Pediatrics

With the flip of the calendar a few short weeks ago, gyms and fitness centers began ramping up their advertising campaigns in hopes of attracting the horde of resolution makers searching for a place where they can inject some exercise into their sedentary lives. A recent survey by C.S. Mott’s Children’s Hospital found that even young people are setting health-related goals with more than half of the parents of 11- to 18-year-olds reporting their children were setting personal goals for themselves. More than 40% of the young people listed more exercise as a target.

However, our personal and professional experiences have taught us that achieving goals, particularly when it comes to exercise, is far more difficult than setting the target. Finding an exercise buddy can be an important motivator on the days when just lacing up one’s sneakers is a stumbling block. Investing in a gym membership and sweating with a peer group can help. However, it is an investment that rarely pays a dividend. Exercise isn’t fun for everyone. For adults, showing up at a gym may be just one more reminder of how they have already lost their competitive edge over their leaner and fitter peers. If they aren’t lucky enough to find a sport or activity that they enjoy, the loneliness of the long-distance runner has little appeal.

A recent study on children in the United Kingdom suggests that at least when it comes to teens and young adults we as physicians may actually have been making things worse for our obese patients by urging them to accept unrealistic activity goals. While it is already known that sedentary time is responsible for 70% of the total increase in cholesterol as children advance to young adulthood an unqualified recommendation for more exercise may not be the best advice.

In an interview with the study author, Andre O. Agbaje MD, MPH, said that in his large study population “light physical activity outperforms moderate to vigorous physical activity by five to eight times in lowering lipids”. While we may be surprised by this counterintuitive finding, Dr. Agbaje points out that an increase in sedentariness from 6 to 9 hours per day translates into a loss of 3 hours of light physical activity. In other words if you’re not sedentary you must be standing at attention or engaged in some light activity.

In my experience, and I suspect yours, it is difficult to get adults to do something, particularly if that something involves exerting energy, even a small amount of energy. The general admonishment of “be more active” is often met with a blank stare and the sometimes unspoken question “Like what?”

You could fall into a bottomless trap with them by suggesting a long list of activities, many of which are probably ones you do or would enjoy but don’t happen to fit with any of their interests or capabilities. Your chances of hitting on a perfect activity that the patient will attempt, let alone adopt, is very slim. Those of you with more patience than I have may choose to persist with this strategy. You could argue that even if the patient only dabbles briefly in one of your recommended activities, this is a minor victory worth celebrating. Who knows? The brief jolt of energy they received from this activity may prompt them to seek and find something else that works.

My interpretation of Dr. Agbaje’s findings is this: If we are going to suggest more activity, aim low. Don’t even mention the heavily weighted words “sport” or “exercise,” which are likely to dredge up bad memories. For adults, “Go shopping” or “Visit a friend” may be sufficient to at least get the person off the couch and on their feet and moving, even if very briefly.

The second message from this study applies more to children and adolescents and is one of those unusual instances in which a negative intervention may be more effective than a positive approach. Acknowledging that we are likely to have difficulty finding even a light activity that the child enjoys, why not pivot to the other side of the equation? Make a list of the child’s primary sedentary “activities.” Then suggest the parents put the child on a couch potato diet by immediately cutting in half the time he or she spends being sedentary. By definition, this will automatically increase his or her light physical activity by 50%. According to Dr. Agbaje’s data, this should be more effective in lowering lipids than in the unlikely event of finding a moderate activity the child accepts.

You can argue that the child will hound his or her parents unmercifully asking to be entertained. This may be true and this persistent complaining will be more likely to come from the older the child and the longer that the child has been allowed to be sedentary. Although the child may appear to have lost the ability to self amuse, I contend this isn’t a permanent loss and, with parental help, self-generated activity is a skill that can be regained if sedentary behavior is curtailed. This is another example of how saying “No!” in the right circumstances is often the most effective remedy for an unhealthy situation. I would never claim saying “No” is easy and helping parents to learn how to say “No” is one of our most difficult challenges. But, nothing else seems to be working.
 

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

With the flip of the calendar a few short weeks ago, gyms and fitness centers began ramping up their advertising campaigns in hopes of attracting the horde of resolution makers searching for a place where they can inject some exercise into their sedentary lives. A recent survey by C.S. Mott’s Children’s Hospital found that even young people are setting health-related goals with more than half of the parents of 11- to 18-year-olds reporting their children were setting personal goals for themselves. More than 40% of the young people listed more exercise as a target.

However, our personal and professional experiences have taught us that achieving goals, particularly when it comes to exercise, is far more difficult than setting the target. Finding an exercise buddy can be an important motivator on the days when just lacing up one’s sneakers is a stumbling block. Investing in a gym membership and sweating with a peer group can help. However, it is an investment that rarely pays a dividend. Exercise isn’t fun for everyone. For adults, showing up at a gym may be just one more reminder of how they have already lost their competitive edge over their leaner and fitter peers. If they aren’t lucky enough to find a sport or activity that they enjoy, the loneliness of the long-distance runner has little appeal.

A recent study on children in the United Kingdom suggests that at least when it comes to teens and young adults we as physicians may actually have been making things worse for our obese patients by urging them to accept unrealistic activity goals. While it is already known that sedentary time is responsible for 70% of the total increase in cholesterol as children advance to young adulthood an unqualified recommendation for more exercise may not be the best advice.

In an interview with the study author, Andre O. Agbaje MD, MPH, said that in his large study population “light physical activity outperforms moderate to vigorous physical activity by five to eight times in lowering lipids”. While we may be surprised by this counterintuitive finding, Dr. Agbaje points out that an increase in sedentariness from 6 to 9 hours per day translates into a loss of 3 hours of light physical activity. In other words if you’re not sedentary you must be standing at attention or engaged in some light activity.

In my experience, and I suspect yours, it is difficult to get adults to do something, particularly if that something involves exerting energy, even a small amount of energy. The general admonishment of “be more active” is often met with a blank stare and the sometimes unspoken question “Like what?”

You could fall into a bottomless trap with them by suggesting a long list of activities, many of which are probably ones you do or would enjoy but don’t happen to fit with any of their interests or capabilities. Your chances of hitting on a perfect activity that the patient will attempt, let alone adopt, is very slim. Those of you with more patience than I have may choose to persist with this strategy. You could argue that even if the patient only dabbles briefly in one of your recommended activities, this is a minor victory worth celebrating. Who knows? The brief jolt of energy they received from this activity may prompt them to seek and find something else that works.

My interpretation of Dr. Agbaje’s findings is this: If we are going to suggest more activity, aim low. Don’t even mention the heavily weighted words “sport” or “exercise,” which are likely to dredge up bad memories. For adults, “Go shopping” or “Visit a friend” may be sufficient to at least get the person off the couch and on their feet and moving, even if very briefly.

The second message from this study applies more to children and adolescents and is one of those unusual instances in which a negative intervention may be more effective than a positive approach. Acknowledging that we are likely to have difficulty finding even a light activity that the child enjoys, why not pivot to the other side of the equation? Make a list of the child’s primary sedentary “activities.” Then suggest the parents put the child on a couch potato diet by immediately cutting in half the time he or she spends being sedentary. By definition, this will automatically increase his or her light physical activity by 50%. According to Dr. Agbaje’s data, this should be more effective in lowering lipids than in the unlikely event of finding a moderate activity the child accepts.

You can argue that the child will hound his or her parents unmercifully asking to be entertained. This may be true and this persistent complaining will be more likely to come from the older the child and the longer that the child has been allowed to be sedentary. Although the child may appear to have lost the ability to self amuse, I contend this isn’t a permanent loss and, with parental help, self-generated activity is a skill that can be regained if sedentary behavior is curtailed. This is another example of how saying “No!” in the right circumstances is often the most effective remedy for an unhealthy situation. I would never claim saying “No” is easy and helping parents to learn how to say “No” is one of our most difficult challenges. But, nothing else seems to be working.
 

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

With the flip of the calendar a few short weeks ago, gyms and fitness centers began ramping up their advertising campaigns in hopes of attracting the horde of resolution makers searching for a place where they can inject some exercise into their sedentary lives. A recent survey by C.S. Mott’s Children’s Hospital found that even young people are setting health-related goals with more than half of the parents of 11- to 18-year-olds reporting their children were setting personal goals for themselves. More than 40% of the young people listed more exercise as a target.

However, our personal and professional experiences have taught us that achieving goals, particularly when it comes to exercise, is far more difficult than setting the target. Finding an exercise buddy can be an important motivator on the days when just lacing up one’s sneakers is a stumbling block. Investing in a gym membership and sweating with a peer group can help. However, it is an investment that rarely pays a dividend. Exercise isn’t fun for everyone. For adults, showing up at a gym may be just one more reminder of how they have already lost their competitive edge over their leaner and fitter peers. If they aren’t lucky enough to find a sport or activity that they enjoy, the loneliness of the long-distance runner has little appeal.

A recent study on children in the United Kingdom suggests that at least when it comes to teens and young adults we as physicians may actually have been making things worse for our obese patients by urging them to accept unrealistic activity goals. While it is already known that sedentary time is responsible for 70% of the total increase in cholesterol as children advance to young adulthood an unqualified recommendation for more exercise may not be the best advice.

In an interview with the study author, Andre O. Agbaje MD, MPH, said that in his large study population “light physical activity outperforms moderate to vigorous physical activity by five to eight times in lowering lipids”. While we may be surprised by this counterintuitive finding, Dr. Agbaje points out that an increase in sedentariness from 6 to 9 hours per day translates into a loss of 3 hours of light physical activity. In other words if you’re not sedentary you must be standing at attention or engaged in some light activity.

In my experience, and I suspect yours, it is difficult to get adults to do something, particularly if that something involves exerting energy, even a small amount of energy. The general admonishment of “be more active” is often met with a blank stare and the sometimes unspoken question “Like what?”

You could fall into a bottomless trap with them by suggesting a long list of activities, many of which are probably ones you do or would enjoy but don’t happen to fit with any of their interests or capabilities. Your chances of hitting on a perfect activity that the patient will attempt, let alone adopt, is very slim. Those of you with more patience than I have may choose to persist with this strategy. You could argue that even if the patient only dabbles briefly in one of your recommended activities, this is a minor victory worth celebrating. Who knows? The brief jolt of energy they received from this activity may prompt them to seek and find something else that works.

My interpretation of Dr. Agbaje’s findings is this: If we are going to suggest more activity, aim low. Don’t even mention the heavily weighted words “sport” or “exercise,” which are likely to dredge up bad memories. For adults, “Go shopping” or “Visit a friend” may be sufficient to at least get the person off the couch and on their feet and moving, even if very briefly.

The second message from this study applies more to children and adolescents and is one of those unusual instances in which a negative intervention may be more effective than a positive approach. Acknowledging that we are likely to have difficulty finding even a light activity that the child enjoys, why not pivot to the other side of the equation? Make a list of the child’s primary sedentary “activities.” Then suggest the parents put the child on a couch potato diet by immediately cutting in half the time he or she spends being sedentary. By definition, this will automatically increase his or her light physical activity by 50%. According to Dr. Agbaje’s data, this should be more effective in lowering lipids than in the unlikely event of finding a moderate activity the child accepts.

You can argue that the child will hound his or her parents unmercifully asking to be entertained. This may be true and this persistent complaining will be more likely to come from the older the child and the longer that the child has been allowed to be sedentary. Although the child may appear to have lost the ability to self amuse, I contend this isn’t a permanent loss and, with parental help, self-generated activity is a skill that can be regained if sedentary behavior is curtailed. This is another example of how saying “No!” in the right circumstances is often the most effective remedy for an unhealthy situation. I would never claim saying “No” is easy and helping parents to learn how to say “No” is one of our most difficult challenges. But, nothing else seems to be working.
 

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

Pediatrician Michelle Collins-Ogle, MD, already has a busy practice helping young people address questions about their gender identity. She has treated more than 230 patients over the past 2 years at Children’s Hospital at Montefiore in the Bronx, New York.

Dr. Collins-Ogle specializes in adolescent medicine in New York, a state without the restrictions on such care that have been enacted in roughly half the country.

On December 13, 2023, Ohio lawmakers passed a bill banning gender-affirming medical care to minors which Gov. Mike DeWine vetoed on December 29. Another 26 states have similar restrictions in place, according to a tally provided to this news organization by the Human Rights Campaign, which tracks this issue.

Clinicians like Dr. Collins-Ogle are feeling the impact. In her practice, Dr. Collins-Ogle met a couple that moved from Texas to New York to allow their child to access gender-affirming medical care.

“They wanted their child to be able to receive medical care, but they also were afraid for their own safety, of having their child taken from them, and being locked up,” Dr. Collins-Ogle told this news organization. 

With patients have also come protestors and harassment. In fact, many physicians are reluctant to speak on this topic amid a recent spate of threats. Psychiatric News reported that conservative pundits and high-profile social media accounts have targeted physicians who provide gender-affirming medical care, spurring harassment campaigns against clinics in cities such as Akron, Boston, and Nashville. “The attackers asserted that the clinics were mutilating children and giving them ‘chemical castration drugs,’ among other claims,” the Psychiatric News reported.

This news organization contacted more than a half dozen organizations that provide gender-affirming care for adolescents and teens seeking interviews about the effects of these restrictions.

All but Montefiore’s Dr. Collins-Ogle turned down the request.

“If my kids are brave enough to come see me, I can’t cower,” Dr. Collins-Ogle said. 

But Dr. Collins-Ogle emphasized she understands why many fellow physicians are concerned about speaking publicly about gender-affirming medical care. 
 

Dissenters Spread Misinformation and Threats

Recent years have seen increasing politicization of this issue, often due to inaccurate depictions of gender-affirming medical care circulating on social media. 

In 2022, the American Medical Association (AMA), the American Academy of Pediatrics (AAP), and the Children’s Hospital Association asked the Justice Department to investigate what they called “increasing threats of violence against physicians, hospitals, and families of children for providing and seeking evidence-based gender-affirming care.” 

The three organizations also called on X (formerly known as Twitter), TikTok, and Meta, which owns Facebook and Instagram, to do more to address coordinated campaigns of disinformation. 

“We cannot stand by as threats of violence against our members and their patients proliferate with little consequence,” said Moira Szilagyi, MD, PhD, then AAP president in a statement. 
 

Medical Groups Defend Care to Prevent Suicide

The AAP, AMA, and other influential medical associations are banding together to fight new legal restrictions on gender-affirming medical care for teens and adolescents. (These briefs do not discuss surgeries typically available for adults.) 

Since 2022, these medical organizations have filed amicus briefs in cases challenging new restrictions put in place in Arkansas, Alabama, Florida, Georgia, Idaho, Indiana, Kentucky, North Dakota, Oklahoma, Tennessee, and Texas. 

