Adolescent Medicine

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

Most adolescents with gender dysphoria who took puberty-blocking drugs for at least 3 months and then progressed to cross-sex hormone treatment were still taking hormones as they entered adulthood, new research of patients at a pioneering Dutch clinic shows.

The study negates past findings that large numbers of youth regret transitioning, say Maria Anna Theodora Catharina van der Loos, MD, and colleagues from the Centre of Expertise on Gender Dysphoria, Amsterdam, in their article published online in The Lancet Child & Adolescent Health. They believe the difference between their findings and those of other studies lies in proper diagnostic evaluation.

“The study aims to demonstrate, with a methodology that is more than adequate, that transgender people who begin their transition in childhood-adolescence do not give up,” Adrián Carrasco Munera, MD, a specialist in family and community medicine and member of the LGTBIQ+ Health Group of the Madrid Society of Family and Community Medicine told the UK Science Media Centre.

The cohort included 720 youth: 220 (31%) were assigned male at birth (AMAB) and 500 (69%) were assigned female at birth (AFAB). At the start of puberty-blocking treatment with a gonadotrophin-releasing hormone agonist, the median age of patients was 14.1 years for AMAB and 16.0 years for AFAB.

Of that cohort, 704 (98%) continued hormone therapy to the end of data collection (Dec. 31, 2018), at which point the median age of patients was 20 years for AMAB and 19 years for AFAB.

Careful consideration of patient needs

All the patients received care at the “Dutch Clinic,” which more than 20 years ago pioneered the approach of giving puberty-blocking drugs to children looking to transition, followed by cross-sex hormones. The study includes the “complete adolescent population” at the facility who met the inclusion criteria.

A similar U.S. study published earlier this year found that 74.4% of individuals who had started gender-affirming hormones before age 18 were still on them 4 years after starting medical treatment.

“However, it is unclear how many of these adolescents [in the U.S. study] used puberty-suppressing treatment before gender-affirming hormone treatment and to what extent they underwent diagnostic evaluation before initiation of medical treatment,” say Dr. van der Loos and colleagues.

She told this news organization that her clinic provides “a thorough diagnostic and mental health assessment” and discussion of fertility preservation prior to any youth being prescribed puberty blockers or cross-sex hormones.

About 40% of adolescents assessed by the gender clinic in Amsterdam go on to receive hormonal treatment.

“The gender identity unit of the Amsterdam UMC is a world leader in all aspects of transgender medicine and is governed by protocolized actions. This is reflected in the quality of the data and methodology of the study, and therefore of its conclusions,” endocrinologist Gilberto Pérez López, MD, Gregorio Marañón General University Hospital, Madrid, told the UK Science Media Centre.

“These findings can and should help and guide the current public and legal debate on the initiation of medical treatment in transgender minors.”

However, he cautioned the study is limited by the fact that the data come from a registry and they looked at only prescriptions issued and not compliance.

Another interesting thing to note in the research is that almost 70% of patients were born girls and they presented at the gender clinics later in adolescence than the natal boys.

“We don’t have a sound reason for this,” Dr. van der Loos noted.

Study limitations

She also acknowledges that the short follow-up data in some individuals make it difficult to draw conclusions about regret, to some extent.

The average use of cross-sex hormones in their study was 3.5 years for males transitioning to females and 2.3 years for females transitioning to males, so on average, this wouldn’t be long enough to see regret, she acknowledged.

Prior research shows that if youth decide to detransition to their natal sex, this can take, on average, 5 years from the start of medical therapy among born females and 7 years among born males.

However, some born males in the study had been taking hormones for 20 years and some natal females for 15 years, said Dr. van der Loos.

Another limitation is that the research only followed individuals until the end of 2018 while some government data estimate that the number of teens identifying as transgender has nearly doubled over the past 5 years.

The authors, Dr. Munera, and Dr. Lopez have reported no relevant financial relationships.

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

Most adolescents with gender dysphoria who took puberty-blocking drugs for at least 3 months and then progressed to cross-sex hormone treatment were still taking hormones as they entered adulthood, new research of patients at a pioneering Dutch clinic shows.

The study negates past findings that large numbers of youth regret transitioning, say Maria Anna Theodora Catharina van der Loos, MD, and colleagues from the Centre of Expertise on Gender Dysphoria, Amsterdam, in their article published online in The Lancet Child & Adolescent Health. They believe the difference between their findings and those of other studies lies in proper diagnostic evaluation.

“The study aims to demonstrate, with a methodology that is more than adequate, that transgender people who begin their transition in childhood-adolescence do not give up,” Adrián Carrasco Munera, MD, a specialist in family and community medicine and member of the LGTBIQ+ Health Group of the Madrid Society of Family and Community Medicine told the UK Science Media Centre.

The cohort included 720 youth: 220 (31%) were assigned male at birth (AMAB) and 500 (69%) were assigned female at birth (AFAB). At the start of puberty-blocking treatment with a gonadotrophin-releasing hormone agonist, the median age of patients was 14.1 years for AMAB and 16.0 years for AFAB.

Of that cohort, 704 (98%) continued hormone therapy to the end of data collection (Dec. 31, 2018), at which point the median age of patients was 20 years for AMAB and 19 years for AFAB.

Careful consideration of patient needs

All the patients received care at the “Dutch Clinic,” which more than 20 years ago pioneered the approach of giving puberty-blocking drugs to children looking to transition, followed by cross-sex hormones. The study includes the “complete adolescent population” at the facility who met the inclusion criteria.

A similar U.S. study published earlier this year found that 74.4% of individuals who had started gender-affirming hormones before age 18 were still on them 4 years after starting medical treatment.

“However, it is unclear how many of these adolescents [in the U.S. study] used puberty-suppressing treatment before gender-affirming hormone treatment and to what extent they underwent diagnostic evaluation before initiation of medical treatment,” say Dr. van der Loos and colleagues.

She told this news organization that her clinic provides “a thorough diagnostic and mental health assessment” and discussion of fertility preservation prior to any youth being prescribed puberty blockers or cross-sex hormones.

About 40% of adolescents assessed by the gender clinic in Amsterdam go on to receive hormonal treatment.

“The gender identity unit of the Amsterdam UMC is a world leader in all aspects of transgender medicine and is governed by protocolized actions. This is reflected in the quality of the data and methodology of the study, and therefore of its conclusions,” endocrinologist Gilberto Pérez López, MD, Gregorio Marañón General University Hospital, Madrid, told the UK Science Media Centre.

“These findings can and should help and guide the current public and legal debate on the initiation of medical treatment in transgender minors.”

However, he cautioned the study is limited by the fact that the data come from a registry and they looked at only prescriptions issued and not compliance.

Another interesting thing to note in the research is that almost 70% of patients were born girls and they presented at the gender clinics later in adolescence than the natal boys.

“We don’t have a sound reason for this,” Dr. van der Loos noted.

Study limitations

She also acknowledges that the short follow-up data in some individuals make it difficult to draw conclusions about regret, to some extent.

The average use of cross-sex hormones in their study was 3.5 years for males transitioning to females and 2.3 years for females transitioning to males, so on average, this wouldn’t be long enough to see regret, she acknowledged.

Prior research shows that if youth decide to detransition to their natal sex, this can take, on average, 5 years from the start of medical therapy among born females and 7 years among born males.

However, some born males in the study had been taking hormones for 20 years and some natal females for 15 years, said Dr. van der Loos.

Another limitation is that the research only followed individuals until the end of 2018 while some government data estimate that the number of teens identifying as transgender has nearly doubled over the past 5 years.

The authors, Dr. Munera, and Dr. Lopez have reported no relevant financial relationships.

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

Most adolescents with gender dysphoria who took puberty-blocking drugs for at least 3 months and then progressed to cross-sex hormone treatment were still taking hormones as they entered adulthood, new research of patients at a pioneering Dutch clinic shows.

The study negates past findings that large numbers of youth regret transitioning, say Maria Anna Theodora Catharina van der Loos, MD, and colleagues from the Centre of Expertise on Gender Dysphoria, Amsterdam, in their article published online in The Lancet Child & Adolescent Health. They believe the difference between their findings and those of other studies lies in proper diagnostic evaluation.

“The study aims to demonstrate, with a methodology that is more than adequate, that transgender people who begin their transition in childhood-adolescence do not give up,” Adrián Carrasco Munera, MD, a specialist in family and community medicine and member of the LGTBIQ+ Health Group of the Madrid Society of Family and Community Medicine told the UK Science Media Centre.

The cohort included 720 youth: 220 (31%) were assigned male at birth (AMAB) and 500 (69%) were assigned female at birth (AFAB). At the start of puberty-blocking treatment with a gonadotrophin-releasing hormone agonist, the median age of patients was 14.1 years for AMAB and 16.0 years for AFAB.

Of that cohort, 704 (98%) continued hormone therapy to the end of data collection (Dec. 31, 2018), at which point the median age of patients was 20 years for AMAB and 19 years for AFAB.

Careful consideration of patient needs

All the patients received care at the “Dutch Clinic,” which more than 20 years ago pioneered the approach of giving puberty-blocking drugs to children looking to transition, followed by cross-sex hormones. The study includes the “complete adolescent population” at the facility who met the inclusion criteria.

A similar U.S. study published earlier this year found that 74.4% of individuals who had started gender-affirming hormones before age 18 were still on them 4 years after starting medical treatment.

“However, it is unclear how many of these adolescents [in the U.S. study] used puberty-suppressing treatment before gender-affirming hormone treatment and to what extent they underwent diagnostic evaluation before initiation of medical treatment,” say Dr. van der Loos and colleagues.

She told this news organization that her clinic provides “a thorough diagnostic and mental health assessment” and discussion of fertility preservation prior to any youth being prescribed puberty blockers or cross-sex hormones.

About 40% of adolescents assessed by the gender clinic in Amsterdam go on to receive hormonal treatment.

“The gender identity unit of the Amsterdam UMC is a world leader in all aspects of transgender medicine and is governed by protocolized actions. This is reflected in the quality of the data and methodology of the study, and therefore of its conclusions,” endocrinologist Gilberto Pérez López, MD, Gregorio Marañón General University Hospital, Madrid, told the UK Science Media Centre.

“These findings can and should help and guide the current public and legal debate on the initiation of medical treatment in transgender minors.”

However, he cautioned the study is limited by the fact that the data come from a registry and they looked at only prescriptions issued and not compliance.

Another interesting thing to note in the research is that almost 70% of patients were born girls and they presented at the gender clinics later in adolescence than the natal boys.

“We don’t have a sound reason for this,” Dr. van der Loos noted.

Study limitations

She also acknowledges that the short follow-up data in some individuals make it difficult to draw conclusions about regret, to some extent.

The average use of cross-sex hormones in their study was 3.5 years for males transitioning to females and 2.3 years for females transitioning to males, so on average, this wouldn’t be long enough to see regret, she acknowledged.

Prior research shows that if youth decide to detransition to their natal sex, this can take, on average, 5 years from the start of medical therapy among born females and 7 years among born males.

However, some born males in the study had been taking hormones for 20 years and some natal females for 15 years, said Dr. van der Loos.

Another limitation is that the research only followed individuals until the end of 2018 while some government data estimate that the number of teens identifying as transgender has nearly doubled over the past 5 years.

The authors, Dr. Munera, and Dr. Lopez have reported no relevant financial relationships.

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

Mental health symptoms at the time of admission to an inpatient psychiatric hospital were significantly more severe during the COVID-19 pandemic compared to the time before the pandemic, based on data from more than 500 individuals.

“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.

In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.

Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).

Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.

Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)

Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.

The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.

However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.

The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.

Mental health symptoms at the time of admission to an inpatient psychiatric hospital were significantly more severe during the COVID-19 pandemic compared to the time before the pandemic, based on data from more than 500 individuals.

“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.

In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.

Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).

Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.

Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)

Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.

The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.

However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.

The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.

Mental health symptoms at the time of admission to an inpatient psychiatric hospital were significantly more severe during the COVID-19 pandemic compared to the time before the pandemic, based on data from more than 500 individuals.

“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.

In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.

Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).

Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.

Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)

Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.

The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.

However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.

The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.

The number of chest reconstruction surgeries performed for adolescents rose nearly fourfold between 2016 and 2019, researchers report in a study published in JAMA Pediatrics.

“To our knowledge, this study is the largest investigation to date of gender-affirming chest reconstruction in a pediatric population. The results demonstrate substantial increases in gender-affirming chest reconstruction for adolescents,” the authors report.

