Kate Johnson

The Canadian Paediatric Society (CPS) has issued a position statement on the diagnosis of anxiety disorders in children and youth. The organization aims to “offer evidence-informed guidance to support pediatric health care providers making decisions around the care of children and adolescents with these conditions.”

“It’s been a long time coming,” lead author Benjamin Klein, MD, assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont., told this news organization. The target audience for the documents includes community pediatricians, subspecialists, family doctors, and nurse practitioners. “There was a great demand from that audience for a position statement, for guidance, obviously in the backdrop of rising child and adolescent mental health incidence over the years and of course COVID,” said Dr. Klein.

The statement was published on the CPS website.
 

‘A comprehensive approach’

Although many other guidelines on this topic are available, it was important to have a Canadian document, said Dr. Klein. “Obviously, there’s going to be a great deal of overlap with European or American guidelines, but it’s just kind of assumed that people want specifically Canadian content. ... Physicians want to know that they’re practicing within a standard of care in Canada.” Dr. Klein is medical director of the Lansdowne Children’s Centre, Brantford, Ont., which provides help for children with communication, developmental, and physical special needs across Ontario.

Anxiety disorders are the most common mental disorders among children and adolescents in Canada, according to the position statement. The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) groups these disorders into separation anxiety disorder, selective mutism, specific phobia, social anxiety disorder (social phobia), panic disorder, agoraphobia, and generalized anxiety disorder.

Distinguishing normal, age-appropriate anxiety from anxiety disorder, while also recognizing other comorbidities, is complicated, said Dr. Klein. “Anxiety is one possible diagnosis or feature, and children with mental health and developmental problems often present with a number of problems. Anxiety may be one of them, but if it’s one of them, it may not be the main driver. So, a comprehensive approach is needed ... combining the medical model with biopsychosocial thinking to give a better picture of anxiety in the context of anything else that may be contributing to a presentation.”

The statement outlines recommendations for anxiety assessment, starting with a screening questionnaire such as the Screen for Child Anxiety Related Disorders (SCARED), which is completed by parents and children, to assess symptom severity. Standardized measures for medical, mental health, and developmental histories are available on the CPS website.

The document next recommends an interview about presenting concerns (such as sleep problems or school difficulties), inciting events, and parent-child interactions. The process includes confidential, nonjudgmental interviews with adolescents using a history-taking tool such as HEEADSSS (Home, Education/Employment, Eating, Activities, Drugs, Sexuality, Suicide/Mental Health, and Safety).

“The diagnosis and treatment of anxiety disorders kind of sounds simple if you just read about it as an isolated thing, but the reality is ... there’s no MRI. It’s detective work,” said Dr. Klein. Clinicians must distinguish between normal anxiety, situational anxiety, and specific anxiety disorder, he added. He usually allows 90 minutes for an anxiety assessment, partly to gain the patient’s trust. “These are sensitive issues. It’s common that people don’t trust a diagnosis if you haven’t spent enough time with them. That relational care piece just needs to be there, or people aren’t going to buy in.”

The CPS position statement was reviewed and endorsed by the Canadian Academy of Child and Adolescent Psychiatry.
 

Methodology unclear

Joanna Henderson, MD, professor of psychiatry at the University of Toronto and director of the Margaret and Wallace McCain Centre for Child, Youth, and Family Mental Health at the Centre for Addiction and Mental Health, Toronto, said that the guidelines have been released at an important time. “Conversations about mental health have become more common, and many children, youth, and families are reaching out for support. It is essential that health care professionals be equipped with accessible information about practices to provide appropriate care. These guidelines support that vision.”

It would be helpful to know more about the methods used to arrive at the recommendations, however, said Dr. Henderson. “It is critical that health care providers be guided by evidence-based guidelines that adhere to criteria for establishing high-quality guidelines. Because the authors did not provide information about their methods, I am not able to provide a comment about the quality of their guidelines. There are established approaches for evaluating quality, and I would encourage the authors to publish as a supplement to this article their methods, including in reference to the Appraisal of Guidelines for Research and Evaluation (AGREE II) checklist.”

In the absence of readily available information about methods, she said, “clinicians are encouraged to use guidelines from sources that provide information about the guideline development process and include quality appraisal,” such as the UK National Institute for Health and Care Excellence, which is “generally recognized as a reputable source for high-quality practice guidelines.”

Responding to this concern, Dr. Klein said, “There is no specific evidence base for diagnosis. That robust science doesn’t exist. No one has done randomized controlled trials of different methods of diagnosing kids with anxiety. We looked at other position statements, we looked at textbooks, and obviously we drew from our own clinical experience, so it comes from clinical judgment and expert opinion.”

Dr. Henderson also noted that in the future “it will be important to contextualize the recommendations by highlighting the importance of cultural competence in conducting assessments and providing treatment.” Moreover, current evidence can be expanded through the incorporation of diverse cultural and racial perspectives, experiences, and data, she added.

Health service providers should reflect on their own potential biases, which can influence clinician-patient interactions, Dr. Henderson continued. It also is important to consider biases in the evidence, which influence practice. Clinicians should also consider how their recommendations fit with patients’ “cultural and race-based experiences, beliefs, and practices.”

No source of funding for the position statement was reported. Dr. Klein and Dr. Henderson had disclosed no relevant financial relationships.

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

The Canadian Paediatric Society (CPS) has issued a position statement on the diagnosis of anxiety disorders in children and youth. The organization aims to “offer evidence-informed guidance to support pediatric health care providers making decisions around the care of children and adolescents with these conditions.”

“It’s been a long time coming,” lead author Benjamin Klein, MD, assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont., told this news organization. The target audience for the documents includes community pediatricians, subspecialists, family doctors, and nurse practitioners. “There was a great demand from that audience for a position statement, for guidance, obviously in the backdrop of rising child and adolescent mental health incidence over the years and of course COVID,” said Dr. Klein.

The statement was published on the CPS website.
 

‘A comprehensive approach’

Although many other guidelines on this topic are available, it was important to have a Canadian document, said Dr. Klein. “Obviously, there’s going to be a great deal of overlap with European or American guidelines, but it’s just kind of assumed that people want specifically Canadian content. ... Physicians want to know that they’re practicing within a standard of care in Canada.” Dr. Klein is medical director of the Lansdowne Children’s Centre, Brantford, Ont., which provides help for children with communication, developmental, and physical special needs across Ontario.

Anxiety disorders are the most common mental disorders among children and adolescents in Canada, according to the position statement. The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) groups these disorders into separation anxiety disorder, selective mutism, specific phobia, social anxiety disorder (social phobia), panic disorder, agoraphobia, and generalized anxiety disorder.

Distinguishing normal, age-appropriate anxiety from anxiety disorder, while also recognizing other comorbidities, is complicated, said Dr. Klein. “Anxiety is one possible diagnosis or feature, and children with mental health and developmental problems often present with a number of problems. Anxiety may be one of them, but if it’s one of them, it may not be the main driver. So, a comprehensive approach is needed ... combining the medical model with biopsychosocial thinking to give a better picture of anxiety in the context of anything else that may be contributing to a presentation.”

The statement outlines recommendations for anxiety assessment, starting with a screening questionnaire such as the Screen for Child Anxiety Related Disorders (SCARED), which is completed by parents and children, to assess symptom severity. Standardized measures for medical, mental health, and developmental histories are available on the CPS website.

The document next recommends an interview about presenting concerns (such as sleep problems or school difficulties), inciting events, and parent-child interactions. The process includes confidential, nonjudgmental interviews with adolescents using a history-taking tool such as HEEADSSS (Home, Education/Employment, Eating, Activities, Drugs, Sexuality, Suicide/Mental Health, and Safety).

“The diagnosis and treatment of anxiety disorders kind of sounds simple if you just read about it as an isolated thing, but the reality is ... there’s no MRI. It’s detective work,” said Dr. Klein. Clinicians must distinguish between normal anxiety, situational anxiety, and specific anxiety disorder, he added. He usually allows 90 minutes for an anxiety assessment, partly to gain the patient’s trust. “These are sensitive issues. It’s common that people don’t trust a diagnosis if you haven’t spent enough time with them. That relational care piece just needs to be there, or people aren’t going to buy in.”

The CPS position statement was reviewed and endorsed by the Canadian Academy of Child and Adolescent Psychiatry.
 

Methodology unclear

Joanna Henderson, MD, professor of psychiatry at the University of Toronto and director of the Margaret and Wallace McCain Centre for Child, Youth, and Family Mental Health at the Centre for Addiction and Mental Health, Toronto, said that the guidelines have been released at an important time. “Conversations about mental health have become more common, and many children, youth, and families are reaching out for support. It is essential that health care professionals be equipped with accessible information about practices to provide appropriate care. These guidelines support that vision.”

It would be helpful to know more about the methods used to arrive at the recommendations, however, said Dr. Henderson. “It is critical that health care providers be guided by evidence-based guidelines that adhere to criteria for establishing high-quality guidelines. Because the authors did not provide information about their methods, I am not able to provide a comment about the quality of their guidelines. There are established approaches for evaluating quality, and I would encourage the authors to publish as a supplement to this article their methods, including in reference to the Appraisal of Guidelines for Research and Evaluation (AGREE II) checklist.”

In the absence of readily available information about methods, she said, “clinicians are encouraged to use guidelines from sources that provide information about the guideline development process and include quality appraisal,” such as the UK National Institute for Health and Care Excellence, which is “generally recognized as a reputable source for high-quality practice guidelines.”

Responding to this concern, Dr. Klein said, “There is no specific evidence base for diagnosis. That robust science doesn’t exist. No one has done randomized controlled trials of different methods of diagnosing kids with anxiety. We looked at other position statements, we looked at textbooks, and obviously we drew from our own clinical experience, so it comes from clinical judgment and expert opinion.”

Dr. Henderson also noted that in the future “it will be important to contextualize the recommendations by highlighting the importance of cultural competence in conducting assessments and providing treatment.” Moreover, current evidence can be expanded through the incorporation of diverse cultural and racial perspectives, experiences, and data, she added.

Health service providers should reflect on their own potential biases, which can influence clinician-patient interactions, Dr. Henderson continued. It also is important to consider biases in the evidence, which influence practice. Clinicians should also consider how their recommendations fit with patients’ “cultural and race-based experiences, beliefs, and practices.”

No source of funding for the position statement was reported. Dr. Klein and Dr. Henderson had disclosed no relevant financial relationships.

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

The Canadian Paediatric Society (CPS) has issued a position statement on the diagnosis of anxiety disorders in children and youth. The organization aims to “offer evidence-informed guidance to support pediatric health care providers making decisions around the care of children and adolescents with these conditions.”

“It’s been a long time coming,” lead author Benjamin Klein, MD, assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont., told this news organization. The target audience for the documents includes community pediatricians, subspecialists, family doctors, and nurse practitioners. “There was a great demand from that audience for a position statement, for guidance, obviously in the backdrop of rising child and adolescent mental health incidence over the years and of course COVID,” said Dr. Klein.

