Pediatrics

I read a few articles recently that raised my concern about a laissez faire attitude regarding treatment and prevention of infectious disease and lack of a broader understanding of why we treat our patients.
 

Strep throat

Let’s start with group A streptococcal pharyngitis – strep throat. There are at least five reasons to treat strep throat with antibiotics.

Lest we forget, there is the prevention of acute rheumatic fever! Of course, acute rheumatic fever is rare in high-income countries like the United States, but we have had outbreaks in the past and we will have outbreaks in the future. All it takes is circulation of rheumatogenic strains and susceptible hosts.

Also, antibiotic treatment may prevent acute post-streptococcal glomerulonephritis, although that benefit is somewhat controversial.

Antibiotic treatment may prevent development of another controversial, nonsuppurative streptococcal complication, namely, pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS).

Second, group A strep causes suppurative complications such as acute otitis media, peritonsillar abscess, mastoiditis, and sepsis, among others, and antibiotic treatment reduces those risks. Group A strep can cause impetigo, cellulitis, necrotizing fasciitis (flesh-eating disease), and toxic shock syndrome; antibiotics reduce those risks.

Third, while strep throat is a self-limited infection in terms of symptoms, it has been clearly shown that antibiotics cause symptoms to resolve more quickly. I must confess that it galls me when pundits suggest that reducing symptoms of any infectious disease by a day or 2 doesn’t matter for children, when adults with even mild symptoms rush to a clinician with hopes of treatment to shorten illness by a day.

Fourth, antibiotics shorten contagion. In fact, treatment in the morning of an office visit can allow a child to return to school the next day.¹

Lastly on this topic, if a clinician had a positive strep culture or rapid test on a patient and did not treat with antibiotics, which is not the standard of care, and that patient went on to a nonsuppurative or suppurative complication, then what?

I am not advocating wholesale antibiotic treatment of all sore throats because antibiotics carry risks from use. Most sore throats are not strep throats. The first step is the examination to decide if a strep test is warranted. There are clinical scoring systems available. But the essence of the clinical criteria relies on age of child (strep is mostly seen in 5- to 15-year-olds), season (not summer), known exposure to strep, absence of rhinorrhea, absence of cough, presence of rapid onset of symptoms, usually with fever, and moderate to severe redness, often with exudates. Gratefully, in the United States, we have rapid strep tests that are covered by insurance. This is not the case even in many other high-income countries and certainly, generally, not available at all in moderate to low income countries. With a rapid test, a point-of-care microbiologic diagnosis can be made with reasonable accuracy. Antibiotic treatment should be reserved for patients with positive laboratory confirmation of Group A streptococci, either by rapid test or culture.
 

Ear infections

Next, let’s address treatment of acute otitis media – ear infections. There are at least six reasons to treat ear infections with antibiotics. Worldwide, the No. 1 cause of acquired deafness in children today is ear infections. This is rarely seen in the United States because we rarely have patients with chronic suppurative otitis media since antibiotics are typically prescribed.

Second, ear infections have suppurative complications such as mastoiditis, labyrinthitis, malignant otitis, brain abscess, sepsis, and meningitis. The World Health Organization attributes 20,000 deaths per year to complications from ear infections.

Third, ear infections can lead to eardrum rupture and subsequent chronic middle ear drainage.

Fourth, untreated otitis more often progresses to a nonsuppurative complication – a cholesteatoma.

Fifth, while earache is a self-limited illness, antibiotics shorten the acute symptoms by a day or 2 and lessen the duration of middle ear effusion after infection that can cause temporary hearing loss. Once again, as a child advocate, I would point out that pain from an ear infection is often severe and the lingering effects of a middle ear effusion are annoying to say the least.

Lastly on this topic, if a clinician makes the diagnosis of an ear infection in a patient and does not treat with antibiotics, the decision should be within the guidelines of the standard of care as described by the American Academy of Pediatrics² with decision-making based on patient age and severity of symptoms.

I am not advocating wholesale antibiotic treatment of all ear pain or presumed ear pain. With this clinical condition we currently do not have a diagnostic test, and therein lies the conundrum. Most acute otitis media occurs among children age 6-24 months old, and this leads most clinicians to overdiagnose the infection. A child in that age group is nonverbal and in the context of a viral upper respiratory illness the symptoms of acute otitis media overlap completely with those of a viral URI. Therefore, an adequate examination is necessary. Confronted with an irritable child who is uncooperative with a challenging otoscopic examination, an ear canal with wax blocking an adequate view of the tympanic membrane, and a parent in a hurry to get back to work or home, the inclination is to observe a “little bit of redness” and prescribe unnecessary antibiotics. Even though redness is not a good diagnostic indicator, whereas a full or bulging eardrum is for the diagnosis of acute otitis media, I shudder at how often I see in a medical record a description of redness of the eardrum and no comment on the fullness that occurs when an authentic infection is most likely.

I could extend this column discussing acute sinusitis and cough illnesses as they are two other conditions associated with infection where antibiotics have their important place and where antibiotics are also overused. Instead, I will end by summarizing my viewpoint that judicious antibiotic use is of high importance for prevention of antibiotic resistance at the individual patient level and the community level. However, we should not become complacent about the risks to untreated children experiencing common respiratory infections because there are many justifiable reasons to treat children as discussed here.

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute at Rochester (N.Y.) General Hospital. He has no conflicts of interest to disclose.

References

1. Schwartz RH et al. A reappraisal of the minimum duration of antibiotic treatment before approval of return to school for children with streptococcal pharyngitis. Pediatr Infect Dis J. 2015 Dec. doi: 10.1097/INF.0000000000000883.

2. Lieberthal AS et al. The diagnosis and management of acute otitis media. Pediatrics. 2013 Mar. doi: 10.1542/peds.2012-3488.

I read a few articles recently that raised my concern about a laissez faire attitude regarding treatment and prevention of infectious disease and lack of a broader understanding of why we treat our patients.
 

Strep throat

Let’s start with group A streptococcal pharyngitis – strep throat. There are at least five reasons to treat strep throat with antibiotics.

Lest we forget, there is the prevention of acute rheumatic fever! Of course, acute rheumatic fever is rare in high-income countries like the United States, but we have had outbreaks in the past and we will have outbreaks in the future. All it takes is circulation of rheumatogenic strains and susceptible hosts.

Also, antibiotic treatment may prevent acute post-streptococcal glomerulonephritis, although that benefit is somewhat controversial.

Antibiotic treatment may prevent development of another controversial, nonsuppurative streptococcal complication, namely, pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS).

Second, group A strep causes suppurative complications such as acute otitis media, peritonsillar abscess, mastoiditis, and sepsis, among others, and antibiotic treatment reduces those risks. Group A strep can cause impetigo, cellulitis, necrotizing fasciitis (flesh-eating disease), and toxic shock syndrome; antibiotics reduce those risks.

Third, while strep throat is a self-limited infection in terms of symptoms, it has been clearly shown that antibiotics cause symptoms to resolve more quickly. I must confess that it galls me when pundits suggest that reducing symptoms of any infectious disease by a day or 2 doesn’t matter for children, when adults with even mild symptoms rush to a clinician with hopes of treatment to shorten illness by a day.

Fourth, antibiotics shorten contagion. In fact, treatment in the morning of an office visit can allow a child to return to school the next day.¹

Lastly on this topic, if a clinician had a positive strep culture or rapid test on a patient and did not treat with antibiotics, which is not the standard of care, and that patient went on to a nonsuppurative or suppurative complication, then what?

I am not advocating wholesale antibiotic treatment of all sore throats because antibiotics carry risks from use. Most sore throats are not strep throats. The first step is the examination to decide if a strep test is warranted. There are clinical scoring systems available. But the essence of the clinical criteria relies on age of child (strep is mostly seen in 5- to 15-year-olds), season (not summer), known exposure to strep, absence of rhinorrhea, absence of cough, presence of rapid onset of symptoms, usually with fever, and moderate to severe redness, often with exudates. Gratefully, in the United States, we have rapid strep tests that are covered by insurance. This is not the case even in many other high-income countries and certainly, generally, not available at all in moderate to low income countries. With a rapid test, a point-of-care microbiologic diagnosis can be made with reasonable accuracy. Antibiotic treatment should be reserved for patients with positive laboratory confirmation of Group A streptococci, either by rapid test or culture.
 