The researchers, from Vanderbilt University School of Medicine, Nashville, Tenn., used the Nationwide Ambulatory Surgery Sample to identify youth with gender dysphoria who underwent top surgery to remove, or, in rare cases, to add breasts.

The authors identified 829 chest surgeries. They adjusted the number to a weighted figure of 1,130 patients who underwent chest reconstruction during the study period. Of those, 98.6% underwent masculinizing surgery to remove breasts, and 1.4% underwent feminizing surgery. Roughly 100 individuals received gender-affirming chest surgeries in 2016. In 2019, the number had risen to 489 – a 389% increase, the authors reported.

Approximately 44% of the patients in the study were aged 17 years at the time of surgery, while 5.5% were younger than 14.

Around 78% of the individuals who underwent chest surgeries in 2019 were White, 2.7% were Black, 12.2% were Hispanic, and 2.5% were Asian or Pacific Islander. Half of the patients who underwent surgery had a household income of $82,000 or more, according to the researchers.

“Most transgender adolescents had either public or private health insurance coverage for these procedures, contrasting with the predominance of self-payers reported in earlier studies on transgender adults,” write the researchers, citing a 2018 study of trends in transgender surgery.

Masculinizing chest reconstruction, such as mastectomy, and feminizing chest reconstruction, such as augmentation mammaplasty, can be performed as outpatient procedures or as ambulatory surgeries, according to another study .

The study was supported by a grant from the National Center for Advancing Translational Sciences Clinical and Translational Science Awards Program. One author has reported receiving grant funding from Merck.

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

The number of chest reconstruction surgeries performed for adolescents rose nearly fourfold between 2016 and 2019, researchers report in a study published in JAMA Pediatrics.

“To our knowledge, this study is the largest investigation to date of gender-affirming chest reconstruction in a pediatric population. The results demonstrate substantial increases in gender-affirming chest reconstruction for adolescents,” the authors report.

The researchers, from Vanderbilt University School of Medicine, Nashville, Tenn., used the Nationwide Ambulatory Surgery Sample to identify youth with gender dysphoria who underwent top surgery to remove, or, in rare cases, to add breasts.

The authors identified 829 chest surgeries. They adjusted the number to a weighted figure of 1,130 patients who underwent chest reconstruction during the study period. Of those, 98.6% underwent masculinizing surgery to remove breasts, and 1.4% underwent feminizing surgery. Roughly 100 individuals received gender-affirming chest surgeries in 2016. In 2019, the number had risen to 489 – a 389% increase, the authors reported.

Approximately 44% of the patients in the study were aged 17 years at the time of surgery, while 5.5% were younger than 14.

Around 78% of the individuals who underwent chest surgeries in 2019 were White, 2.7% were Black, 12.2% were Hispanic, and 2.5% were Asian or Pacific Islander. Half of the patients who underwent surgery had a household income of $82,000 or more, according to the researchers.

“Most transgender adolescents had either public or private health insurance coverage for these procedures, contrasting with the predominance of self-payers reported in earlier studies on transgender adults,” write the researchers, citing a 2018 study of trends in transgender surgery.

Masculinizing chest reconstruction, such as mastectomy, and feminizing chest reconstruction, such as augmentation mammaplasty, can be performed as outpatient procedures or as ambulatory surgeries, according to another study .

The study was supported by a grant from the National Center for Advancing Translational Sciences Clinical and Translational Science Awards Program. One author has reported receiving grant funding from Merck.

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

The number of chest reconstruction surgeries performed for adolescents rose nearly fourfold between 2016 and 2019, researchers report in a study published in JAMA Pediatrics.

“To our knowledge, this study is the largest investigation to date of gender-affirming chest reconstruction in a pediatric population. The results demonstrate substantial increases in gender-affirming chest reconstruction for adolescents,” the authors report.

The researchers, from Vanderbilt University School of Medicine, Nashville, Tenn., used the Nationwide Ambulatory Surgery Sample to identify youth with gender dysphoria who underwent top surgery to remove, or, in rare cases, to add breasts.

The authors identified 829 chest surgeries. They adjusted the number to a weighted figure of 1,130 patients who underwent chest reconstruction during the study period. Of those, 98.6% underwent masculinizing surgery to remove breasts, and 1.4% underwent feminizing surgery. Roughly 100 individuals received gender-affirming chest surgeries in 2016. In 2019, the number had risen to 489 – a 389% increase, the authors reported.

Approximately 44% of the patients in the study were aged 17 years at the time of surgery, while 5.5% were younger than 14.

Around 78% of the individuals who underwent chest surgeries in 2019 were White, 2.7% were Black, 12.2% were Hispanic, and 2.5% were Asian or Pacific Islander. Half of the patients who underwent surgery had a household income of $82,000 or more, according to the researchers.

“Most transgender adolescents had either public or private health insurance coverage for these procedures, contrasting with the predominance of self-payers reported in earlier studies on transgender adults,” write the researchers, citing a 2018 study of trends in transgender surgery.

Masculinizing chest reconstruction, such as mastectomy, and feminizing chest reconstruction, such as augmentation mammaplasty, can be performed as outpatient procedures or as ambulatory surgeries, according to another study .

The study was supported by a grant from the National Center for Advancing Translational Sciences Clinical and Translational Science Awards Program. One author has reported receiving grant funding from Merck.

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

Teens diagnosed with attention-deficit/hyperactivity disorder in childhood reported similar overall quality of life compared with teens with ADHD behaviors but no childhood diagnosis, a new study finds.

The results align with findings from other studies suggesting lower quality of life (QOL) in teens with ADHD, but the current study is the first known to focus on the association between ADHD diagnosis itself vs. ADHD symptoms, and QOL, the researchers wrote. The findings show that at least some of the reduced QOL is associated with the diagnosis itself, they explained.

The researchers directly compared 393 teens with a childhood ADHD diagnosis to 393 matched teens with no ADHD diagnosis but who had hyperactive/inattentive behaviors.

The researchers reviewed self-reports from individuals who were enrolled in a population-based prospective study in Australia. The primary outcome was quality of life at age 14-15, which was measured with Child Health Utility 9D (CHU9D), a validated quality of life measure.
 

Study results

Overall, teens with and without an ADHD diagnosis reported similar levels of overall quality of life; the mean difference in the primary outcome CHU9D score was –0.03 (P = .10). Teens with and without an ADHD diagnosis also showed similar scores on measures of general health, happiness, and peer trust, the researchers noted.

The researchers also reviewed eight other prespecified, self-reported measures: academic self-concept, global health, negative social behaviors, overall happiness, peer trust, psychological sense of school membership, self-efficacy, and self-harm.

Teens diagnosed with ADHD in childhood were more than twice as likely to report self-harm (odds ratio 2.53, P less than .001) and displayed significantly more negative social behaviors (mean difference 1.56, P = .002), compared with teens without an ADHD diagnosis.

Teens diagnosed with ADHD in childhood also scored significantly worse on measures of sense of school membership (mean difference −2.58, P less than .001), academic self-concept (mean difference, −0.14; P = .02), and self-efficacy (mean difference −0.20; P = .007), compared to teens without an ADHD diagnosis.

The average age at ADHD diagnosis was 10 years, and 72% of the ADHD-diagnosed group were boys. No significant differences were noted for levels of hyperactive/inattentive behaviors and between girls and boys, but girls overall and children with the highest levels of hyperactive and inattentive behaviors reported generally worse outcomes, regardless of ADHD diagnosis, the researchers noted.
 

Don’t rush to diagnosis

Although rates of ADHD diagnosis in children continue to rise, the prevalence of hyperactivity and inattentive behaviors appears stable, which suggests a problem with diagnosis, senior author Alexandra Barratt, MBBS, MPH, PhD, professor of public health at the University of Sydney, Australia, said in an interview.

“Our hypothesis was that children who had been diagnosed, and we assume treated for, ADHD would have better outcomes, compared to children matched for hyperactivity/inattention behaviors who were left undiagnosed and untreated, but we were surprised to find that, at best, outcomes were unchanged, and for some outcomes, worse,” Dr. Barratt said.

“Our study provides evidence that diagnosing ADHD may lead, inadvertently, to long-term harms, particularly for children with mild or borderline hyperactivity and inattention behaviors,” she emphasized.

“We can’t say from this study what to do instead, but previously one of our team has looked at stepped diagnosis as an alternative option for children with mild or borderline hyperactivity and inattention behaviors,” she said.

The stepped diagnosis includes such actions as gathering behavior data from multiple sources, and conducting a period of watchful waiting without presumption of a diagnosis or active treatment.

Given the findings of the new study, “I would ask that health professionals considering a child who may have ADHD be aware that there is an evidence gap around the long-term impact of an ADHD diagnosis on children, and to proceed cautiously,” Dr. Barratt said. As for additional research, independent, high-quality, randomized controlled trials of ADHD diagnosis in children with mild or borderline hyperactivity/inattention behaviors are urgently needed, with long-term, patient-centered outcomes including quality of life she noted.

ADHD screening needs improvement

The incidence and prevalence of ADHD is on the rise, but much of the perceived increase in ADHD may be due to overdiagnosis, “and a lack of robust thorough psychological testing as standard of care for diagnosis,” Peter Loper, MD, a pediatrician and psychiatrist at the University of South Carolina, Columbia, said in an interview.

The current study “reinforces the necessity of consistent screening for comorbid mental health problems, and specifically for thoughts of self-harm, in those children who are diagnosed with ADHD,” he said.

Expressing his lack of astonishment about the study findings, Dr. Loper said: “Previous data indicates that while following initial diagnosis of a medical or mental health problem, patients may experience a sense of relief; however, this is followed shortly thereafter by feelings of insufficiency or anxiety related to their specific diagnosis.”

“As it stands now, ADHD is often diagnosed in children and adolescents using basic screening questionnaires,” said Dr. Loper. “The findings of this study may bolster calls for more robust and thorough psychological testing for supporting the diagnosis of ADHD,” he said.

Individuals diagnosed with ADHD can sometimes have difficulty with social skills and relating to others, said Dr. Loper. “They may be more prone to internalize their poor school performance as due to being ‘stupid’ or ‘dumb,’ ” he said. Children and teens with ADHD should, whenever possible, be involved in extracurricular activities that support the development of social skills, he said. Parents’ praise of the process/effort, rather than focusing only on outcomes such as grades, is very important for the esteem of children and teens with ADHD, he added.

The study limitations included the use of observational data vs. data from randomized trials, and the potential for confounding factors in propensity scoring, the researchers wrote. Additional limitations include the size of the sample, which may have been too small to detect additional differences between diagnosed teens and matched controls, they noted.

“As the study authors appropriately cite, a large, randomized trial would be very helpful in supporting additional understanding of this issue,” Dr. Loper added.

The study was supported by the National Health and Medical Research Council The researchers and Dr. Loper had no financial conflicts to disclose.

Teens diagnosed with attention-deficit/hyperactivity disorder in childhood reported similar overall quality of life compared with teens with ADHD behaviors but no childhood diagnosis, a new study finds.

The results align with findings from other studies suggesting lower quality of life (QOL) in teens with ADHD, but the current study is the first known to focus on the association between ADHD diagnosis itself vs. ADHD symptoms, and QOL, the researchers wrote. The findings show that at least some of the reduced QOL is associated with the diagnosis itself, they explained.

The researchers directly compared 393 teens with a childhood ADHD diagnosis to 393 matched teens with no ADHD diagnosis but who had hyperactive/inattentive behaviors.

The researchers reviewed self-reports from individuals who were enrolled in a population-based prospective study in Australia. The primary outcome was quality of life at age 14-15, which was measured with Child Health Utility 9D (CHU9D), a validated quality of life measure.
 

Study results

Overall, teens with and without an ADHD diagnosis reported similar levels of overall quality of life; the mean difference in the primary outcome CHU9D score was –0.03 (P = .10). Teens with and without an ADHD diagnosis also showed similar scores on measures of general health, happiness, and peer trust, the researchers noted.

The researchers also reviewed eight other prespecified, self-reported measures: academic self-concept, global health, negative social behaviors, overall happiness, peer trust, psychological sense of school membership, self-efficacy, and self-harm.

Teens diagnosed with ADHD in childhood were more than twice as likely to report self-harm (odds ratio 2.53, P less than .001) and displayed significantly more negative social behaviors (mean difference 1.56, P = .002), compared with teens without an ADHD diagnosis.

Teens diagnosed with ADHD in childhood also scored significantly worse on measures of sense of school membership (mean difference −2.58, P less than .001), academic self-concept (mean difference, −0.14; P = .02), and self-efficacy (mean difference −0.20; P = .007), compared to teens without an ADHD diagnosis.