The statement was published on the CPS website.
 

‘A comprehensive approach’

Although many other guidelines on this topic are available, it was important to have a Canadian document, said Dr. Klein. “Obviously, there’s going to be a great deal of overlap with European or American guidelines, but it’s just kind of assumed that people want specifically Canadian content. ... Physicians want to know that they’re practicing within a standard of care in Canada.” Dr. Klein is medical director of the Lansdowne Children’s Centre, Brantford, Ont., which provides help for children with communication, developmental, and physical special needs across Ontario.

Anxiety disorders are the most common mental disorders among children and adolescents in Canada, according to the position statement. The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) groups these disorders into separation anxiety disorder, selective mutism, specific phobia, social anxiety disorder (social phobia), panic disorder, agoraphobia, and generalized anxiety disorder.

Distinguishing normal, age-appropriate anxiety from anxiety disorder, while also recognizing other comorbidities, is complicated, said Dr. Klein. “Anxiety is one possible diagnosis or feature, and children with mental health and developmental problems often present with a number of problems. Anxiety may be one of them, but if it’s one of them, it may not be the main driver. So, a comprehensive approach is needed ... combining the medical model with biopsychosocial thinking to give a better picture of anxiety in the context of anything else that may be contributing to a presentation.”

The statement outlines recommendations for anxiety assessment, starting with a screening questionnaire such as the Screen for Child Anxiety Related Disorders (SCARED), which is completed by parents and children, to assess symptom severity. Standardized measures for medical, mental health, and developmental histories are available on the CPS website.

The document next recommends an interview about presenting concerns (such as sleep problems or school difficulties), inciting events, and parent-child interactions. The process includes confidential, nonjudgmental interviews with adolescents using a history-taking tool such as HEEADSSS (Home, Education/Employment, Eating, Activities, Drugs, Sexuality, Suicide/Mental Health, and Safety).

“The diagnosis and treatment of anxiety disorders kind of sounds simple if you just read about it as an isolated thing, but the reality is ... there’s no MRI. It’s detective work,” said Dr. Klein. Clinicians must distinguish between normal anxiety, situational anxiety, and specific anxiety disorder, he added. He usually allows 90 minutes for an anxiety assessment, partly to gain the patient’s trust. “These are sensitive issues. It’s common that people don’t trust a diagnosis if you haven’t spent enough time with them. That relational care piece just needs to be there, or people aren’t going to buy in.”

The CPS position statement was reviewed and endorsed by the Canadian Academy of Child and Adolescent Psychiatry.
 

Methodology unclear

Joanna Henderson, MD, professor of psychiatry at the University of Toronto and director of the Margaret and Wallace McCain Centre for Child, Youth, and Family Mental Health at the Centre for Addiction and Mental Health, Toronto, said that the guidelines have been released at an important time. “Conversations about mental health have become more common, and many children, youth, and families are reaching out for support. It is essential that health care professionals be equipped with accessible information about practices to provide appropriate care. These guidelines support that vision.”

It would be helpful to know more about the methods used to arrive at the recommendations, however, said Dr. Henderson. “It is critical that health care providers be guided by evidence-based guidelines that adhere to criteria for establishing high-quality guidelines. Because the authors did not provide information about their methods, I am not able to provide a comment about the quality of their guidelines. There are established approaches for evaluating quality, and I would encourage the authors to publish as a supplement to this article their methods, including in reference to the Appraisal of Guidelines for Research and Evaluation (AGREE II) checklist.”

In the absence of readily available information about methods, she said, “clinicians are encouraged to use guidelines from sources that provide information about the guideline development process and include quality appraisal,” such as the UK National Institute for Health and Care Excellence, which is “generally recognized as a reputable source for high-quality practice guidelines.”

Responding to this concern, Dr. Klein said, “There is no specific evidence base for diagnosis. That robust science doesn’t exist. No one has done randomized controlled trials of different methods of diagnosing kids with anxiety. We looked at other position statements, we looked at textbooks, and obviously we drew from our own clinical experience, so it comes from clinical judgment and expert opinion.”

Dr. Henderson also noted that in the future “it will be important to contextualize the recommendations by highlighting the importance of cultural competence in conducting assessments and providing treatment.” Moreover, current evidence can be expanded through the incorporation of diverse cultural and racial perspectives, experiences, and data, she added.

Health service providers should reflect on their own potential biases, which can influence clinician-patient interactions, Dr. Henderson continued. It also is important to consider biases in the evidence, which influence practice. Clinicians should also consider how their recommendations fit with patients’ “cultural and race-based experiences, beliefs, and practices.”

No source of funding for the position statement was reported. Dr. Klein and Dr. Henderson had disclosed no relevant financial relationships.

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

MONTREAL – Children and young people with severe atopic dermatitis had a more rapid treatment response with ciclosporin, but more sustained disease control with methotrexate in the TREAT study, investigators reported at the annual meeting of the International Society of Atopic Dermatitis.

The findings are important, since many regulatory bodies require patients to have tried such first-line conventional systemic therapies before moving on to novel therapeutics, explained Carsten Flohr, MD, PhD, research and development lead at St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust London.

“We don’t really have much pediatric trial data; very often the pediatric data that we have is buried in adult trials and when it comes to an adequately powered randomized controlled trial with conventional systemic medication in pediatric patients, we don’t have one – so we’re lacking that gold standard,” said Dr. Flohr, chair in dermatology and population health sciences at King’s College London.

In the TREAT trial, 103 patients with AD (mean age, 10 years) who had not responded to topical treatment, were randomly assigned to oral ciclosporin (4 mg/kg daily) or methotrexate (0.4 mg/kg weekly) for 36 weeks and then followed for another 24 weeks off therapy for the co-primary outcomes of change in objective Scoring Atopic Dermatitis (o-SCORAD) at 12 weeks, as well as time to first significant flare after treatment cessation, defined as returning to baseline o-SCORAD, or restarting a systemic treatment.

Secondary outcomes included disease severity and quality of life (QOL) measures, as well as safety. At baseline, the mean o-SCORAD was 46.81, with mean Eczema Area and Severity Index (EASI) and Patient Oriented Eczema Measure (POEM) scores of 28.05 and 20.62 respectively. The mean Children’s Dermatology Life Quality Index (CDLQI) score was 14.96.

Looking at change in eczema severity measured by o-SCORAD at 12 weeks, ciclosporin was superior to methotrexate, with a mean difference in o-SCORAD change of -5.69 (P =.01). For the co-primary endpoint of time to first significant flare during the 24 weeks after treatment cessation, “there was a trend toward more flare activity in the ciclosporin group, although with a hazard ratio of 1.55, this was statistically not significant,” Dr. Flohr said.

On a graph showing mean EASI scores from baseline through the 60-week study period, Dr. Flohr explained how the score first dropped more precipitously in patients treated with ciclosporin compared with those treated with methotrexate, reaching a statistically significant difference between the groups by 12 weeks (–3.13, P = .0145).

However, after that time, while the EASI score among those on methotrexate continued to drop, the ciclosporin score evened out, so that by 20 weeks, methotrexate EASI scores were better, and remained so until the end of treatment and further, out to 60 weeks (mean difference -6.36, P < .001). “The most interesting bit of this graph is [that] the curve is pointing downwards for methotrexate up to the 9-month point, suggesting these people had not reached their full therapeutic potential yet, whereas if you’re on ciclosporin you plateau and there’s not much additional improvement, if at all, and then people [on ciclosporin] start going up in their disease activity off therapy,” he said.

The same pattern was seen with all the other outcome measures, including o-SCORAD and POEM.

Quality of life significantly improved by about 8 points in both treatment groups, with no significant differences between groups, and this improvement was sustained through the 24 weeks following cessation of therapy. However, during this treatment-free phase, patients on methotrexate had fewer parent-reported flares compared with those on ciclosporin (mean 6.19 vs 5.40 flares, P =.0251), although there was no difference between groups in time to first flare.

Describing the treatment safety as “overall reassuring,” Dr. Flohr said there were slightly more nonserious adverse events in the methotrexate arm (407 vs. 369), with nausea occurring more often in this group (43.1% vs. 17.6%).

“I think we were seeing this clinically, but to see it in a clinical trial gives us more confidence in discussing with parents,” said session moderator Melinda Gooderham, MD, assistant professor at Queens University, Kingston, Ont., and medical director at the SKiN Centre for Dermatology in Peterborough.

What she also took away from the study was safety of these treatments. “The discontinuation rate was not different with either drug, so it’s not like ciclosporin works fast but all these people have problems and discontinue,” Dr. Gooderham told this news organization. “That’s also reassuring.”

Asked which treatment she prefers, Dr. Gooderham, a consultant physician at Peterborough Regional Health Centre, picked methotrexate “because of the lasting effect. But there are times when you may need more rapid control ... where I might choose ciclosporin first, but for me it’s maybe 90% methotrexate first, 10% ciclosporin.”

Dr. Flohr and Dr. Gooderham report no relevant financial relationships. The study was funded by the National Institute for Health and Care Research.

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

MONTREAL – Children and young people with severe atopic dermatitis had a more rapid treatment response with ciclosporin, but more sustained disease control with methotrexate in the TREAT study, investigators reported at the annual meeting of the International Society of Atopic Dermatitis.

The findings are important, since many regulatory bodies require patients to have tried such first-line conventional systemic therapies before moving on to novel therapeutics, explained Carsten Flohr, MD, PhD, research and development lead at St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust London.

“We don’t really have much pediatric trial data; very often the pediatric data that we have is buried in adult trials and when it comes to an adequately powered randomized controlled trial with conventional systemic medication in pediatric patients, we don’t have one – so we’re lacking that gold standard,” said Dr. Flohr, chair in dermatology and population health sciences at King’s College London.

In the TREAT trial, 103 patients with AD (mean age, 10 years) who had not responded to topical treatment, were randomly assigned to oral ciclosporin (4 mg/kg daily) or methotrexate (0.4 mg/kg weekly) for 36 weeks and then followed for another 24 weeks off therapy for the co-primary outcomes of change in objective Scoring Atopic Dermatitis (o-SCORAD) at 12 weeks, as well as time to first significant flare after treatment cessation, defined as returning to baseline o-SCORAD, or restarting a systemic treatment.

Secondary outcomes included disease severity and quality of life (QOL) measures, as well as safety. At baseline, the mean o-SCORAD was 46.81, with mean Eczema Area and Severity Index (EASI) and Patient Oriented Eczema Measure (POEM) scores of 28.05 and 20.62 respectively. The mean Children’s Dermatology Life Quality Index (CDLQI) score was 14.96.