Ear infections

Next, let’s address treatment of acute otitis media – ear infections. There are at least six reasons to treat ear infections with antibiotics. Worldwide, the No. 1 cause of acquired deafness in children today is ear infections. This is rarely seen in the United States because we rarely have patients with chronic suppurative otitis media since antibiotics are typically prescribed.

Second, ear infections have suppurative complications such as mastoiditis, labyrinthitis, malignant otitis, brain abscess, sepsis, and meningitis. The World Health Organization attributes 20,000 deaths per year to complications from ear infections.

Third, ear infections can lead to eardrum rupture and subsequent chronic middle ear drainage.

Fourth, untreated otitis more often progresses to a nonsuppurative complication – a cholesteatoma.

Fifth, while earache is a self-limited illness, antibiotics shorten the acute symptoms by a day or 2 and lessen the duration of middle ear effusion after infection that can cause temporary hearing loss. Once again, as a child advocate, I would point out that pain from an ear infection is often severe and the lingering effects of a middle ear effusion are annoying to say the least.

Lastly on this topic, if a clinician makes the diagnosis of an ear infection in a patient and does not treat with antibiotics, the decision should be within the guidelines of the standard of care as described by the American Academy of Pediatrics² with decision-making based on patient age and severity of symptoms.

I am not advocating wholesale antibiotic treatment of all ear pain or presumed ear pain. With this clinical condition we currently do not have a diagnostic test, and therein lies the conundrum. Most acute otitis media occurs among children age 6-24 months old, and this leads most clinicians to overdiagnose the infection. A child in that age group is nonverbal and in the context of a viral upper respiratory illness the symptoms of acute otitis media overlap completely with those of a viral URI. Therefore, an adequate examination is necessary. Confronted with an irritable child who is uncooperative with a challenging otoscopic examination, an ear canal with wax blocking an adequate view of the tympanic membrane, and a parent in a hurry to get back to work or home, the inclination is to observe a “little bit of redness” and prescribe unnecessary antibiotics. Even though redness is not a good diagnostic indicator, whereas a full or bulging eardrum is for the diagnosis of acute otitis media, I shudder at how often I see in a medical record a description of redness of the eardrum and no comment on the fullness that occurs when an authentic infection is most likely.

I could extend this column discussing acute sinusitis and cough illnesses as they are two other conditions associated with infection where antibiotics have their important place and where antibiotics are also overused. Instead, I will end by summarizing my viewpoint that judicious antibiotic use is of high importance for prevention of antibiotic resistance at the individual patient level and the community level. However, we should not become complacent about the risks to untreated children experiencing common respiratory infections because there are many justifiable reasons to treat children as discussed here.

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute at Rochester (N.Y.) General Hospital. He has no conflicts of interest to disclose.

References

1. Schwartz RH et al. A reappraisal of the minimum duration of antibiotic treatment before approval of return to school for children with streptococcal pharyngitis. Pediatr Infect Dis J. 2015 Dec. doi: 10.1097/INF.0000000000000883.

2. Lieberthal AS et al. The diagnosis and management of acute otitis media. Pediatrics. 2013 Mar. doi: 10.1542/peds.2012-3488.

I read a few articles recently that raised my concern about a laissez faire attitude regarding treatment and prevention of infectious disease and lack of a broader understanding of why we treat our patients.
 

Strep throat

Let’s start with group A streptococcal pharyngitis – strep throat. There are at least five reasons to treat strep throat with antibiotics.

Lest we forget, there is the prevention of acute rheumatic fever! Of course, acute rheumatic fever is rare in high-income countries like the United States, but we have had outbreaks in the past and we will have outbreaks in the future. All it takes is circulation of rheumatogenic strains and susceptible hosts.

Also, antibiotic treatment may prevent acute post-streptococcal glomerulonephritis, although that benefit is somewhat controversial.

Antibiotic treatment may prevent development of another controversial, nonsuppurative streptococcal complication, namely, pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS).

Second, group A strep causes suppurative complications such as acute otitis media, peritonsillar abscess, mastoiditis, and sepsis, among others, and antibiotic treatment reduces those risks. Group A strep can cause impetigo, cellulitis, necrotizing fasciitis (flesh-eating disease), and toxic shock syndrome; antibiotics reduce those risks.

Third, while strep throat is a self-limited infection in terms of symptoms, it has been clearly shown that antibiotics cause symptoms to resolve more quickly. I must confess that it galls me when pundits suggest that reducing symptoms of any infectious disease by a day or 2 doesn’t matter for children, when adults with even mild symptoms rush to a clinician with hopes of treatment to shorten illness by a day.

Fourth, antibiotics shorten contagion. In fact, treatment in the morning of an office visit can allow a child to return to school the next day.¹

Lastly on this topic, if a clinician had a positive strep culture or rapid test on a patient and did not treat with antibiotics, which is not the standard of care, and that patient went on to a nonsuppurative or suppurative complication, then what?

I am not advocating wholesale antibiotic treatment of all sore throats because antibiotics carry risks from use. Most sore throats are not strep throats. The first step is the examination to decide if a strep test is warranted. There are clinical scoring systems available. But the essence of the clinical criteria relies on age of child (strep is mostly seen in 5- to 15-year-olds), season (not summer), known exposure to strep, absence of rhinorrhea, absence of cough, presence of rapid onset of symptoms, usually with fever, and moderate to severe redness, often with exudates. Gratefully, in the United States, we have rapid strep tests that are covered by insurance. This is not the case even in many other high-income countries and certainly, generally, not available at all in moderate to low income countries. With a rapid test, a point-of-care microbiologic diagnosis can be made with reasonable accuracy. Antibiotic treatment should be reserved for patients with positive laboratory confirmation of Group A streptococci, either by rapid test or culture.
 

Ear infections

Next, let’s address treatment of acute otitis media – ear infections. There are at least six reasons to treat ear infections with antibiotics. Worldwide, the No. 1 cause of acquired deafness in children today is ear infections. This is rarely seen in the United States because we rarely have patients with chronic suppurative otitis media since antibiotics are typically prescribed.

Second, ear infections have suppurative complications such as mastoiditis, labyrinthitis, malignant otitis, brain abscess, sepsis, and meningitis. The World Health Organization attributes 20,000 deaths per year to complications from ear infections.

Third, ear infections can lead to eardrum rupture and subsequent chronic middle ear drainage.

Fourth, untreated otitis more often progresses to a nonsuppurative complication – a cholesteatoma.

Fifth, while earache is a self-limited illness, antibiotics shorten the acute symptoms by a day or 2 and lessen the duration of middle ear effusion after infection that can cause temporary hearing loss. Once again, as a child advocate, I would point out that pain from an ear infection is often severe and the lingering effects of a middle ear effusion are annoying to say the least.

Lastly on this topic, if a clinician makes the diagnosis of an ear infection in a patient and does not treat with antibiotics, the decision should be within the guidelines of the standard of care as described by the American Academy of Pediatrics² with decision-making based on patient age and severity of symptoms.

I am not advocating wholesale antibiotic treatment of all ear pain or presumed ear pain. With this clinical condition we currently do not have a diagnostic test, and therein lies the conundrum. Most acute otitis media occurs among children age 6-24 months old, and this leads most clinicians to overdiagnose the infection. A child in that age group is nonverbal and in the context of a viral upper respiratory illness the symptoms of acute otitis media overlap completely with those of a viral URI. Therefore, an adequate examination is necessary. Confronted with an irritable child who is uncooperative with a challenging otoscopic examination, an ear canal with wax blocking an adequate view of the tympanic membrane, and a parent in a hurry to get back to work or home, the inclination is to observe a “little bit of redness” and prescribe unnecessary antibiotics. Even though redness is not a good diagnostic indicator, whereas a full or bulging eardrum is for the diagnosis of acute otitis media, I shudder at how often I see in a medical record a description of redness of the eardrum and no comment on the fullness that occurs when an authentic infection is most likely.

I could extend this column discussing acute sinusitis and cough illnesses as they are two other conditions associated with infection where antibiotics have their important place and where antibiotics are also overused. Instead, I will end by summarizing my viewpoint that judicious antibiotic use is of high importance for prevention of antibiotic resistance at the individual patient level and the community level. However, we should not become complacent about the risks to untreated children experiencing common respiratory infections because there are many justifiable reasons to treat children as discussed here.

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute at Rochester (N.Y.) General Hospital. He has no conflicts of interest to disclose.