Other signers to the amicus briefs: 

• Academic Pediatric Association
• American Academy of Child & Adolescent Psychiatry
• American Academy of Family Physicians
• American Academy of Nursing
• GLMA: Health Professionals Advancing LGBTQ+ Equality
• American College of Obstetricians and Gynecologists
• American College of Osteopathic Pediatricians
• The American College of Physicians
• American Pediatric Society
• Association of Medical School Pediatric Department Chairs, Inc.
• Endocrine Society
• National Association of Pediatric Nurse Practitioners
• The Pediatric Endocrine Society, Societies for Pediatric Urology
• Society for Adolescent Health and Medicine
• Society for Pediatric Research
• The Society of Pediatric Nurses
• World Professional Association for Transgender Health

In these amicus briefs, the medical groups argue that evidence-based guidelines support the use of medication in treating gender dysphoria. The amicus briefs in particular cite an Endocrine Society guideline and the standards of care developed by the World Professional Association for Transgender Health (WPATH).

Research shows that adolescents with gender dysphoria who receive puberty blockers and other medications experience less depression, anxiety, and suicidal ideation, the groups have said.

“In light of this evidence supporting the connection between lack of access to gender-affirming care and lifetime suicide risk, banning such care can put patients’ lives at risk,” the AAP and other groups said.
 

Debate Over Source of Gender Identity Concerns 

Having doubts and concerns about one’s gender remains a relatively rare phenomena, although it appears more common among younger people. 

Among US adults, 0.5% or about 1.3 million people identify as transgender whereas about 1.4% or about 300,000 people in the 13-17–year-old group do so, according to a report issued in 2022 by the Williams Institute of the UCLA School of Law. 
 

Questionable Diagnosis Drives Bans on Care

The term “rapid-onset gender dysphoria,” referring to young people who suddenly question their gender as part of peer group dynamics, persists in political debates. The conservative Heritage Foundation has used the term as well as “social contagion” in its effort to seek restrictions on gender-affirming care for young people. 

Ohio Rep. Gary Click, a Republican, said at an April 2023 hearing that his Save Adolescents from Experimentation (SAFE) bill would prevent teens from being harmed due to “social contagion” or “ rapid-onset gender dysphoria.” 

The bill, which the Ohio legislature cleared in December, would block physicians from starting new patients on puberty blockers. (It also bars surgeries as part of gender-affirming medical care, although hospital officials and physicians told lawmakers these are not done in Ohio.) 

Among the groups opposing Click’s bill were the Ohio chapter of the AAP, the Ohio State Medical Association and several hospitals and hospital groups as well as physicians speaking independently. 

Gender-Affirming Care ‘Buys Time’ to Avoid Impulsive Decisions

Kate Krueck, MD, a pediatrician with a practice in the Columbus area, testified about her experience as the mother of a transgender child who once attempted suicide. 

“It wasn’t always easy to reconstruct my vision of a baby with a vagina into the adolescent before me with a new name and changed pronouns, but they were still the same incredible person,” Krueck said. 

She urged lawmakers to understand how puberty blockers can “buy time” for teens to cope with a body at odds with their vision of themselves, noting that many of the effects of these medications are largely reversible. The side effects that are not reversible, such as facial hair growth and the growth of Adam’s Apple, are certainly outweighed by the risks of withholding treatment, she said. 
 

Bad Patient Experience Drives Detractor Activist

Arguing against that point was Chloe Cole, a detransitioner activist who had returned to a female identity. At the Ohio legislative hearings, Ms. Cole spoke of her experience in California as a teen treated for gender dysphoria.

“I was fast-tracked by medical butchers starting at 13 when I was given cross sex hormones, and they took my breasts away from me at 15 years old,” she said.

Ms. Cole appears frequently to testify in favor of bans on gender-affirming medical care. In 2022, she told the Ohio lawmakers about her experience of attending a class with about a dozen other young people in the midst of female-to-male transitions. She now sees that class as having inadvertently helped reinforce her decision to have her breasts removed.

“Despite all these consultations and classes, I don’t feel like I understood all the ramifications that came with any of the medical decisions I was making,” Ms. Cole said. “I didn’t realize how traumatic the recovery would be, and it wasn’t until I was almost a year post-op that I realized I may want to breastfeed my future children; I will never be able to do that.”

Ms. Cole also spoke in July before the US House subcommittee on the Constitution and Limited Government.

“I look in the mirror sometimes, and I feel like a monster,” Ms. Cole said at the House hearing, which was titled “ The Dangers and Due Process Violations of ‘Gender-Affirming Care’.” 

During the hearing, Shannon Minter, legal director of the National Center for Lesbian Rights (NCLR), who also made a gender transition, thanked Ms. Cole but noted that her case is an exception.

A 2022 Lancet Child and Adolescent Health article reported that 704 (98%) people in the Netherlands who had started gender-affirming medical treatment in adolescence continued to use gender-affirming hormones at follow-up. Ms. Minter credits this high rate of continuation to clinicians taking their duties to adolescents seriously. 

State legislatures and medical boards oversee the regulation of medical practice in the US. But a few Republicans in both chambers of the US Congress have shown an interest in enacting a federal ban restricting physicians’ ability to provide gender-affirming medical care. 

They include Rep. Mike Johnson of Louisiana, who in October 2023 became Speaker of the House. He chaired the July hearing at which Ms. Cole spoke. He’s also a sponsor of a House bill introduced by Rep. Marjorie Taylor Greene (R-GA). 

This measure, which has the support of 45 House Republicans, would make it a felony to perform any gender-affirming care on a minor, and it permits a minor on whom such care is performed to bring a civil action against each individual who provided the care. Sen. JD Vance (R-OH) introduced the companion Senate measure.
 

Reality of Gender-Affirming Care

The drive to pass laws like those in Ohio and Arkansas stem from a lack of knowledge about gender-affirming treatments, including a false idea that doctors prescribe medications at teens’ requests, Montefiore’s Dr. Collins-Ogle said. 

“There’s a misperception that young people will say ‘I’m transgender’ and that those of us who provide care are just giving them hormones or whatever they want. It’s not true, and it doesn’t happen that way,” Dr. Collins-Ogle said. 

At the Children’s Hospital at Montefiore, Dr. Collins-Ogle said her work with patients wrestling with gender identity issues begins with questions. 

“What’s your understanding of dysphoria? Where’s the incongruence between the gender you were assigned at birth and what you’re feeling now? You have to be able to verbalize that” before the treatment proceeds, she said. 

Sometimes teens leave after an initial conversation and then return later when they have a more clearly defined sense of what dysphoria means. 

“There are other kids who clearly, clearly understand that the gender they were assigned at birth is not who they are,” she said. 

Children now wrestle with added concerns that their parents could be put at risk for trying to help them, she said. 

“These kids go through so much. And we have these people in powerful positions telling them that they don’t matter and telling them, ‘We’re going to cut off your access to healthcare, Medicaid; if your parents tried to seek out this care for you, we’re going to put them in jail,’” she said. 

“It’s the biggest factor in fear mongering,” she said. 

Dr. Collins-Ogle said she wonders why legislators who lack medical training are trying to dictate how physicians can practice. 

“I took a Hippocratic oath to do no harm. I have a medical board that I answer to,” she said. “I don’t understand how legislators can get away with legislating about something they know nothing about.”

A version of this article appeared on Medscape.com.

Pediatrician Michelle Collins-Ogle, MD, already has a busy practice helping young people address questions about their gender identity. She has treated more than 230 patients over the past 2 years at Children’s Hospital at Montefiore in the Bronx, New York.

Dr. Collins-Ogle specializes in adolescent medicine in New York, a state without the restrictions on such care that have been enacted in roughly half the country.

On December 13, 2023, Ohio lawmakers passed a bill banning gender-affirming medical care to minors which Gov. Mike DeWine vetoed on December 29. Another 26 states have similar restrictions in place, according to a tally provided to this news organization by the Human Rights Campaign, which tracks this issue.

Clinicians like Dr. Collins-Ogle are feeling the impact. In her practice, Dr. Collins-Ogle met a couple that moved from Texas to New York to allow their child to access gender-affirming medical care.

“They wanted their child to be able to receive medical care, but they also were afraid for their own safety, of having their child taken from them, and being locked up,” Dr. Collins-Ogle told this news organization. 

With patients have also come protestors and harassment. In fact, many physicians are reluctant to speak on this topic amid a recent spate of threats. Psychiatric News reported that conservative pundits and high-profile social media accounts have targeted physicians who provide gender-affirming medical care, spurring harassment campaigns against clinics in cities such as Akron, Boston, and Nashville. “The attackers asserted that the clinics were mutilating children and giving them ‘chemical castration drugs,’ among other claims,” the Psychiatric News reported.

This news organization contacted more than a half dozen organizations that provide gender-affirming care for adolescents and teens seeking interviews about the effects of these restrictions.

All but Montefiore’s Dr. Collins-Ogle turned down the request.

“If my kids are brave enough to come see me, I can’t cower,” Dr. Collins-Ogle said. 

But Dr. Collins-Ogle emphasized she understands why many fellow physicians are concerned about speaking publicly about gender-affirming medical care. 
 

Dissenters Spread Misinformation and Threats

Recent years have seen increasing politicization of this issue, often due to inaccurate depictions of gender-affirming medical care circulating on social media. 

In 2022, the American Medical Association (AMA), the American Academy of Pediatrics (AAP), and the Children’s Hospital Association asked the Justice Department to investigate what they called “increasing threats of violence against physicians, hospitals, and families of children for providing and seeking evidence-based gender-affirming care.” 

The three organizations also called on X (formerly known as Twitter), TikTok, and Meta, which owns Facebook and Instagram, to do more to address coordinated campaigns of disinformation. 

“We cannot stand by as threats of violence against our members and their patients proliferate with little consequence,” said Moira Szilagyi, MD, PhD, then AAP president in a statement. 
 

Medical Groups Defend Care to Prevent Suicide

The AAP, AMA, and other influential medical associations are banding together to fight new legal restrictions on gender-affirming medical care for teens and adolescents. (These briefs do not discuss surgeries typically available for adults.) 

Since 2022, these medical organizations have filed amicus briefs in cases challenging new restrictions put in place in Arkansas, Alabama, Florida, Georgia, Idaho, Indiana, Kentucky, North Dakota, Oklahoma, Tennessee, and Texas. 

Other signers to the amicus briefs: 

• Academic Pediatric Association
• American Academy of Child & Adolescent Psychiatry
• American Academy of Family Physicians
• American Academy of Nursing
• GLMA: Health Professionals Advancing LGBTQ+ Equality
• American College of Obstetricians and Gynecologists
• American College of Osteopathic Pediatricians
• The American College of Physicians
• American Pediatric Society
• Association of Medical School Pediatric Department Chairs, Inc.
• Endocrine Society
• National Association of Pediatric Nurse Practitioners
• The Pediatric Endocrine Society, Societies for Pediatric Urology
• Society for Adolescent Health and Medicine
• Society for Pediatric Research
• The Society of Pediatric Nurses
• World Professional Association for Transgender Health

In these amicus briefs, the medical groups argue that evidence-based guidelines support the use of medication in treating gender dysphoria. The amicus briefs in particular cite an Endocrine Society guideline and the standards of care developed by the World Professional Association for Transgender Health (WPATH).

Research shows that adolescents with gender dysphoria who receive puberty blockers and other medications experience less depression, anxiety, and suicidal ideation, the groups have said.

“In light of this evidence supporting the connection between lack of access to gender-affirming care and lifetime suicide risk, banning such care can put patients’ lives at risk,” the AAP and other groups said.
 

Debate Over Source of Gender Identity Concerns 

Having doubts and concerns about one’s gender remains a relatively rare phenomena, although it appears more common among younger people. 

Among US adults, 0.5% or about 1.3 million people identify as transgender whereas about 1.4% or about 300,000 people in the 13-17–year-old group do so, according to a report issued in 2022 by the Williams Institute of the UCLA School of Law. 
 

Questionable Diagnosis Drives Bans on Care

The term “rapid-onset gender dysphoria,” referring to young people who suddenly question their gender as part of peer group dynamics, persists in political debates. The conservative Heritage Foundation has used the term as well as “social contagion” in its effort to seek restrictions on gender-affirming care for young people. 

Ohio Rep. Gary Click, a Republican, said at an April 2023 hearing that his Save Adolescents from Experimentation (SAFE) bill would prevent teens from being harmed due to “social contagion” or “ rapid-onset gender dysphoria.” 

The bill, which the Ohio legislature cleared in December, would block physicians from starting new patients on puberty blockers. (It also bars surgeries as part of gender-affirming medical care, although hospital officials and physicians told lawmakers these are not done in Ohio.) 

Among the groups opposing Click’s bill were the Ohio chapter of the AAP, the Ohio State Medical Association and several hospitals and hospital groups as well as physicians speaking independently. 

Gender-Affirming Care ‘Buys Time’ to Avoid Impulsive Decisions

Kate Krueck, MD, a pediatrician with a practice in the Columbus area, testified about her experience as the mother of a transgender child who once attempted suicide. 

“It wasn’t always easy to reconstruct my vision of a baby with a vagina into the adolescent before me with a new name and changed pronouns, but they were still the same incredible person,” Krueck said. 

She urged lawmakers to understand how puberty blockers can “buy time” for teens to cope with a body at odds with their vision of themselves, noting that many of the effects of these medications are largely reversible. The side effects that are not reversible, such as facial hair growth and the growth of Adam’s Apple, are certainly outweighed by the risks of withholding treatment, she said. 
 

Bad Patient Experience Drives Detractor Activist

Arguing against that point was Chloe Cole, a detransitioner activist who had returned to a female identity. At the Ohio legislative hearings, Ms. Cole spoke of her experience in California as a teen treated for gender dysphoria.

“I was fast-tracked by medical butchers starting at 13 when I was given cross sex hormones, and they took my breasts away from me at 15 years old,” she said.

Ms. Cole appears frequently to testify in favor of bans on gender-affirming medical care. In 2022, she told the Ohio lawmakers about her experience of attending a class with about a dozen other young people in the midst of female-to-male transitions. She now sees that class as having inadvertently helped reinforce her decision to have her breasts removed.

“Despite all these consultations and classes, I don’t feel like I understood all the ramifications that came with any of the medical decisions I was making,” Ms. Cole said. “I didn’t realize how traumatic the recovery would be, and it wasn’t until I was almost a year post-op that I realized I may want to breastfeed my future children; I will never be able to do that.”

Ms. Cole also spoke in July before the US House subcommittee on the Constitution and Limited Government.

“I look in the mirror sometimes, and I feel like a monster,” Ms. Cole said at the House hearing, which was titled “ The Dangers and Due Process Violations of ‘Gender-Affirming Care’.” 

During the hearing, Shannon Minter, legal director of the National Center for Lesbian Rights (NCLR), who also made a gender transition, thanked Ms. Cole but noted that her case is an exception.

A 2022 Lancet Child and Adolescent Health article reported that 704 (98%) people in the Netherlands who had started gender-affirming medical treatment in adolescence continued to use gender-affirming hormones at follow-up. Ms. Minter credits this high rate of continuation to clinicians taking their duties to adolescents seriously. 