Looking at change in eczema severity measured by o-SCORAD at 12 weeks, ciclosporin was superior to methotrexate, with a mean difference in o-SCORAD change of -5.69 (P =.01). For the co-primary endpoint of time to first significant flare during the 24 weeks after treatment cessation, “there was a trend toward more flare activity in the ciclosporin group, although with a hazard ratio of 1.55, this was statistically not significant,” Dr. Flohr said.

On a graph showing mean EASI scores from baseline through the 60-week study period, Dr. Flohr explained how the score first dropped more precipitously in patients treated with ciclosporin compared with those treated with methotrexate, reaching a statistically significant difference between the groups by 12 weeks (–3.13, P = .0145).

However, after that time, while the EASI score among those on methotrexate continued to drop, the ciclosporin score evened out, so that by 20 weeks, methotrexate EASI scores were better, and remained so until the end of treatment and further, out to 60 weeks (mean difference -6.36, P < .001). “The most interesting bit of this graph is [that] the curve is pointing downwards for methotrexate up to the 9-month point, suggesting these people had not reached their full therapeutic potential yet, whereas if you’re on ciclosporin you plateau and there’s not much additional improvement, if at all, and then people [on ciclosporin] start going up in their disease activity off therapy,” he said.

The same pattern was seen with all the other outcome measures, including o-SCORAD and POEM.

Quality of life significantly improved by about 8 points in both treatment groups, with no significant differences between groups, and this improvement was sustained through the 24 weeks following cessation of therapy. However, during this treatment-free phase, patients on methotrexate had fewer parent-reported flares compared with those on ciclosporin (mean 6.19 vs 5.40 flares, P =.0251), although there was no difference between groups in time to first flare.

Describing the treatment safety as “overall reassuring,” Dr. Flohr said there were slightly more nonserious adverse events in the methotrexate arm (407 vs. 369), with nausea occurring more often in this group (43.1% vs. 17.6%).

“I think we were seeing this clinically, but to see it in a clinical trial gives us more confidence in discussing with parents,” said session moderator Melinda Gooderham, MD, assistant professor at Queens University, Kingston, Ont., and medical director at the SKiN Centre for Dermatology in Peterborough.

What she also took away from the study was safety of these treatments. “The discontinuation rate was not different with either drug, so it’s not like ciclosporin works fast but all these people have problems and discontinue,” Dr. Gooderham told this news organization. “That’s also reassuring.”

Asked which treatment she prefers, Dr. Gooderham, a consultant physician at Peterborough Regional Health Centre, picked methotrexate “because of the lasting effect. But there are times when you may need more rapid control ... where I might choose ciclosporin first, but for me it’s maybe 90% methotrexate first, 10% ciclosporin.”

Dr. Flohr and Dr. Gooderham report no relevant financial relationships. The study was funded by the National Institute for Health and Care Research.

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

MONTREAL – Children and young people with severe atopic dermatitis had a more rapid treatment response with ciclosporin, but more sustained disease control with methotrexate in the TREAT study, investigators reported at the annual meeting of the International Society of Atopic Dermatitis.

The findings are important, since many regulatory bodies require patients to have tried such first-line conventional systemic therapies before moving on to novel therapeutics, explained Carsten Flohr, MD, PhD, research and development lead at St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust London.

“We don’t really have much pediatric trial data; very often the pediatric data that we have is buried in adult trials and when it comes to an adequately powered randomized controlled trial with conventional systemic medication in pediatric patients, we don’t have one – so we’re lacking that gold standard,” said Dr. Flohr, chair in dermatology and population health sciences at King’s College London.

In the TREAT trial, 103 patients with AD (mean age, 10 years) who had not responded to topical treatment, were randomly assigned to oral ciclosporin (4 mg/kg daily) or methotrexate (0.4 mg/kg weekly) for 36 weeks and then followed for another 24 weeks off therapy for the co-primary outcomes of change in objective Scoring Atopic Dermatitis (o-SCORAD) at 12 weeks, as well as time to first significant flare after treatment cessation, defined as returning to baseline o-SCORAD, or restarting a systemic treatment.

Secondary outcomes included disease severity and quality of life (QOL) measures, as well as safety. At baseline, the mean o-SCORAD was 46.81, with mean Eczema Area and Severity Index (EASI) and Patient Oriented Eczema Measure (POEM) scores of 28.05 and 20.62 respectively. The mean Children’s Dermatology Life Quality Index (CDLQI) score was 14.96.

Looking at change in eczema severity measured by o-SCORAD at 12 weeks, ciclosporin was superior to methotrexate, with a mean difference in o-SCORAD change of -5.69 (P =.01). For the co-primary endpoint of time to first significant flare during the 24 weeks after treatment cessation, “there was a trend toward more flare activity in the ciclosporin group, although with a hazard ratio of 1.55, this was statistically not significant,” Dr. Flohr said.

On a graph showing mean EASI scores from baseline through the 60-week study period, Dr. Flohr explained how the score first dropped more precipitously in patients treated with ciclosporin compared with those treated with methotrexate, reaching a statistically significant difference between the groups by 12 weeks (–3.13, P = .0145).

However, after that time, while the EASI score among those on methotrexate continued to drop, the ciclosporin score evened out, so that by 20 weeks, methotrexate EASI scores were better, and remained so until the end of treatment and further, out to 60 weeks (mean difference -6.36, P < .001). “The most interesting bit of this graph is [that] the curve is pointing downwards for methotrexate up to the 9-month point, suggesting these people had not reached their full therapeutic potential yet, whereas if you’re on ciclosporin you plateau and there’s not much additional improvement, if at all, and then people [on ciclosporin] start going up in their disease activity off therapy,” he said.

The same pattern was seen with all the other outcome measures, including o-SCORAD and POEM.

Quality of life significantly improved by about 8 points in both treatment groups, with no significant differences between groups, and this improvement was sustained through the 24 weeks following cessation of therapy. However, during this treatment-free phase, patients on methotrexate had fewer parent-reported flares compared with those on ciclosporin (mean 6.19 vs 5.40 flares, P =.0251), although there was no difference between groups in time to first flare.

Describing the treatment safety as “overall reassuring,” Dr. Flohr said there were slightly more nonserious adverse events in the methotrexate arm (407 vs. 369), with nausea occurring more often in this group (43.1% vs. 17.6%).

“I think we were seeing this clinically, but to see it in a clinical trial gives us more confidence in discussing with parents,” said session moderator Melinda Gooderham, MD, assistant professor at Queens University, Kingston, Ont., and medical director at the SKiN Centre for Dermatology in Peterborough.

What she also took away from the study was safety of these treatments. “The discontinuation rate was not different with either drug, so it’s not like ciclosporin works fast but all these people have problems and discontinue,” Dr. Gooderham told this news organization. “That’s also reassuring.”

Asked which treatment she prefers, Dr. Gooderham, a consultant physician at Peterborough Regional Health Centre, picked methotrexate “because of the lasting effect. But there are times when you may need more rapid control ... where I might choose ciclosporin first, but for me it’s maybe 90% methotrexate first, 10% ciclosporin.”

Dr. Flohr and Dr. Gooderham report no relevant financial relationships. The study was funded by the National Institute for Health and Care Research.

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

MONTREAL – An online behavioral intervention called Eczema Care Online, aimed at supporting self-management of atopic dermatitis (AD), resulted in a “small but sustained” improvement in eczema severity for up to 1 year, according to two randomized controlled trials presented at the annual meeting of the International Society of Atopic Dermatitis.

The intervention, directed either at parents of children with AD or young adults with AD, “is very low cost, evidence based, easily accessible, and free from possible commercial bias,” said investigator Kim Thomas, MD, professor of applied dermatology research and codirector of the Centre of Evidence Based Dermatology, faculty of medicine & health sciences, University of Nottingham (England).

The main focus of the intervention, along with general education, is “getting control” of the condition with flare-control creams and “keeping control” with regular emollient use.

Efficacy of the intervention, available free online, was compared with “usual eczema care” in 340 parents of children with AD up to age 12 and 337 young patients with AD aged 13-25. Participants were randomized to the intervention plus usual care or usual care alone. The primary outcome was the Patient-Oriented Eczema Measure(POEM) at 24 weeks, with a further measurement at 52 weeks.

In the parent group, about half were women and 83% were White, and the median age of their children was 4 years. About 50% of parents had a university degree, making them “possibly better educated than we might want our target audience for this type of intervention,” Dr. Thomas commented. Most of the children had moderate AD.

In the young patient group, the mean age was 19 years, more than three-quarters were female, 83% were White, and most had moderate AD.

At 24 weeks, both intervention groups had improved POEM scores, compared with controls, with a mean difference of 1.5 points in the parent group (P = .002) and 1.7 points in the young patient group (P = .04). “A small difference, but statistically significant and sustained,” Dr. Thomas said, adding that this difference was sustained up to 52 weeks.

In terms of mechanism of action, a secondary outcome looked at the concept of enablement, “which again, seemed to be improved in the intervention group, which suggests it’s something to do with being able to understand and cope with their disease better,” she said. The tool is targeted to “people who wouldn’t normally get to a dermatologist and certainly wouldn’t get access to group interventions.”

An additional aim of the intervention was “to provide a single, consistent message received from every point of contact that people might engage with ... [from] community doctors, pharmacists, dermatologists, and importantly, eczema charities all signposting [the intervention] and sharing a consistent message.”

While the intervention is free and available to patients anywhere, Dr. Thomas emphasized that it is tailored to the U.K. health care system. “If people would like to get in touch and help work with us to maybe adapt it slightly to make it more suitable for your own health care systems, that’s something we’d be very happy to look at with you.”

Asked for comment, Natalie Cunningham, MD, panel moderator, was lukewarm about the tool. “It can be a supplement, but you can never replace the one-on-one patient–health care provider interaction,” she told this news organization. “That could be provided by a nondermatologist and supplemented by an online component,” said Dr. Cunningham, from the Izaak Walton Killam Hospital for Children in Halifax, N.S.

“First-line treatment for eczema, no matter what kind of eczema, is topical steroids, and that is something that requires a lot of education – and something you want to do one on one in person because everyone comes to it with a different experience, baggage, or understanding,” she said. “We need to figure out what the barrier is so that you can do the right education.”

In addition, with systemic AD therapies currently approved for children, parents and young patients need to be able to advocate for specialist care to access these medications, she noted.

Dr. Thomas and Dr. Cunningham reported no relevant financial relationships.

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

MONTREAL – An online behavioral intervention called Eczema Care Online, aimed at supporting self-management of atopic dermatitis (AD), resulted in a “small but sustained” improvement in eczema severity for up to 1 year, according to two randomized controlled trials presented at the annual meeting of the International Society of Atopic Dermatitis.

The intervention, directed either at parents of children with AD or young adults with AD, “is very low cost, evidence based, easily accessible, and free from possible commercial bias,” said investigator Kim Thomas, MD, professor of applied dermatology research and codirector of the Centre of Evidence Based Dermatology, faculty of medicine & health sciences, University of Nottingham (England).