References

1. Schwartz RH et al. A reappraisal of the minimum duration of antibiotic treatment before approval of return to school for children with streptococcal pharyngitis. Pediatr Infect Dis J. 2015 Dec. doi: 10.1097/INF.0000000000000883.

2. Lieberthal AS et al. The diagnosis and management of acute otitis media. Pediatrics. 2013 Mar. doi: 10.1542/peds.2012-3488.

All infants and children perinatally exposed to the hepatitis C virus (HCV) should be tested and, if necessary, treated, according to new guidance from the Centers for Disease Control and Prevention.

In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.

HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).

About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.

This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
 

The new recommendations

• Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
• Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
• Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.

“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
 

A growing problem

The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.

Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.

The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.

Northwell Health

Northwestern Medicine

Northwestern Medicine

All infants and children perinatally exposed to the hepatitis C virus (HCV) should be tested and, if necessary, treated, according to new guidance from the Centers for Disease Control and Prevention.

In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.

HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).

About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.

This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
 

The new recommendations

• Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
• Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
• Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.

“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
 

A growing problem

The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.

Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.

The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.

Northwell Health

Northwestern Medicine

Northwestern Medicine

All infants and children perinatally exposed to the hepatitis C virus (HCV) should be tested and, if necessary, treated, according to new guidance from the Centers for Disease Control and Prevention.

In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.

HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).

About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.

This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
 

The new recommendations

• Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
• Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
• Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.

“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
 

A growing problem

The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.

Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.

The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.

Northwell Health

Northwestern Medicine

Northwestern Medicine

Pulmonologist Evan Stepp, MD, FCCP, has a teenage daughter who doesn’t smoke or vape – as far as he knows, Stepp will admit – but the statistics on youth smoking are alarming enough to have him worried.

On one hand, fewer Americans are smoking today than ever before. Since 1992, the percentage of people who told Gallup that they’d had a cigarette in the past week has dropped from 28% to 11%. Meanwhile, the rate of new lung cancer cases declined from 65 per every 100,000 people in 1992 to 34 per 100,000 in 2020, according to the National Cancer Institute.

While those statistics are worth celebrating, they hide an alarming reality: A disproportionate number of teens and young adults today are addicted to nicotine.

According to a November 2022 report from the Centers for Disease Control and Prevention (CDC), 1 in 6 high school students and 1 in 20 middle schoolers are using a nicotine product at least once every day.

“It’s a completely different picture for nicotine cessation in youth,” Dr. Stepp, who is an associate professor at National Jewish Health in Denver, said. “Because of the fact that the nicotine addiction is occurring in a developing brain, which raises many other nicotine-related harms.”
 

Why teens vape

Today’s teens are smoking less actual tobacco, and, instead, overwhelmingly prefer e-cigarettes or vaping. In fact, 85% of high school–aged smokers and 72% of middle school smokers reach for a vape over regular cigarettes or smokeless tobacco, according to the CDC.

It’s not hard to understand why: e-cigarettes use a heating element to turn a nicotine-infused liquid into an aerosol, with no open flame, ash, or lingering smoke. The vapes themselves are easy to conceal, and if someone needed to hide an e-cigarette from particularly perceptive parents or teachers, they can find vapes built into hoodies, fake smartwatches, and USB drives.

Plus, the liquids often come in flavors like fruit, bubble gum, mint, and vanilla, because unflavored nicotine isn’t exactly appealing. “Huge concentrations of nicotine salts are just miserable to breathe in,” Dr. Stepp said. “Flavors are necessary to make these products palatable, and those flavors end up being a huge draw for youth users to get exposed to nicotine addiction.”
 

Challenges surrounding smoking cessation in youth

The powerful effect of nicotine in youth means the need for effective cessation strategies is both more urgent and more difficult. But while physicians can prescribe to adults the antidepressants varenicline and bupropion, along with nicotine replacement therapy, to help ease withdrawal symptoms, the US Food and Drug Administration (FDA) has not approved those medications for anyone under the age of 18.

Research on cessation medications in young people is limited: A recent meta-analysis found only four studies on people between the ages of 12 and 21. In teens, antidepressants seem to help quitting for the first few weeks but are unproven as a long-term solution.

“That really has been a challenge for the 1 in 6 high school students who are current users of tobacco products,” said pediatrician, Susan Walley, MD, a co-author of the American Academy of Pediatrics’ recent position papers on children and smoking.

“One of the things that is important to keep at the forefront of the conversation is that nicotine addiction is a chronic medical disease, and it’s a form of substance abuse,” Dr. Walley said. “We know that we need more research in adolescent tobacco cessation, and it really is about the funding, about research dollars.”

Without medications, smoking cessation in teens relies largely on counseling strategies. A 2017 review published by Cochrane Library found that group counseling was the most effective quitting method, with teens participating in group sessions 35% more likely to stop using nicotine products up to a year later, compared with teens who did not receive any counseling.

Counseling can help educate teens (and parents) on some of the realities of e-cigarettes, bridging the gap between well-established anti-smoking campaigns and the anti-vape campaigns that have yet to catch up.

“We have done a great job promoting cigarette use as dangerous,” Dr. Walley said. “[But] many teens who would never pick up a cigarette –because they know the health risks – are vaping.”
 

How to get a teen to quit

Cessation and prevention strategies are closely linked, and interventions can start in middle school-aged children up through high school and young adults. Simply asking a 12-year-old, “Do you know anyone who smokes?” can help start a conversation that leads to an attempt to quit.

Teens may be compelled to smoke through digital advertising and influencer endorsements on social media platforms, but Gen Z is turned off by the idea that it’s being manipulated by the tobacco industry. Juul, for example, is partially owned by Altria, which makes Marlboros, and Vuse is wholly owned by R.J. Reynolds, which makes Camel cigarettes.

“If you can get somebody to understand that Big Tobacco is trying to manipulate you as a young person to want to illegally obtain and use their products, which are incredibly addictive, thus ensuring you will remain a loyal customer, that could be the thing that pushes them over the hump,” Dr. Stepp said. “You push it away like you would push away a parent trying to tell you how to park a car in the driveway.”

And just because a smoker relapses, it doesn’t mean the cessation was a complete failure. The younger someone is when they stop smoking, the less likely they are to suffer from the long-term health consequences of smoking, according to a 2021 study in the Journal of the American Medical Association. “With the right counseling,” Dr. Walley said, “each relapse is an opportunity for losing the habit permanently.”

This article was adapted from the Summer 2023 online issue of CHEST Advocates. For the full article – and to engage with the other content from this issue – visit https://chestnet.org/chest-­advocates.

Pulmonologist Evan Stepp, MD, FCCP, has a teenage daughter who doesn’t smoke or vape – as far as he knows, Stepp will admit – but the statistics on youth smoking are alarming enough to have him worried.

On one hand, fewer Americans are smoking today than ever before. Since 1992, the percentage of people who told Gallup that they’d had a cigarette in the past week has dropped from 28% to 11%. Meanwhile, the rate of new lung cancer cases declined from 65 per every 100,000 people in 1992 to 34 per 100,000 in 2020, according to the National Cancer Institute.

While those statistics are worth celebrating, they hide an alarming reality: A disproportionate number of teens and young adults today are addicted to nicotine.

According to a November 2022 report from the Centers for Disease Control and Prevention (CDC), 1 in 6 high school students and 1 in 20 middle schoolers are using a nicotine product at least once every day.

“It’s a completely different picture for nicotine cessation in youth,” Dr. Stepp, who is an associate professor at National Jewish Health in Denver, said. “Because of the fact that the nicotine addiction is occurring in a developing brain, which raises many other nicotine-related harms.”
 

Why teens vape

Today’s teens are smoking less actual tobacco, and, instead, overwhelmingly prefer e-cigarettes or vaping. In fact, 85% of high school–aged smokers and 72% of middle school smokers reach for a vape over regular cigarettes or smokeless tobacco, according to the CDC.

It’s not hard to understand why: e-cigarettes use a heating element to turn a nicotine-infused liquid into an aerosol, with no open flame, ash, or lingering smoke. The vapes themselves are easy to conceal, and if someone needed to hide an e-cigarette from particularly perceptive parents or teachers, they can find vapes built into hoodies, fake smartwatches, and USB drives.

Plus, the liquids often come in flavors like fruit, bubble gum, mint, and vanilla, because unflavored nicotine isn’t exactly appealing. “Huge concentrations of nicotine salts are just miserable to breathe in,” Dr. Stepp said. “Flavors are necessary to make these products palatable, and those flavors end up being a huge draw for youth users to get exposed to nicotine addiction.”
 