State legislatures and medical boards oversee the regulation of medical practice in the US. But a few Republicans in both chambers of the US Congress have shown an interest in enacting a federal ban restricting physicians’ ability to provide gender-affirming medical care. 

They include Rep. Mike Johnson of Louisiana, who in October 2023 became Speaker of the House. He chaired the July hearing at which Ms. Cole spoke. He’s also a sponsor of a House bill introduced by Rep. Marjorie Taylor Greene (R-GA). 

This measure, which has the support of 45 House Republicans, would make it a felony to perform any gender-affirming care on a minor, and it permits a minor on whom such care is performed to bring a civil action against each individual who provided the care. Sen. JD Vance (R-OH) introduced the companion Senate measure.
 

Reality of Gender-Affirming Care

The drive to pass laws like those in Ohio and Arkansas stem from a lack of knowledge about gender-affirming treatments, including a false idea that doctors prescribe medications at teens’ requests, Montefiore’s Dr. Collins-Ogle said. 

“There’s a misperception that young people will say ‘I’m transgender’ and that those of us who provide care are just giving them hormones or whatever they want. It’s not true, and it doesn’t happen that way,” Dr. Collins-Ogle said. 

At the Children’s Hospital at Montefiore, Dr. Collins-Ogle said her work with patients wrestling with gender identity issues begins with questions. 

“What’s your understanding of dysphoria? Where’s the incongruence between the gender you were assigned at birth and what you’re feeling now? You have to be able to verbalize that” before the treatment proceeds, she said. 

Sometimes teens leave after an initial conversation and then return later when they have a more clearly defined sense of what dysphoria means. 

“There are other kids who clearly, clearly understand that the gender they were assigned at birth is not who they are,” she said. 

Children now wrestle with added concerns that their parents could be put at risk for trying to help them, she said. 

“These kids go through so much. And we have these people in powerful positions telling them that they don’t matter and telling them, ‘We’re going to cut off your access to healthcare, Medicaid; if your parents tried to seek out this care for you, we’re going to put them in jail,’” she said. 

“It’s the biggest factor in fear mongering,” she said. 

Dr. Collins-Ogle said she wonders why legislators who lack medical training are trying to dictate how physicians can practice. 

“I took a Hippocratic oath to do no harm. I have a medical board that I answer to,” she said. “I don’t understand how legislators can get away with legislating about something they know nothing about.”

A version of this article appeared on Medscape.com.

Pediatrician Michelle Collins-Ogle, MD, already has a busy practice helping young people address questions about their gender identity. She has treated more than 230 patients over the past 2 years at Children’s Hospital at Montefiore in the Bronx, New York.

Dr. Collins-Ogle specializes in adolescent medicine in New York, a state without the restrictions on such care that have been enacted in roughly half the country.

On December 13, 2023, Ohio lawmakers passed a bill banning gender-affirming medical care to minors which Gov. Mike DeWine vetoed on December 29. Another 26 states have similar restrictions in place, according to a tally provided to this news organization by the Human Rights Campaign, which tracks this issue.

Clinicians like Dr. Collins-Ogle are feeling the impact. In her practice, Dr. Collins-Ogle met a couple that moved from Texas to New York to allow their child to access gender-affirming medical care.

“They wanted their child to be able to receive medical care, but they also were afraid for their own safety, of having their child taken from them, and being locked up,” Dr. Collins-Ogle told this news organization. 

With patients have also come protestors and harassment. In fact, many physicians are reluctant to speak on this topic amid a recent spate of threats. Psychiatric News reported that conservative pundits and high-profile social media accounts have targeted physicians who provide gender-affirming medical care, spurring harassment campaigns against clinics in cities such as Akron, Boston, and Nashville. “The attackers asserted that the clinics were mutilating children and giving them ‘chemical castration drugs,’ among other claims,” the Psychiatric News reported.

This news organization contacted more than a half dozen organizations that provide gender-affirming care for adolescents and teens seeking interviews about the effects of these restrictions.

All but Montefiore’s Dr. Collins-Ogle turned down the request.

“If my kids are brave enough to come see me, I can’t cower,” Dr. Collins-Ogle said. 

But Dr. Collins-Ogle emphasized she understands why many fellow physicians are concerned about speaking publicly about gender-affirming medical care. 
 

Dissenters Spread Misinformation and Threats

Recent years have seen increasing politicization of this issue, often due to inaccurate depictions of gender-affirming medical care circulating on social media. 

In 2022, the American Medical Association (AMA), the American Academy of Pediatrics (AAP), and the Children’s Hospital Association asked the Justice Department to investigate what they called “increasing threats of violence against physicians, hospitals, and families of children for providing and seeking evidence-based gender-affirming care.” 

The three organizations also called on X (formerly known as Twitter), TikTok, and Meta, which owns Facebook and Instagram, to do more to address coordinated campaigns of disinformation. 

“We cannot stand by as threats of violence against our members and their patients proliferate with little consequence,” said Moira Szilagyi, MD, PhD, then AAP president in a statement. 
 

Medical Groups Defend Care to Prevent Suicide

The AAP, AMA, and other influential medical associations are banding together to fight new legal restrictions on gender-affirming medical care for teens and adolescents. (These briefs do not discuss surgeries typically available for adults.) 

Since 2022, these medical organizations have filed amicus briefs in cases challenging new restrictions put in place in Arkansas, Alabama, Florida, Georgia, Idaho, Indiana, Kentucky, North Dakota, Oklahoma, Tennessee, and Texas. 

Other signers to the amicus briefs: 

• Academic Pediatric Association
• American Academy of Child & Adolescent Psychiatry
• American Academy of Family Physicians
• American Academy of Nursing
• GLMA: Health Professionals Advancing LGBTQ+ Equality
• American College of Obstetricians and Gynecologists
• American College of Osteopathic Pediatricians
• The American College of Physicians
• American Pediatric Society
• Association of Medical School Pediatric Department Chairs, Inc.
• Endocrine Society
• National Association of Pediatric Nurse Practitioners
• The Pediatric Endocrine Society, Societies for Pediatric Urology
• Society for Adolescent Health and Medicine
• Society for Pediatric Research
• The Society of Pediatric Nurses
• World Professional Association for Transgender Health

In these amicus briefs, the medical groups argue that evidence-based guidelines support the use of medication in treating gender dysphoria. The amicus briefs in particular cite an Endocrine Society guideline and the standards of care developed by the World Professional Association for Transgender Health (WPATH).

Research shows that adolescents with gender dysphoria who receive puberty blockers and other medications experience less depression, anxiety, and suicidal ideation, the groups have said.

“In light of this evidence supporting the connection between lack of access to gender-affirming care and lifetime suicide risk, banning such care can put patients’ lives at risk,” the AAP and other groups said.
 

Debate Over Source of Gender Identity Concerns 

Having doubts and concerns about one’s gender remains a relatively rare phenomena, although it appears more common among younger people. 

Among US adults, 0.5% or about 1.3 million people identify as transgender whereas about 1.4% or about 300,000 people in the 13-17–year-old group do so, according to a report issued in 2022 by the Williams Institute of the UCLA School of Law. 
 

Questionable Diagnosis Drives Bans on Care

The term “rapid-onset gender dysphoria,” referring to young people who suddenly question their gender as part of peer group dynamics, persists in political debates. The conservative Heritage Foundation has used the term as well as “social contagion” in its effort to seek restrictions on gender-affirming care for young people. 

Ohio Rep. Gary Click, a Republican, said at an April 2023 hearing that his Save Adolescents from Experimentation (SAFE) bill would prevent teens from being harmed due to “social contagion” or “ rapid-onset gender dysphoria.” 

The bill, which the Ohio legislature cleared in December, would block physicians from starting new patients on puberty blockers. (It also bars surgeries as part of gender-affirming medical care, although hospital officials and physicians told lawmakers these are not done in Ohio.) 

Among the groups opposing Click’s bill were the Ohio chapter of the AAP, the Ohio State Medical Association and several hospitals and hospital groups as well as physicians speaking independently. 

Gender-Affirming Care ‘Buys Time’ to Avoid Impulsive Decisions

Kate Krueck, MD, a pediatrician with a practice in the Columbus area, testified about her experience as the mother of a transgender child who once attempted suicide. 

“It wasn’t always easy to reconstruct my vision of a baby with a vagina into the adolescent before me with a new name and changed pronouns, but they were still the same incredible person,” Krueck said. 

She urged lawmakers to understand how puberty blockers can “buy time” for teens to cope with a body at odds with their vision of themselves, noting that many of the effects of these medications are largely reversible. The side effects that are not reversible, such as facial hair growth and the growth of Adam’s Apple, are certainly outweighed by the risks of withholding treatment, she said. 
 

Bad Patient Experience Drives Detractor Activist

Arguing against that point was Chloe Cole, a detransitioner activist who had returned to a female identity. At the Ohio legislative hearings, Ms. Cole spoke of her experience in California as a teen treated for gender dysphoria.

“I was fast-tracked by medical butchers starting at 13 when I was given cross sex hormones, and they took my breasts away from me at 15 years old,” she said.

Ms. Cole appears frequently to testify in favor of bans on gender-affirming medical care. In 2022, she told the Ohio lawmakers about her experience of attending a class with about a dozen other young people in the midst of female-to-male transitions. She now sees that class as having inadvertently helped reinforce her decision to have her breasts removed.

“Despite all these consultations and classes, I don’t feel like I understood all the ramifications that came with any of the medical decisions I was making,” Ms. Cole said. “I didn’t realize how traumatic the recovery would be, and it wasn’t until I was almost a year post-op that I realized I may want to breastfeed my future children; I will never be able to do that.”

Ms. Cole also spoke in July before the US House subcommittee on the Constitution and Limited Government.

“I look in the mirror sometimes, and I feel like a monster,” Ms. Cole said at the House hearing, which was titled “ The Dangers and Due Process Violations of ‘Gender-Affirming Care’.” 

During the hearing, Shannon Minter, legal director of the National Center for Lesbian Rights (NCLR), who also made a gender transition, thanked Ms. Cole but noted that her case is an exception.

A 2022 Lancet Child and Adolescent Health article reported that 704 (98%) people in the Netherlands who had started gender-affirming medical treatment in adolescence continued to use gender-affirming hormones at follow-up. Ms. Minter credits this high rate of continuation to clinicians taking their duties to adolescents seriously. 

State legislatures and medical boards oversee the regulation of medical practice in the US. But a few Republicans in both chambers of the US Congress have shown an interest in enacting a federal ban restricting physicians’ ability to provide gender-affirming medical care. 

They include Rep. Mike Johnson of Louisiana, who in October 2023 became Speaker of the House. He chaired the July hearing at which Ms. Cole spoke. He’s also a sponsor of a House bill introduced by Rep. Marjorie Taylor Greene (R-GA). 

This measure, which has the support of 45 House Republicans, would make it a felony to perform any gender-affirming care on a minor, and it permits a minor on whom such care is performed to bring a civil action against each individual who provided the care. Sen. JD Vance (R-OH) introduced the companion Senate measure.
 

Reality of Gender-Affirming Care

The drive to pass laws like those in Ohio and Arkansas stem from a lack of knowledge about gender-affirming treatments, including a false idea that doctors prescribe medications at teens’ requests, Montefiore’s Dr. Collins-Ogle said. 

“There’s a misperception that young people will say ‘I’m transgender’ and that those of us who provide care are just giving them hormones or whatever they want. It’s not true, and it doesn’t happen that way,” Dr. Collins-Ogle said. 

At the Children’s Hospital at Montefiore, Dr. Collins-Ogle said her work with patients wrestling with gender identity issues begins with questions. 

“What’s your understanding of dysphoria? Where’s the incongruence between the gender you were assigned at birth and what you’re feeling now? You have to be able to verbalize that” before the treatment proceeds, she said. 

Sometimes teens leave after an initial conversation and then return later when they have a more clearly defined sense of what dysphoria means. 

“There are other kids who clearly, clearly understand that the gender they were assigned at birth is not who they are,” she said. 

Children now wrestle with added concerns that their parents could be put at risk for trying to help them, she said. 

“These kids go through so much. And we have these people in powerful positions telling them that they don’t matter and telling them, ‘We’re going to cut off your access to healthcare, Medicaid; if your parents tried to seek out this care for you, we’re going to put them in jail,’” she said. 

“It’s the biggest factor in fear mongering,” she said. 

Dr. Collins-Ogle said she wonders why legislators who lack medical training are trying to dictate how physicians can practice. 

“I took a Hippocratic oath to do no harm. I have a medical board that I answer to,” she said. “I don’t understand how legislators can get away with legislating about something they know nothing about.”

A version of this article appeared on Medscape.com.

Evidence-based guidelines for managing atopic dermatitis (AD) issued by The American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) incorporate a decade of new treatments and new methodological standards for making recommendations. The new guidelines update 2012 recommendations.

The JTFPP AD guidelines represent “an evolution” in trustworthy allergy guidelines and provide systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to a rigorous guideline development process, the involvement of the patient and caregiver voice from start to finish, clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation, task force cochair Derek K. Chu, MD, PhD, said in an interview. Dr. Chu, director of the Evidence in Allergy research group at McMaster University, Hamilton, Ontario, Canada, cochaired the task force with Lynda Schneider, MD, section chief of the allergy and asthma program at Boston Children’s Hospital.

The new guidelines were published online on December 17, 2023, in Annals of Allergy, Asthma, & Immunology. They include 25 recommendations and address optimal use of topical treatments, such as topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical crisaborole, and topical antimicrobials; dilute bleach baths; dietary elimination; allergen immunotherapy by subcutaneous (SCIT) and sublingual (SLIT) routes; and systemic treatments with dupilumab and tralokinumab, cyclosporine, azathioprine, methotrexate, mycophenolate, oral JAK inhibitors, systemic corticosteroids; and phototherapy.

“There’s something in here for all clinicians — from primary care to AD experts— and patients may benefit as well, so the key individual recommendations will vary,” Dr. Chu told this news organization.

“Throughout the guideline, we emphasize shared decision-making, key factors to consider for each recommendation, and the specific evidence behind each recommendation,” he said. “There is a major focus on addressing equity, diversity, inclusiveness; and addressing health disparities, and key gaps to address in future research.”

Among the changes to the 2012 JTFPP guidelines, the 2023 update suggests using dilute bleach baths for patients with AD with moderate to severe disease as an additive therapy and suggests using allergen immunotherapy (AIT) for moderate to severe AD.

In other changes, the 2023 update suggests against using elimination diets for AD; recommends against very low dose baricitinib (1 mg); suggests against azathioprine, methotrexate, and mycophenolate mofetil; and suggests against adding topical JAK inhibitors, such as ruxolitinib, for patients with mild to moderate AD refractory to moisturization alone.

The 38-page guidelines include an infographic that summarizes comparative effects of systemic treatments on patient-important outcomes for AD that are important to patients, and includes other key summary tables that can be used at the point of care.