The main focus of the intervention, along with general education, is “getting control” of the condition with flare-control creams and “keeping control” with regular emollient use.

Efficacy of the intervention, available free online, was compared with “usual eczema care” in 340 parents of children with AD up to age 12 and 337 young patients with AD aged 13-25. Participants were randomized to the intervention plus usual care or usual care alone. The primary outcome was the Patient-Oriented Eczema Measure(POEM) at 24 weeks, with a further measurement at 52 weeks.

In the parent group, about half were women and 83% were White, and the median age of their children was 4 years. About 50% of parents had a university degree, making them “possibly better educated than we might want our target audience for this type of intervention,” Dr. Thomas commented. Most of the children had moderate AD.

In the young patient group, the mean age was 19 years, more than three-quarters were female, 83% were White, and most had moderate AD.

At 24 weeks, both intervention groups had improved POEM scores, compared with controls, with a mean difference of 1.5 points in the parent group (P = .002) and 1.7 points in the young patient group (P = .04). “A small difference, but statistically significant and sustained,” Dr. Thomas said, adding that this difference was sustained up to 52 weeks.

In terms of mechanism of action, a secondary outcome looked at the concept of enablement, “which again, seemed to be improved in the intervention group, which suggests it’s something to do with being able to understand and cope with their disease better,” she said. The tool is targeted to “people who wouldn’t normally get to a dermatologist and certainly wouldn’t get access to group interventions.”

An additional aim of the intervention was “to provide a single, consistent message received from every point of contact that people might engage with ... [from] community doctors, pharmacists, dermatologists, and importantly, eczema charities all signposting [the intervention] and sharing a consistent message.”

While the intervention is free and available to patients anywhere, Dr. Thomas emphasized that it is tailored to the U.K. health care system. “If people would like to get in touch and help work with us to maybe adapt it slightly to make it more suitable for your own health care systems, that’s something we’d be very happy to look at with you.”

Asked for comment, Natalie Cunningham, MD, panel moderator, was lukewarm about the tool. “It can be a supplement, but you can never replace the one-on-one patient–health care provider interaction,” she told this news organization. “That could be provided by a nondermatologist and supplemented by an online component,” said Dr. Cunningham, from the Izaak Walton Killam Hospital for Children in Halifax, N.S.

“First-line treatment for eczema, no matter what kind of eczema, is topical steroids, and that is something that requires a lot of education – and something you want to do one on one in person because everyone comes to it with a different experience, baggage, or understanding,” she said. “We need to figure out what the barrier is so that you can do the right education.”

In addition, with systemic AD therapies currently approved for children, parents and young patients need to be able to advocate for specialist care to access these medications, she noted.

Dr. Thomas and Dr. Cunningham reported no relevant financial relationships.

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

MONTREAL – An online behavioral intervention called Eczema Care Online, aimed at supporting self-management of atopic dermatitis (AD), resulted in a “small but sustained” improvement in eczema severity for up to 1 year, according to two randomized controlled trials presented at the annual meeting of the International Society of Atopic Dermatitis.

The intervention, directed either at parents of children with AD or young adults with AD, “is very low cost, evidence based, easily accessible, and free from possible commercial bias,” said investigator Kim Thomas, MD, professor of applied dermatology research and codirector of the Centre of Evidence Based Dermatology, faculty of medicine & health sciences, University of Nottingham (England).

The main focus of the intervention, along with general education, is “getting control” of the condition with flare-control creams and “keeping control” with regular emollient use.

Efficacy of the intervention, available free online, was compared with “usual eczema care” in 340 parents of children with AD up to age 12 and 337 young patients with AD aged 13-25. Participants were randomized to the intervention plus usual care or usual care alone. The primary outcome was the Patient-Oriented Eczema Measure(POEM) at 24 weeks, with a further measurement at 52 weeks.

In the parent group, about half were women and 83% were White, and the median age of their children was 4 years. About 50% of parents had a university degree, making them “possibly better educated than we might want our target audience for this type of intervention,” Dr. Thomas commented. Most of the children had moderate AD.

In the young patient group, the mean age was 19 years, more than three-quarters were female, 83% were White, and most had moderate AD.

At 24 weeks, both intervention groups had improved POEM scores, compared with controls, with a mean difference of 1.5 points in the parent group (P = .002) and 1.7 points in the young patient group (P = .04). “A small difference, but statistically significant and sustained,” Dr. Thomas said, adding that this difference was sustained up to 52 weeks.

In terms of mechanism of action, a secondary outcome looked at the concept of enablement, “which again, seemed to be improved in the intervention group, which suggests it’s something to do with being able to understand and cope with their disease better,” she said. The tool is targeted to “people who wouldn’t normally get to a dermatologist and certainly wouldn’t get access to group interventions.”

An additional aim of the intervention was “to provide a single, consistent message received from every point of contact that people might engage with ... [from] community doctors, pharmacists, dermatologists, and importantly, eczema charities all signposting [the intervention] and sharing a consistent message.”

While the intervention is free and available to patients anywhere, Dr. Thomas emphasized that it is tailored to the U.K. health care system. “If people would like to get in touch and help work with us to maybe adapt it slightly to make it more suitable for your own health care systems, that’s something we’d be very happy to look at with you.”

Asked for comment, Natalie Cunningham, MD, panel moderator, was lukewarm about the tool. “It can be a supplement, but you can never replace the one-on-one patient–health care provider interaction,” she told this news organization. “That could be provided by a nondermatologist and supplemented by an online component,” said Dr. Cunningham, from the Izaak Walton Killam Hospital for Children in Halifax, N.S.

“First-line treatment for eczema, no matter what kind of eczema, is topical steroids, and that is something that requires a lot of education – and something you want to do one on one in person because everyone comes to it with a different experience, baggage, or understanding,” she said. “We need to figure out what the barrier is so that you can do the right education.”

In addition, with systemic AD therapies currently approved for children, parents and young patients need to be able to advocate for specialist care to access these medications, she noted.

Dr. Thomas and Dr. Cunningham reported no relevant financial relationships.

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

Women eating a reduced-fat vegan diet combined with a daily serving of soybeans experienced a 78% reduction in frequency of menopausal hot flashes over 12 weeks, in a small, nonblinded, randomized-controlled trial.

“We do not fully understand yet why this combination works, but it seems that these three elements are key: avoiding animal products, reducing fat, and adding a serving of soybeans,” lead researcher Neal Barnard, MD, explained in a press release. “These new results suggest that a diet change should be considered as a first-line treatment for troublesome vasomotor symptoms, including night sweats and hot flashes,” added Dr. Barnard, who is president of the Physicians Committee for Responsible Medicine, and adjunct professor at George Washington University, Washington. 

Elliott O’Donovan Photography

But, while “the findings from this very small study complement everything we know about the benefits of an excellent diet and the health benefits of soy,” they should be interpreted with some caution, commented Susan Reed, MD, president of the North American Menopause Society, and associate program director of the women’s reproductive research program at the University of Washington, Seattle.

For the trial, called WAVS (Women’s Study for the Alleviation of Vasomotor Symptoms), the researchers randomized 84 postmenopausal women with at least two moderate to severe hot flashes daily to either the intervention or usual diet, with a total of 71 subjects completing the 12-week study, published in Menopause. Criteria for exclusion included any cause of vasomotor symptoms other than natural menopause, current use of a low-fat, vegan diet that includes daily soy products, soy allergy, and body mass index < 18.5 kg/m².

Participants in the intervention group were asked to avoid animal-derived foods, minimize their use of oils and fatty foods such as nuts and avocados, and include half a cup (86 g) of cooked soybeans daily in their diets. They were also offered 1-hour virtual group meetings each week, in which a registered dietitian or research staff provided information on food preparation and managing common dietary challenges.

Control group participants were asked to continue their usual diets and attend four 1-hour group sessions.

At baseline and then after the 12-week study period, dietary intake was self-recorded for 2 weekdays and 1 weekend day, hot flash frequency and severity was recorded for 1 week using a mobile app, and the effect of menopausal symptoms on quality of life was measured using the vasomotor, psychosocial, physical, and sexual domains of the Menopause-Specific Quality of Life (MENQOL) questionnaire.

Equol production was also assessed in a subset of 15 intervention and 12 control participants who had urinary isoflavone concentrations measured after eating half a cup (86 g) of soybeans twice daily for 3 days. This was based on the theory that diets such as the intervention in this study “seem to foster the growth of gut bacteria capable of converting daidzein to equol,” noted the authors. The ability to produce equol is detected more frequently in individuals following vegetarian diets than in omnivores and … has been proposed as a factor in soy’s apparent health benefits.”

The study found that total hot flash frequency decreased by 78% in the intervention group (P < .001) and 39% (P < .001) in the control group (between-group P = .003), and moderate to severe hot flashes decreased by 88% versus 34%, respectively (from 5.0 to 0.6 per day, P < .001 vs. from 4.4 to 2.9 per day, P < .001; between-group P < .001). Among participants with at least seven moderate to severe hot flashes per day at baseline, moderate to severe hot flashes decreased by 93% (from 10.6 to 0.7 per day) in the intervention group (P < .001) and 36% (from 9.0 to 5.8 per day) in the control group (P = .01, between-group P < .001). The changes in hot flashes were paralleled by changes in the MENQOL findings, with significant between-group differences in the vasomotor (P = 0.004), physical (P = 0.01), and sexual (P = 0.03) domains.

Changes in frequency of severe hot flashes correlated directly with changes in fat intake, and inversely with changes in carbohydrate and fiber intake, such that “the greater the reduction in fat intake and the greater the increases in carbohydrate and fiber consumption, the greater the reduction in severe hot flashes,” noted the researchers. Mean body weight also decreased by 3.6 kg in the intervention group and 0.2 kg in the control group (P < .001). “Equol-production status had no apparent effect on hot flashes,” they added.

The study is the second phase of WAVS, which comprises two parts, the first of which showed similar results, but was conducted in the fall, raising questions about whether cooler temperatures were partly responsible for the results. Phase 2 of WAVS enrolled participants in the spring “ruling out the effect of outside temperature,” noted the authors.

“Eating a healthy diet at midlife is so important for long-term health and a sense of well-being for peri- and postmenopausal women,” said Dr Reed, but she urged caution in interpreting the findings. “This was an unblinded study,” she told this news organization. “Women were recruited to this study anticipating that they would be in a study on a soy diet. Individuals who sign up for a study are hoping for benefit from the intervention. The controls who don’t get the soy diet are often disappointed, so there is no benefit from a nonblinded control arm for their hot flashes. And that is exactly what we saw here. Blinded studies can hide what you are getting, so everyone in the study (intervention and controls) has the same anticipated benefit.  But you cannot blind a soy diet.”

Dr. Reed also noted that, while the biologic mechanism of benefit should be equol production, this was not shown – given that both equol producers and nonproducers in the soy intervention reported marked symptom reduction.