The average age at ADHD diagnosis was 10 years, and 72% of the ADHD-diagnosed group were boys. No significant differences were noted for levels of hyperactive/inattentive behaviors and between girls and boys, but girls overall and children with the highest levels of hyperactive and inattentive behaviors reported generally worse outcomes, regardless of ADHD diagnosis, the researchers noted.
 

Don’t rush to diagnosis

Although rates of ADHD diagnosis in children continue to rise, the prevalence of hyperactivity and inattentive behaviors appears stable, which suggests a problem with diagnosis, senior author Alexandra Barratt, MBBS, MPH, PhD, professor of public health at the University of Sydney, Australia, said in an interview.

“Our hypothesis was that children who had been diagnosed, and we assume treated for, ADHD would have better outcomes, compared to children matched for hyperactivity/inattention behaviors who were left undiagnosed and untreated, but we were surprised to find that, at best, outcomes were unchanged, and for some outcomes, worse,” Dr. Barratt said.

“Our study provides evidence that diagnosing ADHD may lead, inadvertently, to long-term harms, particularly for children with mild or borderline hyperactivity and inattention behaviors,” she emphasized.

“We can’t say from this study what to do instead, but previously one of our team has looked at stepped diagnosis as an alternative option for children with mild or borderline hyperactivity and inattention behaviors,” she said.

The stepped diagnosis includes such actions as gathering behavior data from multiple sources, and conducting a period of watchful waiting without presumption of a diagnosis or active treatment.

Given the findings of the new study, “I would ask that health professionals considering a child who may have ADHD be aware that there is an evidence gap around the long-term impact of an ADHD diagnosis on children, and to proceed cautiously,” Dr. Barratt said. As for additional research, independent, high-quality, randomized controlled trials of ADHD diagnosis in children with mild or borderline hyperactivity/inattention behaviors are urgently needed, with long-term, patient-centered outcomes including quality of life she noted.

ADHD screening needs improvement

The incidence and prevalence of ADHD is on the rise, but much of the perceived increase in ADHD may be due to overdiagnosis, “and a lack of robust thorough psychological testing as standard of care for diagnosis,” Peter Loper, MD, a pediatrician and psychiatrist at the University of South Carolina, Columbia, said in an interview.

The current study “reinforces the necessity of consistent screening for comorbid mental health problems, and specifically for thoughts of self-harm, in those children who are diagnosed with ADHD,” he said.

Expressing his lack of astonishment about the study findings, Dr. Loper said: “Previous data indicates that while following initial diagnosis of a medical or mental health problem, patients may experience a sense of relief; however, this is followed shortly thereafter by feelings of insufficiency or anxiety related to their specific diagnosis.”

“As it stands now, ADHD is often diagnosed in children and adolescents using basic screening questionnaires,” said Dr. Loper. “The findings of this study may bolster calls for more robust and thorough psychological testing for supporting the diagnosis of ADHD,” he said.

Individuals diagnosed with ADHD can sometimes have difficulty with social skills and relating to others, said Dr. Loper. “They may be more prone to internalize their poor school performance as due to being ‘stupid’ or ‘dumb,’ ” he said. Children and teens with ADHD should, whenever possible, be involved in extracurricular activities that support the development of social skills, he said. Parents’ praise of the process/effort, rather than focusing only on outcomes such as grades, is very important for the esteem of children and teens with ADHD, he added.

The study limitations included the use of observational data vs. data from randomized trials, and the potential for confounding factors in propensity scoring, the researchers wrote. Additional limitations include the size of the sample, which may have been too small to detect additional differences between diagnosed teens and matched controls, they noted.

“As the study authors appropriately cite, a large, randomized trial would be very helpful in supporting additional understanding of this issue,” Dr. Loper added.

The study was supported by the National Health and Medical Research Council The researchers and Dr. Loper had no financial conflicts to disclose.

Teens diagnosed with attention-deficit/hyperactivity disorder in childhood reported similar overall quality of life compared with teens with ADHD behaviors but no childhood diagnosis, a new study finds.

The results align with findings from other studies suggesting lower quality of life (QOL) in teens with ADHD, but the current study is the first known to focus on the association between ADHD diagnosis itself vs. ADHD symptoms, and QOL, the researchers wrote. The findings show that at least some of the reduced QOL is associated with the diagnosis itself, they explained.

The researchers directly compared 393 teens with a childhood ADHD diagnosis to 393 matched teens with no ADHD diagnosis but who had hyperactive/inattentive behaviors.

The researchers reviewed self-reports from individuals who were enrolled in a population-based prospective study in Australia. The primary outcome was quality of life at age 14-15, which was measured with Child Health Utility 9D (CHU9D), a validated quality of life measure.
 

Study results

Overall, teens with and without an ADHD diagnosis reported similar levels of overall quality of life; the mean difference in the primary outcome CHU9D score was –0.03 (P = .10). Teens with and without an ADHD diagnosis also showed similar scores on measures of general health, happiness, and peer trust, the researchers noted.

The researchers also reviewed eight other prespecified, self-reported measures: academic self-concept, global health, negative social behaviors, overall happiness, peer trust, psychological sense of school membership, self-efficacy, and self-harm.

Teens diagnosed with ADHD in childhood were more than twice as likely to report self-harm (odds ratio 2.53, P less than .001) and displayed significantly more negative social behaviors (mean difference 1.56, P = .002), compared with teens without an ADHD diagnosis.

Teens diagnosed with ADHD in childhood also scored significantly worse on measures of sense of school membership (mean difference −2.58, P less than .001), academic self-concept (mean difference, −0.14; P = .02), and self-efficacy (mean difference −0.20; P = .007), compared to teens without an ADHD diagnosis.

The average age at ADHD diagnosis was 10 years, and 72% of the ADHD-diagnosed group were boys. No significant differences were noted for levels of hyperactive/inattentive behaviors and between girls and boys, but girls overall and children with the highest levels of hyperactive and inattentive behaviors reported generally worse outcomes, regardless of ADHD diagnosis, the researchers noted.
 

Don’t rush to diagnosis

Although rates of ADHD diagnosis in children continue to rise, the prevalence of hyperactivity and inattentive behaviors appears stable, which suggests a problem with diagnosis, senior author Alexandra Barratt, MBBS, MPH, PhD, professor of public health at the University of Sydney, Australia, said in an interview.

“Our hypothesis was that children who had been diagnosed, and we assume treated for, ADHD would have better outcomes, compared to children matched for hyperactivity/inattention behaviors who were left undiagnosed and untreated, but we were surprised to find that, at best, outcomes were unchanged, and for some outcomes, worse,” Dr. Barratt said.

“Our study provides evidence that diagnosing ADHD may lead, inadvertently, to long-term harms, particularly for children with mild or borderline hyperactivity and inattention behaviors,” she emphasized.

“We can’t say from this study what to do instead, but previously one of our team has looked at stepped diagnosis as an alternative option for children with mild or borderline hyperactivity and inattention behaviors,” she said.

The stepped diagnosis includes such actions as gathering behavior data from multiple sources, and conducting a period of watchful waiting without presumption of a diagnosis or active treatment.

Given the findings of the new study, “I would ask that health professionals considering a child who may have ADHD be aware that there is an evidence gap around the long-term impact of an ADHD diagnosis on children, and to proceed cautiously,” Dr. Barratt said. As for additional research, independent, high-quality, randomized controlled trials of ADHD diagnosis in children with mild or borderline hyperactivity/inattention behaviors are urgently needed, with long-term, patient-centered outcomes including quality of life she noted.

ADHD screening needs improvement

The incidence and prevalence of ADHD is on the rise, but much of the perceived increase in ADHD may be due to overdiagnosis, “and a lack of robust thorough psychological testing as standard of care for diagnosis,” Peter Loper, MD, a pediatrician and psychiatrist at the University of South Carolina, Columbia, said in an interview.

The current study “reinforces the necessity of consistent screening for comorbid mental health problems, and specifically for thoughts of self-harm, in those children who are diagnosed with ADHD,” he said.

Expressing his lack of astonishment about the study findings, Dr. Loper said: “Previous data indicates that while following initial diagnosis of a medical or mental health problem, patients may experience a sense of relief; however, this is followed shortly thereafter by feelings of insufficiency or anxiety related to their specific diagnosis.”

“As it stands now, ADHD is often diagnosed in children and adolescents using basic screening questionnaires,” said Dr. Loper. “The findings of this study may bolster calls for more robust and thorough psychological testing for supporting the diagnosis of ADHD,” he said.

Individuals diagnosed with ADHD can sometimes have difficulty with social skills and relating to others, said Dr. Loper. “They may be more prone to internalize their poor school performance as due to being ‘stupid’ or ‘dumb,’ ” he said. Children and teens with ADHD should, whenever possible, be involved in extracurricular activities that support the development of social skills, he said. Parents’ praise of the process/effort, rather than focusing only on outcomes such as grades, is very important for the esteem of children and teens with ADHD, he added.

The study limitations included the use of observational data vs. data from randomized trials, and the potential for confounding factors in propensity scoring, the researchers wrote. Additional limitations include the size of the sample, which may have been too small to detect additional differences between diagnosed teens and matched controls, they noted.

“As the study authors appropriately cite, a large, randomized trial would be very helpful in supporting additional understanding of this issue,” Dr. Loper added.

The study was supported by the National Health and Medical Research Council The researchers and Dr. Loper had no financial conflicts to disclose.

Geographic location within the United States appears to have an impact on the specific symptoms of polycystic ovary syndrome (PCOS) that any one particular woman will develop, according to a new prospective cohort study.

Women in California were more likely to exhibit high levels of testosterone (hyperandrogenism), while women in Alabama with PCOS had more metabolic dysfunction and hirsutism.

And although the women in Alabama were younger and had a higher body mass index (BMI), even after adjusting for these factors, the clinical differences were still present between the geographic locations, the authors said.

“This study suggests there are regional differences in hormonal and metabolic parameters in women with PCOS in California and Alabama, highlighting the impact of differing genetic and environmental modulators on PCOS development,” Katherine VanHise, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues wrote in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
 

Genetic and environmental factors play a role

Prior research has looked at variations in symptoms of PCOS across countries and identified differences in hirsutism and its prevalence, which is greater in Middle Eastern, Mediterranean, and Indian women, noted senior author Margareta D. Pisarska, MD.

And women of some other backgrounds “are at increased risk of developing metabolic syndrome and insulin resistance, including South Asian, African, and Hispanic women, so they are at a greater risk trajectory of developing manifestations later on in life that can ultimately lead to adverse outcomes in overall health,” Dr. Pisarska, director of the division of reproductive endocrinology and infertility in obstetrics and gynecology at Cedars-Sinai, told this news organization.

“We do see regional differences in the diagnosis of PCOS [in the United States] as well as the manifestations of PCOS including high andrenoemia, hirsutism, and metabolic parameters ... and we need to better understand it because, at least in the entire population, weight was not the entire factor contributing to these differences,” she explained.

“So there are definitely environmental factors and possibly genetic factors that we need to take into consideration as we try to study these women and try to help them decrease their risk of metabolic syndrome later in life,” she noted.
 

Differences not attributable to race either

PCOS is a common endocrine disorder affecting women and female adolescents worldwide. Diagnosis usually requires at least two of the following to be present: ovulatory dysfunction, hyperandrogenism, and/or polycystic ovarian morphology.

Because of the prior work that had identified differences in symptoms among women with PCOS in different countries, the investigators set out to determine if women of the same race would have distinct hormonal and metabolic traits of PCOS in two geographical locations in the United States, suggesting geo-epidemiologic contributors of the disease

They evaluated 889 women at the University of Alabama at Birmingham and 721 at Cedars-Sinai Medical Center. Participants in Birmingham were a mean age of 28 years, had a mean BMI of 33.1 kg/m2, a mean waist-to-hip ratio of 0.8, and a mean hirsute rate of 84.6%. Participants in California were a mean age of 29.5 years, had an average BMI of 30.1 kg/m2, a mean waist-to-hip ratio of 0.9, and a mean hirsute rate of 72.8%.

The study team gathered data on menstrual cycle history, metabolic and hormonal parameters, and demographic data for each participant. They assessed hirsutism based on modified Ferriman-Gallwey scores of four or more. Patients were classified as having hyperandrogenemia if they had elevated androgen values greater than the 95th percentile of all values or androgen values that exceeded laboratory reference ranges.