In addition to addressing evidence underlying each recommendation, the guideline’s eAppendix contains 1- to 2-page handouts that address practical issues for each treatment and can be used to facilitate shared decision making.

Dr. Chu said that the updated guidelines “provide important changes to almost all aspects of AD care — my own and my colleagues’ — and I strongly recommend all clinicians treating AD to read the full guidelines and use them in clinical practice. We’re grateful to all our contributors, especially our patient and caregiver partners, for helping make these guidelines. We will continue to periodically update the guidelines as part of maintaining them as living guidelines.”

The guidelines incorporate the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence.

The work was funded by the AAAAI/ACAAI JTFPP. Dr. Chu disclosed that he has received a faculty development award from the AAAAI Foundation and research grants to McMaster from the Canadian Institutes of Health Research, the Ontario Ministry of Health, and the Ontario Medical Association.

Evidence-based guidelines for managing atopic dermatitis (AD) issued by The American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) incorporate a decade of new treatments and new methodological standards for making recommendations. The new guidelines update 2012 recommendations.

The JTFPP AD guidelines represent “an evolution” in trustworthy allergy guidelines and provide systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to a rigorous guideline development process, the involvement of the patient and caregiver voice from start to finish, clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation, task force cochair Derek K. Chu, MD, PhD, said in an interview. Dr. Chu, director of the Evidence in Allergy research group at McMaster University, Hamilton, Ontario, Canada, cochaired the task force with Lynda Schneider, MD, section chief of the allergy and asthma program at Boston Children’s Hospital.

The new guidelines were published online on December 17, 2023, in Annals of Allergy, Asthma, & Immunology. They include 25 recommendations and address optimal use of topical treatments, such as topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical crisaborole, and topical antimicrobials; dilute bleach baths; dietary elimination; allergen immunotherapy by subcutaneous (SCIT) and sublingual (SLIT) routes; and systemic treatments with dupilumab and tralokinumab, cyclosporine, azathioprine, methotrexate, mycophenolate, oral JAK inhibitors, systemic corticosteroids; and phototherapy.

“There’s something in here for all clinicians — from primary care to AD experts— and patients may benefit as well, so the key individual recommendations will vary,” Dr. Chu told this news organization.

“Throughout the guideline, we emphasize shared decision-making, key factors to consider for each recommendation, and the specific evidence behind each recommendation,” he said. “There is a major focus on addressing equity, diversity, inclusiveness; and addressing health disparities, and key gaps to address in future research.”

Among the changes to the 2012 JTFPP guidelines, the 2023 update suggests using dilute bleach baths for patients with AD with moderate to severe disease as an additive therapy and suggests using allergen immunotherapy (AIT) for moderate to severe AD.

In other changes, the 2023 update suggests against using elimination diets for AD; recommends against very low dose baricitinib (1 mg); suggests against azathioprine, methotrexate, and mycophenolate mofetil; and suggests against adding topical JAK inhibitors, such as ruxolitinib, for patients with mild to moderate AD refractory to moisturization alone.

The 38-page guidelines include an infographic that summarizes comparative effects of systemic treatments on patient-important outcomes for AD that are important to patients, and includes other key summary tables that can be used at the point of care.

In addition to addressing evidence underlying each recommendation, the guideline’s eAppendix contains 1- to 2-page handouts that address practical issues for each treatment and can be used to facilitate shared decision making.

Dr. Chu said that the updated guidelines “provide important changes to almost all aspects of AD care — my own and my colleagues’ — and I strongly recommend all clinicians treating AD to read the full guidelines and use them in clinical practice. We’re grateful to all our contributors, especially our patient and caregiver partners, for helping make these guidelines. We will continue to periodically update the guidelines as part of maintaining them as living guidelines.”

The guidelines incorporate the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence.

The work was funded by the AAAAI/ACAAI JTFPP. Dr. Chu disclosed that he has received a faculty development award from the AAAAI Foundation and research grants to McMaster from the Canadian Institutes of Health Research, the Ontario Ministry of Health, and the Ontario Medical Association.

Evidence-based guidelines for managing atopic dermatitis (AD) issued by The American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) incorporate a decade of new treatments and new methodological standards for making recommendations. The new guidelines update 2012 recommendations.

The JTFPP AD guidelines represent “an evolution” in trustworthy allergy guidelines and provide systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to a rigorous guideline development process, the involvement of the patient and caregiver voice from start to finish, clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation, task force cochair Derek K. Chu, MD, PhD, said in an interview. Dr. Chu, director of the Evidence in Allergy research group at McMaster University, Hamilton, Ontario, Canada, cochaired the task force with Lynda Schneider, MD, section chief of the allergy and asthma program at Boston Children’s Hospital.

The new guidelines were published online on December 17, 2023, in Annals of Allergy, Asthma, & Immunology. They include 25 recommendations and address optimal use of topical treatments, such as topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical crisaborole, and topical antimicrobials; dilute bleach baths; dietary elimination; allergen immunotherapy by subcutaneous (SCIT) and sublingual (SLIT) routes; and systemic treatments with dupilumab and tralokinumab, cyclosporine, azathioprine, methotrexate, mycophenolate, oral JAK inhibitors, systemic corticosteroids; and phototherapy.

“There’s something in here for all clinicians — from primary care to AD experts— and patients may benefit as well, so the key individual recommendations will vary,” Dr. Chu told this news organization.

“Throughout the guideline, we emphasize shared decision-making, key factors to consider for each recommendation, and the specific evidence behind each recommendation,” he said. “There is a major focus on addressing equity, diversity, inclusiveness; and addressing health disparities, and key gaps to address in future research.”

Among the changes to the 2012 JTFPP guidelines, the 2023 update suggests using dilute bleach baths for patients with AD with moderate to severe disease as an additive therapy and suggests using allergen immunotherapy (AIT) for moderate to severe AD.

In other changes, the 2023 update suggests against using elimination diets for AD; recommends against very low dose baricitinib (1 mg); suggests against azathioprine, methotrexate, and mycophenolate mofetil; and suggests against adding topical JAK inhibitors, such as ruxolitinib, for patients with mild to moderate AD refractory to moisturization alone.

The 38-page guidelines include an infographic that summarizes comparative effects of systemic treatments on patient-important outcomes for AD that are important to patients, and includes other key summary tables that can be used at the point of care.

In addition to addressing evidence underlying each recommendation, the guideline’s eAppendix contains 1- to 2-page handouts that address practical issues for each treatment and can be used to facilitate shared decision making.

Dr. Chu said that the updated guidelines “provide important changes to almost all aspects of AD care — my own and my colleagues’ — and I strongly recommend all clinicians treating AD to read the full guidelines and use them in clinical practice. We’re grateful to all our contributors, especially our patient and caregiver partners, for helping make these guidelines. We will continue to periodically update the guidelines as part of maintaining them as living guidelines.”

The guidelines incorporate the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence.

The work was funded by the AAAAI/ACAAI JTFPP. Dr. Chu disclosed that he has received a faculty development award from the AAAAI Foundation and research grants to McMaster from the Canadian Institutes of Health Research, the Ontario Ministry of Health, and the Ontario Medical Association.

TOPLINE:

The time arrived at peak blood pressure (BP) velocity (TAPV) was significantly earlier in children with moderate to severe (MS) obstructive sleep apnea (OSA) than in controls.

METHODOLOGY:

• The researchers compared 24-hour circadian BP in children with OSA and controls to examine the impact of OSA on circadian BP.
• The study population included 219 children aged 5-14 years: 52 with mild OSA, 50 with MS OSA, and 117 controls.
• Participants underwent 24-hour BP monitoring and actigraphy; models included the times of BP peaks and TAPV.

TAKEAWAY:

• Children with MS OSA had a TAPV for diastolic BP in the morning, an average of 51 minutes earlier than controls (P < .001).
• Evening TAPV was significantly earlier in the children with MS OSA than in controls for both systolic BP (SBP) and diastolic BP (DBP) (95 min, P < .001 and 28 min, P = .028, respectively).
• Midday SBP and DBP velocity nadirs were significantly earlier in the children with MS OSA than in controls (57 min, P < .001 and 38 min, P < .01, respectively).
• Overall, children with MS OSA reached most BP values significantly earlier than controls, and both SBP and DBP were significantly elevated in the MS OSA group compared with the control group.

IN PRACTICE:

“The findings provide an essential puzzle piece in our understanding of the cardiovascular effects of OSA in children,” wrote the authors of an accompanying editorial.

SOURCE:

The lead author of the study was Md Tareq Ferdous Khan, MD, of the University of Cincinnati, Cincinnati, Ohio; the authors of the accompanying editorial were Kate Ching-Ching Chan, MD, and Albert Martin Li, MD, of the Chinese University of Hong Kong, China. The study was published online in the journal Sleep on December 13, 2023, along with the accompanying editorial.

LIMITATIONS:

More research is needed to investigate the potential mechanisms of action, optimize methodology, and investigate circadian biology via actigraphy and biomarkers, the authors of an accompanying editorial wrote.

DISCLOSURES:

The study received no outside funding. The researchers and editorialists had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

The time arrived at peak blood pressure (BP) velocity (TAPV) was significantly earlier in children with moderate to severe (MS) obstructive sleep apnea (OSA) than in controls.

METHODOLOGY:

• The researchers compared 24-hour circadian BP in children with OSA and controls to examine the impact of OSA on circadian BP.
• The study population included 219 children aged 5-14 years: 52 with mild OSA, 50 with MS OSA, and 117 controls.
• Participants underwent 24-hour BP monitoring and actigraphy; models included the times of BP peaks and TAPV.

TAKEAWAY:

• Children with MS OSA had a TAPV for diastolic BP in the morning, an average of 51 minutes earlier than controls (P < .001).
• Evening TAPV was significantly earlier in the children with MS OSA than in controls for both systolic BP (SBP) and diastolic BP (DBP) (95 min, P < .001 and 28 min, P = .028, respectively).
• Midday SBP and DBP velocity nadirs were significantly earlier in the children with MS OSA than in controls (57 min, P < .001 and 38 min, P < .01, respectively).
• Overall, children with MS OSA reached most BP values significantly earlier than controls, and both SBP and DBP were significantly elevated in the MS OSA group compared with the control group.

IN PRACTICE:

“The findings provide an essential puzzle piece in our understanding of the cardiovascular effects of OSA in children,” wrote the authors of an accompanying editorial.

SOURCE:

The lead author of the study was Md Tareq Ferdous Khan, MD, of the University of Cincinnati, Cincinnati, Ohio; the authors of the accompanying editorial were Kate Ching-Ching Chan, MD, and Albert Martin Li, MD, of the Chinese University of Hong Kong, China. The study was published online in the journal Sleep on December 13, 2023, along with the accompanying editorial.

LIMITATIONS:

More research is needed to investigate the potential mechanisms of action, optimize methodology, and investigate circadian biology via actigraphy and biomarkers, the authors of an accompanying editorial wrote.

DISCLOSURES:

The study received no outside funding. The researchers and editorialists had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

The time arrived at peak blood pressure (BP) velocity (TAPV) was significantly earlier in children with moderate to severe (MS) obstructive sleep apnea (OSA) than in controls.

METHODOLOGY:

• The researchers compared 24-hour circadian BP in children with OSA and controls to examine the impact of OSA on circadian BP.
• The study population included 219 children aged 5-14 years: 52 with mild OSA, 50 with MS OSA, and 117 controls.
• Participants underwent 24-hour BP monitoring and actigraphy; models included the times of BP peaks and TAPV.

TAKEAWAY:

• Children with MS OSA had a TAPV for diastolic BP in the morning, an average of 51 minutes earlier than controls (P < .001).
• Evening TAPV was significantly earlier in the children with MS OSA than in controls for both systolic BP (SBP) and diastolic BP (DBP) (95 min, P < .001 and 28 min, P = .028, respectively).
• Midday SBP and DBP velocity nadirs were significantly earlier in the children with MS OSA than in controls (57 min, P < .001 and 38 min, P < .01, respectively).
• Overall, children with MS OSA reached most BP values significantly earlier than controls, and both SBP and DBP were significantly elevated in the MS OSA group compared with the control group.

IN PRACTICE:

“The findings provide an essential puzzle piece in our understanding of the cardiovascular effects of OSA in children,” wrote the authors of an accompanying editorial.

SOURCE:

The lead author of the study was Md Tareq Ferdous Khan, MD, of the University of Cincinnati, Cincinnati, Ohio; the authors of the accompanying editorial were Kate Ching-Ching Chan, MD, and Albert Martin Li, MD, of the Chinese University of Hong Kong, China. The study was published online in the journal Sleep on December 13, 2023, along with the accompanying editorial.

LIMITATIONS:

More research is needed to investigate the potential mechanisms of action, optimize methodology, and investigate circadian biology via actigraphy and biomarkers, the authors of an accompanying editorial wrote.

DISCLOSURES:

The study received no outside funding. The researchers and editorialists had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

A first-of-its-kind partial heart transplant in a neonate delivered valves that continue to grow and function beyond 1 year of age, researchers said.

The surgery was performed on the 18th day of life of a 5-pound newborn boy diagnosed prenatally with persistent truncus arteriosus and severe truncal valve dysfunction. The procedure involved transplantation of the part of the heart containing the aorta and pulmonary valves from an infant donor upon cardiac death.

The standard of care for neonatal heart valve implants are cadaver grafts. But these grafts are not viable and can’t grow or self-repair. Therefore, recipient neonates need to undergo repeated implant-exchange surgeries until an adult-sized heart valve can fit. Clinical outcomes generally are poor.

“We have learned that these partial heart transplant valves, when procured fresh and the [recipient] baby is placed on low-dose antirejection medicine, can grow with the child and function completely normally,” Joseph W. Turek, MD, PhD, MBA of Duke University Medical Center in Durham, North Carolina, told this news organization.

“This represents a new field in heart surgery that could dramatically change the way we care for children with poorly functioning heart valves by allowing valve implants that grow with them.”

A case report describing the novel intervention was published online on January 2, 2024, in JAMA.

‘Expected to Last a Lifetime’

The donor was a 2-day-old female weighing 8 pounds. Delivery had been complicated by hypoxic ischemic brain injury, but echocardiography showed structurally normal, functioning outflow heart valves. The heart was donated after cardiac death and procured using standard surgical techniques.

The recipient infant’s operation involved sternotomy, cardiopulmonary bypass, and cardioplegic arrest of the heart. The pulmonary artery ostia and coronary artery buttons were dissected, and the infant’s irreparable truncal valve was excised.

The donor aortic root was transplanted first, using donor tissue to close the ventricular septal defect. Then, the coronary artery buttons were reimplanted; the right ventricular outflow tract was enlarged; and the pulmonary root was transplanted. Postoperative immunosuppression followed.

On the follow-up at age 14 months, the transplanted valves showed no obstruction or insufficiency on echocardiography. Now, almost 21 months later, the recipient is doing well, Dr. Turek said. “His family has shared his many milestones with me, including eating his first birthday cake, videos of his first steps, and his newfound oral appetite (he was largely g-tube fed for a while).”