“Only prior studies with estrogen interventions have observed reductions of hot flashes of the amount reported here,” she concluded. “Hopefully future large studies will clarify the role of soy diet for decreasing hot flashes.”

Dr. Barnard writes books and articles and gives lectures related to nutrition and health and has received royalties and honoraria from these sources. Dr. Reed has no relevant disclosures.

Women eating a reduced-fat vegan diet combined with a daily serving of soybeans experienced a 78% reduction in frequency of menopausal hot flashes over 12 weeks, in a small, nonblinded, randomized-controlled trial.

“We do not fully understand yet why this combination works, but it seems that these three elements are key: avoiding animal products, reducing fat, and adding a serving of soybeans,” lead researcher Neal Barnard, MD, explained in a press release. “These new results suggest that a diet change should be considered as a first-line treatment for troublesome vasomotor symptoms, including night sweats and hot flashes,” added Dr. Barnard, who is president of the Physicians Committee for Responsible Medicine, and adjunct professor at George Washington University, Washington. 

Elliott O’Donovan Photography

But, while “the findings from this very small study complement everything we know about the benefits of an excellent diet and the health benefits of soy,” they should be interpreted with some caution, commented Susan Reed, MD, president of the North American Menopause Society, and associate program director of the women’s reproductive research program at the University of Washington, Seattle.

For the trial, called WAVS (Women’s Study for the Alleviation of Vasomotor Symptoms), the researchers randomized 84 postmenopausal women with at least two moderate to severe hot flashes daily to either the intervention or usual diet, with a total of 71 subjects completing the 12-week study, published in Menopause. Criteria for exclusion included any cause of vasomotor symptoms other than natural menopause, current use of a low-fat, vegan diet that includes daily soy products, soy allergy, and body mass index < 18.5 kg/m².

Participants in the intervention group were asked to avoid animal-derived foods, minimize their use of oils and fatty foods such as nuts and avocados, and include half a cup (86 g) of cooked soybeans daily in their diets. They were also offered 1-hour virtual group meetings each week, in which a registered dietitian or research staff provided information on food preparation and managing common dietary challenges.

Control group participants were asked to continue their usual diets and attend four 1-hour group sessions.

At baseline and then after the 12-week study period, dietary intake was self-recorded for 2 weekdays and 1 weekend day, hot flash frequency and severity was recorded for 1 week using a mobile app, and the effect of menopausal symptoms on quality of life was measured using the vasomotor, psychosocial, physical, and sexual domains of the Menopause-Specific Quality of Life (MENQOL) questionnaire.

Equol production was also assessed in a subset of 15 intervention and 12 control participants who had urinary isoflavone concentrations measured after eating half a cup (86 g) of soybeans twice daily for 3 days. This was based on the theory that diets such as the intervention in this study “seem to foster the growth of gut bacteria capable of converting daidzein to equol,” noted the authors. The ability to produce equol is detected more frequently in individuals following vegetarian diets than in omnivores and … has been proposed as a factor in soy’s apparent health benefits.”

The study found that total hot flash frequency decreased by 78% in the intervention group (P < .001) and 39% (P < .001) in the control group (between-group P = .003), and moderate to severe hot flashes decreased by 88% versus 34%, respectively (from 5.0 to 0.6 per day, P < .001 vs. from 4.4 to 2.9 per day, P < .001; between-group P < .001). Among participants with at least seven moderate to severe hot flashes per day at baseline, moderate to severe hot flashes decreased by 93% (from 10.6 to 0.7 per day) in the intervention group (P < .001) and 36% (from 9.0 to 5.8 per day) in the control group (P = .01, between-group P < .001). The changes in hot flashes were paralleled by changes in the MENQOL findings, with significant between-group differences in the vasomotor (P = 0.004), physical (P = 0.01), and sexual (P = 0.03) domains.

Changes in frequency of severe hot flashes correlated directly with changes in fat intake, and inversely with changes in carbohydrate and fiber intake, such that “the greater the reduction in fat intake and the greater the increases in carbohydrate and fiber consumption, the greater the reduction in severe hot flashes,” noted the researchers. Mean body weight also decreased by 3.6 kg in the intervention group and 0.2 kg in the control group (P < .001). “Equol-production status had no apparent effect on hot flashes,” they added.

The study is the second phase of WAVS, which comprises two parts, the first of which showed similar results, but was conducted in the fall, raising questions about whether cooler temperatures were partly responsible for the results. Phase 2 of WAVS enrolled participants in the spring “ruling out the effect of outside temperature,” noted the authors.

“Eating a healthy diet at midlife is so important for long-term health and a sense of well-being for peri- and postmenopausal women,” said Dr Reed, but she urged caution in interpreting the findings. “This was an unblinded study,” she told this news organization. “Women were recruited to this study anticipating that they would be in a study on a soy diet. Individuals who sign up for a study are hoping for benefit from the intervention. The controls who don’t get the soy diet are often disappointed, so there is no benefit from a nonblinded control arm for their hot flashes. And that is exactly what we saw here. Blinded studies can hide what you are getting, so everyone in the study (intervention and controls) has the same anticipated benefit.  But you cannot blind a soy diet.”

Dr. Reed also noted that, while the biologic mechanism of benefit should be equol production, this was not shown – given that both equol producers and nonproducers in the soy intervention reported marked symptom reduction.

“Only prior studies with estrogen interventions have observed reductions of hot flashes of the amount reported here,” she concluded. “Hopefully future large studies will clarify the role of soy diet for decreasing hot flashes.”

Dr. Barnard writes books and articles and gives lectures related to nutrition and health and has received royalties and honoraria from these sources. Dr. Reed has no relevant disclosures.

Women eating a reduced-fat vegan diet combined with a daily serving of soybeans experienced a 78% reduction in frequency of menopausal hot flashes over 12 weeks, in a small, nonblinded, randomized-controlled trial.

“We do not fully understand yet why this combination works, but it seems that these three elements are key: avoiding animal products, reducing fat, and adding a serving of soybeans,” lead researcher Neal Barnard, MD, explained in a press release. “These new results suggest that a diet change should be considered as a first-line treatment for troublesome vasomotor symptoms, including night sweats and hot flashes,” added Dr. Barnard, who is president of the Physicians Committee for Responsible Medicine, and adjunct professor at George Washington University, Washington. 

Elliott O’Donovan Photography

But, while “the findings from this very small study complement everything we know about the benefits of an excellent diet and the health benefits of soy,” they should be interpreted with some caution, commented Susan Reed, MD, president of the North American Menopause Society, and associate program director of the women’s reproductive research program at the University of Washington, Seattle.

For the trial, called WAVS (Women’s Study for the Alleviation of Vasomotor Symptoms), the researchers randomized 84 postmenopausal women with at least two moderate to severe hot flashes daily to either the intervention or usual diet, with a total of 71 subjects completing the 12-week study, published in Menopause. Criteria for exclusion included any cause of vasomotor symptoms other than natural menopause, current use of a low-fat, vegan diet that includes daily soy products, soy allergy, and body mass index < 18.5 kg/m².

Participants in the intervention group were asked to avoid animal-derived foods, minimize their use of oils and fatty foods such as nuts and avocados, and include half a cup (86 g) of cooked soybeans daily in their diets. They were also offered 1-hour virtual group meetings each week, in which a registered dietitian or research staff provided information on food preparation and managing common dietary challenges.

Control group participants were asked to continue their usual diets and attend four 1-hour group sessions.

At baseline and then after the 12-week study period, dietary intake was self-recorded for 2 weekdays and 1 weekend day, hot flash frequency and severity was recorded for 1 week using a mobile app, and the effect of menopausal symptoms on quality of life was measured using the vasomotor, psychosocial, physical, and sexual domains of the Menopause-Specific Quality of Life (MENQOL) questionnaire.

Equol production was also assessed in a subset of 15 intervention and 12 control participants who had urinary isoflavone concentrations measured after eating half a cup (86 g) of soybeans twice daily for 3 days. This was based on the theory that diets such as the intervention in this study “seem to foster the growth of gut bacteria capable of converting daidzein to equol,” noted the authors. The ability to produce equol is detected more frequently in individuals following vegetarian diets than in omnivores and … has been proposed as a factor in soy’s apparent health benefits.”

The study found that total hot flash frequency decreased by 78% in the intervention group (P < .001) and 39% (P < .001) in the control group (between-group P = .003), and moderate to severe hot flashes decreased by 88% versus 34%, respectively (from 5.0 to 0.6 per day, P < .001 vs. from 4.4 to 2.9 per day, P < .001; between-group P < .001). Among participants with at least seven moderate to severe hot flashes per day at baseline, moderate to severe hot flashes decreased by 93% (from 10.6 to 0.7 per day) in the intervention group (P < .001) and 36% (from 9.0 to 5.8 per day) in the control group (P = .01, between-group P < .001). The changes in hot flashes were paralleled by changes in the MENQOL findings, with significant between-group differences in the vasomotor (P = 0.004), physical (P = 0.01), and sexual (P = 0.03) domains.

Changes in frequency of severe hot flashes correlated directly with changes in fat intake, and inversely with changes in carbohydrate and fiber intake, such that “the greater the reduction in fat intake and the greater the increases in carbohydrate and fiber consumption, the greater the reduction in severe hot flashes,” noted the researchers. Mean body weight also decreased by 3.6 kg in the intervention group and 0.2 kg in the control group (P < .001). “Equol-production status had no apparent effect on hot flashes,” they added.

The study is the second phase of WAVS, which comprises two parts, the first of which showed similar results, but was conducted in the fall, raising questions about whether cooler temperatures were partly responsible for the results. Phase 2 of WAVS enrolled participants in the spring “ruling out the effect of outside temperature,” noted the authors.

“Eating a healthy diet at midlife is so important for long-term health and a sense of well-being for peri- and postmenopausal women,” said Dr Reed, but she urged caution in interpreting the findings. “This was an unblinded study,” she told this news organization. “Women were recruited to this study anticipating that they would be in a study on a soy diet. Individuals who sign up for a study are hoping for benefit from the intervention. The controls who don’t get the soy diet are often disappointed, so there is no benefit from a nonblinded control arm for their hot flashes. And that is exactly what we saw here. Blinded studies can hide what you are getting, so everyone in the study (intervention and controls) has the same anticipated benefit.  But you cannot blind a soy diet.”

Dr. Reed also noted that, while the biologic mechanism of benefit should be equol production, this was not shown – given that both equol producers and nonproducers in the soy intervention reported marked symptom reduction.

“Only prior studies with estrogen interventions have observed reductions of hot flashes of the amount reported here,” she concluded. “Hopefully future large studies will clarify the role of soy diet for decreasing hot flashes.”

Dr. Barnard writes books and articles and gives lectures related to nutrition and health and has received royalties and honoraria from these sources. Dr. Reed has no relevant disclosures.