The findings showed that Alabama women with PCOS had elevated homeostatic model assessment for insulin resistance scores (adjusted beta coefficient, 3.6; P < .001) and were more likely to be hirsute (adjusted odds ratio, 1.8; P < .001) after adjustment for BMI and age than those in California.

In contrast, women with PCOS in California were more likely to have elevated free testosterone and total testosterone values than women in Alabama (both P < .001). These findings persisted after adjusting for age and BMI.

When stratified by White race, these findings were similar. Notably, BMI and waist-to-hip ratio did not vary between regions in Black women with PCOS, although variations in metabolic dysfunction and androgen profiles persisted.

“This study supports regional differences in hormonal and metabolic parameters in women with PCOS in the United States, highlighting the impact of the environment on PCOS phenotype. Individuals of the same race in different geographical locations of the United States may have differing genetic predispositions for developing diseases such as PCOS,” the researchers said.

“Ongoing research is needed to identify modifiable environmental risk factors for PCOS that may be race and ethnic specific to bring precision medicine to the management of PCOS,” they conclude.

This work was supported in part by grants from the National Institutes of Health and an endowment of the Helping Hand of Los Angeles. Dr. VanHise reported no relevant financial relationships.

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

Geographic location within the United States appears to have an impact on the specific symptoms of polycystic ovary syndrome (PCOS) that any one particular woman will develop, according to a new prospective cohort study.

Women in California were more likely to exhibit high levels of testosterone (hyperandrogenism), while women in Alabama with PCOS had more metabolic dysfunction and hirsutism.

And although the women in Alabama were younger and had a higher body mass index (BMI), even after adjusting for these factors, the clinical differences were still present between the geographic locations, the authors said.

“This study suggests there are regional differences in hormonal and metabolic parameters in women with PCOS in California and Alabama, highlighting the impact of differing genetic and environmental modulators on PCOS development,” Katherine VanHise, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues wrote in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
 

Genetic and environmental factors play a role

Prior research has looked at variations in symptoms of PCOS across countries and identified differences in hirsutism and its prevalence, which is greater in Middle Eastern, Mediterranean, and Indian women, noted senior author Margareta D. Pisarska, MD.

And women of some other backgrounds “are at increased risk of developing metabolic syndrome and insulin resistance, including South Asian, African, and Hispanic women, so they are at a greater risk trajectory of developing manifestations later on in life that can ultimately lead to adverse outcomes in overall health,” Dr. Pisarska, director of the division of reproductive endocrinology and infertility in obstetrics and gynecology at Cedars-Sinai, told this news organization.

“We do see regional differences in the diagnosis of PCOS [in the United States] as well as the manifestations of PCOS including high andrenoemia, hirsutism, and metabolic parameters ... and we need to better understand it because, at least in the entire population, weight was not the entire factor contributing to these differences,” she explained.

“So there are definitely environmental factors and possibly genetic factors that we need to take into consideration as we try to study these women and try to help them decrease their risk of metabolic syndrome later in life,” she noted.
 

Differences not attributable to race either

PCOS is a common endocrine disorder affecting women and female adolescents worldwide. Diagnosis usually requires at least two of the following to be present: ovulatory dysfunction, hyperandrogenism, and/or polycystic ovarian morphology.

Because of the prior work that had identified differences in symptoms among women with PCOS in different countries, the investigators set out to determine if women of the same race would have distinct hormonal and metabolic traits of PCOS in two geographical locations in the United States, suggesting geo-epidemiologic contributors of the disease

They evaluated 889 women at the University of Alabama at Birmingham and 721 at Cedars-Sinai Medical Center. Participants in Birmingham were a mean age of 28 years, had a mean BMI of 33.1 kg/m2, a mean waist-to-hip ratio of 0.8, and a mean hirsute rate of 84.6%. Participants in California were a mean age of 29.5 years, had an average BMI of 30.1 kg/m2, a mean waist-to-hip ratio of 0.9, and a mean hirsute rate of 72.8%.

The study team gathered data on menstrual cycle history, metabolic and hormonal parameters, and demographic data for each participant. They assessed hirsutism based on modified Ferriman-Gallwey scores of four or more. Patients were classified as having hyperandrogenemia if they had elevated androgen values greater than the 95th percentile of all values or androgen values that exceeded laboratory reference ranges.

The findings showed that Alabama women with PCOS had elevated homeostatic model assessment for insulin resistance scores (adjusted beta coefficient, 3.6; P < .001) and were more likely to be hirsute (adjusted odds ratio, 1.8; P < .001) after adjustment for BMI and age than those in California.

In contrast, women with PCOS in California were more likely to have elevated free testosterone and total testosterone values than women in Alabama (both P < .001). These findings persisted after adjusting for age and BMI.

When stratified by White race, these findings were similar. Notably, BMI and waist-to-hip ratio did not vary between regions in Black women with PCOS, although variations in metabolic dysfunction and androgen profiles persisted.

“This study supports regional differences in hormonal and metabolic parameters in women with PCOS in the United States, highlighting the impact of the environment on PCOS phenotype. Individuals of the same race in different geographical locations of the United States may have differing genetic predispositions for developing diseases such as PCOS,” the researchers said.

“Ongoing research is needed to identify modifiable environmental risk factors for PCOS that may be race and ethnic specific to bring precision medicine to the management of PCOS,” they conclude.

This work was supported in part by grants from the National Institutes of Health and an endowment of the Helping Hand of Los Angeles. Dr. VanHise reported no relevant financial relationships.

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

Geographic location within the United States appears to have an impact on the specific symptoms of polycystic ovary syndrome (PCOS) that any one particular woman will develop, according to a new prospective cohort study.

Women in California were more likely to exhibit high levels of testosterone (hyperandrogenism), while women in Alabama with PCOS had more metabolic dysfunction and hirsutism.

And although the women in Alabama were younger and had a higher body mass index (BMI), even after adjusting for these factors, the clinical differences were still present between the geographic locations, the authors said.

“This study suggests there are regional differences in hormonal and metabolic parameters in women with PCOS in California and Alabama, highlighting the impact of differing genetic and environmental modulators on PCOS development,” Katherine VanHise, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues wrote in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
 

Genetic and environmental factors play a role

Prior research has looked at variations in symptoms of PCOS across countries and identified differences in hirsutism and its prevalence, which is greater in Middle Eastern, Mediterranean, and Indian women, noted senior author Margareta D. Pisarska, MD.

And women of some other backgrounds “are at increased risk of developing metabolic syndrome and insulin resistance, including South Asian, African, and Hispanic women, so they are at a greater risk trajectory of developing manifestations later on in life that can ultimately lead to adverse outcomes in overall health,” Dr. Pisarska, director of the division of reproductive endocrinology and infertility in obstetrics and gynecology at Cedars-Sinai, told this news organization.

“We do see regional differences in the diagnosis of PCOS [in the United States] as well as the manifestations of PCOS including high andrenoemia, hirsutism, and metabolic parameters ... and we need to better understand it because, at least in the entire population, weight was not the entire factor contributing to these differences,” she explained.

“So there are definitely environmental factors and possibly genetic factors that we need to take into consideration as we try to study these women and try to help them decrease their risk of metabolic syndrome later in life,” she noted.
 

Differences not attributable to race either

PCOS is a common endocrine disorder affecting women and female adolescents worldwide. Diagnosis usually requires at least two of the following to be present: ovulatory dysfunction, hyperandrogenism, and/or polycystic ovarian morphology.

Because of the prior work that had identified differences in symptoms among women with PCOS in different countries, the investigators set out to determine if women of the same race would have distinct hormonal and metabolic traits of PCOS in two geographical locations in the United States, suggesting geo-epidemiologic contributors of the disease

They evaluated 889 women at the University of Alabama at Birmingham and 721 at Cedars-Sinai Medical Center. Participants in Birmingham were a mean age of 28 years, had a mean BMI of 33.1 kg/m2, a mean waist-to-hip ratio of 0.8, and a mean hirsute rate of 84.6%. Participants in California were a mean age of 29.5 years, had an average BMI of 30.1 kg/m2, a mean waist-to-hip ratio of 0.9, and a mean hirsute rate of 72.8%.

The study team gathered data on menstrual cycle history, metabolic and hormonal parameters, and demographic data for each participant. They assessed hirsutism based on modified Ferriman-Gallwey scores of four or more. Patients were classified as having hyperandrogenemia if they had elevated androgen values greater than the 95th percentile of all values or androgen values that exceeded laboratory reference ranges.

The findings showed that Alabama women with PCOS had elevated homeostatic model assessment for insulin resistance scores (adjusted beta coefficient, 3.6; P < .001) and were more likely to be hirsute (adjusted odds ratio, 1.8; P < .001) after adjustment for BMI and age than those in California.

In contrast, women with PCOS in California were more likely to have elevated free testosterone and total testosterone values than women in Alabama (both P < .001). These findings persisted after adjusting for age and BMI.

When stratified by White race, these findings were similar. Notably, BMI and waist-to-hip ratio did not vary between regions in Black women with PCOS, although variations in metabolic dysfunction and androgen profiles persisted.

“This study supports regional differences in hormonal and metabolic parameters in women with PCOS in the United States, highlighting the impact of the environment on PCOS phenotype. Individuals of the same race in different geographical locations of the United States may have differing genetic predispositions for developing diseases such as PCOS,” the researchers said.

“Ongoing research is needed to identify modifiable environmental risk factors for PCOS that may be race and ethnic specific to bring precision medicine to the management of PCOS,” they conclude.

This work was supported in part by grants from the National Institutes of Health and an endowment of the Helping Hand of Los Angeles. Dr. VanHise reported no relevant financial relationships.

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

More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they worry even more than in the past about their patients and the risk of accidental pregnancies. Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.

The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.

As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.

“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.

The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.

But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”

The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
 

Methotrexate prescriptions

Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”

“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”

The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.

Perspective: A Georgia dermatologist

Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.

That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.

Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”

Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
 

Perspective: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.

And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
 

Perspective: A Connecticut dermatologist

The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.

Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”

For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.

Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”

Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
 

Need for EC education

In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.

The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.

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

More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they worry even more than in the past about their patients and the risk of accidental pregnancies. Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.

The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.

As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.

“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.

The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.

But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”

The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
 

Methotrexate prescriptions

Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”

“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”

The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.

Perspective: A Georgia dermatologist

Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.

That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.

Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”

Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
 

Perspective: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.

And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
 

Perspective: A Connecticut dermatologist

The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.

Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”

For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.

Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”

Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
 

Need for EC education

In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.

The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.

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

More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they worry even more than in the past about their patients and the risk of accidental pregnancies. Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.

The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.

As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.

“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.

The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.

But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”

The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
 

Methotrexate prescriptions

Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”

“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”

The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.

Perspective: A Georgia dermatologist

Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.

That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.

Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”

Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
 

Perspective: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.

And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
 

Perspective: A Connecticut dermatologist

The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.

Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”

For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.

Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”

Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
 

Need for EC education

In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.

The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.

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

Counting calories should not be the focus of weight-loss strategies for children with obesity, according to an expert who said pediatricians need to change the way they discuss weight with their patients.

During a plenary session of the American Academy of Pediatrics National Conference, Joseph A. Skelton, MD, professor of pediatrics at Wake Forest University School of Medicine, Winston-Salem, N.C., said pediatricians should recognize the behavioral, physical, environmental, and genetic factors that contribute to obesity. For instance, food deserts are on the rise, and they undermine the ability of parents to feed their children healthy meals. In addition, more children are less physically active.

“Obesity is a lot more complex than calories in, calories out,” Dr. Skelton said. “We choose to treat issues of obesity as personal responsibility – ‘you did this to yourself’ – but when you look at how we move around and live our lives, our food systems, our policies, the social and environmental changes have caused shifts in our behavior.”

According to Dr. Skelton, bias against children with obesity can harm their self-image and weaken their motivations for losing weight. In addition, doctors may change how they deliver care on the basis of stereotypes regarding obese children. These stereotypes are often reinforced in media portrayals, Dr. Skelton said.

“When children or when adults who have excess weight or obesity are portrayed, they are portrayed typically in a negative fashion,” Dr. Skelton said. “There’s increasing evidence that weight bias and weight discrimination are increasing the morbidity we see in patients who develop obesity.”

For many children with obesity, visits to the pediatrician often center on weight, regardless of the reason for the appointment. Weight stigma and bias on the part of health care providers can increase stress, as well as adverse health outcomes in children, according to a 2019 study (Curr Opin Endocrinol Diabetes Obes. 2019 Feb 1. doi: 10.1097/MED.0000000000000453). Dr. Skelton recommended that pediatricians listen to their patients’ concerns and make a personalized care plan.