“The rationale for partial heart transplant is that pediatric heart transplants grow,” Dr. Turek and coauthors wrote. “Moreover, failure of heart transplant outflow valves is exceedingly rare. While heart transplant long-term outcomes are limited by inevitable ventricular dysfunction, partial heart transplants spare the native ventricles and are therefore expected to last a lifetime.”

‘Domino Hearts’

“While this particular baby had truncus arteriosus, this operation should prove to be beneficial for a host of congenital heart conditions with valves that are either too small or poorly functioning,” Dr. Turek said. “We have performed subsequent partial heart operations for babies with aortic stenosis, tetralogy of Fallot with pulmonary atresia, and biventricular outflow tract obstruction.”

The challenge is organ availability, he noted. “While this procedure does make use of hearts that would be otherwise unusable for full heart transplant, such as hearts with poor ventricular function or hearts removed from recipients of full heart transplants (aka domino hearts), the availability is still low compared to the need.”

With domino hearts, “you could potentially double the number of hearts that are used for the benefit of children with heart disease,” Dr. Turek said in a Duke communication released with the paper. In a domino heart procedure, a patient who has healthy valves but needs stronger heart muscle receives a full heart transplant, and the healthy valves are then donated to another patient in need, creating a domino effect.

Since this breakthrough procedure in 2022, partial heart transplants have been performed 13 times at four centers, including nine at Duke, three of which used the domino technique.

For now, Dr. Turek told this news organization, “we are hoping to receive funds for a clinical trial that will evaluate these partial heart transplant valves on a larger basis and determine an optimal antirejection dose necessary to maintain viability.”

Preclinical research leading to this case report was supported by the Brett Boyer Foundation. Dr. Turek reported no conflicts of interest.

A version of this article appeared on Medscape.com.

A first-of-its-kind partial heart transplant in a neonate delivered valves that continue to grow and function beyond 1 year of age, researchers said.

The surgery was performed on the 18th day of life of a 5-pound newborn boy diagnosed prenatally with persistent truncus arteriosus and severe truncal valve dysfunction. The procedure involved transplantation of the part of the heart containing the aorta and pulmonary valves from an infant donor upon cardiac death.

The standard of care for neonatal heart valve implants are cadaver grafts. But these grafts are not viable and can’t grow or self-repair. Therefore, recipient neonates need to undergo repeated implant-exchange surgeries until an adult-sized heart valve can fit. Clinical outcomes generally are poor.

“We have learned that these partial heart transplant valves, when procured fresh and the [recipient] baby is placed on low-dose antirejection medicine, can grow with the child and function completely normally,” Joseph W. Turek, MD, PhD, MBA of Duke University Medical Center in Durham, North Carolina, told this news organization.

“This represents a new field in heart surgery that could dramatically change the way we care for children with poorly functioning heart valves by allowing valve implants that grow with them.”

A case report describing the novel intervention was published online on January 2, 2024, in JAMA.

‘Expected to Last a Lifetime’

The donor was a 2-day-old female weighing 8 pounds. Delivery had been complicated by hypoxic ischemic brain injury, but echocardiography showed structurally normal, functioning outflow heart valves. The heart was donated after cardiac death and procured using standard surgical techniques.

The recipient infant’s operation involved sternotomy, cardiopulmonary bypass, and cardioplegic arrest of the heart. The pulmonary artery ostia and coronary artery buttons were dissected, and the infant’s irreparable truncal valve was excised.

The donor aortic root was transplanted first, using donor tissue to close the ventricular septal defect. Then, the coronary artery buttons were reimplanted; the right ventricular outflow tract was enlarged; and the pulmonary root was transplanted. Postoperative immunosuppression followed.

On the follow-up at age 14 months, the transplanted valves showed no obstruction or insufficiency on echocardiography. Now, almost 21 months later, the recipient is doing well, Dr. Turek said. “His family has shared his many milestones with me, including eating his first birthday cake, videos of his first steps, and his newfound oral appetite (he was largely g-tube fed for a while).”

“The rationale for partial heart transplant is that pediatric heart transplants grow,” Dr. Turek and coauthors wrote. “Moreover, failure of heart transplant outflow valves is exceedingly rare. While heart transplant long-term outcomes are limited by inevitable ventricular dysfunction, partial heart transplants spare the native ventricles and are therefore expected to last a lifetime.”

‘Domino Hearts’

“While this particular baby had truncus arteriosus, this operation should prove to be beneficial for a host of congenital heart conditions with valves that are either too small or poorly functioning,” Dr. Turek said. “We have performed subsequent partial heart operations for babies with aortic stenosis, tetralogy of Fallot with pulmonary atresia, and biventricular outflow tract obstruction.”

The challenge is organ availability, he noted. “While this procedure does make use of hearts that would be otherwise unusable for full heart transplant, such as hearts with poor ventricular function or hearts removed from recipients of full heart transplants (aka domino hearts), the availability is still low compared to the need.”

With domino hearts, “you could potentially double the number of hearts that are used for the benefit of children with heart disease,” Dr. Turek said in a Duke communication released with the paper. In a domino heart procedure, a patient who has healthy valves but needs stronger heart muscle receives a full heart transplant, and the healthy valves are then donated to another patient in need, creating a domino effect.

Since this breakthrough procedure in 2022, partial heart transplants have been performed 13 times at four centers, including nine at Duke, three of which used the domino technique.

For now, Dr. Turek told this news organization, “we are hoping to receive funds for a clinical trial that will evaluate these partial heart transplant valves on a larger basis and determine an optimal antirejection dose necessary to maintain viability.”

Preclinical research leading to this case report was supported by the Brett Boyer Foundation. Dr. Turek reported no conflicts of interest.

A version of this article appeared on Medscape.com.

A first-of-its-kind partial heart transplant in a neonate delivered valves that continue to grow and function beyond 1 year of age, researchers said.

The surgery was performed on the 18th day of life of a 5-pound newborn boy diagnosed prenatally with persistent truncus arteriosus and severe truncal valve dysfunction. The procedure involved transplantation of the part of the heart containing the aorta and pulmonary valves from an infant donor upon cardiac death.

The standard of care for neonatal heart valve implants are cadaver grafts. But these grafts are not viable and can’t grow or self-repair. Therefore, recipient neonates need to undergo repeated implant-exchange surgeries until an adult-sized heart valve can fit. Clinical outcomes generally are poor.

“We have learned that these partial heart transplant valves, when procured fresh and the [recipient] baby is placed on low-dose antirejection medicine, can grow with the child and function completely normally,” Joseph W. Turek, MD, PhD, MBA of Duke University Medical Center in Durham, North Carolina, told this news organization.

“This represents a new field in heart surgery that could dramatically change the way we care for children with poorly functioning heart valves by allowing valve implants that grow with them.”

A case report describing the novel intervention was published online on January 2, 2024, in JAMA.

‘Expected to Last a Lifetime’

The donor was a 2-day-old female weighing 8 pounds. Delivery had been complicated by hypoxic ischemic brain injury, but echocardiography showed structurally normal, functioning outflow heart valves. The heart was donated after cardiac death and procured using standard surgical techniques.

The recipient infant’s operation involved sternotomy, cardiopulmonary bypass, and cardioplegic arrest of the heart. The pulmonary artery ostia and coronary artery buttons were dissected, and the infant’s irreparable truncal valve was excised.

The donor aortic root was transplanted first, using donor tissue to close the ventricular septal defect. Then, the coronary artery buttons were reimplanted; the right ventricular outflow tract was enlarged; and the pulmonary root was transplanted. Postoperative immunosuppression followed.

On the follow-up at age 14 months, the transplanted valves showed no obstruction or insufficiency on echocardiography. Now, almost 21 months later, the recipient is doing well, Dr. Turek said. “His family has shared his many milestones with me, including eating his first birthday cake, videos of his first steps, and his newfound oral appetite (he was largely g-tube fed for a while).”

“The rationale for partial heart transplant is that pediatric heart transplants grow,” Dr. Turek and coauthors wrote. “Moreover, failure of heart transplant outflow valves is exceedingly rare. While heart transplant long-term outcomes are limited by inevitable ventricular dysfunction, partial heart transplants spare the native ventricles and are therefore expected to last a lifetime.”

‘Domino Hearts’

“While this particular baby had truncus arteriosus, this operation should prove to be beneficial for a host of congenital heart conditions with valves that are either too small or poorly functioning,” Dr. Turek said. “We have performed subsequent partial heart operations for babies with aortic stenosis, tetralogy of Fallot with pulmonary atresia, and biventricular outflow tract obstruction.”

The challenge is organ availability, he noted. “While this procedure does make use of hearts that would be otherwise unusable for full heart transplant, such as hearts with poor ventricular function or hearts removed from recipients of full heart transplants (aka domino hearts), the availability is still low compared to the need.”

With domino hearts, “you could potentially double the number of hearts that are used for the benefit of children with heart disease,” Dr. Turek said in a Duke communication released with the paper. In a domino heart procedure, a patient who has healthy valves but needs stronger heart muscle receives a full heart transplant, and the healthy valves are then donated to another patient in need, creating a domino effect.

Since this breakthrough procedure in 2022, partial heart transplants have been performed 13 times at four centers, including nine at Duke, three of which used the domino technique.

For now, Dr. Turek told this news organization, “we are hoping to receive funds for a clinical trial that will evaluate these partial heart transplant valves on a larger basis and determine an optimal antirejection dose necessary to maintain viability.”

Preclinical research leading to this case report was supported by the Brett Boyer Foundation. Dr. Turek reported no conflicts of interest.

A version of this article appeared on Medscape.com.

In the opinion of David Rosmarin, MD, the approval of dupilumab in 2017 for the treatment of moderate to severe, resistant atopic dermatitis (AD) marked an inflection point in dermatology.

“Dupilumab has revolutionized AD, and the [interleukin] IL-4 receptor target isn’t going away,” Dr. Rosmarin, who chairs the department of dermatology at Indiana University, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. “It’s truly an exciting time because we have a lot of different treatments in the pipeline that target IL-4 and other receptors.”

In a review of AD biologic therapies in development, he highlighted the following:

CM310 (Stapokibart): This IL-4 receptor alpha monoclonal antibody, which is being developed by Keymed Biosciences, inhibits IL-4 and IL-13 signaling. In a phase 3 randomized study of patients with moderate to severe AD, presented as an abstract at the 2023 European Academy of Dermatology and Venereology (EADV) meeting, it showed results similar to those of dupilumab. Specifically, at week 16, Eczema Area and Severity Index (EASI)-75 scores were achieved in 66.9% of patients in the CM310 group and 25.8% of patients in the placebo group, while the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a reduction of greater than or equal to 2 points from baseline was 44.2% in the CM310 group, compared with 16.1% in the placebo group (P < .0001 for both associations). According to Dr. Rosmarin, other novel anti-IL-4 receptor antibodies for AD include AK120, which is being developed by Akeso Biopharma, and CBP-201 (rademikibart), which is being developed by Connect Biopharma.

Eblasakimab. Under development by ASLAN Pharmaceuticals, this biologic is a potential first-in-class, monoclonal antibody that binds to IL-13Ralpha1 with high affinity and blocks the signaling of IL-4 and IL-13 through the type-2 receptor. In the TREK-AD monotherapy phase 2b trial in patients with moderate to severe AD, presented as an abstract at the 2023 EADV meeting, the primary endpoint of EASI percent change from baseline to week 16, was met for eblasakimab doses 600 mg Q4W, 300mg Q2W, and 400mg Q2W vs. placebo (73.0% [P = .001], 69.8% [P = .005], and 65.8% [P = .029] vs. 51.1%), respectively.

Nemolizumab. Under development by Galderma, nemolizumab is a first-in-class IL-31 receptor alpha antagonist. “Many people refer to IL-31 as the itch cytokine,” Dr. Rosmarin said. “That’s probably a little oversimplified, but it’s certainly a powerful medication in development for prurigo nodularis as well as AD.”

Dr. Rosmarin

Results from the ARCADIA 1 and 2 trials, which included the concurrent use of topical corticosteroids and calcineurin inhibitors and were presented as an abstract at the 2023 EADV meeting, showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared with placebo. Specifically, 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the IGA score, compared with 24.6% and 26.0% in the placebo group (P < .0006, P = .001). In addition, 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the EASI, compared with 29.0% and 30.2% in the placebo group (P < .0001, P = .0011). “There are similar results regardless of the degree of itch patients are starting out with at baseline,” Dr. Rosmarin said. “It’s a very rapid response, by week 4, and that continues to improve through week 16.”

Amlitelimab. Under development by Sanofi, this monoclonal antibody binds to OX40-Ligand, and is designed for patients with moderate to severe AD. According to results of a phase 2b trial that were presented in an abstract at the 2023 EADV meeting, patients treated with amlitelimab 250 mg Q4W with a 500 mg loading dose showed a 61.5% improvement in the average EASI score from baseline at week 16, compared with 29.4% of those who received placebo (P <.0001), with continued improvement seen through 24 weeks. “There are really strong results with EASI scores; clearly this medicine works compared to the placebo,” Dr. Rosmarin said. “It’s also improving other biomarkers as well, including eosinophils, IL-13, TARC [serum thymus and activation-regulated chemokine], and IL-22.”

138559 (Temtokibart). Under development by LEO, 138559 is the first biologic to show the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In a phase 2a study abstract presented at the 2023 EADV meeting, the mean change in EASI from baseline to Week 16 was significantly greater for patients in the 138559-treated group compared with those in the placebo group (–15.3 vs. –3.5; P = .003). In addition, at week 16, significantly greater proportions of patients in the 138559 group relative to those in the placebo group achieved an EASI75 score (41.6% vs. 13.7%; P = .011) and an EASI-90 score (30.8% vs. 3.5%; P = .003). “With this particular receptor you’re not only blocking IL-22, but you’re blocking IL-20 and IL-24 as well,” Dr. Rosmarin said. “It really may be that it’s IL-20 and IL-24 that are more responsible for the pathogenic effect.”

Dr. Rosmarin disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies, including Galderma and Sanofi.

In the opinion of David Rosmarin, MD, the approval of dupilumab in 2017 for the treatment of moderate to severe, resistant atopic dermatitis (AD) marked an inflection point in dermatology.

“Dupilumab has revolutionized AD, and the [interleukin] IL-4 receptor target isn’t going away,” Dr. Rosmarin, who chairs the department of dermatology at Indiana University, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. “It’s truly an exciting time because we have a lot of different treatments in the pipeline that target IL-4 and other receptors.”