Challenges surrounding smoking cessation in youth

The powerful effect of nicotine in youth means the need for effective cessation strategies is both more urgent and more difficult. But while physicians can prescribe to adults the antidepressants varenicline and bupropion, along with nicotine replacement therapy, to help ease withdrawal symptoms, the US Food and Drug Administration (FDA) has not approved those medications for anyone under the age of 18.

Research on cessation medications in young people is limited: A recent meta-analysis found only four studies on people between the ages of 12 and 21. In teens, antidepressants seem to help quitting for the first few weeks but are unproven as a long-term solution.

“That really has been a challenge for the 1 in 6 high school students who are current users of tobacco products,” said pediatrician, Susan Walley, MD, a co-author of the American Academy of Pediatrics’ recent position papers on children and smoking.

“One of the things that is important to keep at the forefront of the conversation is that nicotine addiction is a chronic medical disease, and it’s a form of substance abuse,” Dr. Walley said. “We know that we need more research in adolescent tobacco cessation, and it really is about the funding, about research dollars.”

Without medications, smoking cessation in teens relies largely on counseling strategies. A 2017 review published by Cochrane Library found that group counseling was the most effective quitting method, with teens participating in group sessions 35% more likely to stop using nicotine products up to a year later, compared with teens who did not receive any counseling.

Counseling can help educate teens (and parents) on some of the realities of e-cigarettes, bridging the gap between well-established anti-smoking campaigns and the anti-vape campaigns that have yet to catch up.

“We have done a great job promoting cigarette use as dangerous,” Dr. Walley said. “[But] many teens who would never pick up a cigarette –because they know the health risks – are vaping.”
 

How to get a teen to quit

Cessation and prevention strategies are closely linked, and interventions can start in middle school-aged children up through high school and young adults. Simply asking a 12-year-old, “Do you know anyone who smokes?” can help start a conversation that leads to an attempt to quit.

Teens may be compelled to smoke through digital advertising and influencer endorsements on social media platforms, but Gen Z is turned off by the idea that it’s being manipulated by the tobacco industry. Juul, for example, is partially owned by Altria, which makes Marlboros, and Vuse is wholly owned by R.J. Reynolds, which makes Camel cigarettes.

“If you can get somebody to understand that Big Tobacco is trying to manipulate you as a young person to want to illegally obtain and use their products, which are incredibly addictive, thus ensuring you will remain a loyal customer, that could be the thing that pushes them over the hump,” Dr. Stepp said. “You push it away like you would push away a parent trying to tell you how to park a car in the driveway.”

And just because a smoker relapses, it doesn’t mean the cessation was a complete failure. The younger someone is when they stop smoking, the less likely they are to suffer from the long-term health consequences of smoking, according to a 2021 study in the Journal of the American Medical Association. “With the right counseling,” Dr. Walley said, “each relapse is an opportunity for losing the habit permanently.”

This article was adapted from the Summer 2023 online issue of CHEST Advocates. For the full article – and to engage with the other content from this issue – visit https://chestnet.org/chest-­advocates.

Pulmonologist Evan Stepp, MD, FCCP, has a teenage daughter who doesn’t smoke or vape – as far as he knows, Stepp will admit – but the statistics on youth smoking are alarming enough to have him worried.

On one hand, fewer Americans are smoking today than ever before. Since 1992, the percentage of people who told Gallup that they’d had a cigarette in the past week has dropped from 28% to 11%. Meanwhile, the rate of new lung cancer cases declined from 65 per every 100,000 people in 1992 to 34 per 100,000 in 2020, according to the National Cancer Institute.

While those statistics are worth celebrating, they hide an alarming reality: A disproportionate number of teens and young adults today are addicted to nicotine.

According to a November 2022 report from the Centers for Disease Control and Prevention (CDC), 1 in 6 high school students and 1 in 20 middle schoolers are using a nicotine product at least once every day.

“It’s a completely different picture for nicotine cessation in youth,” Dr. Stepp, who is an associate professor at National Jewish Health in Denver, said. “Because of the fact that the nicotine addiction is occurring in a developing brain, which raises many other nicotine-related harms.”
 

Why teens vape

Today’s teens are smoking less actual tobacco, and, instead, overwhelmingly prefer e-cigarettes or vaping. In fact, 85% of high school–aged smokers and 72% of middle school smokers reach for a vape over regular cigarettes or smokeless tobacco, according to the CDC.

It’s not hard to understand why: e-cigarettes use a heating element to turn a nicotine-infused liquid into an aerosol, with no open flame, ash, or lingering smoke. The vapes themselves are easy to conceal, and if someone needed to hide an e-cigarette from particularly perceptive parents or teachers, they can find vapes built into hoodies, fake smartwatches, and USB drives.

Plus, the liquids often come in flavors like fruit, bubble gum, mint, and vanilla, because unflavored nicotine isn’t exactly appealing. “Huge concentrations of nicotine salts are just miserable to breathe in,” Dr. Stepp said. “Flavors are necessary to make these products palatable, and those flavors end up being a huge draw for youth users to get exposed to nicotine addiction.”
 

Challenges surrounding smoking cessation in youth

The powerful effect of nicotine in youth means the need for effective cessation strategies is both more urgent and more difficult. But while physicians can prescribe to adults the antidepressants varenicline and bupropion, along with nicotine replacement therapy, to help ease withdrawal symptoms, the US Food and Drug Administration (FDA) has not approved those medications for anyone under the age of 18.

Research on cessation medications in young people is limited: A recent meta-analysis found only four studies on people between the ages of 12 and 21. In teens, antidepressants seem to help quitting for the first few weeks but are unproven as a long-term solution.

“That really has been a challenge for the 1 in 6 high school students who are current users of tobacco products,” said pediatrician, Susan Walley, MD, a co-author of the American Academy of Pediatrics’ recent position papers on children and smoking.

“One of the things that is important to keep at the forefront of the conversation is that nicotine addiction is a chronic medical disease, and it’s a form of substance abuse,” Dr. Walley said. “We know that we need more research in adolescent tobacco cessation, and it really is about the funding, about research dollars.”

Without medications, smoking cessation in teens relies largely on counseling strategies. A 2017 review published by Cochrane Library found that group counseling was the most effective quitting method, with teens participating in group sessions 35% more likely to stop using nicotine products up to a year later, compared with teens who did not receive any counseling.

Counseling can help educate teens (and parents) on some of the realities of e-cigarettes, bridging the gap between well-established anti-smoking campaigns and the anti-vape campaigns that have yet to catch up.

“We have done a great job promoting cigarette use as dangerous,” Dr. Walley said. “[But] many teens who would never pick up a cigarette –because they know the health risks – are vaping.”
 

How to get a teen to quit

Cessation and prevention strategies are closely linked, and interventions can start in middle school-aged children up through high school and young adults. Simply asking a 12-year-old, “Do you know anyone who smokes?” can help start a conversation that leads to an attempt to quit.

Teens may be compelled to smoke through digital advertising and influencer endorsements on social media platforms, but Gen Z is turned off by the idea that it’s being manipulated by the tobacco industry. Juul, for example, is partially owned by Altria, which makes Marlboros, and Vuse is wholly owned by R.J. Reynolds, which makes Camel cigarettes.

“If you can get somebody to understand that Big Tobacco is trying to manipulate you as a young person to want to illegally obtain and use their products, which are incredibly addictive, thus ensuring you will remain a loyal customer, that could be the thing that pushes them over the hump,” Dr. Stepp said. “You push it away like you would push away a parent trying to tell you how to park a car in the driveway.”

And just because a smoker relapses, it doesn’t mean the cessation was a complete failure. The younger someone is when they stop smoking, the less likely they are to suffer from the long-term health consequences of smoking, according to a 2021 study in the Journal of the American Medical Association. “With the right counseling,” Dr. Walley said, “each relapse is an opportunity for losing the habit permanently.”

This article was adapted from the Summer 2023 online issue of CHEST Advocates. For the full article – and to engage with the other content from this issue – visit https://chestnet.org/chest-­advocates.

WASHINGTON – Transgender and other gender-diverse youth who visited the emergency department (ED) at a single institution had more than five times greater odds of a positive suicide screening compared with their cisgender peers, according to a study presented at the annual meeting of the American Academy of Pediatrics.