Dr. Skelton said doctors can pull from projects such as Health at Every Size, which offers templates for personalized health plans for children with obesity. It has a heavy focus on a weight-neutral approach to pediatric health.

“There are various ways to manage weight in a healthy and safe way,” Dr. Skelton said.

Evidence-based methods of treating obesity include focusing on health and healthy behaviors rather than weight and using the body mass index as a screening tool for further conversations about overall health, rather than as an indicator of health based on weight.

Dr. Skelton also encouraged pediatricians to be on the alert for indicators of disordered eating, which can include dieting, teasing, or talking excessively about weight at home and can involve reading misinformation about dieting online.

“Your job is to educate people on the dangers of following unscientific information online,” Dr. Skelton said. “We can address issues of weight health in a way that is patient centered and is very safe, without unintended consequences.” Brooke Sweeney, MD, professor of internal medicine and pediatrics at University of Missouri–Kansas City, said problems with weight bias in society and in clinical practice can lead to false assumptions about people who have obesity.

“It’s normal to gain adipose, or fat tissue, at different times in life, during puberty or pregnancy, and some people normally gain more weight than others,” Dr. Sweeney said.

The body will try to maintain a weight set point. That set point is influenced by many factors, such as genetics, environment, and lifestyle.

“When you lose weight, your body tries to get you back to the set point, decreasing energy expenditure and increasing hunger and reward pathways,” she said. “We have gained so much knowledge through research to better understand the pathophysiology of obesity, and we are making good progress on improving advanced treatments for increased weight in children.”

Dr. Skelton reports no relevant financial relationships.

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

Counting calories should not be the focus of weight-loss strategies for children with obesity, according to an expert who said pediatricians need to change the way they discuss weight with their patients.

During a plenary session of the American Academy of Pediatrics National Conference, Joseph A. Skelton, MD, professor of pediatrics at Wake Forest University School of Medicine, Winston-Salem, N.C., said pediatricians should recognize the behavioral, physical, environmental, and genetic factors that contribute to obesity. For instance, food deserts are on the rise, and they undermine the ability of parents to feed their children healthy meals. In addition, more children are less physically active.

“Obesity is a lot more complex than calories in, calories out,” Dr. Skelton said. “We choose to treat issues of obesity as personal responsibility – ‘you did this to yourself’ – but when you look at how we move around and live our lives, our food systems, our policies, the social and environmental changes have caused shifts in our behavior.”

According to Dr. Skelton, bias against children with obesity can harm their self-image and weaken their motivations for losing weight. In addition, doctors may change how they deliver care on the basis of stereotypes regarding obese children. These stereotypes are often reinforced in media portrayals, Dr. Skelton said.

“When children or when adults who have excess weight or obesity are portrayed, they are portrayed typically in a negative fashion,” Dr. Skelton said. “There’s increasing evidence that weight bias and weight discrimination are increasing the morbidity we see in patients who develop obesity.”

For many children with obesity, visits to the pediatrician often center on weight, regardless of the reason for the appointment. Weight stigma and bias on the part of health care providers can increase stress, as well as adverse health outcomes in children, according to a 2019 study (Curr Opin Endocrinol Diabetes Obes. 2019 Feb 1. doi: 10.1097/MED.0000000000000453). Dr. Skelton recommended that pediatricians listen to their patients’ concerns and make a personalized care plan.

Dr. Skelton said doctors can pull from projects such as Health at Every Size, which offers templates for personalized health plans for children with obesity. It has a heavy focus on a weight-neutral approach to pediatric health.

“There are various ways to manage weight in a healthy and safe way,” Dr. Skelton said.

Evidence-based methods of treating obesity include focusing on health and healthy behaviors rather than weight and using the body mass index as a screening tool for further conversations about overall health, rather than as an indicator of health based on weight.

Dr. Skelton also encouraged pediatricians to be on the alert for indicators of disordered eating, which can include dieting, teasing, or talking excessively about weight at home and can involve reading misinformation about dieting online.

“Your job is to educate people on the dangers of following unscientific information online,” Dr. Skelton said. “We can address issues of weight health in a way that is patient centered and is very safe, without unintended consequences.” Brooke Sweeney, MD, professor of internal medicine and pediatrics at University of Missouri–Kansas City, said problems with weight bias in society and in clinical practice can lead to false assumptions about people who have obesity.

“It’s normal to gain adipose, or fat tissue, at different times in life, during puberty or pregnancy, and some people normally gain more weight than others,” Dr. Sweeney said.

The body will try to maintain a weight set point. That set point is influenced by many factors, such as genetics, environment, and lifestyle.

“When you lose weight, your body tries to get you back to the set point, decreasing energy expenditure and increasing hunger and reward pathways,” she said. “We have gained so much knowledge through research to better understand the pathophysiology of obesity, and we are making good progress on improving advanced treatments for increased weight in children.”

Dr. Skelton reports no relevant financial relationships.

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

Counting calories should not be the focus of weight-loss strategies for children with obesity, according to an expert who said pediatricians need to change the way they discuss weight with their patients.

During a plenary session of the American Academy of Pediatrics National Conference, Joseph A. Skelton, MD, professor of pediatrics at Wake Forest University School of Medicine, Winston-Salem, N.C., said pediatricians should recognize the behavioral, physical, environmental, and genetic factors that contribute to obesity. For instance, food deserts are on the rise, and they undermine the ability of parents to feed their children healthy meals. In addition, more children are less physically active.

“Obesity is a lot more complex than calories in, calories out,” Dr. Skelton said. “We choose to treat issues of obesity as personal responsibility – ‘you did this to yourself’ – but when you look at how we move around and live our lives, our food systems, our policies, the social and environmental changes have caused shifts in our behavior.”

According to Dr. Skelton, bias against children with obesity can harm their self-image and weaken their motivations for losing weight. In addition, doctors may change how they deliver care on the basis of stereotypes regarding obese children. These stereotypes are often reinforced in media portrayals, Dr. Skelton said.

“When children or when adults who have excess weight or obesity are portrayed, they are portrayed typically in a negative fashion,” Dr. Skelton said. “There’s increasing evidence that weight bias and weight discrimination are increasing the morbidity we see in patients who develop obesity.”

For many children with obesity, visits to the pediatrician often center on weight, regardless of the reason for the appointment. Weight stigma and bias on the part of health care providers can increase stress, as well as adverse health outcomes in children, according to a 2019 study (Curr Opin Endocrinol Diabetes Obes. 2019 Feb 1. doi: 10.1097/MED.0000000000000453). Dr. Skelton recommended that pediatricians listen to their patients’ concerns and make a personalized care plan.

Dr. Skelton said doctors can pull from projects such as Health at Every Size, which offers templates for personalized health plans for children with obesity. It has a heavy focus on a weight-neutral approach to pediatric health.

“There are various ways to manage weight in a healthy and safe way,” Dr. Skelton said.

Evidence-based methods of treating obesity include focusing on health and healthy behaviors rather than weight and using the body mass index as a screening tool for further conversations about overall health, rather than as an indicator of health based on weight.

Dr. Skelton also encouraged pediatricians to be on the alert for indicators of disordered eating, which can include dieting, teasing, or talking excessively about weight at home and can involve reading misinformation about dieting online.

“Your job is to educate people on the dangers of following unscientific information online,” Dr. Skelton said. “We can address issues of weight health in a way that is patient centered and is very safe, without unintended consequences.” Brooke Sweeney, MD, professor of internal medicine and pediatrics at University of Missouri–Kansas City, said problems with weight bias in society and in clinical practice can lead to false assumptions about people who have obesity.

“It’s normal to gain adipose, or fat tissue, at different times in life, during puberty or pregnancy, and some people normally gain more weight than others,” Dr. Sweeney said.

The body will try to maintain a weight set point. That set point is influenced by many factors, such as genetics, environment, and lifestyle.

“When you lose weight, your body tries to get you back to the set point, decreasing energy expenditure and increasing hunger and reward pathways,” she said. “We have gained so much knowledge through research to better understand the pathophysiology of obesity, and we are making good progress on improving advanced treatments for increased weight in children.”

Dr. Skelton reports no relevant financial relationships.

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

ANAHEIM, CALIF. – A modular digital intervention to teach mental health skills to youth awaiting transfer to psychiatric care appeared feasible to implement and acceptable to teens and their parents, according to a study presented at the American Academy of Pediatrics National Conference.

“This program has the potential to teach evidence-based mental health skills to youth during boarding, providing a head start on recovery prior to psychiatric hospitalization,” study coauthor Samantha House, DO, MPH, section chief of pediatric hospital medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., told attendees.

Mental health boarding has become increasingly common as psychiatric care resources have been stretched by a crisis in pediatric mental health that began even before the COVID pandemic. Since youth often don’t receive evidence-based therapies while boarding, Dr. House and her coauthor, JoAnna K. Leyenaar, MD, PhD, MPH, developed a pilot program called I-CARE, which stands for Improving Care, Accelerating Recovery and Education.

I-CARE is a digital health intervention that combines videos on a tablet with workbook exercises that teach mental health skills. The seven modules include an introduction and one each on schedule-making, safety planning, psychoeducation, behavioral activation, relaxation skills, and mindfulness skills. Licensed nursing assistants who have received a 6-hour training from a clinical psychologist administer the program and provide safety supervision during boarding.

“I-CARE was designed to be largely self-directed, supported by ‘coaches’ who are not mental health professionals,” Dr. Leyenaar, vice chair of research in the department of pediatrics and an associate professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. With this model, the program requires minimal additional resources beyond the tablets and workbooks, and is designed for implementation in settings with few or no mental health professionals, she said.

Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington, Seattle, and an attending physician at Seattle Children’s Hospital, was not involved in the study but was excited to see it.

“I think it’s a really good idea, and I like that it’s being studied,” Dr. Breuner said in an interview. She said the health care and public health system has let down an entire population who data had shown were experiencing mental health problems.

“We knew before the pandemic that behavioral health issues were creeping up slowly with anxiety, depression, suicidal ideation, and, of course, substance use disorders and eating disorders, and not a lot was being done about it,” Dr. Breuner said, and the pandemic exacerbated those issues. ”I don’t know why no one realized that this was going to be the downstream effect of having no socialization for kids for 18 months and limited resources for those who we need desperately to provide care for,” especially BIPOC [Black, Indigenous, and people of color] kids and underresourced kids.

That sentiment is exactly what inspired the creation of the program, according to Dr. Leyenaar.

The I-CARE program was implemented at Dartmouth Hitchcock Medical Center in November 2021 for adolescents aged 12-17 who were boarding because of suicidality or self-harm. The program and study excluded youth with psychosis and other cognitive or behavioral conditions that didn’t fit with the skills taught by the module training.

The researchers qualitatively evaluated the I-CARE program in youth who were offered at least two I-CARE modules and with parents present during boarding.

Twenty-four youth, with a median age of 14, were offered the I-CARE program between November 2021 and April 2022 while boarding for a median 8 days. Most of the patients were female (79%), and a third were transgender or gender diverse. Most were White (83%), and about two-thirds had Medicaid (62.5%). The most common diagnoses among the participants were major depressive disorder (71%) and generalized anxiety disorder (46%). Others included PTSD (29%), restrictive eating disorder (21%), and bipolar disorder (12.5%).

All offered the program completed the first module, and 79% participated in additional modules. The main reason for discontinuation was transfer to another facility, but a few youth either refused to engage with the program or felt they knew the material well enough that they weren’t benefiting from it.

The evaluation involved 16 youth, seven parents, and 17 clinicians. On a Likert scale, the composite score for the program’s appropriateness – suitability, applicability, and meeting needs – was an average 3.7, with a higher rating from clinicians (4.3) and caregivers (3.5) than youth (2.8).

“Some youth felt the intervention was better suited for a younger audience or those with less familiarity with mental health skills, but they acknowledged that the intervention would be helpful and appropriate for others,” Dr. House, who is also an assistant professor of pediatrics at Geisel School of Medicine, said.

Youth rated the acceptability of the program more highly (3.6) and all three groups found it easy to use, with an average feasibility score of 4 across the board. The program’s acceptability received an average score of 4 from parents and clinicians.

”Teens seem to particularly value the psychoeducation module that explains the relationship between thoughts and feelings, as well as the opportunity to develop a personalized safety plan,” Dr. Leyenaar said.

Among the challenges expressed by the participating teens were that the loud sounds and beeping in the hospital made it difficult to practice mindfulness and that they often had to wait for staff to be available to do I-CARE.