In a review of AD biologic therapies in development, he highlighted the following:

CM310 (Stapokibart): This IL-4 receptor alpha monoclonal antibody, which is being developed by Keymed Biosciences, inhibits IL-4 and IL-13 signaling. In a phase 3 randomized study of patients with moderate to severe AD, presented as an abstract at the 2023 European Academy of Dermatology and Venereology (EADV) meeting, it showed results similar to those of dupilumab. Specifically, at week 16, Eczema Area and Severity Index (EASI)-75 scores were achieved in 66.9% of patients in the CM310 group and 25.8% of patients in the placebo group, while the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a reduction of greater than or equal to 2 points from baseline was 44.2% in the CM310 group, compared with 16.1% in the placebo group (P < .0001 for both associations). According to Dr. Rosmarin, other novel anti-IL-4 receptor antibodies for AD include AK120, which is being developed by Akeso Biopharma, and CBP-201 (rademikibart), which is being developed by Connect Biopharma.

Eblasakimab. Under development by ASLAN Pharmaceuticals, this biologic is a potential first-in-class, monoclonal antibody that binds to IL-13Ralpha1 with high affinity and blocks the signaling of IL-4 and IL-13 through the type-2 receptor. In the TREK-AD monotherapy phase 2b trial in patients with moderate to severe AD, presented as an abstract at the 2023 EADV meeting, the primary endpoint of EASI percent change from baseline to week 16, was met for eblasakimab doses 600 mg Q4W, 300mg Q2W, and 400mg Q2W vs. placebo (73.0% [P = .001], 69.8% [P = .005], and 65.8% [P = .029] vs. 51.1%), respectively.

Nemolizumab. Under development by Galderma, nemolizumab is a first-in-class IL-31 receptor alpha antagonist. “Many people refer to IL-31 as the itch cytokine,” Dr. Rosmarin said. “That’s probably a little oversimplified, but it’s certainly a powerful medication in development for prurigo nodularis as well as AD.”

Dr. Rosmarin

Results from the ARCADIA 1 and 2 trials, which included the concurrent use of topical corticosteroids and calcineurin inhibitors and were presented as an abstract at the 2023 EADV meeting, showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared with placebo. Specifically, 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the IGA score, compared with 24.6% and 26.0% in the placebo group (P < .0006, P = .001). In addition, 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the EASI, compared with 29.0% and 30.2% in the placebo group (P < .0001, P = .0011). “There are similar results regardless of the degree of itch patients are starting out with at baseline,” Dr. Rosmarin said. “It’s a very rapid response, by week 4, and that continues to improve through week 16.”

Amlitelimab. Under development by Sanofi, this monoclonal antibody binds to OX40-Ligand, and is designed for patients with moderate to severe AD. According to results of a phase 2b trial that were presented in an abstract at the 2023 EADV meeting, patients treated with amlitelimab 250 mg Q4W with a 500 mg loading dose showed a 61.5% improvement in the average EASI score from baseline at week 16, compared with 29.4% of those who received placebo (P <.0001), with continued improvement seen through 24 weeks. “There are really strong results with EASI scores; clearly this medicine works compared to the placebo,” Dr. Rosmarin said. “It’s also improving other biomarkers as well, including eosinophils, IL-13, TARC [serum thymus and activation-regulated chemokine], and IL-22.”

138559 (Temtokibart). Under development by LEO, 138559 is the first biologic to show the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In a phase 2a study abstract presented at the 2023 EADV meeting, the mean change in EASI from baseline to Week 16 was significantly greater for patients in the 138559-treated group compared with those in the placebo group (–15.3 vs. –3.5; P = .003). In addition, at week 16, significantly greater proportions of patients in the 138559 group relative to those in the placebo group achieved an EASI75 score (41.6% vs. 13.7%; P = .011) and an EASI-90 score (30.8% vs. 3.5%; P = .003). “With this particular receptor you’re not only blocking IL-22, but you’re blocking IL-20 and IL-24 as well,” Dr. Rosmarin said. “It really may be that it’s IL-20 and IL-24 that are more responsible for the pathogenic effect.”

Dr. Rosmarin disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies, including Galderma and Sanofi.

In the opinion of David Rosmarin, MD, the approval of dupilumab in 2017 for the treatment of moderate to severe, resistant atopic dermatitis (AD) marked an inflection point in dermatology.

“Dupilumab has revolutionized AD, and the [interleukin] IL-4 receptor target isn’t going away,” Dr. Rosmarin, who chairs the department of dermatology at Indiana University, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. “It’s truly an exciting time because we have a lot of different treatments in the pipeline that target IL-4 and other receptors.”

In a review of AD biologic therapies in development, he highlighted the following:

CM310 (Stapokibart): This IL-4 receptor alpha monoclonal antibody, which is being developed by Keymed Biosciences, inhibits IL-4 and IL-13 signaling. In a phase 3 randomized study of patients with moderate to severe AD, presented as an abstract at the 2023 European Academy of Dermatology and Venereology (EADV) meeting, it showed results similar to those of dupilumab. Specifically, at week 16, Eczema Area and Severity Index (EASI)-75 scores were achieved in 66.9% of patients in the CM310 group and 25.8% of patients in the placebo group, while the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a reduction of greater than or equal to 2 points from baseline was 44.2% in the CM310 group, compared with 16.1% in the placebo group (P < .0001 for both associations). According to Dr. Rosmarin, other novel anti-IL-4 receptor antibodies for AD include AK120, which is being developed by Akeso Biopharma, and CBP-201 (rademikibart), which is being developed by Connect Biopharma.

Eblasakimab. Under development by ASLAN Pharmaceuticals, this biologic is a potential first-in-class, monoclonal antibody that binds to IL-13Ralpha1 with high affinity and blocks the signaling of IL-4 and IL-13 through the type-2 receptor. In the TREK-AD monotherapy phase 2b trial in patients with moderate to severe AD, presented as an abstract at the 2023 EADV meeting, the primary endpoint of EASI percent change from baseline to week 16, was met for eblasakimab doses 600 mg Q4W, 300mg Q2W, and 400mg Q2W vs. placebo (73.0% [P = .001], 69.8% [P = .005], and 65.8% [P = .029] vs. 51.1%), respectively.

Nemolizumab. Under development by Galderma, nemolizumab is a first-in-class IL-31 receptor alpha antagonist. “Many people refer to IL-31 as the itch cytokine,” Dr. Rosmarin said. “That’s probably a little oversimplified, but it’s certainly a powerful medication in development for prurigo nodularis as well as AD.”

Dr. Rosmarin

Results from the ARCADIA 1 and 2 trials, which included the concurrent use of topical corticosteroids and calcineurin inhibitors and were presented as an abstract at the 2023 EADV meeting, showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared with placebo. Specifically, 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the IGA score, compared with 24.6% and 26.0% in the placebo group (P < .0006, P = .001). In addition, 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the EASI, compared with 29.0% and 30.2% in the placebo group (P < .0001, P = .0011). “There are similar results regardless of the degree of itch patients are starting out with at baseline,” Dr. Rosmarin said. “It’s a very rapid response, by week 4, and that continues to improve through week 16.”

Amlitelimab. Under development by Sanofi, this monoclonal antibody binds to OX40-Ligand, and is designed for patients with moderate to severe AD. According to results of a phase 2b trial that were presented in an abstract at the 2023 EADV meeting, patients treated with amlitelimab 250 mg Q4W with a 500 mg loading dose showed a 61.5% improvement in the average EASI score from baseline at week 16, compared with 29.4% of those who received placebo (P <.0001), with continued improvement seen through 24 weeks. “There are really strong results with EASI scores; clearly this medicine works compared to the placebo,” Dr. Rosmarin said. “It’s also improving other biomarkers as well, including eosinophils, IL-13, TARC [serum thymus and activation-regulated chemokine], and IL-22.”

138559 (Temtokibart). Under development by LEO, 138559 is the first biologic to show the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In a phase 2a study abstract presented at the 2023 EADV meeting, the mean change in EASI from baseline to Week 16 was significantly greater for patients in the 138559-treated group compared with those in the placebo group (–15.3 vs. –3.5; P = .003). In addition, at week 16, significantly greater proportions of patients in the 138559 group relative to those in the placebo group achieved an EASI75 score (41.6% vs. 13.7%; P = .011) and an EASI-90 score (30.8% vs. 3.5%; P = .003). “With this particular receptor you’re not only blocking IL-22, but you’re blocking IL-20 and IL-24 as well,” Dr. Rosmarin said. “It really may be that it’s IL-20 and IL-24 that are more responsible for the pathogenic effect.”

Dr. Rosmarin disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies, including Galderma and Sanofi.

TOPLINE:

Nearly half of the US Food and Drug Administration (FDA) approvals for dermatologic drugs between 2012 and 2022 were considered first in class or first in indication.

METHODOLOGY:

• Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
• In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
• They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.

TAKEAWAY:

• The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
• Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
• An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
• Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.

IN PRACTICE:

While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.

SOURCE:

First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.

LIMITATIONS:

They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.

DISCLOSURES:

Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly half of the US Food and Drug Administration (FDA) approvals for dermatologic drugs between 2012 and 2022 were considered first in class or first in indication.

METHODOLOGY:

• Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
• In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
• They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.

TAKEAWAY:

• The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
• Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
• An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
• Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.

IN PRACTICE:

While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.

SOURCE:

First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.

LIMITATIONS:

They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.

DISCLOSURES:

Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly half of the US Food and Drug Administration (FDA) approvals for dermatologic drugs between 2012 and 2022 were considered first in class or first in indication.

METHODOLOGY:

• Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
• In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
• They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.

TAKEAWAY:

• The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
• Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
• An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
• Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.

IN PRACTICE:

While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.

SOURCE:

First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.

LIMITATIONS:

They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.

DISCLOSURES:

Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.

A version of this article appeared on Medscape.com.

Use of oral amoxicillin-clavulanic acid for 5 days was noninferior to a 10-day course of treatment among children with noncomplicated febrile urinary tract infections (UTIs), according to new research.

Well-appearing children with febrile UTIs are generally treated with a 10-day course of oral antibiotics, but the effectiveness of a 5-day course has not been evaluated, wrote Giovanni Montini, MD, of the University of Milan, Milan, Italy, and colleagues.

Robert W. Frenck Jr, MD, a director of the Center for Vaccine Research at Cincinnati Children’s Hospital Medical Center, Ohio, said he was not surprised that the shorter course was sufficient to treat these cases. The antibiotic concentration in the urine often significantly exceeds the levels in the blood, he said.

Dr. Frenck, who was not involved in the study, said that he saw no real barriers to the use of a shorter course of therapy in clinical practice.

“I think both parents and the medical team would be happy to be able to use a shorter course of therapy,” he said.

In the study published in Pediatrics , researchers randomized 142 children aged 3 months to 5 years with uncomplicated febrile UTIs to 50 mg/kg/d of amoxicillin-clavulanate for either the short or standard period. The study took place at eight pediatric emergency departments in Italy between May 2020 and September 2022. All patients received prescriptions for 5 days of antibiotics, and those randomized to the standard course received a second prescription after randomization.

The primary endpoint was recurrence of the UTI within 30 days of completion of therapy. Secondary endpoints included clinical recovery at the end of treatment, adverse events related to the therapy, and signs of antibiotic resistance.

The UTI recurrence rate within 30 days of treatment completion was 2.8% in the short-course group and 14.3% in the standard group. A post hoc analysis excluding patients with vesicoureteral reflux and non–Escherichia coli UTIs further confirmed the noninferiority of short-course treatment.

“It is a bit surprising that the short-course group had fewer relapses within 30 days of discontinuing antibiotics,” Dr. Frenck said. “However, the differences may be due to small sample sizes and do not appear to be statistically significant differences in recurrence rates.”

Resolution of symptoms was similar between the short-course and standard groups (97.2% and 92.9%, respectively), and indications of antibiotic resistance were similar between the groups. No adverse events were reported in the standard group, and one case of diarrhea occurred in the short-course group.

The findings were limited by the study’s unblinded randomization, so parents were aware of the trial and were potentially sensitized to look for signs of infection. Researchers also relied on parent reports of adverse drug effects rather than through a standardized questionnaire, the researchers noted.

Dr. Frenck said a potential benefit to shortening treatment is that adherence usually increases.

“But you only want to decrease the length of a course of medicine if you can do so without compromising the effectiveness of the treatment,” Dr. Frenck said.

Dr. Frenck also noted a recent study, which demonstrated that 5 days of antibiotics had equivalent efficacy as 10 days for uncomplicated pneumonia.

“The current paper further demonstrates that shorter courses of antibiotics may be possible for other mild forms of infections.”

Looking ahead, researchers could evaluate the use of short-course antibiotics for other common infections such as otitis media, he noted.

The study was supported by the Ministry of Health, Rome, Italy, in collaboration with the Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy. The researchers report no financial conflicts. Dr. Frenck disclosed conducting clinical trials for Pfizer, Moderna, AstraZeneca, Merck, and GSK; none of those trials were for antibiotics or urinary tract infections.

A version of this article appeared on Medscape.com.

Use of oral amoxicillin-clavulanic acid for 5 days was noninferior to a 10-day course of treatment among children with noncomplicated febrile urinary tract infections (UTIs), according to new research.

Well-appearing children with febrile UTIs are generally treated with a 10-day course of oral antibiotics, but the effectiveness of a 5-day course has not been evaluated, wrote Giovanni Montini, MD, of the University of Milan, Milan, Italy, and colleagues.

Robert W. Frenck Jr, MD, a director of the Center for Vaccine Research at Cincinnati Children’s Hospital Medical Center, Ohio, said he was not surprised that the shorter course was sufficient to treat these cases. The antibiotic concentration in the urine often significantly exceeds the levels in the blood, he said.

Dr. Frenck, who was not involved in the study, said that he saw no real barriers to the use of a shorter course of therapy in clinical practice.

“I think both parents and the medical team would be happy to be able to use a shorter course of therapy,” he said.

In the study published in Pediatrics , researchers randomized 142 children aged 3 months to 5 years with uncomplicated febrile UTIs to 50 mg/kg/d of amoxicillin-clavulanate for either the short or standard period. The study took place at eight pediatric emergency departments in Italy between May 2020 and September 2022. All patients received prescriptions for 5 days of antibiotics, and those randomized to the standard course received a second prescription after randomization.

The primary endpoint was recurrence of the UTI within 30 days of completion of therapy. Secondary endpoints included clinical recovery at the end of treatment, adverse events related to the therapy, and signs of antibiotic resistance.

The UTI recurrence rate within 30 days of treatment completion was 2.8% in the short-course group and 14.3% in the standard group. A post hoc analysis excluding patients with vesicoureteral reflux and non–Escherichia coli UTIs further confirmed the noninferiority of short-course treatment.

“It is a bit surprising that the short-course group had fewer relapses within 30 days of discontinuing antibiotics,” Dr. Frenck said. “However, the differences may be due to small sample sizes and do not appear to be statistically significant differences in recurrence rates.”

Resolution of symptoms was similar between the short-course and standard groups (97.2% and 92.9%, respectively), and indications of antibiotic resistance were similar between the groups. No adverse events were reported in the standard group, and one case of diarrhea occurred in the short-course group.

