, a clinical assistant professor in the Department of Psychiatry at the University of Illinois College of Medicine in Chicago. She is also the cofounder and chief medical officer of SunCloud Health, an outpatient eating disorder treatment center in Illinois.

Dr. Dennis’ concerns reflect a growing unease among eating disorder specialists as obesity medications gain traction for adolescent use. A recent study published in JAMA Pediatrics showed nearly 80% of teens in treatment for obesity reported symptoms of disordered eating at the outset of an intervention. These included signs of binge eating and loss of control.

The randomized clinical trial, conducted from 2018 to 2023, examined 141 adolescents with obesity undergoing interventions like low-energy diets or intermittent energy restriction. Almost half scored as having risk for an undiagnosed eating disorder, as defined by the Eating Disorder Examination Questionnaire (EDE-Q).

At the end of the intervention, many teens continued to have symptoms of disordered eating, while a smaller group was newly scored as having a risk for an eating disorder.
 

Weight Loss and Eating Disorders: A Balancing Act

The findings illuminate a significant challenge for pediatricians and primary care clinicians: Balancing effective weight management with the risk of exacerbating or triggering eating disorders, said Hiba Jebeile, PhD, a research dietitian at The Children’s Hospital at Westmead in Australia, and the study’s lead author. Adding weight loss medication on top of the equation can further complicate care.

“It is helpful for obesity and eating disorder services to work together, with clear referral pathways, to manage these adolescents,” Dr. Jebeile said.

The US Food and Drug Administration approved semaglutide for weight loss in adolescents aged 12-17 years in December 2020. One study found that the number of adolescents prescribed GLP-1 receptor agonists (GLP-1 RAs) for type 2 diabetes and weight management rose from 8722 to 60,567 between 2020 and 2023 — a nearly sevenfold increase.

“The number of adolescents taking these medications is going up because they work,” said Suzanne Cuda, MD, medical director of Alamo City Healthy Kids and Families, a medical weight management clinic in San Antonio. The medications have been shown to treat type 2 diabetes, lower blood pressure, and reduce the risk for cardiovascular diseases.

“The younger you are, the better the outcome,” Dr. Cuda said.

How GLP-1 agonists may affect adolescents in the long run is not yet clear. Existing studies on GLP-1 medications in patients with eating disorders have shown mixed results. Some studies indicate that the drugs decrease binge episodes for those with binge eating disorder or bulimia nervosa. However, these studies had small sample sizes and measured only short-term effects, leaving long-term outcomes and risks unknown.

Traditional treatments for eating disorders emphasize regular eating patterns, body acceptance, addressing weight stigma, and improving attunement to hunger and fullness cues — approaches that may conflict with the effects of GLP-1 agonists. These drugs suppress appetite, alter metabolic signals, and may unintentionally reinforce weight loss as a primary goal, creating a potential disconnect between the aims of recovery from eating disorders and the biologic effects of the medication, experts said.

Dr. Cuda said she has cared for adolescents with diagnosed eating disorders in her practice who are seeking GLP-1 agonists. She said she first works with patients to treat the underlying disorder before prescribing medication.

“One of the concerns is the extreme reductions in calories that could be induced by GLP-1 RA in children and adolescents,” she said. Unlike adults, adolescents use caloric energy not just for physical activity but also for growing and developing, she said.

“They can’t catch up on that growth and development,” she added.
 

 

 

Advice for Screening and Monitoring

The National Eating Disorders Association raised concerns about the potential misuse of these medications and their potential to exacerbate eating disorder behaviors in people who are already at a higher risk of developing one of the conditions, including those with existing mental health disorders, stress, who have already dieted, and who have experienced weight-centric bullying.

Clinicians should be on the lookout for patients seeking GLP-1s who present with symptoms of an eating disorder that may be less apparent, such as picky eating, insomnia or difficulty sleeping, or, for girls, irregular menstrual periods, Dr. Dennis said. These patients may be more likely to go undiagnosed or misdiagnosed. Research also suggests that people of color are less likely to be diagnosed or receive specialty care for eating disorders.

Discussions between patients and clinicians about obesity treatment prior to prescribing provide a crucial opportunity to screen and monitor for disordered eating, which Dr. Dennis said does not universally occur currently.

Dr. Dennis recommended initial assessments using validated screening tools like the EDE-Q and the Center for Epidemiologic Studies Depression Scale Revised, 10-Item Version.

Ongoing monitoring throughout treatment is essential, with initial monthly check-ins that include dietary counseling to detect subtle changes in eating behaviors or attitudes toward food and body image, Dr. Cuda said.

The Obesity Medicine Association (OMA) has stressed the importance of a collaborative approach involving connections with mental health professionals specializing in eating disorders and dietitians.