“I feel like not many people have been trained yet,” one teen said, “so to have more nurses available to do I-CARE would be helpful.”

Another participant found the coaches helpful. “Sometimes they were my nurse, sometimes they were someone I never met before. … and also, they were all really, really nice,” the teen said.

Another teen regarded the material as “really surface-level mental health stuff” that they thought “could be helpful to other people who are here for the first time.” But others found the content more beneficial.

“The videos were helpful. … I was worried that they weren’t going to be very informative, but they did make sense to me,” one participant said. “They weren’t overcomplicating things. … They weren’t saying anything I didn’t understand, so that was good.”

The researchers next plan to conduct a multisite study to determine the program’s effectiveness in improving health outcomes and reducing suicidal ideation. Dr. House and Dr. Leyenaar are looking at ways to refine the program.

”We may narrow the age range for participants, with an upper age limit of 16, since some older teens said that the modules were best suited for a younger audience,” Dr. Leyenaar said. “We are also discussing how to best support youth who are readmitted to our hospital and have participated in I-CARE previously.”

Dr. Breuner said she would be interested to see, in future studies of the program, whether it reduced the likelihood of inpatient psychiatric stay, the length of psychiatric stay after admission, or the risk of readmission. She also wondered if the program might be offered in languages other than English, whether a version might be specifically designed for BIPOC youth, and whether the researchers had considered offering the intervention to caregivers as well.

The modules are teaching the kids but should they also be teaching the parents? Dr. Breuner wondered. A lot of times, she said, the parents are bringing these kids in because they don’t know what to do and can’t deal with them anymore. Offering modules on the same skills to caregivers would also enable the caregivers to reinforce and reteach the skills to their children, especially if the youth struggled to really take in what the modules were trying to teach.

Dr. Leyenaar said she expects buy-in for a program like this would be high at other institutions, but it’s premature to scale it up until they’ve conducted at least another clinical trial on its effectiveness. The biggest potential barrier to buy-in that Dr. Breuner perceived would be cost.

“It’s always difficult when it costs money” since the hospital needs to train the clinicians who provide the care, Dr. Breuner said, but it’s possible those costs could be offset if the program reduces the risk of readmission or return to the emergency department.

While the overall risk of harms from the intervention are low, Dr. Breuner said it is important to be conscious that the intervention may not necessarily be appropriate for all youth.

“There’s always risk when there’s a trauma background, and you have to be very careful, especially with mindfulness training,” Dr. Breuner said. For those with a history of abuse or other adverse childhood experiences “for someone to get into a very calm, still place can actually be counterproductive.”

Dr. Breuner especially appreciated that the researchers involved the youth and caregivers in the evaluation process. “That the parents expressed positive attitudes is really incredible,” she said.

Dr. House, Dr. Leyenaar, and Dr. Breuner had no disclosures. No external funding was noted for the study.

ANAHEIM, CALIF. – A modular digital intervention to teach mental health skills to youth awaiting transfer to psychiatric care appeared feasible to implement and acceptable to teens and their parents, according to a study presented at the American Academy of Pediatrics National Conference.

“This program has the potential to teach evidence-based mental health skills to youth during boarding, providing a head start on recovery prior to psychiatric hospitalization,” study coauthor Samantha House, DO, MPH, section chief of pediatric hospital medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., told attendees.

Mental health boarding has become increasingly common as psychiatric care resources have been stretched by a crisis in pediatric mental health that began even before the COVID pandemic. Since youth often don’t receive evidence-based therapies while boarding, Dr. House and her coauthor, JoAnna K. Leyenaar, MD, PhD, MPH, developed a pilot program called I-CARE, which stands for Improving Care, Accelerating Recovery and Education.

I-CARE is a digital health intervention that combines videos on a tablet with workbook exercises that teach mental health skills. The seven modules include an introduction and one each on schedule-making, safety planning, psychoeducation, behavioral activation, relaxation skills, and mindfulness skills. Licensed nursing assistants who have received a 6-hour training from a clinical psychologist administer the program and provide safety supervision during boarding.

“I-CARE was designed to be largely self-directed, supported by ‘coaches’ who are not mental health professionals,” Dr. Leyenaar, vice chair of research in the department of pediatrics and an associate professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. With this model, the program requires minimal additional resources beyond the tablets and workbooks, and is designed for implementation in settings with few or no mental health professionals, she said.

Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington, Seattle, and an attending physician at Seattle Children’s Hospital, was not involved in the study but was excited to see it.

“I think it’s a really good idea, and I like that it’s being studied,” Dr. Breuner said in an interview. She said the health care and public health system has let down an entire population who data had shown were experiencing mental health problems.

“We knew before the pandemic that behavioral health issues were creeping up slowly with anxiety, depression, suicidal ideation, and, of course, substance use disorders and eating disorders, and not a lot was being done about it,” Dr. Breuner said, and the pandemic exacerbated those issues. ”I don’t know why no one realized that this was going to be the downstream effect of having no socialization for kids for 18 months and limited resources for those who we need desperately to provide care for,” especially BIPOC [Black, Indigenous, and people of color] kids and underresourced kids.

That sentiment is exactly what inspired the creation of the program, according to Dr. Leyenaar.

The I-CARE program was implemented at Dartmouth Hitchcock Medical Center in November 2021 for adolescents aged 12-17 who were boarding because of suicidality or self-harm. The program and study excluded youth with psychosis and other cognitive or behavioral conditions that didn’t fit with the skills taught by the module training.

The researchers qualitatively evaluated the I-CARE program in youth who were offered at least two I-CARE modules and with parents present during boarding.

Twenty-four youth, with a median age of 14, were offered the I-CARE program between November 2021 and April 2022 while boarding for a median 8 days. Most of the patients were female (79%), and a third were transgender or gender diverse. Most were White (83%), and about two-thirds had Medicaid (62.5%). The most common diagnoses among the participants were major depressive disorder (71%) and generalized anxiety disorder (46%). Others included PTSD (29%), restrictive eating disorder (21%), and bipolar disorder (12.5%).

All offered the program completed the first module, and 79% participated in additional modules. The main reason for discontinuation was transfer to another facility, but a few youth either refused to engage with the program or felt they knew the material well enough that they weren’t benefiting from it.

The evaluation involved 16 youth, seven parents, and 17 clinicians. On a Likert scale, the composite score for the program’s appropriateness – suitability, applicability, and meeting needs – was an average 3.7, with a higher rating from clinicians (4.3) and caregivers (3.5) than youth (2.8).

“Some youth felt the intervention was better suited for a younger audience or those with less familiarity with mental health skills, but they acknowledged that the intervention would be helpful and appropriate for others,” Dr. House, who is also an assistant professor of pediatrics at Geisel School of Medicine, said.

Youth rated the acceptability of the program more highly (3.6) and all three groups found it easy to use, with an average feasibility score of 4 across the board. The program’s acceptability received an average score of 4 from parents and clinicians.

”Teens seem to particularly value the psychoeducation module that explains the relationship between thoughts and feelings, as well as the opportunity to develop a personalized safety plan,” Dr. Leyenaar said.

Among the challenges expressed by the participating teens were that the loud sounds and beeping in the hospital made it difficult to practice mindfulness and that they often had to wait for staff to be available to do I-CARE.

“I feel like not many people have been trained yet,” one teen said, “so to have more nurses available to do I-CARE would be helpful.”

Another participant found the coaches helpful. “Sometimes they were my nurse, sometimes they were someone I never met before. … and also, they were all really, really nice,” the teen said.

Another teen regarded the material as “really surface-level mental health stuff” that they thought “could be helpful to other people who are here for the first time.” But others found the content more beneficial.

“The videos were helpful. … I was worried that they weren’t going to be very informative, but they did make sense to me,” one participant said. “They weren’t overcomplicating things. … They weren’t saying anything I didn’t understand, so that was good.”

The researchers next plan to conduct a multisite study to determine the program’s effectiveness in improving health outcomes and reducing suicidal ideation. Dr. House and Dr. Leyenaar are looking at ways to refine the program.

”We may narrow the age range for participants, with an upper age limit of 16, since some older teens said that the modules were best suited for a younger audience,” Dr. Leyenaar said. “We are also discussing how to best support youth who are readmitted to our hospital and have participated in I-CARE previously.”

Dr. Breuner said she would be interested to see, in future studies of the program, whether it reduced the likelihood of inpatient psychiatric stay, the length of psychiatric stay after admission, or the risk of readmission. She also wondered if the program might be offered in languages other than English, whether a version might be specifically designed for BIPOC youth, and whether the researchers had considered offering the intervention to caregivers as well.

The modules are teaching the kids but should they also be teaching the parents? Dr. Breuner wondered. A lot of times, she said, the parents are bringing these kids in because they don’t know what to do and can’t deal with them anymore. Offering modules on the same skills to caregivers would also enable the caregivers to reinforce and reteach the skills to their children, especially if the youth struggled to really take in what the modules were trying to teach.

Dr. Leyenaar said she expects buy-in for a program like this would be high at other institutions, but it’s premature to scale it up until they’ve conducted at least another clinical trial on its effectiveness. The biggest potential barrier to buy-in that Dr. Breuner perceived would be cost.

“It’s always difficult when it costs money” since the hospital needs to train the clinicians who provide the care, Dr. Breuner said, but it’s possible those costs could be offset if the program reduces the risk of readmission or return to the emergency department.

While the overall risk of harms from the intervention are low, Dr. Breuner said it is important to be conscious that the intervention may not necessarily be appropriate for all youth.

“There’s always risk when there’s a trauma background, and you have to be very careful, especially with mindfulness training,” Dr. Breuner said. For those with a history of abuse or other adverse childhood experiences “for someone to get into a very calm, still place can actually be counterproductive.”

Dr. Breuner especially appreciated that the researchers involved the youth and caregivers in the evaluation process. “That the parents expressed positive attitudes is really incredible,” she said.

Dr. House, Dr. Leyenaar, and Dr. Breuner had no disclosures. No external funding was noted for the study.

ANAHEIM, CALIF. – A modular digital intervention to teach mental health skills to youth awaiting transfer to psychiatric care appeared feasible to implement and acceptable to teens and their parents, according to a study presented at the American Academy of Pediatrics National Conference.

“This program has the potential to teach evidence-based mental health skills to youth during boarding, providing a head start on recovery prior to psychiatric hospitalization,” study coauthor Samantha House, DO, MPH, section chief of pediatric hospital medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., told attendees.

Mental health boarding has become increasingly common as psychiatric care resources have been stretched by a crisis in pediatric mental health that began even before the COVID pandemic. Since youth often don’t receive evidence-based therapies while boarding, Dr. House and her coauthor, JoAnna K. Leyenaar, MD, PhD, MPH, developed a pilot program called I-CARE, which stands for Improving Care, Accelerating Recovery and Education.

I-CARE is a digital health intervention that combines videos on a tablet with workbook exercises that teach mental health skills. The seven modules include an introduction and one each on schedule-making, safety planning, psychoeducation, behavioral activation, relaxation skills, and mindfulness skills. Licensed nursing assistants who have received a 6-hour training from a clinical psychologist administer the program and provide safety supervision during boarding.

“I-CARE was designed to be largely self-directed, supported by ‘coaches’ who are not mental health professionals,” Dr. Leyenaar, vice chair of research in the department of pediatrics and an associate professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. With this model, the program requires minimal additional resources beyond the tablets and workbooks, and is designed for implementation in settings with few or no mental health professionals, she said.

Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington, Seattle, and an attending physician at Seattle Children’s Hospital, was not involved in the study but was excited to see it.

“I think it’s a really good idea, and I like that it’s being studied,” Dr. Breuner said in an interview. She said the health care and public health system has let down an entire population who data had shown were experiencing mental health problems.

“We knew before the pandemic that behavioral health issues were creeping up slowly with anxiety, depression, suicidal ideation, and, of course, substance use disorders and eating disorders, and not a lot was being done about it,” Dr. Breuner said, and the pandemic exacerbated those issues. ”I don’t know why no one realized that this was going to be the downstream effect of having no socialization for kids for 18 months and limited resources for those who we need desperately to provide care for,” especially BIPOC [Black, Indigenous, and people of color] kids and underresourced kids.

That sentiment is exactly what inspired the creation of the program, according to Dr. Leyenaar.

The I-CARE program was implemented at Dartmouth Hitchcock Medical Center in November 2021 for adolescents aged 12-17 who were boarding because of suicidality or self-harm. The program and study excluded youth with psychosis and other cognitive or behavioral conditions that didn’t fit with the skills taught by the module training.