The findings were limited by the study’s unblinded randomization, so parents were aware of the trial and were potentially sensitized to look for signs of infection. Researchers also relied on parent reports of adverse drug effects rather than through a standardized questionnaire, the researchers noted.

Dr. Frenck said a potential benefit to shortening treatment is that adherence usually increases.

“But you only want to decrease the length of a course of medicine if you can do so without compromising the effectiveness of the treatment,” Dr. Frenck said.

Dr. Frenck also noted a recent study, which demonstrated that 5 days of antibiotics had equivalent efficacy as 10 days for uncomplicated pneumonia.

“The current paper further demonstrates that shorter courses of antibiotics may be possible for other mild forms of infections.”

Looking ahead, researchers could evaluate the use of short-course antibiotics for other common infections such as otitis media, he noted.

The study was supported by the Ministry of Health, Rome, Italy, in collaboration with the Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy. The researchers report no financial conflicts. Dr. Frenck disclosed conducting clinical trials for Pfizer, Moderna, AstraZeneca, Merck, and GSK; none of those trials were for antibiotics or urinary tract infections.

A version of this article appeared on Medscape.com.

Use of oral amoxicillin-clavulanic acid for 5 days was noninferior to a 10-day course of treatment among children with noncomplicated febrile urinary tract infections (UTIs), according to new research.

Well-appearing children with febrile UTIs are generally treated with a 10-day course of oral antibiotics, but the effectiveness of a 5-day course has not been evaluated, wrote Giovanni Montini, MD, of the University of Milan, Milan, Italy, and colleagues.

Robert W. Frenck Jr, MD, a director of the Center for Vaccine Research at Cincinnati Children’s Hospital Medical Center, Ohio, said he was not surprised that the shorter course was sufficient to treat these cases. The antibiotic concentration in the urine often significantly exceeds the levels in the blood, he said.

Dr. Frenck, who was not involved in the study, said that he saw no real barriers to the use of a shorter course of therapy in clinical practice.

“I think both parents and the medical team would be happy to be able to use a shorter course of therapy,” he said.

In the study published in Pediatrics , researchers randomized 142 children aged 3 months to 5 years with uncomplicated febrile UTIs to 50 mg/kg/d of amoxicillin-clavulanate for either the short or standard period. The study took place at eight pediatric emergency departments in Italy between May 2020 and September 2022. All patients received prescriptions for 5 days of antibiotics, and those randomized to the standard course received a second prescription after randomization.

The primary endpoint was recurrence of the UTI within 30 days of completion of therapy. Secondary endpoints included clinical recovery at the end of treatment, adverse events related to the therapy, and signs of antibiotic resistance.

The UTI recurrence rate within 30 days of treatment completion was 2.8% in the short-course group and 14.3% in the standard group. A post hoc analysis excluding patients with vesicoureteral reflux and non–Escherichia coli UTIs further confirmed the noninferiority of short-course treatment.

“It is a bit surprising that the short-course group had fewer relapses within 30 days of discontinuing antibiotics,” Dr. Frenck said. “However, the differences may be due to small sample sizes and do not appear to be statistically significant differences in recurrence rates.”

Resolution of symptoms was similar between the short-course and standard groups (97.2% and 92.9%, respectively), and indications of antibiotic resistance were similar between the groups. No adverse events were reported in the standard group, and one case of diarrhea occurred in the short-course group.

The findings were limited by the study’s unblinded randomization, so parents were aware of the trial and were potentially sensitized to look for signs of infection. Researchers also relied on parent reports of adverse drug effects rather than through a standardized questionnaire, the researchers noted.

Dr. Frenck said a potential benefit to shortening treatment is that adherence usually increases.

“But you only want to decrease the length of a course of medicine if you can do so without compromising the effectiveness of the treatment,” Dr. Frenck said.

Dr. Frenck also noted a recent study, which demonstrated that 5 days of antibiotics had equivalent efficacy as 10 days for uncomplicated pneumonia.

“The current paper further demonstrates that shorter courses of antibiotics may be possible for other mild forms of infections.”

Looking ahead, researchers could evaluate the use of short-course antibiotics for other common infections such as otitis media, he noted.

The study was supported by the Ministry of Health, Rome, Italy, in collaboration with the Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy. The researchers report no financial conflicts. Dr. Frenck disclosed conducting clinical trials for Pfizer, Moderna, AstraZeneca, Merck, and GSK; none of those trials were for antibiotics or urinary tract infections.

A version of this article appeared on Medscape.com.

TOPLINE:

Light physical activity during childhood may lower blood cholesterol levels more effectively than moderate to vigorous physical activity, regardless of body fat mass.

METHODOLOGY:

• Researchers analyzed the data of 792 children (58% females) from the Avon Longitudinal Study of Parents and Children (ALSPAC) UK birth cohort.
• The measures included accelerometer-based sedentary time, light physical activity, and moderate to vigorous physical activity at ages 11, 15, and 24 years.
• The children had complete measurements of fasting high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride, and total cholesterol levels at ages 15 , 17, and 24 years.
• Data also included measures of body mass, composition (fat and lean mass), insulin resistance, inflammation, and other cardiometabolic, socioeconomic, and lifestyle factors.
• The researchers conducted two types of analyses: Mediation path, to examine how fat and lean body mass affected longitudinal associations of activity level with blood lipids over 13 years, and temporal path, to look at temporal relationships between activity and lipid levels at ages 15 and 24 years only.

TAKEAWAY:

• Higher cumulative light physical activity from childhood through young adulthood was associated with a fivefold to eightfold decrease in total cholesterol, while total body fat mass decreased the impact of light physical activity on total cholesterol by 6%.
• Higher cumulative moderate to vigorous physical activity over 13 years led to a modest decrease in total cholesterol, an effect reduced to nonsignificance by the presence of higher fat mass.
• More cumulative sedentary time was associated with increasing total cholesterol.

IN PRACTICE:

“Light physical activity provides an opportunity for persons with obesity to follow a path to potentially benefit from the lipid-lowering effect of mild exercise,» wrote the author.

SOURCE:

Andrew O. Agbaje, from the Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland, conducted this study. It was published online December 14, 2023, in the Journal of Clinical Endocrinology and Metabolism.

LIMITATIONS:

The study included mostly White participants, so the findings might not apply to diverse racial and ethnic groups. The accelerometer data were gathered using a 60-second epoch, a duration known to underestimate moderate to vigorous physical activity in pediatric populations. There were no measures of fasting plasma lipids at age 11 years. The study also lacked data on participants’ dietary habits, alcohol intake, and menstrual cycle.

DISCLOSURES:

The ALSPAC UK birth cohort is funded by the UK Medical Research Council, the Wellcome Trust, and the University of Bristol. The author is funded by multiple foundations. No conflicts of interest were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Light physical activity during childhood may lower blood cholesterol levels more effectively than moderate to vigorous physical activity, regardless of body fat mass.

METHODOLOGY:

• Researchers analyzed the data of 792 children (58% females) from the Avon Longitudinal Study of Parents and Children (ALSPAC) UK birth cohort.
• The measures included accelerometer-based sedentary time, light physical activity, and moderate to vigorous physical activity at ages 11, 15, and 24 years.
• The children had complete measurements of fasting high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride, and total cholesterol levels at ages 15 , 17, and 24 years.
• Data also included measures of body mass, composition (fat and lean mass), insulin resistance, inflammation, and other cardiometabolic, socioeconomic, and lifestyle factors.
• The researchers conducted two types of analyses: Mediation path, to examine how fat and lean body mass affected longitudinal associations of activity level with blood lipids over 13 years, and temporal path, to look at temporal relationships between activity and lipid levels at ages 15 and 24 years only.

TAKEAWAY:

• Higher cumulative light physical activity from childhood through young adulthood was associated with a fivefold to eightfold decrease in total cholesterol, while total body fat mass decreased the impact of light physical activity on total cholesterol by 6%.
• Higher cumulative moderate to vigorous physical activity over 13 years led to a modest decrease in total cholesterol, an effect reduced to nonsignificance by the presence of higher fat mass.
• More cumulative sedentary time was associated with increasing total cholesterol.

IN PRACTICE:

“Light physical activity provides an opportunity for persons with obesity to follow a path to potentially benefit from the lipid-lowering effect of mild exercise,» wrote the author.

SOURCE:

Andrew O. Agbaje, from the Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland, conducted this study. It was published online December 14, 2023, in the Journal of Clinical Endocrinology and Metabolism.

LIMITATIONS:

The study included mostly White participants, so the findings might not apply to diverse racial and ethnic groups. The accelerometer data were gathered using a 60-second epoch, a duration known to underestimate moderate to vigorous physical activity in pediatric populations. There were no measures of fasting plasma lipids at age 11 years. The study also lacked data on participants’ dietary habits, alcohol intake, and menstrual cycle.

DISCLOSURES:

The ALSPAC UK birth cohort is funded by the UK Medical Research Council, the Wellcome Trust, and the University of Bristol. The author is funded by multiple foundations. No conflicts of interest were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Light physical activity during childhood may lower blood cholesterol levels more effectively than moderate to vigorous physical activity, regardless of body fat mass.

METHODOLOGY:

• Researchers analyzed the data of 792 children (58% females) from the Avon Longitudinal Study of Parents and Children (ALSPAC) UK birth cohort.
• The measures included accelerometer-based sedentary time, light physical activity, and moderate to vigorous physical activity at ages 11, 15, and 24 years.
• The children had complete measurements of fasting high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride, and total cholesterol levels at ages 15 , 17, and 24 years.
• Data also included measures of body mass, composition (fat and lean mass), insulin resistance, inflammation, and other cardiometabolic, socioeconomic, and lifestyle factors.
• The researchers conducted two types of analyses: Mediation path, to examine how fat and lean body mass affected longitudinal associations of activity level with blood lipids over 13 years, and temporal path, to look at temporal relationships between activity and lipid levels at ages 15 and 24 years only.

TAKEAWAY:

• Higher cumulative light physical activity from childhood through young adulthood was associated with a fivefold to eightfold decrease in total cholesterol, while total body fat mass decreased the impact of light physical activity on total cholesterol by 6%.
• Higher cumulative moderate to vigorous physical activity over 13 years led to a modest decrease in total cholesterol, an effect reduced to nonsignificance by the presence of higher fat mass.
• More cumulative sedentary time was associated with increasing total cholesterol.

IN PRACTICE:

“Light physical activity provides an opportunity for persons with obesity to follow a path to potentially benefit from the lipid-lowering effect of mild exercise,» wrote the author.

SOURCE:

Andrew O. Agbaje, from the Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland, conducted this study. It was published online December 14, 2023, in the Journal of Clinical Endocrinology and Metabolism.

LIMITATIONS:

The study included mostly White participants, so the findings might not apply to diverse racial and ethnic groups. The accelerometer data were gathered using a 60-second epoch, a duration known to underestimate moderate to vigorous physical activity in pediatric populations. There were no measures of fasting plasma lipids at age 11 years. The study also lacked data on participants’ dietary habits, alcohol intake, and menstrual cycle.

DISCLOSURES:

The ALSPAC UK birth cohort is funded by the UK Medical Research Council, the Wellcome Trust, and the University of Bristol. The author is funded by multiple foundations. No conflicts of interest were reported.

A version of this article appeared on Medscape.com.

While adults, many of whom don’t meet the clinical definition of obesity, scramble to procure glucagon-like peptide 1 (GLP-1) agonists for weight loss, pediatric obesity specialists said their young patients who could benefit more over the long term often are unable to access the potentially life-altering medications.

The US Food and Drug Administration (FDA) approved two GLP-1 agonists — both marketed by Novo Nordisk — for use in adolescents aged ≥ 12 years: Wegovy (semaglutide) in December 2022 and Saxenda (liraglutide) in December 2020. Novo Nordisk and Eli Lilly — which makes the dual glucose-dependent insulinotropic polypetide/GLP-1 agonist tirzepatide (Zepbound) — are also investigating the drugs for obesity in children as young as age 6 years. The crushing demand for semaglutide in the last year — driving a thriving market in compounded versions and online prescriptions — has made it increasingly difficult to find pharmacies that can fill prescriptions, pediatricians told this news organization.

“It’s been more difficult to get people initiated now than it was a year ago,” said Brooke Sweeney, MD, medical director of weight management services at Children’s Mercy in Kansas City, Missouri. “Because of the supply issues, for the most part we›re not starting anyone new because I don›t have enough medication to keep my patients on it who are already on it,” she said.

Sarah Raatz, MD, a pediatrician at the University of Minnesota’s Center for Pediatric Obesity Medicine, said, “I actually haven’t really been prescribing many of these medications as of late.” Both liraglutide and semaglutide “are largely unavailable or quite hard to get a hold of,” Dr. Raatz told this news organization.

Susma Shanti Vaidya, MPH, MD, associate medical director of the IDEAL pediatric obesity clinic at Children›s National Hospital in Washington, DC, said that patients taking GLP-1 agonists in her practice have reduced their body mass index and have seen resolution of prediabetes, diabetes, and fatty liver disease. «I had one patient who had severe obstructive sleep apnea which resolved with semaglutide.»

But when they can’t find the medications, it can lead to a plateauing of weight loss and a reversal of hard-won victories, Dr. Vaidya said.

Insurance Denials Also Growing

In January 2023, the American Academy of Pediatrics urged aggressive treatment of childhood obesity, including using FDA-approved medications such as GLP-1 agonists combined with lifestyle and dietary modifications.

The US Preventive Services Task Force, however, has issued a draft proposal that recommends a variety of lifestyle and behavior modification interventions for children and adolescents but says the evidence does not yet support recommending bariatric surgery or medications.

Insurance coverage for children — even for FDA-approved indications and the age 12-and-over population — has become increasingly difficult, said the pediatric obesity specialists. Insurers are also creating hurdles that make getting coverage more difficult, they said.

Some insurers track an adolescent’s weight trajectory, “and if they’re not meeting a certain response threshold set by the insurance company, then they can pull coverage and then we have to try to advocate for why continued coverage might be beneficial and necessary,” Dr. Raatz said.

Insurers in the region around Children’s Mercy are erecting similar barriers, said Sweeney. Interim weight loss goals are challenging in pediatrics — given that adolescents are constantly changing and growing, she said.

Dr. Vaidya said she’s had success with commercial insurers but that the Washington, DC, and Maryland Medicaid programs have been stingier.

All the pediatricians said they expect greater restrictions in 2024.

Dr. Vaidya said some patients told her they had been notified that prior authorization will be required for new prescriptions for a GLP-1 agonist.

“We will just kind of be forced to see what happens when these medications are taken away from patients who have benefited from them,” Dr. Raatz said.
 

Some Parents Asking for GLP-1 Agonists

Pediatric obesity specialists said more parents are asking if a GLP-1 agonist might be appropriate for their children this year than in 2022.