“If you have a chance to send them to an obesity medicine specialist, you should do that,” said Dr. Cuda, who coauthored the OMA statement. “It’s impractical to expect a primary care physician to do everything: Screen for dietary disorders, do a full dietary counseling, follow up on their activity.”

For patients showing signs of disordered eating, clinicians should avoid recommending restrictive dietary approaches, like cutting out food groups such as carbohydrates or a restricted calorie goal. Instead, they can suggest focusing on healthier lifestyle habits and referring to a psychotherapist, the experts said. Clinicians also should be prepared to adjust or pause GLP-1 agonists if disordered eating disorder symptoms worsen.

“I think a weight-agnostic approach where the focus of care is not weight loss but increase in health protective behaviors and nutritional intake is safest for all kids, especially those with eating disorders or eating disorder risk factors,” Dr. Dennis said.

Various authors of the eating disorder study reported receiving grants, advisory board fees, and speaker fees from entities including the National Health and Medical Research Council of Australia, Eli Lilly, Novo Nordisk, Nu-Mega Ingredients, and the National Institutes of Health, among others.
 

A version of this article appeared on Medscape.com.

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Biomarkers in Cord Blood May Predict AD Onset in Newborns, Study Suggests

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TOPLINE:

Newborns who go on to develop atopic dermatitis (AD) show higher transepidermal water loss (TEWL) and cord blood serum levels of CCL17/thymus- and activation-regulated chemokine (TARC) and interleukin (IL) 31.

METHODOLOGY:

  • Researchers conducted a prospective study to evaluate the predictive role of serologic biomarkers and cutaneous markers and the development of AD in 40 full-term newborns from a university hospital in Italy.
  • Cord blood was collected at birth and analyzed for serum biomarkers such as CCL17/TARC and IL-31.
  • TEWL and skin hydration rates were measured at 1, 6, and 12 months, and dermatological features such as dryness, cradle cap, and eczematous lesions were also monitored during visits.

TAKEAWAY:

  • At 6 months, 16 infants had symptoms of AD, which included dry skin, pruritus, and keratosis pilaris, which persisted at 12 months. Their mean Eczema Area and Severity Index score was 6.6 at 6 months and 2.9 at 12 months.
  • Infants with signs of AD had significantly higher TEWL levels at the anterior cubital fossa at 1, 6, and 12 months than those without AD.
  • Cord blood levels of CCL17/TARC and IL-31 were significantly higher in infants with AD.
  • A correlation was found between TEWL values and CCL17 levels at 1, 6, and 12 months.

IN PRACTICE:

This study highlights the potential of cord serum/TARC and IL-31 levels as predictive markers for AD onset in infancy, in combination with cutaneous markers,” the authors wrote. “Stratified interventions based on these variables, family history, FLG [filaggrin] variations, and other biomarkers could offer more targeted approaches to AD prevention and management, especially during the first year of life,” they added.

SOURCE:

The study was led by Angelo Massimiliano D’Erme, MD, PhD, of the Dermatology Unit, in the Department of Medical and Oncology, University of Pisa, Pisa, Italy, and was published online in JAMA Dermatology.

LIMITATIONS:

The limitations included the observational design and small sample size, and it was a single-center study.

DISCLOSURES:

The authors did not disclose any funding information. One author disclosed receiving personal fees from various pharmaceutical companies and serving as a founder and chairman of a nonprofit organization.

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

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TOPLINE:

Newborns who go on to develop atopic dermatitis (AD) show higher transepidermal water loss (TEWL) and cord blood serum levels of CCL17/thymus- and activation-regulated chemokine (TARC) and interleukin (IL) 31.

METHODOLOGY:

  • Researchers conducted a prospective study to evaluate the predictive role of serologic biomarkers and cutaneous markers and the development of AD in 40 full-term newborns from a university hospital in Italy.
  • Cord blood was collected at birth and analyzed for serum biomarkers such as CCL17/TARC and IL-31.
  • TEWL and skin hydration rates were measured at 1, 6, and 12 months, and dermatological features such as dryness, cradle cap, and eczematous lesions were also monitored during visits.

TAKEAWAY:

  • At 6 months, 16 infants had symptoms of AD, which included dry skin, pruritus, and keratosis pilaris, which persisted at 12 months. Their mean Eczema Area and Severity Index score was 6.6 at 6 months and 2.9 at 12 months.
  • Infants with signs of AD had significantly higher TEWL levels at the anterior cubital fossa at 1, 6, and 12 months than those without AD.
  • Cord blood levels of CCL17/TARC and IL-31 were significantly higher in infants with AD.
  • A correlation was found between TEWL values and CCL17 levels at 1, 6, and 12 months.