The researchers qualitatively evaluated the I-CARE program in youth who were offered at least two I-CARE modules and with parents present during boarding.

Twenty-four youth, with a median age of 14, were offered the I-CARE program between November 2021 and April 2022 while boarding for a median 8 days. Most of the patients were female (79%), and a third were transgender or gender diverse. Most were White (83%), and about two-thirds had Medicaid (62.5%). The most common diagnoses among the participants were major depressive disorder (71%) and generalized anxiety disorder (46%). Others included PTSD (29%), restrictive eating disorder (21%), and bipolar disorder (12.5%).

All offered the program completed the first module, and 79% participated in additional modules. The main reason for discontinuation was transfer to another facility, but a few youth either refused to engage with the program or felt they knew the material well enough that they weren’t benefiting from it.

The evaluation involved 16 youth, seven parents, and 17 clinicians. On a Likert scale, the composite score for the program’s appropriateness – suitability, applicability, and meeting needs – was an average 3.7, with a higher rating from clinicians (4.3) and caregivers (3.5) than youth (2.8).

“Some youth felt the intervention was better suited for a younger audience or those with less familiarity with mental health skills, but they acknowledged that the intervention would be helpful and appropriate for others,” Dr. House, who is also an assistant professor of pediatrics at Geisel School of Medicine, said.

Youth rated the acceptability of the program more highly (3.6) and all three groups found it easy to use, with an average feasibility score of 4 across the board. The program’s acceptability received an average score of 4 from parents and clinicians.

”Teens seem to particularly value the psychoeducation module that explains the relationship between thoughts and feelings, as well as the opportunity to develop a personalized safety plan,” Dr. Leyenaar said.

Among the challenges expressed by the participating teens were that the loud sounds and beeping in the hospital made it difficult to practice mindfulness and that they often had to wait for staff to be available to do I-CARE.

“I feel like not many people have been trained yet,” one teen said, “so to have more nurses available to do I-CARE would be helpful.”

Another participant found the coaches helpful. “Sometimes they were my nurse, sometimes they were someone I never met before. … and also, they were all really, really nice,” the teen said.

Another teen regarded the material as “really surface-level mental health stuff” that they thought “could be helpful to other people who are here for the first time.” But others found the content more beneficial.

“The videos were helpful. … I was worried that they weren’t going to be very informative, but they did make sense to me,” one participant said. “They weren’t overcomplicating things. … They weren’t saying anything I didn’t understand, so that was good.”

The researchers next plan to conduct a multisite study to determine the program’s effectiveness in improving health outcomes and reducing suicidal ideation. Dr. House and Dr. Leyenaar are looking at ways to refine the program.

”We may narrow the age range for participants, with an upper age limit of 16, since some older teens said that the modules were best suited for a younger audience,” Dr. Leyenaar said. “We are also discussing how to best support youth who are readmitted to our hospital and have participated in I-CARE previously.”

Dr. Breuner said she would be interested to see, in future studies of the program, whether it reduced the likelihood of inpatient psychiatric stay, the length of psychiatric stay after admission, or the risk of readmission. She also wondered if the program might be offered in languages other than English, whether a version might be specifically designed for BIPOC youth, and whether the researchers had considered offering the intervention to caregivers as well.

The modules are teaching the kids but should they also be teaching the parents? Dr. Breuner wondered. A lot of times, she said, the parents are bringing these kids in because they don’t know what to do and can’t deal with them anymore. Offering modules on the same skills to caregivers would also enable the caregivers to reinforce and reteach the skills to their children, especially if the youth struggled to really take in what the modules were trying to teach.

Dr. Leyenaar said she expects buy-in for a program like this would be high at other institutions, but it’s premature to scale it up until they’ve conducted at least another clinical trial on its effectiveness. The biggest potential barrier to buy-in that Dr. Breuner perceived would be cost.

“It’s always difficult when it costs money” since the hospital needs to train the clinicians who provide the care, Dr. Breuner said, but it’s possible those costs could be offset if the program reduces the risk of readmission or return to the emergency department.

While the overall risk of harms from the intervention are low, Dr. Breuner said it is important to be conscious that the intervention may not necessarily be appropriate for all youth.

“There’s always risk when there’s a trauma background, and you have to be very careful, especially with mindfulness training,” Dr. Breuner said. For those with a history of abuse or other adverse childhood experiences “for someone to get into a very calm, still place can actually be counterproductive.”

Dr. Breuner especially appreciated that the researchers involved the youth and caregivers in the evaluation process. “That the parents expressed positive attitudes is really incredible,” she said.

Dr. House, Dr. Leyenaar, and Dr. Breuner had no disclosures. No external funding was noted for the study.

Treatment with deuruxolitinib and ritlecitinib, two investigational Janus kinase (JAK) inhibitors, resulted in substantial regrowth of scalp hair for patients with alopecia areata (AA) in separate studies reported at the annual congress of the European Academy of Dermatology and Venereology.

In the THRIVE-AA1 study, the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or lower –which indicates that hair regrowth has occurred on at least 80% of the scalp – was achieved among patients taking deuruxolitinib, which was a significantly higher proportion than with placebo (P < .0001). Importantly, the JAK inhibitor’s effects were seen in as early as 4 weeks, and there was significant improvement in both eyelash and eyebrow hair regrowth.

In the unrelated ALLEGRO-LT study, effects from treatment with the JAK inhibitor ritlecitinib appeared to be sustained for 2 years; 69.6% of patients treated with ritlecitinib had a SALT score of 20 or lower by 24 months.

These data are “very exciting for alopecia areata because the patients selected are very severe,” observed Mahtab Samimi, MD, PhD, who cochaired the late-breaking session in which the study findings were discussed.

THRIVE-AA1 included only patients with hair loss of 50% or more. The ALLEGRO-LT study included patients with total scalp or total body hair loss (areata totalis/areata universalis) of 25%-50% at enrollment.

Moreover, “very stringent criteria” were used. SALT scores of 10 or less were evaluated in both studies, observed Dr. Samimi, professor of dermatology at the University of Tours (France).

“We can be ambitious now for our patients with alopecia areata; that’s really good news,” Dr. Samimi added.

Deuruxolitinib and the THRIVE trials

Deuruxolitinib is an oral JAK1/JAK2 inhibitor that has been tested in two similarly designed, multinational, randomized, double-blind, placebo-controlled phase 3 trials in patients with AA, THRIVE-AA1 and THRIVE-AA2.

Two doses of deuruxolitinib, 8 mg and 12 mg given twice daily, were evaluated in the trials, which altogether included just over 1,200 patients.

Results of THRIVE-AA1 have been reported by the manufacturer. Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., presented a more comprehensive review at the EADV meeting.

He reported that at 24 weeks, SALT scores of 20 or lower were achieved by 30% of adults with AA who were treated with deuruxolitinib 8 mg and by 42% of those treated with deuruxolitinib 12 mg. This primary endpoint was seen in only 1% of the placebo-treated patients.

The more stringent endpoint of having a SALT score of 10 or less, which indicates that hair regrowth has occurred over 90% of the scalp, was met by 21% of patients who received deuruxolitinib 8 mg twice a day and by 35% of those who received the 12-mg dose twice a day at 24 weeks. This endpoint was not reached by any of the placebo-treated patients.

“This is truly transformative therapy,” Dr. King said when presenting the findings. “We know that the chances of spontaneous remission when you have severe disease is next to zero,” he added.

There were reasonably high rates of patient satisfaction with the treatment, according to Dr. King. He said that 42% of those who took 8 mg twice a day and 53% of those who took 12 mg twice a day said they were “very satisfied” or “satisfied” with the degree of scalp hair regrowth achieved, compared with 5% for placebo.

Safety was as expected, and there were no signs of any blood clots, said Dr. King. Common treatment-emergent adverse events (TEAEs) that affected 5% or more of patients included acne and headache. Serious TEAEs were reported by 1.1% and 0.5% of those taking the 8-mg and 12-mg twice-daily doses, respectively, compared with 2.9% of those who received placebo.

Overall, the results look promising for deuruxolitinib, he added. He noted that almost all patients included in the trial have opted to continue in the open-label long-term safety study.

Prescribing information of the JAK inhibitors approved by the U.S. Food and Drug Administration includes a boxed warning about risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. The warning is based on experience with another JAK inhibitor for patients with rheumatoid arthritis.
 

Ritlecitinib and the ALLEGRO studies

Interim results of the ongoing, open-label, phase 3 ALLEGRO-LT study with ritlecitinib were presented separately by Athanasios Tsianakas, MD, head of the department of dermatology at Fachklinik Bad Bentheim, Germany.

Ritlecitinib, which targets JAK3 and also the TEC family of tyrosine kinases, had met all of its endpoints in the prior ALLEGRO Phase 2b/3 study, Dr. Tsianakas said. Those included the benchmarks of a SALT score of 20 or less and a SALT score of 10 or less.

“Ritlecitinib showed a very good long-term efficacy and good safety profile in our adolescent and adult patients suffering from alopecia areata,” said Dr. Tsianakas.

A total of 447 patients were included in the trial. They were treated with 50 mg of ritlecitinib every day; some had already participated in the ALLEGRO trial, while others had been newly recruited. The latter group entered the trial after a 4-week run-in period, during which a 200-mg daily loading dose was given for 4 weeks.

Most (86%) patients had been exposed to ritlecitinib for at least 12 months; one-fifth had discontinued treatment at the data cutoff, generally because the patients no longer met the eligibility criteria for the trial.

Safety was paramount, Dr. Tsianakas highlighted. There were few adverse events that led to temporary or permanent discontinuation of the study drug. The most common TEAEs that affected 5% or more of patients included headache and acne. There were two cases of MACE (one nonfatal myocardial infarction and one nonfatal stroke).

The proportion of patients with a SALT score of 20 or less was 2.5% at 1 month, 27.9% at 3 months, 50.1% at 6 months, 59.8% at 9 months, and 65.5% at 12 months. Thereafter, there was little shift in the response. A sustained effect, in which a SALT score of 20 or less was seen out to 24 months, occurred in 69.9% of patients.

A similar pattern was seen for SALT scores of 10 or less, ranging from 16.5% at 3 months to 62.5% at 24 months.
 

Following in baricitinib’s footsteps?

This not the first time that JAK inhibitors have been shown to have beneficial effects for patients with AA. Baricitinib (Olumiant) recently became the first JAK inhibitor to be granted marketing approval for AA in the United States, largely on the basis of two pivotal phase 3 studies, BRAVE-AA1 and BRAVE-AA2.

“This is just such an incredibly exciting time,” said Dr. King. “Our discoveries in the lab are being translated into effective therapies for patients with diseases for which we’ve not previously had therapies,” he commented.

“Our concept of interferon gamma– and interleukin-15–mediated disease is probably not true for everybody,” said, Dr. King, who acknowledged that some patients with AA do not respond to JAK-inhibitor therapy or may need additional or alternative treatment.

“It’s probably not that homogeneous a disease,” he added. “It’s fascinating that the very first drugs for this disease are showing efficacy in as many patients as they are.”

The THRIVE-AAI study was funded by CONCERT Pharmaceuticals. Dr. King has served on advisory boards, has provided consulting services to, or has been a trial investigator for multiple pharmaceutical companies, including CoNCERT Pharmaceuticals. The ALLEGRO-LT study was funded by Pfizer. Dr. Tsianakas has acted as a clinical trial investigator and speaker for Pfizer.

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

Treatment with deuruxolitinib and ritlecitinib, two investigational Janus kinase (JAK) inhibitors, resulted in substantial regrowth of scalp hair for patients with alopecia areata (AA) in separate studies reported at the annual congress of the European Academy of Dermatology and Venereology.

In the THRIVE-AA1 study, the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or lower –which indicates that hair regrowth has occurred on at least 80% of the scalp – was achieved among patients taking deuruxolitinib, which was a significantly higher proportion than with placebo (P < .0001). Importantly, the JAK inhibitor’s effects were seen in as early as 4 weeks, and there was significant improvement in both eyelash and eyebrow hair regrowth.

In the unrelated ALLEGRO-LT study, effects from treatment with the JAK inhibitor ritlecitinib appeared to be sustained for 2 years; 69.6% of patients treated with ritlecitinib had a SALT score of 20 or lower by 24 months.

These data are “very exciting for alopecia areata because the patients selected are very severe,” observed Mahtab Samimi, MD, PhD, who cochaired the late-breaking session in which the study findings were discussed.

THRIVE-AA1 included only patients with hair loss of 50% or more. The ALLEGRO-LT study included patients with total scalp or total body hair loss (areata totalis/areata universalis) of 25%-50% at enrollment.