Dr. Sweeney said parents ask for the medications when they feel they have exhausted all other options for their children. “These parents are not coming because they are concerned about the cosmetic effects of the weight,” she said. In most cases, children she sees have been struggling for years with extreme hunger and lack of satiety and may have prediabetes or diabetes. Many are being bullied in school because of their weight. They have only marginally been helped by interventions suggested by primary care or dietitians or other specialists, Dr. Sweeney said.

“Starting semaglutide really is life-changing for some of these patients,” Dr. Vaidya said. One patient said, “it just stopped the food chatter,” she added, noting that the adolescent no longer felt ruled by cravings.

In a recent poll by Morning Consult, 65% of parents of children with weight-related issues said they would be interested in GLP-1 agonists for their kids. A third of all parents said they would be interested in having their children use the drugs if they were available.
 

Lifelong Medication?

Parents — and adolescents — are generally counseled that obesity is a chronic disease and GLP-1 agonists are likely a lifelong treatment.

With the medications, “our first step is to get induction of weight loss and get your set point decreased enough that we can get you to a healthier weight for your body,” Dr. Sweeney said.

She tells patients and families, “I can’t tell you that you’re necessarily going to be on this medication at this dose for the rest of your life, but you will need treatment for life.”

Based on current knowledge, the risks for lifelong obesity outweigh the risk for the medications. Dr. Sweeney said she would like to see more data. “There absolutely is an evidence gap, and we need more information on the long-term effectiveness and safety.”

“When we start kids on this medication, I’m very clear that we are going to try to get to the lowest effective dose,” Dr. Vaidya said. She also emphasizes to parents that the medications must be used in conjunction with continued lifestyle modifications. She expressed hope that as clinicians gain more experience, and patients’ comorbidities resolve, perhaps it will be possible in some cases to take individuals “off for a period of time, with the understanding that they might have to go back on in a few months.”

“We’re weighing the pros and cons of being on a medication long term but we’re also weighing the pros and cons of weight-related health complications long term,” Dr. Raatz said.

Dr. Raatz also said clinicians have much to learn about the long-term safety of GLP-1 agonists in their pediatric patients.

She tells parents and families, “we expect that this is going to be a long-term medication, and this is going to be something that we’re going to continue to monitor.”

Dr. Sweeney reports that she is a speaker and unpaid consultant on Rhythm Pharmaceuticals’ Imcivree (setmelanotide) medication and that she consults for Eli Lilly. Dr. Raatz is a coprincipal investigator for a Novo Nordisk trial of semaglutide in young children and will be a co-PI for a similar trial for Eli Lilly’s tirzepatide but receives no consulting fees or honoraria. Dr. Vaidya reported no conflicts.

A version of this article appeared on Medscape.com.

While adults, many of whom don’t meet the clinical definition of obesity, scramble to procure glucagon-like peptide 1 (GLP-1) agonists for weight loss, pediatric obesity specialists said their young patients who could benefit more over the long term often are unable to access the potentially life-altering medications.

The US Food and Drug Administration (FDA) approved two GLP-1 agonists — both marketed by Novo Nordisk — for use in adolescents aged ≥ 12 years: Wegovy (semaglutide) in December 2022 and Saxenda (liraglutide) in December 2020. Novo Nordisk and Eli Lilly — which makes the dual glucose-dependent insulinotropic polypetide/GLP-1 agonist tirzepatide (Zepbound) — are also investigating the drugs for obesity in children as young as age 6 years. The crushing demand for semaglutide in the last year — driving a thriving market in compounded versions and online prescriptions — has made it increasingly difficult to find pharmacies that can fill prescriptions, pediatricians told this news organization.

“It’s been more difficult to get people initiated now than it was a year ago,” said Brooke Sweeney, MD, medical director of weight management services at Children’s Mercy in Kansas City, Missouri. “Because of the supply issues, for the most part we›re not starting anyone new because I don›t have enough medication to keep my patients on it who are already on it,” she said.

Sarah Raatz, MD, a pediatrician at the University of Minnesota’s Center for Pediatric Obesity Medicine, said, “I actually haven’t really been prescribing many of these medications as of late.” Both liraglutide and semaglutide “are largely unavailable or quite hard to get a hold of,” Dr. Raatz told this news organization.

Susma Shanti Vaidya, MPH, MD, associate medical director of the IDEAL pediatric obesity clinic at Children›s National Hospital in Washington, DC, said that patients taking GLP-1 agonists in her practice have reduced their body mass index and have seen resolution of prediabetes, diabetes, and fatty liver disease. «I had one patient who had severe obstructive sleep apnea which resolved with semaglutide.»

But when they can’t find the medications, it can lead to a plateauing of weight loss and a reversal of hard-won victories, Dr. Vaidya said.

Insurance Denials Also Growing

In January 2023, the American Academy of Pediatrics urged aggressive treatment of childhood obesity, including using FDA-approved medications such as GLP-1 agonists combined with lifestyle and dietary modifications.

The US Preventive Services Task Force, however, has issued a draft proposal that recommends a variety of lifestyle and behavior modification interventions for children and adolescents but says the evidence does not yet support recommending bariatric surgery or medications.

Insurance coverage for children — even for FDA-approved indications and the age 12-and-over population — has become increasingly difficult, said the pediatric obesity specialists. Insurers are also creating hurdles that make getting coverage more difficult, they said.

Some insurers track an adolescent’s weight trajectory, “and if they’re not meeting a certain response threshold set by the insurance company, then they can pull coverage and then we have to try to advocate for why continued coverage might be beneficial and necessary,” Dr. Raatz said.

Insurers in the region around Children’s Mercy are erecting similar barriers, said Sweeney. Interim weight loss goals are challenging in pediatrics — given that adolescents are constantly changing and growing, she said.

Dr. Vaidya said she’s had success with commercial insurers but that the Washington, DC, and Maryland Medicaid programs have been stingier.

All the pediatricians said they expect greater restrictions in 2024.

Dr. Vaidya said some patients told her they had been notified that prior authorization will be required for new prescriptions for a GLP-1 agonist.

“We will just kind of be forced to see what happens when these medications are taken away from patients who have benefited from them,” Dr. Raatz said.
 

Some Parents Asking for GLP-1 Agonists

Pediatric obesity specialists said more parents are asking if a GLP-1 agonist might be appropriate for their children this year than in 2022.

Dr. Sweeney said parents ask for the medications when they feel they have exhausted all other options for their children. “These parents are not coming because they are concerned about the cosmetic effects of the weight,” she said. In most cases, children she sees have been struggling for years with extreme hunger and lack of satiety and may have prediabetes or diabetes. Many are being bullied in school because of their weight. They have only marginally been helped by interventions suggested by primary care or dietitians or other specialists, Dr. Sweeney said.

“Starting semaglutide really is life-changing for some of these patients,” Dr. Vaidya said. One patient said, “it just stopped the food chatter,” she added, noting that the adolescent no longer felt ruled by cravings.

In a recent poll by Morning Consult, 65% of parents of children with weight-related issues said they would be interested in GLP-1 agonists for their kids. A third of all parents said they would be interested in having their children use the drugs if they were available.
 

Lifelong Medication?

Parents — and adolescents — are generally counseled that obesity is a chronic disease and GLP-1 agonists are likely a lifelong treatment.

With the medications, “our first step is to get induction of weight loss and get your set point decreased enough that we can get you to a healthier weight for your body,” Dr. Sweeney said.

She tells patients and families, “I can’t tell you that you’re necessarily going to be on this medication at this dose for the rest of your life, but you will need treatment for life.”

Based on current knowledge, the risks for lifelong obesity outweigh the risk for the medications. Dr. Sweeney said she would like to see more data. “There absolutely is an evidence gap, and we need more information on the long-term effectiveness and safety.”

“When we start kids on this medication, I’m very clear that we are going to try to get to the lowest effective dose,” Dr. Vaidya said. She also emphasizes to parents that the medications must be used in conjunction with continued lifestyle modifications. She expressed hope that as clinicians gain more experience, and patients’ comorbidities resolve, perhaps it will be possible in some cases to take individuals “off for a period of time, with the understanding that they might have to go back on in a few months.”

“We’re weighing the pros and cons of being on a medication long term but we’re also weighing the pros and cons of weight-related health complications long term,” Dr. Raatz said.

Dr. Raatz also said clinicians have much to learn about the long-term safety of GLP-1 agonists in their pediatric patients.

She tells parents and families, “we expect that this is going to be a long-term medication, and this is going to be something that we’re going to continue to monitor.”

Dr. Sweeney reports that she is a speaker and unpaid consultant on Rhythm Pharmaceuticals’ Imcivree (setmelanotide) medication and that she consults for Eli Lilly. Dr. Raatz is a coprincipal investigator for a Novo Nordisk trial of semaglutide in young children and will be a co-PI for a similar trial for Eli Lilly’s tirzepatide but receives no consulting fees or honoraria. Dr. Vaidya reported no conflicts.

A version of this article appeared on Medscape.com.

While adults, many of whom don’t meet the clinical definition of obesity, scramble to procure glucagon-like peptide 1 (GLP-1) agonists for weight loss, pediatric obesity specialists said their young patients who could benefit more over the long term often are unable to access the potentially life-altering medications.

The US Food and Drug Administration (FDA) approved two GLP-1 agonists — both marketed by Novo Nordisk — for use in adolescents aged ≥ 12 years: Wegovy (semaglutide) in December 2022 and Saxenda (liraglutide) in December 2020. Novo Nordisk and Eli Lilly — which makes the dual glucose-dependent insulinotropic polypetide/GLP-1 agonist tirzepatide (Zepbound) — are also investigating the drugs for obesity in children as young as age 6 years. The crushing demand for semaglutide in the last year — driving a thriving market in compounded versions and online prescriptions — has made it increasingly difficult to find pharmacies that can fill prescriptions, pediatricians told this news organization.

“It’s been more difficult to get people initiated now than it was a year ago,” said Brooke Sweeney, MD, medical director of weight management services at Children’s Mercy in Kansas City, Missouri. “Because of the supply issues, for the most part we›re not starting anyone new because I don›t have enough medication to keep my patients on it who are already on it,” she said.

Sarah Raatz, MD, a pediatrician at the University of Minnesota’s Center for Pediatric Obesity Medicine, said, “I actually haven’t really been prescribing many of these medications as of late.” Both liraglutide and semaglutide “are largely unavailable or quite hard to get a hold of,” Dr. Raatz told this news organization.

Susma Shanti Vaidya, MPH, MD, associate medical director of the IDEAL pediatric obesity clinic at Children›s National Hospital in Washington, DC, said that patients taking GLP-1 agonists in her practice have reduced their body mass index and have seen resolution of prediabetes, diabetes, and fatty liver disease. «I had one patient who had severe obstructive sleep apnea which resolved with semaglutide.»

But when they can’t find the medications, it can lead to a plateauing of weight loss and a reversal of hard-won victories, Dr. Vaidya said.

Insurance Denials Also Growing

In January 2023, the American Academy of Pediatrics urged aggressive treatment of childhood obesity, including using FDA-approved medications such as GLP-1 agonists combined with lifestyle and dietary modifications.

The US Preventive Services Task Force, however, has issued a draft proposal that recommends a variety of lifestyle and behavior modification interventions for children and adolescents but says the evidence does not yet support recommending bariatric surgery or medications.

Insurance coverage for children — even for FDA-approved indications and the age 12-and-over population — has become increasingly difficult, said the pediatric obesity specialists. Insurers are also creating hurdles that make getting coverage more difficult, they said.

Some insurers track an adolescent’s weight trajectory, “and if they’re not meeting a certain response threshold set by the insurance company, then they can pull coverage and then we have to try to advocate for why continued coverage might be beneficial and necessary,” Dr. Raatz said.

Insurers in the region around Children’s Mercy are erecting similar barriers, said Sweeney. Interim weight loss goals are challenging in pediatrics — given that adolescents are constantly changing and growing, she said.

Dr. Vaidya said she’s had success with commercial insurers but that the Washington, DC, and Maryland Medicaid programs have been stingier.

All the pediatricians said they expect greater restrictions in 2024.

Dr. Vaidya said some patients told her they had been notified that prior authorization will be required for new prescriptions for a GLP-1 agonist.

“We will just kind of be forced to see what happens when these medications are taken away from patients who have benefited from them,” Dr. Raatz said.
 

Some Parents Asking for GLP-1 Agonists

Pediatric obesity specialists said more parents are asking if a GLP-1 agonist might be appropriate for their children this year than in 2022.

Dr. Sweeney said parents ask for the medications when they feel they have exhausted all other options for their children. “These parents are not coming because they are concerned about the cosmetic effects of the weight,” she said. In most cases, children she sees have been struggling for years with extreme hunger and lack of satiety and may have prediabetes or diabetes. Many are being bullied in school because of their weight. They have only marginally been helped by interventions suggested by primary care or dietitians or other specialists, Dr. Sweeney said.

“Starting semaglutide really is life-changing for some of these patients,” Dr. Vaidya said. One patient said, “it just stopped the food chatter,” she added, noting that the adolescent no longer felt ruled by cravings.

In a recent poll by Morning Consult, 65% of parents of children with weight-related issues said they would be interested in GLP-1 agonists for their kids. A third of all parents said they would be interested in having their children use the drugs if they were available.
 

Lifelong Medication?

Parents — and adolescents — are generally counseled that obesity is a chronic disease and GLP-1 agonists are likely a lifelong treatment.

With the medications, “our first step is to get induction of weight loss and get your set point decreased enough that we can get you to a healthier weight for your body,” Dr. Sweeney said.

She tells patients and families, “I can’t tell you that you’re necessarily going to be on this medication at this dose for the rest of your life, but you will need treatment for life.”

Based on current knowledge, the risks for lifelong obesity outweigh the risk for the medications. Dr. Sweeney said she would like to see more data. “There absolutely is an evidence gap, and we need more information on the long-term effectiveness and safety.”

“When we start kids on this medication, I’m very clear that we are going to try to get to the lowest effective dose,” Dr. Vaidya said. She also emphasizes to parents that the medications must be used in conjunction with continued lifestyle modifications. She expressed hope that as clinicians gain more experience, and patients’ comorbidities resolve, perhaps it will be possible in some cases to take individuals “off for a period of time, with the understanding that they might have to go back on in a few months.”

“We’re weighing the pros and cons of being on a medication long term but we’re also weighing the pros and cons of weight-related health complications long term,” Dr. Raatz said.

Dr. Raatz also said clinicians have much to learn about the long-term safety of GLP-1 agonists in their pediatric patients.

She tells parents and families, “we expect that this is going to be a long-term medication, and this is going to be something that we’re going to continue to monitor.”

Dr. Sweeney reports that she is a speaker and unpaid consultant on Rhythm Pharmaceuticals’ Imcivree (setmelanotide) medication and that she consults for Eli Lilly. Dr. Raatz is a coprincipal investigator for a Novo Nordisk trial of semaglutide in young children and will be a co-PI for a similar trial for Eli Lilly’s tirzepatide but receives no consulting fees or honoraria. Dr. Vaidya reported no conflicts.

A version of this article appeared on Medscape.com.