“The take-home message here is this study emphasizes the importance of universal screening to identify gender-diverse youth at risk,” Amanda Burnside, PhD, assistant professor of psychiatry and behavioral sciences at Ann and Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, told attendees. “We really need to develop robust strategies and systems to link better mental health services.”

Ann and Robert H. Lurie Children’s Hospital of Chicago

Suicide rates in transgender and gender-diverse youth are exceptionally high among youth in the U.S., Dr. Burnside said during her presentation. For example, the 2022 LGBTQ health survey from the Trevor Project found that much higher percentages of transgender and gender nonconforming youth had considered suicide in the past year compared with cisgender youth, even within the LGBTQ umbrella. Among nearly 34,000 LGBTQ youth aged 13-24, nearly half of trans females (48%) and more than half of trans males (59%) had considered suicide, compared with 28% of cisgender males and 37% of cisgender females. The rate among nonbinary/genderqueer individuals was 53%, and it was 48% for those questioning their gender.

Current methods of identifying trans and gender-diverse (TGD) youth in the hospital, however, may not actually be capturing the entire population.

“In health care settings, research involving TGD individuals has historically been limited to specialized clinic populations or youth with gender-specific diagnostic codes documented in the electronic medical record,” an approach that “likely significantly underestimates the prevalence of TGD youth in health care settings.” While at least one study has attempted to bridge this gap by searching the EMR for keywords, that study only tried to identify trans youth and not other youth on the gender diversity spectrum, such as nonbinary youth or those questioning their gender identity. Dr. Burnside and her colleagues therefore designed a study that used keywords to identify both trans youth and other gender-diverse youth who visited the ED so they could assess the rate of positive suicide screens in this population.
 

Underestimating the population at risk?

The researchers conducted a retrospective cross-sectional study of EMR data for all ED visits during which the patient underwent suicide screening. For the period of November 2019 to August 2022, they collected data on the screening results and the patient’s gender identity, age, race/ethnicity, insurance status, chief complaint in the ED and child opportunity index, which assess a youth’s access to resources based on geography. The suicide screener used was the Ask Suicide–Screening Questions (ASQ) tool.

The keywords they looked for in the EMR to identify trans and gender-diverse youth included transgender, pronouns, agender, gender dysphoria, male-to-female, female-to-male, nonbinary, preferred name, and they/them (captured as a complete term, not as “they” and “them” separately).

“If a keyword was present, the surrounding text was extracted and reviewed by two members of our team,” Dr. Burnside explained in her presentation. “We categorized keywords into either indicative of gender-diverse identity or not, and if it wasn’t clear based on the text extracted, we would conduct a manual chart review,” though that only occurred in about 3% of cases, she added.

Among 15,413 ED encounters with a suicide screen, the researchers identified 1,126 of these keywords in the EMR, among which 91.2% were classified as referring to a gender-diverse patient. Nearly all of the words were at least 90% effective in identify a gender-diverse youth, Dr. Burnside said, and all of the 197 instances of “they/them” were classified as gender diverse.

The accuracy was a little lower for the two keywords that appeared most frequently: For “pronouns,” 86.3% of 306 instances were classified as gender diverse, and for “transgender,” 83.1% of 207 instances were classified as gender diverse. Since some providers ask all patients their pronouns, the presence of “pronouns” in the EMR alone did not necessarily indicate the patient was gender diverse, Dr. Burnside said. A common reason the term “transgender” occurred in the EMR of non–gender diverse patients is that the department’s list of crisis resources includes transgender hotlines.

After identifying all the keywords, the researchers determined how many of these occurred in unique ED encounters and removed those with incomplete screening. Overall, they found 565 encounters by 399 gender-diverse individuals who had a suicide screening, representing 4.6% of total visits. This percentage is slightly lower than recent population-based estimates of gender-diverse youth, the researchers noted.

This population ranged from 8 to 23 years old, and 43% were publicly insured. The chief complaint for most of the patients (77.5%) was a mental health one. They were predominantly White (43%) or Hispanic (35%), with 10% Black youth, 4% Asian youth, and 8% youth who were “other” or two or more races. About half (52%) lived in a neighborhood with a “low” or “very low” child opportunity index.

Within this population, 81% of the patients screened positive on the suicide screening, compared with 23% positive screens across all ED visits. One in ten (10%) gender-diverse youth had active suicidal ideation, compared with 3.4% of the rest of the ED patient population. The researchers calculated that gender-diverse youth had 5.35 times greater odds of screening positive than cisgender youth in the ED (95% confidence interval [CI] 8.7-15.92). Further, a quarter (25%) of the trans and gender-diverse youth who screened positive for suicide risk had come to the ED for a primary complaint unrelated to mental health.

“We had a kid who came in because he broke his arm who had active suicidal ideation,” study coauthor Jennifer A. Hoffmann, MD, assistant professor of pediatrics at the Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, mentioned after the presentation. That particular patient even had a suicide plan, but was identified as actively suicidal only because of the screening. In other cases, she said, a youth may come in with self-inflicted injuries, and while those are the primary complaint, they are linked with suicidal ideation.

Ann & Robert H. Lurie Children's Hospital of Chicago

Uncovering valuable information

Jason Rafferty, MD, MPH, EdM, clinical assistant professor of pediatrics and of psychiatry and human behavior at Brown University, Providence, R.I., who attended the presentation, noted that the study provides information on a population that’s often difficult to get through traditional EMR research methods.

Brown University

“A lot of medical record systems don’t have uniform ways of capturing [gender diversity], but what we know as providers is that kids are really struggling and that it’s not a surprise that we’re seeing these disparities with suicidality,” Dr. Rafferty said.

The study also provides more discrete estimates by age than what most other current research measures, which tends to be lifetime suicidality as opposed to suicidal thoughts or attempts within the past year, Dr. Rafferty added.

”What this shows is, for adolescents, the risk of suicide is something we need to be paying attention to. Because it’s not that it’s something that only happens in adults, this really dispels a lot of the misquoting of the data that’s out there.” That kind of information is valuable for determining resource allocation, he said. “A disparity like this really underlies the importance of mental health resources in this field,” he said.

Dr. Burnside, Dr. Hoffmann, and Dr. Rafferty had no disclosures, and no external funding sources were noted.

WASHINGTON – Transgender and other gender-diverse youth who visited the emergency department (ED) at a single institution had more than five times greater odds of a positive suicide screening compared with their cisgender peers, according to a study presented at the annual meeting of the American Academy of Pediatrics.

“The take-home message here is this study emphasizes the importance of universal screening to identify gender-diverse youth at risk,” Amanda Burnside, PhD, assistant professor of psychiatry and behavioral sciences at Ann and Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, told attendees. “We really need to develop robust strategies and systems to link better mental health services.”

Ann and Robert H. Lurie Children’s Hospital of Chicago

Suicide rates in transgender and gender-diverse youth are exceptionally high among youth in the U.S., Dr. Burnside said during her presentation. For example, the 2022 LGBTQ health survey from the Trevor Project found that much higher percentages of transgender and gender nonconforming youth had considered suicide in the past year compared with cisgender youth, even within the LGBTQ umbrella. Among nearly 34,000 LGBTQ youth aged 13-24, nearly half of trans females (48%) and more than half of trans males (59%) had considered suicide, compared with 28% of cisgender males and 37% of cisgender females. The rate among nonbinary/genderqueer individuals was 53%, and it was 48% for those questioning their gender.

Current methods of identifying trans and gender-diverse (TGD) youth in the hospital, however, may not actually be capturing the entire population.

“In health care settings, research involving TGD individuals has historically been limited to specialized clinic populations or youth with gender-specific diagnostic codes documented in the electronic medical record,” an approach that “likely significantly underestimates the prevalence of TGD youth in health care settings.” While at least one study has attempted to bridge this gap by searching the EMR for keywords, that study only tried to identify trans youth and not other youth on the gender diversity spectrum, such as nonbinary youth or those questioning their gender identity. Dr. Burnside and her colleagues therefore designed a study that used keywords to identify both trans youth and other gender-diverse youth who visited the ED so they could assess the rate of positive suicide screens in this population.
 

Underestimating the population at risk?

The researchers conducted a retrospective cross-sectional study of EMR data for all ED visits during which the patient underwent suicide screening. For the period of November 2019 to August 2022, they collected data on the screening results and the patient’s gender identity, age, race/ethnicity, insurance status, chief complaint in the ED and child opportunity index, which assess a youth’s access to resources based on geography. The suicide screener used was the Ask Suicide–Screening Questions (ASQ) tool.