MONTREAL – Remote assessment of atopic dermatitis (AD) severity is possible through the use of patient-provided clinical photos – opening a new avenue for improving access for patients, as well as the possibility of conducting remote clinical trials that would be less expensive and less burdensome for participants, according to investigators, who presented the study at the annual meeting of the International Society of Atopic Dermatitis.

Still, practical barriers need to be addressed, particularly the problem of image quality, noted study investigator Aviël Ragamin, MD, from the department of dermatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.

“Good-quality images are crucial, [and] in our study, patients didn’t have any incentive to provide images because they had already received their medical consultation,” he explained. He suggested that this problem could be overcome by providing technical support for patients and compensation for trial participants.

The study included 87 children (median age, 7 years), who were assessed for AD severity at an academic outpatient clinic. The in-person visit included assessment with the Eczema Area and Severity Index (EASI) score, as well as the collection of whole-body clinical images. Parents were then asked to return home and to provide their own clinical images and self-administered EASI assessments of their child for comparison. Four raters were asked to rate all images twice and to compare in-clinic and self-administered EASI scores based on the images.

At the in-clinic visit, the median EASI score of the group was 8.8. The majority of patients had moderate (46.6%) or severe (14.8%) AD. Roughly 40% of the patients had darker skin (Fitzpatrick skin types IV–VI).

Using Spearman rank correlation of 1,534 in-clinic and 425 patient-provided images, the study found good inter- and intra-rater reliability for clinical image assessment and strong agreement between images and the in-clinic EASI scores. The top outliers in the assessment were individuals with either darker skin or significant postinflammatory hyperpigmentation, which are “the most difficult cases to rate, based on images,” Dr. Ragamin noted.

There was only moderate correlation between the in-clinic and self-administered EASI scores, with a significant number of patients either underestimating or overestimating their AD severity, he added.

Overall, the main problem with remote assessment seems to be the feasibility of patients providing images, said Dr. Ragamin. Only 36.8% of parents provided any images at all, and of these, 1 of 5 were deemed too blurry, leaving just 13 for final assessment, he explained.

“Pragmatically, it’s tricky,” said Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, who was asked to comment on the study. “It takes long enough to do an EASI score in person, let alone looking through blurry pictures that take too long to load into your electronic medical record. We know it works, but when our hospital went virtual [during the COVID pandemic] ... most of my patients with chronic eczema weren’t even sending me pictures.”

Regarding the utility of remote, full-body photography in clinical practice, he said, “There’s too many feasibility hoops to jump through at this point. The most promise I see is for clinical trials, where it’s hard to get people to come in.”

Dr. Ragamin and Dr. Drucker have disclosed no relevant financial relationships.

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

MONTREAL – Remote assessment of atopic dermatitis (AD) severity is possible through the use of patient-provided clinical photos – opening a new avenue for improving access for patients, as well as the possibility of conducting remote clinical trials that would be less expensive and less burdensome for participants, according to investigators, who presented the study at the annual meeting of the International Society of Atopic Dermatitis.

Still, practical barriers need to be addressed, particularly the problem of image quality, noted study investigator Aviël Ragamin, MD, from the department of dermatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.

“Good-quality images are crucial, [and] in our study, patients didn’t have any incentive to provide images because they had already received their medical consultation,” he explained. He suggested that this problem could be overcome by providing technical support for patients and compensation for trial participants.

The study included 87 children (median age, 7 years), who were assessed for AD severity at an academic outpatient clinic. The in-person visit included assessment with the Eczema Area and Severity Index (EASI) score, as well as the collection of whole-body clinical images. Parents were then asked to return home and to provide their own clinical images and self-administered EASI assessments of their child for comparison. Four raters were asked to rate all images twice and to compare in-clinic and self-administered EASI scores based on the images.

At the in-clinic visit, the median EASI score of the group was 8.8. The majority of patients had moderate (46.6%) or severe (14.8%) AD. Roughly 40% of the patients had darker skin (Fitzpatrick skin types IV–VI).

Using Spearman rank correlation of 1,534 in-clinic and 425 patient-provided images, the study found good inter- and intra-rater reliability for clinical image assessment and strong agreement between images and the in-clinic EASI scores. The top outliers in the assessment were individuals with either darker skin or significant postinflammatory hyperpigmentation, which are “the most difficult cases to rate, based on images,” Dr. Ragamin noted.

There was only moderate correlation between the in-clinic and self-administered EASI scores, with a significant number of patients either underestimating or overestimating their AD severity, he added.

Overall, the main problem with remote assessment seems to be the feasibility of patients providing images, said Dr. Ragamin. Only 36.8% of parents provided any images at all, and of these, 1 of 5 were deemed too blurry, leaving just 13 for final assessment, he explained.

“Pragmatically, it’s tricky,” said Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, who was asked to comment on the study. “It takes long enough to do an EASI score in person, let alone looking through blurry pictures that take too long to load into your electronic medical record. We know it works, but when our hospital went virtual [during the COVID pandemic] ... most of my patients with chronic eczema weren’t even sending me pictures.”

Regarding the utility of remote, full-body photography in clinical practice, he said, “There’s too many feasibility hoops to jump through at this point. The most promise I see is for clinical trials, where it’s hard to get people to come in.”

Dr. Ragamin and Dr. Drucker have disclosed no relevant financial relationships.

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

MONTREAL – Remote assessment of atopic dermatitis (AD) severity is possible through the use of patient-provided clinical photos – opening a new avenue for improving access for patients, as well as the possibility of conducting remote clinical trials that would be less expensive and less burdensome for participants, according to investigators, who presented the study at the annual meeting of the International Society of Atopic Dermatitis.

Still, practical barriers need to be addressed, particularly the problem of image quality, noted study investigator Aviël Ragamin, MD, from the department of dermatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.

“Good-quality images are crucial, [and] in our study, patients didn’t have any incentive to provide images because they had already received their medical consultation,” he explained. He suggested that this problem could be overcome by providing technical support for patients and compensation for trial participants.

The study included 87 children (median age, 7 years), who were assessed for AD severity at an academic outpatient clinic. The in-person visit included assessment with the Eczema Area and Severity Index (EASI) score, as well as the collection of whole-body clinical images. Parents were then asked to return home and to provide their own clinical images and self-administered EASI assessments of their child for comparison. Four raters were asked to rate all images twice and to compare in-clinic and self-administered EASI scores based on the images.

At the in-clinic visit, the median EASI score of the group was 8.8. The majority of patients had moderate (46.6%) or severe (14.8%) AD. Roughly 40% of the patients had darker skin (Fitzpatrick skin types IV–VI).

Using Spearman rank correlation of 1,534 in-clinic and 425 patient-provided images, the study found good inter- and intra-rater reliability for clinical image assessment and strong agreement between images and the in-clinic EASI scores. The top outliers in the assessment were individuals with either darker skin or significant postinflammatory hyperpigmentation, which are “the most difficult cases to rate, based on images,” Dr. Ragamin noted.

There was only moderate correlation between the in-clinic and self-administered EASI scores, with a significant number of patients either underestimating or overestimating their AD severity, he added.

Overall, the main problem with remote assessment seems to be the feasibility of patients providing images, said Dr. Ragamin. Only 36.8% of parents provided any images at all, and of these, 1 of 5 were deemed too blurry, leaving just 13 for final assessment, he explained.

“Pragmatically, it’s tricky,” said Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, who was asked to comment on the study. “It takes long enough to do an EASI score in person, let alone looking through blurry pictures that take too long to load into your electronic medical record. We know it works, but when our hospital went virtual [during the COVID pandemic] ... most of my patients with chronic eczema weren’t even sending me pictures.”

Regarding the utility of remote, full-body photography in clinical practice, he said, “There’s too many feasibility hoops to jump through at this point. The most promise I see is for clinical trials, where it’s hard to get people to come in.”

Dr. Ragamin and Dr. Drucker have disclosed no relevant financial relationships.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

MONTREAL – Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.

“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).

The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.

At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.

“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”

The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.

“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.

“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.

“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”

Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”

He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.

Dr. Williams and Dr. Drucker report no relevant financial relationships.

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

MONTREAL – Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.

“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).

The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.

At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.

“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”

The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.

“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.

“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.

“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”

Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”

He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.

Dr. Williams and Dr. Drucker report no relevant financial relationships.

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

MONTREAL – Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.

“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).

The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.

At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.

“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”

The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.

“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.

“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.

“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”

Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”

He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.

Dr. Williams and Dr. Drucker report no relevant financial relationships.

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

MONTREAL – Systemic treatment of atopic dermatitis (AD) boosts mood in addition to relieving skin symptoms, according to a prospective, real-world, clinical cohort study presented at the annual meeting of the International Society of Atopic Dermatitis.

“Randomized, controlled, phase 3 studies have shown that systemic treatment of AD reduces depressive symptoms, but whether this holds true in real-world cohorts remains to be shown,” said study investigator Lina Ivert, MD, PhD, of the dermatology and venereology unit in the department of medicine at the Karolinska Institutet, Stockholm.

The study used data from SwedAD, a newly launched web-based Swedish national registry of patients with AD on systemic treatment between June 2017 and August 2021. Participants were followed at 6 and 12 months for the primary outcome of depressive symptoms using the Montgomery–Åsberg Depression Rating Scale–self-report (MADRS-S). Secondary outcomes included the Eczema Area and Severity Index (EASI) score, Patient-Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI), and pruritus visual analog scale/numeric rating scale (VAS/NRS).

At baseline, 120 patients (median age, 39 years; 57.5% men) were started on dupilumab (n = 91), methotrexate (26), or cyclosporin (3). Although almost half had no depression at baseline, mild depression was present in 29.2%, with moderate and severe depression in 20% and 4.2%, respectively.

Among 59 patients with 6-month follow-up data (48 on dupilumab, 10 on methotrexate, 1 on cyclosporin), all nine depressive symptoms in MADRS-S improved significantly, with reduced sleep improving the most (from a median of 3 points to a median of 1 point). Similarly, overall MADRS-S scores improved (from a median of 14 points to a median of 5; P < .001), as did EASI scores (from a median of 20.5 to 2), POEM scores (from a median of 22 to 6), DLQI (from a median of 15 to 3), and pruritus scores (from a median of 7.1 to 1.8; all P < .001).

The analysis also found a strong correlation between the MADRS-S score and all of the secondary outcomes (P < .001 for all). All these improvements remained significant among the 36 patients with 12-month follow-up data.

“The median MADRS-S reduction also remained when we excluded eight patients who were on antidepressants during the study period, so these results cannot be explained by psychiatric medication,” noted Dr. Ivert, adding that three patients with severe suicide ideation at baseline improved their MADRS-S suicide item to less than 2 points. “So, this study taught us to look at the suicide item score and not only the total MADRS-S score,” she commented.