Moreover, “very stringent criteria” were used. SALT scores of 10 or less were evaluated in both studies, observed Dr. Samimi, professor of dermatology at the University of Tours (France).

“We can be ambitious now for our patients with alopecia areata; that’s really good news,” Dr. Samimi added.

Deuruxolitinib and the THRIVE trials

Deuruxolitinib is an oral JAK1/JAK2 inhibitor that has been tested in two similarly designed, multinational, randomized, double-blind, placebo-controlled phase 3 trials in patients with AA, THRIVE-AA1 and THRIVE-AA2.

Two doses of deuruxolitinib, 8 mg and 12 mg given twice daily, were evaluated in the trials, which altogether included just over 1,200 patients.

Results of THRIVE-AA1 have been reported by the manufacturer. Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., presented a more comprehensive review at the EADV meeting.

He reported that at 24 weeks, SALT scores of 20 or lower were achieved by 30% of adults with AA who were treated with deuruxolitinib 8 mg and by 42% of those treated with deuruxolitinib 12 mg. This primary endpoint was seen in only 1% of the placebo-treated patients.

The more stringent endpoint of having a SALT score of 10 or less, which indicates that hair regrowth has occurred over 90% of the scalp, was met by 21% of patients who received deuruxolitinib 8 mg twice a day and by 35% of those who received the 12-mg dose twice a day at 24 weeks. This endpoint was not reached by any of the placebo-treated patients.

“This is truly transformative therapy,” Dr. King said when presenting the findings. “We know that the chances of spontaneous remission when you have severe disease is next to zero,” he added.

There were reasonably high rates of patient satisfaction with the treatment, according to Dr. King. He said that 42% of those who took 8 mg twice a day and 53% of those who took 12 mg twice a day said they were “very satisfied” or “satisfied” with the degree of scalp hair regrowth achieved, compared with 5% for placebo.

Safety was as expected, and there were no signs of any blood clots, said Dr. King. Common treatment-emergent adverse events (TEAEs) that affected 5% or more of patients included acne and headache. Serious TEAEs were reported by 1.1% and 0.5% of those taking the 8-mg and 12-mg twice-daily doses, respectively, compared with 2.9% of those who received placebo.

Overall, the results look promising for deuruxolitinib, he added. He noted that almost all patients included in the trial have opted to continue in the open-label long-term safety study.

Prescribing information of the JAK inhibitors approved by the U.S. Food and Drug Administration includes a boxed warning about risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. The warning is based on experience with another JAK inhibitor for patients with rheumatoid arthritis.
 

Ritlecitinib and the ALLEGRO studies

Interim results of the ongoing, open-label, phase 3 ALLEGRO-LT study with ritlecitinib were presented separately by Athanasios Tsianakas, MD, head of the department of dermatology at Fachklinik Bad Bentheim, Germany.

Ritlecitinib, which targets JAK3 and also the TEC family of tyrosine kinases, had met all of its endpoints in the prior ALLEGRO Phase 2b/3 study, Dr. Tsianakas said. Those included the benchmarks of a SALT score of 20 or less and a SALT score of 10 or less.

“Ritlecitinib showed a very good long-term efficacy and good safety profile in our adolescent and adult patients suffering from alopecia areata,” said Dr. Tsianakas.

A total of 447 patients were included in the trial. They were treated with 50 mg of ritlecitinib every day; some had already participated in the ALLEGRO trial, while others had been newly recruited. The latter group entered the trial after a 4-week run-in period, during which a 200-mg daily loading dose was given for 4 weeks.

Most (86%) patients had been exposed to ritlecitinib for at least 12 months; one-fifth had discontinued treatment at the data cutoff, generally because the patients no longer met the eligibility criteria for the trial.

Safety was paramount, Dr. Tsianakas highlighted. There were few adverse events that led to temporary or permanent discontinuation of the study drug. The most common TEAEs that affected 5% or more of patients included headache and acne. There were two cases of MACE (one nonfatal myocardial infarction and one nonfatal stroke).

The proportion of patients with a SALT score of 20 or less was 2.5% at 1 month, 27.9% at 3 months, 50.1% at 6 months, 59.8% at 9 months, and 65.5% at 12 months. Thereafter, there was little shift in the response. A sustained effect, in which a SALT score of 20 or less was seen out to 24 months, occurred in 69.9% of patients.

A similar pattern was seen for SALT scores of 10 or less, ranging from 16.5% at 3 months to 62.5% at 24 months.
 

Following in baricitinib’s footsteps?

This not the first time that JAK inhibitors have been shown to have beneficial effects for patients with AA. Baricitinib (Olumiant) recently became the first JAK inhibitor to be granted marketing approval for AA in the United States, largely on the basis of two pivotal phase 3 studies, BRAVE-AA1 and BRAVE-AA2.

“This is just such an incredibly exciting time,” said Dr. King. “Our discoveries in the lab are being translated into effective therapies for patients with diseases for which we’ve not previously had therapies,” he commented.

“Our concept of interferon gamma– and interleukin-15–mediated disease is probably not true for everybody,” said, Dr. King, who acknowledged that some patients with AA do not respond to JAK-inhibitor therapy or may need additional or alternative treatment.

“It’s probably not that homogeneous a disease,” he added. “It’s fascinating that the very first drugs for this disease are showing efficacy in as many patients as they are.”

The THRIVE-AAI study was funded by CONCERT Pharmaceuticals. Dr. King has served on advisory boards, has provided consulting services to, or has been a trial investigator for multiple pharmaceutical companies, including CoNCERT Pharmaceuticals. The ALLEGRO-LT study was funded by Pfizer. Dr. Tsianakas has acted as a clinical trial investigator and speaker for Pfizer.

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

Treatment with deuruxolitinib and ritlecitinib, two investigational Janus kinase (JAK) inhibitors, resulted in substantial regrowth of scalp hair for patients with alopecia areata (AA) in separate studies reported at the annual congress of the European Academy of Dermatology and Venereology.

In the THRIVE-AA1 study, the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or lower –which indicates that hair regrowth has occurred on at least 80% of the scalp – was achieved among patients taking deuruxolitinib, which was a significantly higher proportion than with placebo (P < .0001). Importantly, the JAK inhibitor’s effects were seen in as early as 4 weeks, and there was significant improvement in both eyelash and eyebrow hair regrowth.

In the unrelated ALLEGRO-LT study, effects from treatment with the JAK inhibitor ritlecitinib appeared to be sustained for 2 years; 69.6% of patients treated with ritlecitinib had a SALT score of 20 or lower by 24 months.

These data are “very exciting for alopecia areata because the patients selected are very severe,” observed Mahtab Samimi, MD, PhD, who cochaired the late-breaking session in which the study findings were discussed.

THRIVE-AA1 included only patients with hair loss of 50% or more. The ALLEGRO-LT study included patients with total scalp or total body hair loss (areata totalis/areata universalis) of 25%-50% at enrollment.

Moreover, “very stringent criteria” were used. SALT scores of 10 or less were evaluated in both studies, observed Dr. Samimi, professor of dermatology at the University of Tours (France).

“We can be ambitious now for our patients with alopecia areata; that’s really good news,” Dr. Samimi added.

Deuruxolitinib and the THRIVE trials

Deuruxolitinib is an oral JAK1/JAK2 inhibitor that has been tested in two similarly designed, multinational, randomized, double-blind, placebo-controlled phase 3 trials in patients with AA, THRIVE-AA1 and THRIVE-AA2.

Two doses of deuruxolitinib, 8 mg and 12 mg given twice daily, were evaluated in the trials, which altogether included just over 1,200 patients.

Results of THRIVE-AA1 have been reported by the manufacturer. Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., presented a more comprehensive review at the EADV meeting.

He reported that at 24 weeks, SALT scores of 20 or lower were achieved by 30% of adults with AA who were treated with deuruxolitinib 8 mg and by 42% of those treated with deuruxolitinib 12 mg. This primary endpoint was seen in only 1% of the placebo-treated patients.

The more stringent endpoint of having a SALT score of 10 or less, which indicates that hair regrowth has occurred over 90% of the scalp, was met by 21% of patients who received deuruxolitinib 8 mg twice a day and by 35% of those who received the 12-mg dose twice a day at 24 weeks. This endpoint was not reached by any of the placebo-treated patients.

“This is truly transformative therapy,” Dr. King said when presenting the findings. “We know that the chances of spontaneous remission when you have severe disease is next to zero,” he added.

There were reasonably high rates of patient satisfaction with the treatment, according to Dr. King. He said that 42% of those who took 8 mg twice a day and 53% of those who took 12 mg twice a day said they were “very satisfied” or “satisfied” with the degree of scalp hair regrowth achieved, compared with 5% for placebo.

Safety was as expected, and there were no signs of any blood clots, said Dr. King. Common treatment-emergent adverse events (TEAEs) that affected 5% or more of patients included acne and headache. Serious TEAEs were reported by 1.1% and 0.5% of those taking the 8-mg and 12-mg twice-daily doses, respectively, compared with 2.9% of those who received placebo.

Overall, the results look promising for deuruxolitinib, he added. He noted that almost all patients included in the trial have opted to continue in the open-label long-term safety study.

Prescribing information of the JAK inhibitors approved by the U.S. Food and Drug Administration includes a boxed warning about risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. The warning is based on experience with another JAK inhibitor for patients with rheumatoid arthritis.
 

Ritlecitinib and the ALLEGRO studies

Interim results of the ongoing, open-label, phase 3 ALLEGRO-LT study with ritlecitinib were presented separately by Athanasios Tsianakas, MD, head of the department of dermatology at Fachklinik Bad Bentheim, Germany.

Ritlecitinib, which targets JAK3 and also the TEC family of tyrosine kinases, had met all of its endpoints in the prior ALLEGRO Phase 2b/3 study, Dr. Tsianakas said. Those included the benchmarks of a SALT score of 20 or less and a SALT score of 10 or less.

“Ritlecitinib showed a very good long-term efficacy and good safety profile in our adolescent and adult patients suffering from alopecia areata,” said Dr. Tsianakas.

A total of 447 patients were included in the trial. They were treated with 50 mg of ritlecitinib every day; some had already participated in the ALLEGRO trial, while others had been newly recruited. The latter group entered the trial after a 4-week run-in period, during which a 200-mg daily loading dose was given for 4 weeks.

Most (86%) patients had been exposed to ritlecitinib for at least 12 months; one-fifth had discontinued treatment at the data cutoff, generally because the patients no longer met the eligibility criteria for the trial.

Safety was paramount, Dr. Tsianakas highlighted. There were few adverse events that led to temporary or permanent discontinuation of the study drug. The most common TEAEs that affected 5% or more of patients included headache and acne. There were two cases of MACE (one nonfatal myocardial infarction and one nonfatal stroke).

The proportion of patients with a SALT score of 20 or less was 2.5% at 1 month, 27.9% at 3 months, 50.1% at 6 months, 59.8% at 9 months, and 65.5% at 12 months. Thereafter, there was little shift in the response. A sustained effect, in which a SALT score of 20 or less was seen out to 24 months, occurred in 69.9% of patients.

A similar pattern was seen for SALT scores of 10 or less, ranging from 16.5% at 3 months to 62.5% at 24 months.
 

Following in baricitinib’s footsteps?

This not the first time that JAK inhibitors have been shown to have beneficial effects for patients with AA. Baricitinib (Olumiant) recently became the first JAK inhibitor to be granted marketing approval for AA in the United States, largely on the basis of two pivotal phase 3 studies, BRAVE-AA1 and BRAVE-AA2.

“This is just such an incredibly exciting time,” said Dr. King. “Our discoveries in the lab are being translated into effective therapies for patients with diseases for which we’ve not previously had therapies,” he commented.

“Our concept of interferon gamma– and interleukin-15–mediated disease is probably not true for everybody,” said, Dr. King, who acknowledged that some patients with AA do not respond to JAK-inhibitor therapy or may need additional or alternative treatment.

“It’s probably not that homogeneous a disease,” he added. “It’s fascinating that the very first drugs for this disease are showing efficacy in as many patients as they are.”

The THRIVE-AAI study was funded by CONCERT Pharmaceuticals. Dr. King has served on advisory boards, has provided consulting services to, or has been a trial investigator for multiple pharmaceutical companies, including CoNCERT Pharmaceuticals. The ALLEGRO-LT study was funded by Pfizer. Dr. Tsianakas has acted as a clinical trial investigator and speaker for Pfizer.

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