The keywords they looked for in the EMR to identify trans and gender-diverse youth included transgender, pronouns, agender, gender dysphoria, male-to-female, female-to-male, nonbinary, preferred name, and they/them (captured as a complete term, not as “they” and “them” separately).

“If a keyword was present, the surrounding text was extracted and reviewed by two members of our team,” Dr. Burnside explained in her presentation. “We categorized keywords into either indicative of gender-diverse identity or not, and if it wasn’t clear based on the text extracted, we would conduct a manual chart review,” though that only occurred in about 3% of cases, she added.

Among 15,413 ED encounters with a suicide screen, the researchers identified 1,126 of these keywords in the EMR, among which 91.2% were classified as referring to a gender-diverse patient. Nearly all of the words were at least 90% effective in identify a gender-diverse youth, Dr. Burnside said, and all of the 197 instances of “they/them” were classified as gender diverse.

The accuracy was a little lower for the two keywords that appeared most frequently: For “pronouns,” 86.3% of 306 instances were classified as gender diverse, and for “transgender,” 83.1% of 207 instances were classified as gender diverse. Since some providers ask all patients their pronouns, the presence of “pronouns” in the EMR alone did not necessarily indicate the patient was gender diverse, Dr. Burnside said. A common reason the term “transgender” occurred in the EMR of non–gender diverse patients is that the department’s list of crisis resources includes transgender hotlines.

After identifying all the keywords, the researchers determined how many of these occurred in unique ED encounters and removed those with incomplete screening. Overall, they found 565 encounters by 399 gender-diverse individuals who had a suicide screening, representing 4.6% of total visits. This percentage is slightly lower than recent population-based estimates of gender-diverse youth, the researchers noted.

This population ranged from 8 to 23 years old, and 43% were publicly insured. The chief complaint for most of the patients (77.5%) was a mental health one. They were predominantly White (43%) or Hispanic (35%), with 10% Black youth, 4% Asian youth, and 8% youth who were “other” or two or more races. About half (52%) lived in a neighborhood with a “low” or “very low” child opportunity index.

Within this population, 81% of the patients screened positive on the suicide screening, compared with 23% positive screens across all ED visits. One in ten (10%) gender-diverse youth had active suicidal ideation, compared with 3.4% of the rest of the ED patient population. The researchers calculated that gender-diverse youth had 5.35 times greater odds of screening positive than cisgender youth in the ED (95% confidence interval [CI] 8.7-15.92). Further, a quarter (25%) of the trans and gender-diverse youth who screened positive for suicide risk had come to the ED for a primary complaint unrelated to mental health.

“We had a kid who came in because he broke his arm who had active suicidal ideation,” study coauthor Jennifer A. Hoffmann, MD, assistant professor of pediatrics at the Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, mentioned after the presentation. That particular patient even had a suicide plan, but was identified as actively suicidal only because of the screening. In other cases, she said, a youth may come in with self-inflicted injuries, and while those are the primary complaint, they are linked with suicidal ideation.

Ann & Robert H. Lurie Children's Hospital of Chicago

Uncovering valuable information

Jason Rafferty, MD, MPH, EdM, clinical assistant professor of pediatrics and of psychiatry and human behavior at Brown University, Providence, R.I., who attended the presentation, noted that the study provides information on a population that’s often difficult to get through traditional EMR research methods.

Brown University

“A lot of medical record systems don’t have uniform ways of capturing [gender diversity], but what we know as providers is that kids are really struggling and that it’s not a surprise that we’re seeing these disparities with suicidality,” Dr. Rafferty said.

The study also provides more discrete estimates by age than what most other current research measures, which tends to be lifetime suicidality as opposed to suicidal thoughts or attempts within the past year, Dr. Rafferty added.

”What this shows is, for adolescents, the risk of suicide is something we need to be paying attention to. Because it’s not that it’s something that only happens in adults, this really dispels a lot of the misquoting of the data that’s out there.” That kind of information is valuable for determining resource allocation, he said. “A disparity like this really underlies the importance of mental health resources in this field,” he said.

Dr. Burnside, Dr. Hoffmann, and Dr. Rafferty had no disclosures, and no external funding sources were noted.

WASHINGTON – Transgender and other gender-diverse youth who visited the emergency department (ED) at a single institution had more than five times greater odds of a positive suicide screening compared with their cisgender peers, according to a study presented at the annual meeting of the American Academy of Pediatrics.

“The take-home message here is this study emphasizes the importance of universal screening to identify gender-diverse youth at risk,” Amanda Burnside, PhD, assistant professor of psychiatry and behavioral sciences at Ann and Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, told attendees. “We really need to develop robust strategies and systems to link better mental health services.”

Ann and Robert H. Lurie Children’s Hospital of Chicago

Suicide rates in transgender and gender-diverse youth are exceptionally high among youth in the U.S., Dr. Burnside said during her presentation. For example, the 2022 LGBTQ health survey from the Trevor Project found that much higher percentages of transgender and gender nonconforming youth had considered suicide in the past year compared with cisgender youth, even within the LGBTQ umbrella. Among nearly 34,000 LGBTQ youth aged 13-24, nearly half of trans females (48%) and more than half of trans males (59%) had considered suicide, compared with 28% of cisgender males and 37% of cisgender females. The rate among nonbinary/genderqueer individuals was 53%, and it was 48% for those questioning their gender.

Current methods of identifying trans and gender-diverse (TGD) youth in the hospital, however, may not actually be capturing the entire population.

“In health care settings, research involving TGD individuals has historically been limited to specialized clinic populations or youth with gender-specific diagnostic codes documented in the electronic medical record,” an approach that “likely significantly underestimates the prevalence of TGD youth in health care settings.” While at least one study has attempted to bridge this gap by searching the EMR for keywords, that study only tried to identify trans youth and not other youth on the gender diversity spectrum, such as nonbinary youth or those questioning their gender identity. Dr. Burnside and her colleagues therefore designed a study that used keywords to identify both trans youth and other gender-diverse youth who visited the ED so they could assess the rate of positive suicide screens in this population.
 

Underestimating the population at risk?

The researchers conducted a retrospective cross-sectional study of EMR data for all ED visits during which the patient underwent suicide screening. For the period of November 2019 to August 2022, they collected data on the screening results and the patient’s gender identity, age, race/ethnicity, insurance status, chief complaint in the ED and child opportunity index, which assess a youth’s access to resources based on geography. The suicide screener used was the Ask Suicide–Screening Questions (ASQ) tool.

The keywords they looked for in the EMR to identify trans and gender-diverse youth included transgender, pronouns, agender, gender dysphoria, male-to-female, female-to-male, nonbinary, preferred name, and they/them (captured as a complete term, not as “they” and “them” separately).

“If a keyword was present, the surrounding text was extracted and reviewed by two members of our team,” Dr. Burnside explained in her presentation. “We categorized keywords into either indicative of gender-diverse identity or not, and if it wasn’t clear based on the text extracted, we would conduct a manual chart review,” though that only occurred in about 3% of cases, she added.

Among 15,413 ED encounters with a suicide screen, the researchers identified 1,126 of these keywords in the EMR, among which 91.2% were classified as referring to a gender-diverse patient. Nearly all of the words were at least 90% effective in identify a gender-diverse youth, Dr. Burnside said, and all of the 197 instances of “they/them” were classified as gender diverse.

The accuracy was a little lower for the two keywords that appeared most frequently: For “pronouns,” 86.3% of 306 instances were classified as gender diverse, and for “transgender,” 83.1% of 207 instances were classified as gender diverse. Since some providers ask all patients their pronouns, the presence of “pronouns” in the EMR alone did not necessarily indicate the patient was gender diverse, Dr. Burnside said. A common reason the term “transgender” occurred in the EMR of non–gender diverse patients is that the department’s list of crisis resources includes transgender hotlines.

After identifying all the keywords, the researchers determined how many of these occurred in unique ED encounters and removed those with incomplete screening. Overall, they found 565 encounters by 399 gender-diverse individuals who had a suicide screening, representing 4.6% of total visits. This percentage is slightly lower than recent population-based estimates of gender-diverse youth, the researchers noted.

This population ranged from 8 to 23 years old, and 43% were publicly insured. The chief complaint for most of the patients (77.5%) was a mental health one. They were predominantly White (43%) or Hispanic (35%), with 10% Black youth, 4% Asian youth, and 8% youth who were “other” or two or more races. About half (52%) lived in a neighborhood with a “low” or “very low” child opportunity index.