Comparing patients treated with dupilumab with those treated with methotrexate, the analysis showed that though baseline median MADRS-S scores did not differ significantly between them, there was a significant 6-month reduction in the dupilumab group but not in the methotrexate group.

Asked to comment on the findings, moderator Marissa Joseph, MD, a pediatric dermatologist at the University of Toronto, said that “the mental health effects of inflammatory skin conditions like atopic dermatitis are well known, but whether or not they are well explored in the patient-physician interaction is a whole other scenario.” There are time constraints, she said, adding, “it sometimes takes some deep-diving ... but exploring those types of symptoms is something we need to do more of, and the severity of the disease and reasons for treatment are not just what you can see.”

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

MONTREAL – Systemic treatment of atopic dermatitis (AD) boosts mood in addition to relieving skin symptoms, according to a prospective, real-world, clinical cohort study presented at the annual meeting of the International Society of Atopic Dermatitis.

“Randomized, controlled, phase 3 studies have shown that systemic treatment of AD reduces depressive symptoms, but whether this holds true in real-world cohorts remains to be shown,” said study investigator Lina Ivert, MD, PhD, of the dermatology and venereology unit in the department of medicine at the Karolinska Institutet, Stockholm.

The study used data from SwedAD, a newly launched web-based Swedish national registry of patients with AD on systemic treatment between June 2017 and August 2021. Participants were followed at 6 and 12 months for the primary outcome of depressive symptoms using the Montgomery–Åsberg Depression Rating Scale–self-report (MADRS-S). Secondary outcomes included the Eczema Area and Severity Index (EASI) score, Patient-Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI), and pruritus visual analog scale/numeric rating scale (VAS/NRS).

At baseline, 120 patients (median age, 39 years; 57.5% men) were started on dupilumab (n = 91), methotrexate (26), or cyclosporin (3). Although almost half had no depression at baseline, mild depression was present in 29.2%, with moderate and severe depression in 20% and 4.2%, respectively.

Among 59 patients with 6-month follow-up data (48 on dupilumab, 10 on methotrexate, 1 on cyclosporin), all nine depressive symptoms in MADRS-S improved significantly, with reduced sleep improving the most (from a median of 3 points to a median of 1 point). Similarly, overall MADRS-S scores improved (from a median of 14 points to a median of 5; P < .001), as did EASI scores (from a median of 20.5 to 2), POEM scores (from a median of 22 to 6), DLQI (from a median of 15 to 3), and pruritus scores (from a median of 7.1 to 1.8; all P < .001).

The analysis also found a strong correlation between the MADRS-S score and all of the secondary outcomes (P < .001 for all). All these improvements remained significant among the 36 patients with 12-month follow-up data.

“The median MADRS-S reduction also remained when we excluded eight patients who were on antidepressants during the study period, so these results cannot be explained by psychiatric medication,” noted Dr. Ivert, adding that three patients with severe suicide ideation at baseline improved their MADRS-S suicide item to less than 2 points. “So, this study taught us to look at the suicide item score and not only the total MADRS-S score,” she commented.

Comparing patients treated with dupilumab with those treated with methotrexate, the analysis showed that though baseline median MADRS-S scores did not differ significantly between them, there was a significant 6-month reduction in the dupilumab group but not in the methotrexate group.

Asked to comment on the findings, moderator Marissa Joseph, MD, a pediatric dermatologist at the University of Toronto, said that “the mental health effects of inflammatory skin conditions like atopic dermatitis are well known, but whether or not they are well explored in the patient-physician interaction is a whole other scenario.” There are time constraints, she said, adding, “it sometimes takes some deep-diving ... but exploring those types of symptoms is something we need to do more of, and the severity of the disease and reasons for treatment are not just what you can see.”

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

MONTREAL – Systemic treatment of atopic dermatitis (AD) boosts mood in addition to relieving skin symptoms, according to a prospective, real-world, clinical cohort study presented at the annual meeting of the International Society of Atopic Dermatitis.

“Randomized, controlled, phase 3 studies have shown that systemic treatment of AD reduces depressive symptoms, but whether this holds true in real-world cohorts remains to be shown,” said study investigator Lina Ivert, MD, PhD, of the dermatology and venereology unit in the department of medicine at the Karolinska Institutet, Stockholm.

The study used data from SwedAD, a newly launched web-based Swedish national registry of patients with AD on systemic treatment between June 2017 and August 2021. Participants were followed at 6 and 12 months for the primary outcome of depressive symptoms using the Montgomery–Åsberg Depression Rating Scale–self-report (MADRS-S). Secondary outcomes included the Eczema Area and Severity Index (EASI) score, Patient-Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI), and pruritus visual analog scale/numeric rating scale (VAS/NRS).

At baseline, 120 patients (median age, 39 years; 57.5% men) were started on dupilumab (n = 91), methotrexate (26), or cyclosporin (3). Although almost half had no depression at baseline, mild depression was present in 29.2%, with moderate and severe depression in 20% and 4.2%, respectively.

Among 59 patients with 6-month follow-up data (48 on dupilumab, 10 on methotrexate, 1 on cyclosporin), all nine depressive symptoms in MADRS-S improved significantly, with reduced sleep improving the most (from a median of 3 points to a median of 1 point). Similarly, overall MADRS-S scores improved (from a median of 14 points to a median of 5; P < .001), as did EASI scores (from a median of 20.5 to 2), POEM scores (from a median of 22 to 6), DLQI (from a median of 15 to 3), and pruritus scores (from a median of 7.1 to 1.8; all P < .001).

The analysis also found a strong correlation between the MADRS-S score and all of the secondary outcomes (P < .001 for all). All these improvements remained significant among the 36 patients with 12-month follow-up data.

“The median MADRS-S reduction also remained when we excluded eight patients who were on antidepressants during the study period, so these results cannot be explained by psychiatric medication,” noted Dr. Ivert, adding that three patients with severe suicide ideation at baseline improved their MADRS-S suicide item to less than 2 points. “So, this study taught us to look at the suicide item score and not only the total MADRS-S score,” she commented.

Comparing patients treated with dupilumab with those treated with methotrexate, the analysis showed that though baseline median MADRS-S scores did not differ significantly between them, there was a significant 6-month reduction in the dupilumab group but not in the methotrexate group.

Asked to comment on the findings, moderator Marissa Joseph, MD, a pediatric dermatologist at the University of Toronto, said that “the mental health effects of inflammatory skin conditions like atopic dermatitis are well known, but whether or not they are well explored in the patient-physician interaction is a whole other scenario.” There are time constraints, she said, adding, “it sometimes takes some deep-diving ... but exploring those types of symptoms is something we need to do more of, and the severity of the disease and reasons for treatment are not just what you can see.”

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

Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.

“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.

“This is a stark lesson that when novel public health emergencies arise, extant ones cannot go by the wayside, or we risk exacerbating them, such as we see here,” he said in an interview.

The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.

Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.

Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.

The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.

Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).

Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.

“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.

The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.

In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).

The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.

Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.

Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”

The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”

The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.

Dr. Morgan and Dr. Gandhi reported no conflicts of interest.

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

Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.

“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.

“This is a stark lesson that when novel public health emergencies arise, extant ones cannot go by the wayside, or we risk exacerbating them, such as we see here,” he said in an interview.

The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.

Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.

Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.

The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.

Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).

Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.

“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.

The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.

In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).

The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.

Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.

Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”

The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”

The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.

Dr. Morgan and Dr. Gandhi reported no conflicts of interest.

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

Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.

“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.

“This is a stark lesson that when novel public health emergencies arise, extant ones cannot go by the wayside, or we risk exacerbating them, such as we see here,” he said in an interview.

The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.

Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.

Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.

The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.

Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).

Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.

“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.

The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.

In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).

The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.

Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.

Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”

The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”

The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.

Dr. Morgan and Dr. Gandhi reported no conflicts of interest.

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

Patients with relapsing multiple sclerosis (MS) treated with intravenous ublituximab had fewer relapses and brain lesions compared with those treated with oral teriflunomide, although both therapies resulted in similar rates of worsening disability, according to results of the two identical phase 3 ULTIMATE I and II trials.

“In these two 96-week trials involving participants with MS, annualized relapse rates were lower with intravenous ublituximab than with oral teriflunomide. Ublituximab was associated with infusion-related reactions. Larger and longer trials are required to determine the efficacy and safety of ublituximab in patients with relapsing MS, including comparison with other disease-modifying treatments such as existing anti-CD20 monoclonal antibodies,” noted lead author Lawrence Steinman, MD, professor of neurology and neurological sciences, pediatrics, and genetics at Stanford (Calif.) University, and colleagues.

Two trials

The double-blind, double-dummy ULTIMATE I and II trials enrolled 549 and 545 participants respectively, with a median follow-up of 95 weeks. Subjects, aged between 18 and 55 years, were randomized to receive either oral placebo and intravenous ublituximab (150 mg on day 1, followed by 450 mg on day 15 and at weeks 24, 48, and 72), or oral teriflunomide (14 mg once daily) and intravenous placebo. The primary endpoint was the annualized relapse rate, defined as the number of confirmed MS relapses per participant-year, with a range of secondary end points including number of lesions on magnetic resonance imaging (MRI) by 96 weeks, and worsening of disability confirmed at 12 weeks.

Prevention and management of infusion-related reactions was with oral antihistamine and dexamethasone, administered 30 to 60 minutes before each intravenous dose of ublituximab or placebo, as well as reductions in infusion flow rates and discretionary acetaminophen.

Results for the primary endpoint in ULTIMATE I showed the adjusted annualized relapse rate over a period of 96 weeks was 0.08 in the ublituximab group and 0.19 in the teriflunomide group (rate ratio, 0.41; P < .001). Corresponding rates for ULTIMATE II were 0.09 and 0.18 (rate ratio, 0.51; P = .002).

The mean number of lesions in both ublituximab arms of the trials was 0.02 and 0.01 compared with 0.49 and 0.25 in the teriflunomide arms (rate ratios 0.03 and 0.04 respectively; P < .001 for both).
 

Similar disability worsening in both groups

A pooled analysis of the two trials showed worsening disability in 5.2% of the ublituximab group, and 5.9% of the teriflunomide group (hazard ratio, 0.84; P = 0.51). “In both trials, teriflunomide was associated with a numerically lower rate of worsening of disability than that reported in previous studies with this drug, but no conclusions can be drawn from these comparisons,” noted the authors.

Infusion-related reactions occurred in 47.7% of the participants in the ublituximab group, consisting mainly of mild to moderate pyrexia, headache, chills, and influenza-like illness. “The reactions may have been related to cytokine release from immune cells (B and NK cells) on interaction of the Fc antibody domain with Fc gamma receptors on effector cells,” they suggested.

Although no opportunistic infections occurred, a higher frequency of infections, including serious infections, was observed with ublituximab (5.0%) than with teriflunomide (2.9%).