IN PRACTICE:

This study highlights the potential of cord serum/TARC and IL-31 levels as predictive markers for AD onset in infancy, in combination with cutaneous markers,” the authors wrote. “Stratified interventions based on these variables, family history, FLG [filaggrin] variations, and other biomarkers could offer more targeted approaches to AD prevention and management, especially during the first year of life,” they added.

SOURCE:

The study was led by Angelo Massimiliano D’Erme, MD, PhD, of the Dermatology Unit, in the Department of Medical and Oncology, University of Pisa, Pisa, Italy, and was published online in JAMA Dermatology.

LIMITATIONS:

The limitations included the observational design and small sample size, and it was a single-center study.

DISCLOSURES:

The authors did not disclose any funding information. One author disclosed receiving personal fees from various pharmaceutical companies and serving as a founder and chairman of a nonprofit organization.

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

 

TOPLINE:

Newborns who go on to develop atopic dermatitis (AD) show higher transepidermal water loss (TEWL) and cord blood serum levels of CCL17/thymus- and activation-regulated chemokine (TARC) and interleukin (IL) 31.

METHODOLOGY:

  • Researchers conducted a prospective study to evaluate the predictive role of serologic biomarkers and cutaneous markers and the development of AD in 40 full-term newborns from a university hospital in Italy.
  • Cord blood was collected at birth and analyzed for serum biomarkers such as CCL17/TARC and IL-31.
  • TEWL and skin hydration rates were measured at 1, 6, and 12 months, and dermatological features such as dryness, cradle cap, and eczematous lesions were also monitored during visits.

TAKEAWAY:

  • At 6 months, 16 infants had symptoms of AD, which included dry skin, pruritus, and keratosis pilaris, which persisted at 12 months. Their mean Eczema Area and Severity Index score was 6.6 at 6 months and 2.9 at 12 months.
  • Infants with signs of AD had significantly higher TEWL levels at the anterior cubital fossa at 1, 6, and 12 months than those without AD.
  • Cord blood levels of CCL17/TARC and IL-31 were significantly higher in infants with AD.
  • A correlation was found between TEWL values and CCL17 levels at 1, 6, and 12 months.

IN PRACTICE:

This study highlights the potential of cord serum/TARC and IL-31 levels as predictive markers for AD onset in infancy, in combination with cutaneous markers,” the authors wrote. “Stratified interventions based on these variables, family history, FLG [filaggrin] variations, and other biomarkers could offer more targeted approaches to AD prevention and management, especially during the first year of life,” they added.

SOURCE:

The study was led by Angelo Massimiliano D’Erme, MD, PhD, of the Dermatology Unit, in the Department of Medical and Oncology, University of Pisa, Pisa, Italy, and was published online in JAMA Dermatology.

LIMITATIONS:

The limitations included the observational design and small sample size, and it was a single-center study.

DISCLOSURES:

The authors did not disclose any funding information. One author disclosed receiving personal fees from various pharmaceutical companies and serving as a founder and chairman of a nonprofit organization.

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

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New Options for Treating Atopic Dermatitis Available, and in Development

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Mon, 09/23/2024 - 11:50

— If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.

“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). Dr. Sidbury, chief of the Division of Dermatology at Seattle Children’s Hospital, Seattle, highlighted two agents for AD: Lebrikizumab and nemolizumab. Lebrikizumab is a monoclonal antibody that binds to interleukin (IL)-13 and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)

Dr. Robert Sidbury

In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.

“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.

In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.

Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)

In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.

Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
 

A version of this article appeared on Medscape.com.

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— If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.

“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). Dr. Sidbury, chief of the Division of Dermatology at Seattle Children’s Hospital, Seattle, highlighted two agents for AD: Lebrikizumab and nemolizumab. Lebrikizumab is a monoclonal antibody that binds to interleukin (IL)-13 and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)

Dr. Robert Sidbury

In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.

“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.

In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.

Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)

In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.

Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
 

A version of this article appeared on Medscape.com.

— If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.

“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). Dr. Sidbury, chief of the Division of Dermatology at Seattle Children’s Hospital, Seattle, highlighted two agents for AD: Lebrikizumab and nemolizumab. Lebrikizumab is a monoclonal antibody that binds to interleukin (IL)-13 and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)

Dr. Robert Sidbury

In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.

“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.

In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.

Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)

In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.

Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
 

A version of this article appeared on Medscape.com.

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Whooping Cough Rising Fast, Especially Among Teens

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Whooping cough is surging in the United States, with four times as many cases reported so far this year, compared to all of 2023. 

The CDC said 14,569 cases had been reported as of Sept. 14, compared to 3475 in all of 2023. 

There were 291 new cases reported for the week ending Sept. 14, with New York having the most cases, 44, followed by Ohio, Pennsylvania, and Oklahoma with 38 each. That’s the most cases in a single week since 2015.