Within this population, 81% of the patients screened positive on the suicide screening, compared with 23% positive screens across all ED visits. One in ten (10%) gender-diverse youth had active suicidal ideation, compared with 3.4% of the rest of the ED patient population. The researchers calculated that gender-diverse youth had 5.35 times greater odds of screening positive than cisgender youth in the ED (95% confidence interval [CI] 8.7-15.92). Further, a quarter (25%) of the trans and gender-diverse youth who screened positive for suicide risk had come to the ED for a primary complaint unrelated to mental health.

“We had a kid who came in because he broke his arm who had active suicidal ideation,” study coauthor Jennifer A. Hoffmann, MD, assistant professor of pediatrics at the Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, mentioned after the presentation. That particular patient even had a suicide plan, but was identified as actively suicidal only because of the screening. In other cases, she said, a youth may come in with self-inflicted injuries, and while those are the primary complaint, they are linked with suicidal ideation.

Ann & Robert H. Lurie Children's Hospital of Chicago

Uncovering valuable information

Jason Rafferty, MD, MPH, EdM, clinical assistant professor of pediatrics and of psychiatry and human behavior at Brown University, Providence, R.I., who attended the presentation, noted that the study provides information on a population that’s often difficult to get through traditional EMR research methods.

Brown University

“A lot of medical record systems don’t have uniform ways of capturing [gender diversity], but what we know as providers is that kids are really struggling and that it’s not a surprise that we’re seeing these disparities with suicidality,” Dr. Rafferty said.

The study also provides more discrete estimates by age than what most other current research measures, which tends to be lifetime suicidality as opposed to suicidal thoughts or attempts within the past year, Dr. Rafferty added.

”What this shows is, for adolescents, the risk of suicide is something we need to be paying attention to. Because it’s not that it’s something that only happens in adults, this really dispels a lot of the misquoting of the data that’s out there.” That kind of information is valuable for determining resource allocation, he said. “A disparity like this really underlies the importance of mental health resources in this field,” he said.

Dr. Burnside, Dr. Hoffmann, and Dr. Rafferty had no disclosures, and no external funding sources were noted.

TOPLINE:

Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth still used flavored products, which have been shown to both entice teens and keep them vaping.

METHODOLOGY:

• The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
• The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
• The overall response rate was 30.5%.
• “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
• The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.

TAKEAWAY:

• The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
• From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
• Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
• Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.

IN PRACTICE:

“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.

SOURCE:

The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.

LIMITATIONS:

Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.

DISCLOSURES:

No potential conflicts of interest were disclosed.

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

TOPLINE:

Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth still used flavored products, which have been shown to both entice teens and keep them vaping.

METHODOLOGY:

• The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
• The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
• The overall response rate was 30.5%.
• “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
• The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.

TAKEAWAY:

• The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
• From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
• Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
• Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.

IN PRACTICE:

“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.

SOURCE:

The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.

LIMITATIONS:

Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.

DISCLOSURES:

No potential conflicts of interest were disclosed.

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

TOPLINE:

Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth still used flavored products, which have been shown to both entice teens and keep them vaping.

METHODOLOGY:

• The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
• The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
• The overall response rate was 30.5%.
• “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
• The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.

TAKEAWAY:

• The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
• From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
• Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
• Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.

IN PRACTICE:

“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.

SOURCE:

The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.

LIMITATIONS:

Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.

DISCLOSURES:

No potential conflicts of interest were disclosed.

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

Health care providers who give this year’s Moderna COVID-19 vaccine to children aged 6 months to 11 years should be sure they withdraw the correct volume of the vaccine from the vial to ensure a proper dose, the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.

That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”

The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.

“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.

Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.

“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.

A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
 

No safety risks identified

“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.

“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
 

One parent’s experience

Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.

A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
 

Perhaps more reactions, no danger

“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”

If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”

Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”

The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”

A version of this article appeared on Medscape.com.

Health care providers who give this year’s Moderna COVID-19 vaccine to children aged 6 months to 11 years should be sure they withdraw the correct volume of the vaccine from the vial to ensure a proper dose, the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.

That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”

The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.

“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.

Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.

“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.

A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
 

No safety risks identified

“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.

“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
 

One parent’s experience

Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.

A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
 

Perhaps more reactions, no danger

“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”

If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”

Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”

The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”

A version of this article appeared on Medscape.com.

Health care providers who give this year’s Moderna COVID-19 vaccine to children aged 6 months to 11 years should be sure they withdraw the correct volume of the vaccine from the vial to ensure a proper dose, the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.

That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”

The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.

“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.

Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.

“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.

A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
 

No safety risks identified

“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.

“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
 

One parent’s experience

Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.

A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
 

Perhaps more reactions, no danger

“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”

If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”

Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”

The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”

A version of this article appeared on Medscape.com.

PHOENIX – Open-label extension studies of two neonatal Fc receptor–blocking antibodies showed good safety and efficacy in patients with myasthenia gravis (MG). The two drugs, rozanolixizumab (Rystiggo, UCB) and efgartigimod PH20 (Vyvgart, Argenx SE), received Food and Drug Administration approval in June 2023 and December 2021, respectively, for the treatment of MG.

The neonatal Fc receptor binds to IgG within cells and recycles it back into the blood, leading to increased serum levels. The antibodies bind to the neonatal Fc receptor and promote its degradation, therefore preventing IgG recycling without interfering with its production. They do not affect the levels of other immunoglobulin isotypes.

At the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM), researchers presented data from an open-label extension study following the phase 3 MycarinG trial of rozanolixizumab and the ADAPT-SC+ study of efgartigimod.

In the MycarinG study, rozanolixizumab “showed both statistically significant and clinically meaningful improvements in multiple endpoints,” said Vera Bril, MD, during a presentation of the results.

Rozanolixizumab is approved for MG patients who are anti–acetylcholine receptor (AchR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positive. Efgartigimod is approved for MG patients who are AChR positive.

After completing MycarinG, patients were eligible to enroll in one of two open-label studies, one of each dose.

The new efficacy analysis focused on 110 patients who underwent two or more consecutive symptom-driven treatment cycles. A safety analysis focused on 188 patients who received at least one cycle of treatment.

“The post hoc analysis showed that the clinically meaningful improvements in the generalized myasthenia gravis symptoms were maintained over time for the cohort across rozanolixizumab cycles, while individual patients move through the consecutive treatment cycles, rozanolixizumab had an acceptable safety profile that was maintained across repeated treatments cycles. This is consistent with previous results of rozanolixizumab,” said Dr. Bril, who is a clinical investigator at University of Toronto
 

A reduction in steroid use?

During the Q&A session, George Small, MD, asked if the study had shown a reduction in steroid use among patients with MG.

As clinical associate director of neurology at Allegheny Medical Center, Pittsburgh, he has overseen the care of several hundred patients with generalized MG, as well as participated in clinical trials. “Many physicians use steroids for very quick responses in their patients. I love steroids and I hate steroids. I’ve helped save people’s lives with them, but I’ve also probably hastened their demise, unfortunately, because of the long-term side effects of the medications. Many neurologists in the community will over-utilize steroids because they don’t have access to these more expensive therapies. I look forward to both using these medications more as they become FDA approved and being an advocate for them, because it is my belief that they help decrease the use of steroids,” said Dr. Small in an interview.

Even if new medications do reduce steroid use, there remains a hurdle with insurance companies. “I’ve felt I’ve been forced to use treatments that I know may not be efficacious in the short term in order to get authorization for more expensive therapies that I use now. I’ve had patients admitted to the hospital as I’ve tried to jump through hoops that the insurance companies demanded,” said Dr. Small.
 

Clinical improvements seen

In the MycarinG study, patients received weekly injections of 7 mg/kg, 10 mg/kg rozanolixizumab, or placebo over a 6-week period. Both treatment groups had reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo.

MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were consistent across treatment cycles. The mean MG-ADL score dropped by about 4 points at week 6. At around week 10, the mean improvement declined to 2 points, and then by week 14 it increased to 3 points, where it remained consistent out to 50 weeks. A similar pattern was seen in QMG scores, with an approximate 5-point drop at 6 weeks, then about a 1.5-point improvement at 10 weeks, then a mean decrease of around 4 points that stayed stable out to 50 weeks.

Over all cycles of treatment, 89.9% of patients experienced a treatment-emergent adverse event, including 22.3% who had a serious TEAE; the study dropout rate because of TEAEs was 15.4%.