While the ULTIMATE trials showed no difference between ublituximab and teriflunomide in confirmed worsening of disability, only a small percentage of participants in either arm showed deterioration, Dr. Coyle remarked. “In a relatively short trial (96 weeks), in a relapsing population on active treatment, this result was not surprising … If the study was bigger, or longer it would increase the chances of seeing a progressive slow worsening component to affect the EDSS [Expanded Disability Status Scale],” she added.
 

Equivalent efficacy

Ultimately, “it appears likely” that ublituximab is “equivalent in efficacy” to the earlier anti-CD20 agents ocrelizumab and ofatumumab, Dr. Coyle said. While all three agents target B-cells, “ublituximab targets a novel CD20 binding site, and is bioengineered to have a particularly potent antibody dependent cell cytotoxicity lysis mechanism,” she added. “It has been touted to ultimately allow a short infusion of 1 hour.”

Although the serious infection rate is slightly higher with ublituximab (5.0% vs. 2.5% for ofatumumab, and 1.3% for ocrelizumab), “it is still low,” and infusion-related reactions are also higher with ublituximab, she added (47.7% vs. 20.2% and 34.3%, respectively). She suggested factors that might influence which treatment is chosen for a given patient might include cost, convenience, whether it is more or less likely to cause low IgG, interference with vaccination, or influence on cancer or COVID risk.

The trials were supported by TG Therapeutics.

Dr. Coyle has received consulting fees from Accordant, Biogen, Bristol Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio and grant funding from Actelion, Alkermes, Bristol Myers Squibb, CorEvitas LLD, Genentech/Roche, Sanofi Genzyme, MedDay, NINDS, and Novartis.

Patients with relapsing multiple sclerosis (MS) treated with intravenous ublituximab had fewer relapses and brain lesions compared with those treated with oral teriflunomide, although both therapies resulted in similar rates of worsening disability, according to results of the two identical phase 3 ULTIMATE I and II trials.

“In these two 96-week trials involving participants with MS, annualized relapse rates were lower with intravenous ublituximab than with oral teriflunomide. Ublituximab was associated with infusion-related reactions. Larger and longer trials are required to determine the efficacy and safety of ublituximab in patients with relapsing MS, including comparison with other disease-modifying treatments such as existing anti-CD20 monoclonal antibodies,” noted lead author Lawrence Steinman, MD, professor of neurology and neurological sciences, pediatrics, and genetics at Stanford (Calif.) University, and colleagues.

Two trials

The double-blind, double-dummy ULTIMATE I and II trials enrolled 549 and 545 participants respectively, with a median follow-up of 95 weeks. Subjects, aged between 18 and 55 years, were randomized to receive either oral placebo and intravenous ublituximab (150 mg on day 1, followed by 450 mg on day 15 and at weeks 24, 48, and 72), or oral teriflunomide (14 mg once daily) and intravenous placebo. The primary endpoint was the annualized relapse rate, defined as the number of confirmed MS relapses per participant-year, with a range of secondary end points including number of lesions on magnetic resonance imaging (MRI) by 96 weeks, and worsening of disability confirmed at 12 weeks.

Prevention and management of infusion-related reactions was with oral antihistamine and dexamethasone, administered 30 to 60 minutes before each intravenous dose of ublituximab or placebo, as well as reductions in infusion flow rates and discretionary acetaminophen.

Results for the primary endpoint in ULTIMATE I showed the adjusted annualized relapse rate over a period of 96 weeks was 0.08 in the ublituximab group and 0.19 in the teriflunomide group (rate ratio, 0.41; P < .001). Corresponding rates for ULTIMATE II were 0.09 and 0.18 (rate ratio, 0.51; P = .002).

The mean number of lesions in both ublituximab arms of the trials was 0.02 and 0.01 compared with 0.49 and 0.25 in the teriflunomide arms (rate ratios 0.03 and 0.04 respectively; P < .001 for both).
 

Similar disability worsening in both groups

A pooled analysis of the two trials showed worsening disability in 5.2% of the ublituximab group, and 5.9% of the teriflunomide group (hazard ratio, 0.84; P = 0.51). “In both trials, teriflunomide was associated with a numerically lower rate of worsening of disability than that reported in previous studies with this drug, but no conclusions can be drawn from these comparisons,” noted the authors.

Infusion-related reactions occurred in 47.7% of the participants in the ublituximab group, consisting mainly of mild to moderate pyrexia, headache, chills, and influenza-like illness. “The reactions may have been related to cytokine release from immune cells (B and NK cells) on interaction of the Fc antibody domain with Fc gamma receptors on effector cells,” they suggested.

Although no opportunistic infections occurred, a higher frequency of infections, including serious infections, was observed with ublituximab (5.0%) than with teriflunomide (2.9%).

While the ULTIMATE trials showed no difference between ublituximab and teriflunomide in confirmed worsening of disability, only a small percentage of participants in either arm showed deterioration, Dr. Coyle remarked. “In a relatively short trial (96 weeks), in a relapsing population on active treatment, this result was not surprising … If the study was bigger, or longer it would increase the chances of seeing a progressive slow worsening component to affect the EDSS [Expanded Disability Status Scale],” she added.
 

Equivalent efficacy

Ultimately, “it appears likely” that ublituximab is “equivalent in efficacy” to the earlier anti-CD20 agents ocrelizumab and ofatumumab, Dr. Coyle said. While all three agents target B-cells, “ublituximab targets a novel CD20 binding site, and is bioengineered to have a particularly potent antibody dependent cell cytotoxicity lysis mechanism,” she added. “It has been touted to ultimately allow a short infusion of 1 hour.”

Although the serious infection rate is slightly higher with ublituximab (5.0% vs. 2.5% for ofatumumab, and 1.3% for ocrelizumab), “it is still low,” and infusion-related reactions are also higher with ublituximab, she added (47.7% vs. 20.2% and 34.3%, respectively). She suggested factors that might influence which treatment is chosen for a given patient might include cost, convenience, whether it is more or less likely to cause low IgG, interference with vaccination, or influence on cancer or COVID risk.

The trials were supported by TG Therapeutics.

Dr. Coyle has received consulting fees from Accordant, Biogen, Bristol Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio and grant funding from Actelion, Alkermes, Bristol Myers Squibb, CorEvitas LLD, Genentech/Roche, Sanofi Genzyme, MedDay, NINDS, and Novartis.

Patients with relapsing multiple sclerosis (MS) treated with intravenous ublituximab had fewer relapses and brain lesions compared with those treated with oral teriflunomide, although both therapies resulted in similar rates of worsening disability, according to results of the two identical phase 3 ULTIMATE I and II trials.

“In these two 96-week trials involving participants with MS, annualized relapse rates were lower with intravenous ublituximab than with oral teriflunomide. Ublituximab was associated with infusion-related reactions. Larger and longer trials are required to determine the efficacy and safety of ublituximab in patients with relapsing MS, including comparison with other disease-modifying treatments such as existing anti-CD20 monoclonal antibodies,” noted lead author Lawrence Steinman, MD, professor of neurology and neurological sciences, pediatrics, and genetics at Stanford (Calif.) University, and colleagues.

Two trials

The double-blind, double-dummy ULTIMATE I and II trials enrolled 549 and 545 participants respectively, with a median follow-up of 95 weeks. Subjects, aged between 18 and 55 years, were randomized to receive either oral placebo and intravenous ublituximab (150 mg on day 1, followed by 450 mg on day 15 and at weeks 24, 48, and 72), or oral teriflunomide (14 mg once daily) and intravenous placebo. The primary endpoint was the annualized relapse rate, defined as the number of confirmed MS relapses per participant-year, with a range of secondary end points including number of lesions on magnetic resonance imaging (MRI) by 96 weeks, and worsening of disability confirmed at 12 weeks.

Prevention and management of infusion-related reactions was with oral antihistamine and dexamethasone, administered 30 to 60 minutes before each intravenous dose of ublituximab or placebo, as well as reductions in infusion flow rates and discretionary acetaminophen.

Results for the primary endpoint in ULTIMATE I showed the adjusted annualized relapse rate over a period of 96 weeks was 0.08 in the ublituximab group and 0.19 in the teriflunomide group (rate ratio, 0.41; P < .001). Corresponding rates for ULTIMATE II were 0.09 and 0.18 (rate ratio, 0.51; P = .002).

The mean number of lesions in both ublituximab arms of the trials was 0.02 and 0.01 compared with 0.49 and 0.25 in the teriflunomide arms (rate ratios 0.03 and 0.04 respectively; P < .001 for both).
 

Similar disability worsening in both groups

A pooled analysis of the two trials showed worsening disability in 5.2% of the ublituximab group, and 5.9% of the teriflunomide group (hazard ratio, 0.84; P = 0.51). “In both trials, teriflunomide was associated with a numerically lower rate of worsening of disability than that reported in previous studies with this drug, but no conclusions can be drawn from these comparisons,” noted the authors.

Infusion-related reactions occurred in 47.7% of the participants in the ublituximab group, consisting mainly of mild to moderate pyrexia, headache, chills, and influenza-like illness. “The reactions may have been related to cytokine release from immune cells (B and NK cells) on interaction of the Fc antibody domain with Fc gamma receptors on effector cells,” they suggested.

Although no opportunistic infections occurred, a higher frequency of infections, including serious infections, was observed with ublituximab (5.0%) than with teriflunomide (2.9%).

While the ULTIMATE trials showed no difference between ublituximab and teriflunomide in confirmed worsening of disability, only a small percentage of participants in either arm showed deterioration, Dr. Coyle remarked. “In a relatively short trial (96 weeks), in a relapsing population on active treatment, this result was not surprising … If the study was bigger, or longer it would increase the chances of seeing a progressive slow worsening component to affect the EDSS [Expanded Disability Status Scale],” she added.
 

Equivalent efficacy

Ultimately, “it appears likely” that ublituximab is “equivalent in efficacy” to the earlier anti-CD20 agents ocrelizumab and ofatumumab, Dr. Coyle said. While all three agents target B-cells, “ublituximab targets a novel CD20 binding site, and is bioengineered to have a particularly potent antibody dependent cell cytotoxicity lysis mechanism,” she added. “It has been touted to ultimately allow a short infusion of 1 hour.”

Although the serious infection rate is slightly higher with ublituximab (5.0% vs. 2.5% for ofatumumab, and 1.3% for ocrelizumab), “it is still low,” and infusion-related reactions are also higher with ublituximab, she added (47.7% vs. 20.2% and 34.3%, respectively). She suggested factors that might influence which treatment is chosen for a given patient might include cost, convenience, whether it is more or less likely to cause low IgG, interference with vaccination, or influence on cancer or COVID risk.

The trials were supported by TG Therapeutics.

Dr. Coyle has received consulting fees from Accordant, Biogen, Bristol Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio and grant funding from Actelion, Alkermes, Bristol Myers Squibb, CorEvitas LLD, Genentech/Roche, Sanofi Genzyme, MedDay, NINDS, and Novartis.