Whooping cough, also called pertussis, is a respiratory illness spread through coughing, sneezing, or breathing very close to another person. Babies are given the DTaP vaccine to protect against whooping cough, diphtheria, and tetanus. Because the vaccine effectiveness wanes faster for whooping cough than the two other illnesses, boosters are recommended every decade or so.
 

Why the Whooping Cough Vaccine Is Important

Whooping cough is a very contagious bacteria, so vaccination is an important step to avoid it.

But many children in their tweens aren’t getting boosters, and that age group is driving the whooping cough outbreak.

“With the increase in vaccine hesitancy that has been going on since the COVID-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” Tina Tan, MD, president-elect of the Infectious Diseases Society of America, told NBC News.

Also, people are not social distancing the way they did during the height of the COVID pandemic, when whooping cough numbers went down.

“Levels of pertussis dropped dramatically when we were all masking, and now this huge increase is getting us back to pre-pandemic levels, and probably a little above that,” Thomas Murray, MD, a Yale Medicine pediatric infectious diseases specialist, said in a news release from the school. “It’s a contagious respiratory virus that can spread fairly quickly through the population.”

FDA advisers were scheduled to meet Sept. 20 to discuss developing more effective boosters for whooping cough.
 

A version of this article appeared on WebMD.com.

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Whooping cough is surging in the United States, with four times as many cases reported so far this year, compared to all of 2023. 

The CDC said 14,569 cases had been reported as of Sept. 14, compared to 3475 in all of 2023. 

There were 291 new cases reported for the week ending Sept. 14, with New York having the most cases, 44, followed by Ohio, Pennsylvania, and Oklahoma with 38 each. That’s the most cases in a single week since 2015.

Whooping cough, also called pertussis, is a respiratory illness spread through coughing, sneezing, or breathing very close to another person. Babies are given the DTaP vaccine to protect against whooping cough, diphtheria, and tetanus. Because the vaccine effectiveness wanes faster for whooping cough than the two other illnesses, boosters are recommended every decade or so.
 

Why the Whooping Cough Vaccine Is Important

Whooping cough is a very contagious bacteria, so vaccination is an important step to avoid it.

But many children in their tweens aren’t getting boosters, and that age group is driving the whooping cough outbreak.

“With the increase in vaccine hesitancy that has been going on since the COVID-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” Tina Tan, MD, president-elect of the Infectious Diseases Society of America, told NBC News.

Also, people are not social distancing the way they did during the height of the COVID pandemic, when whooping cough numbers went down.

“Levels of pertussis dropped dramatically when we were all masking, and now this huge increase is getting us back to pre-pandemic levels, and probably a little above that,” Thomas Murray, MD, a Yale Medicine pediatric infectious diseases specialist, said in a news release from the school. “It’s a contagious respiratory virus that can spread fairly quickly through the population.”

FDA advisers were scheduled to meet Sept. 20 to discuss developing more effective boosters for whooping cough.
 

A version of this article appeared on WebMD.com.

Whooping cough is surging in the United States, with four times as many cases reported so far this year, compared to all of 2023. 

The CDC said 14,569 cases had been reported as of Sept. 14, compared to 3475 in all of 2023. 

There were 291 new cases reported for the week ending Sept. 14, with New York having the most cases, 44, followed by Ohio, Pennsylvania, and Oklahoma with 38 each. That’s the most cases in a single week since 2015.

Whooping cough, also called pertussis, is a respiratory illness spread through coughing, sneezing, or breathing very close to another person. Babies are given the DTaP vaccine to protect against whooping cough, diphtheria, and tetanus. Because the vaccine effectiveness wanes faster for whooping cough than the two other illnesses, boosters are recommended every decade or so.
 

Why the Whooping Cough Vaccine Is Important

Whooping cough is a very contagious bacteria, so vaccination is an important step to avoid it.

But many children in their tweens aren’t getting boosters, and that age group is driving the whooping cough outbreak.

“With the increase in vaccine hesitancy that has been going on since the COVID-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” Tina Tan, MD, president-elect of the Infectious Diseases Society of America, told NBC News.

Also, people are not social distancing the way they did during the height of the COVID pandemic, when whooping cough numbers went down.

“Levels of pertussis dropped dramatically when we were all masking, and now this huge increase is getting us back to pre-pandemic levels, and probably a little above that,” Thomas Murray, MD, a Yale Medicine pediatric infectious diseases specialist, said in a news release from the school. “It’s a contagious respiratory virus that can spread fairly quickly through the population.”

FDA advisers were scheduled to meet Sept. 20 to discuss developing more effective boosters for whooping cough.
 

A version of this article appeared on WebMD.com.

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