In the ADAPT-SC study, 110 patients were randomized to 10 mg/kg intravenous efgartigimod or 1,000 mg efgartigimod PH20, which is formulated with recombinant human hyaluronidase to allow for rapid administration of larger volumes. After completion of ADAPT-SC, 105 patients from both groups and an additional 79 patients entered the open-label extension study with 1,000 mg efgartigimod PH20.

The study included 141 patients who were AChR-Ab positive and 38 who were AChR-Ab negative. In the first cycle, 34.6% experienced an injection-site reaction, which steadily dropped to 11.5% by the sixth cycle. After each cycle of treatment, the mean change in MG-ADL from study baseline at week 4 was between 4.1 and 4.7 points. The mean change in Myasthenia Gravis Quality of Life 15-Item Questionnaire revisited from study baseline at week 4 was between 5.1 and 6.5 points. The mean change in EuroQoL 5-dimension, 5-level visual analog scale was between 12.3 and 16.0 points at week 4.

MyCarinG was funded by UCB Pharma. ADAPT-SC was funded by Argenx SE. Dr. Bril has financial relationships with Behring, Argenyx, Alexion, Immunovant, Alnylam, Akcea, Takeda, Sanofi, Ionis, Roche, Novo Nordisk, Octapharma, Momenta, Pfizer, CSL Behring, Grifols, Powell Mansfield, UCB, and Viela Bio. Dr. Small is on the speaker’s bureau for Alexion.

PHOENIX – Open-label extension studies of two neonatal Fc receptor–blocking antibodies showed good safety and efficacy in patients with myasthenia gravis (MG). The two drugs, rozanolixizumab (Rystiggo, UCB) and efgartigimod PH20 (Vyvgart, Argenx SE), received Food and Drug Administration approval in June 2023 and December 2021, respectively, for the treatment of MG.

The neonatal Fc receptor binds to IgG within cells and recycles it back into the blood, leading to increased serum levels. The antibodies bind to the neonatal Fc receptor and promote its degradation, therefore preventing IgG recycling without interfering with its production. They do not affect the levels of other immunoglobulin isotypes.

At the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM), researchers presented data from an open-label extension study following the phase 3 MycarinG trial of rozanolixizumab and the ADAPT-SC+ study of efgartigimod.

In the MycarinG study, rozanolixizumab “showed both statistically significant and clinically meaningful improvements in multiple endpoints,” said Vera Bril, MD, during a presentation of the results.

Rozanolixizumab is approved for MG patients who are anti–acetylcholine receptor (AchR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positive. Efgartigimod is approved for MG patients who are AChR positive.

After completing MycarinG, patients were eligible to enroll in one of two open-label studies, one of each dose.

The new efficacy analysis focused on 110 patients who underwent two or more consecutive symptom-driven treatment cycles. A safety analysis focused on 188 patients who received at least one cycle of treatment.

“The post hoc analysis showed that the clinically meaningful improvements in the generalized myasthenia gravis symptoms were maintained over time for the cohort across rozanolixizumab cycles, while individual patients move through the consecutive treatment cycles, rozanolixizumab had an acceptable safety profile that was maintained across repeated treatments cycles. This is consistent with previous results of rozanolixizumab,” said Dr. Bril, who is a clinical investigator at University of Toronto
 

A reduction in steroid use?

During the Q&A session, George Small, MD, asked if the study had shown a reduction in steroid use among patients with MG.

As clinical associate director of neurology at Allegheny Medical Center, Pittsburgh, he has overseen the care of several hundred patients with generalized MG, as well as participated in clinical trials. “Many physicians use steroids for very quick responses in their patients. I love steroids and I hate steroids. I’ve helped save people’s lives with them, but I’ve also probably hastened their demise, unfortunately, because of the long-term side effects of the medications. Many neurologists in the community will over-utilize steroids because they don’t have access to these more expensive therapies. I look forward to both using these medications more as they become FDA approved and being an advocate for them, because it is my belief that they help decrease the use of steroids,” said Dr. Small in an interview.

Even if new medications do reduce steroid use, there remains a hurdle with insurance companies. “I’ve felt I’ve been forced to use treatments that I know may not be efficacious in the short term in order to get authorization for more expensive therapies that I use now. I’ve had patients admitted to the hospital as I’ve tried to jump through hoops that the insurance companies demanded,” said Dr. Small.
 

Clinical improvements seen

In the MycarinG study, patients received weekly injections of 7 mg/kg, 10 mg/kg rozanolixizumab, or placebo over a 6-week period. Both treatment groups had reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo.

MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were consistent across treatment cycles. The mean MG-ADL score dropped by about 4 points at week 6. At around week 10, the mean improvement declined to 2 points, and then by week 14 it increased to 3 points, where it remained consistent out to 50 weeks. A similar pattern was seen in QMG scores, with an approximate 5-point drop at 6 weeks, then about a 1.5-point improvement at 10 weeks, then a mean decrease of around 4 points that stayed stable out to 50 weeks.

Over all cycles of treatment, 89.9% of patients experienced a treatment-emergent adverse event, including 22.3% who had a serious TEAE; the study dropout rate because of TEAEs was 15.4%.

In the ADAPT-SC study, 110 patients were randomized to 10 mg/kg intravenous efgartigimod or 1,000 mg efgartigimod PH20, which is formulated with recombinant human hyaluronidase to allow for rapid administration of larger volumes. After completion of ADAPT-SC, 105 patients from both groups and an additional 79 patients entered the open-label extension study with 1,000 mg efgartigimod PH20.

The study included 141 patients who were AChR-Ab positive and 38 who were AChR-Ab negative. In the first cycle, 34.6% experienced an injection-site reaction, which steadily dropped to 11.5% by the sixth cycle. After each cycle of treatment, the mean change in MG-ADL from study baseline at week 4 was between 4.1 and 4.7 points. The mean change in Myasthenia Gravis Quality of Life 15-Item Questionnaire revisited from study baseline at week 4 was between 5.1 and 6.5 points. The mean change in EuroQoL 5-dimension, 5-level visual analog scale was between 12.3 and 16.0 points at week 4.

MyCarinG was funded by UCB Pharma. ADAPT-SC was funded by Argenx SE. Dr. Bril has financial relationships with Behring, Argenyx, Alexion, Immunovant, Alnylam, Akcea, Takeda, Sanofi, Ionis, Roche, Novo Nordisk, Octapharma, Momenta, Pfizer, CSL Behring, Grifols, Powell Mansfield, UCB, and Viela Bio. Dr. Small is on the speaker’s bureau for Alexion.

PHOENIX – Open-label extension studies of two neonatal Fc receptor–blocking antibodies showed good safety and efficacy in patients with myasthenia gravis (MG). The two drugs, rozanolixizumab (Rystiggo, UCB) and efgartigimod PH20 (Vyvgart, Argenx SE), received Food and Drug Administration approval in June 2023 and December 2021, respectively, for the treatment of MG.

The neonatal Fc receptor binds to IgG within cells and recycles it back into the blood, leading to increased serum levels. The antibodies bind to the neonatal Fc receptor and promote its degradation, therefore preventing IgG recycling without interfering with its production. They do not affect the levels of other immunoglobulin isotypes.

At the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM), researchers presented data from an open-label extension study following the phase 3 MycarinG trial of rozanolixizumab and the ADAPT-SC+ study of efgartigimod.

In the MycarinG study, rozanolixizumab “showed both statistically significant and clinically meaningful improvements in multiple endpoints,” said Vera Bril, MD, during a presentation of the results.

Rozanolixizumab is approved for MG patients who are anti–acetylcholine receptor (AchR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positive. Efgartigimod is approved for MG patients who are AChR positive.

After completing MycarinG, patients were eligible to enroll in one of two open-label studies, one of each dose.

The new efficacy analysis focused on 110 patients who underwent two or more consecutive symptom-driven treatment cycles. A safety analysis focused on 188 patients who received at least one cycle of treatment.

“The post hoc analysis showed that the clinically meaningful improvements in the generalized myasthenia gravis symptoms were maintained over time for the cohort across rozanolixizumab cycles, while individual patients move through the consecutive treatment cycles, rozanolixizumab had an acceptable safety profile that was maintained across repeated treatments cycles. This is consistent with previous results of rozanolixizumab,” said Dr. Bril, who is a clinical investigator at University of Toronto
 

A reduction in steroid use?

During the Q&A session, George Small, MD, asked if the study had shown a reduction in steroid use among patients with MG.

As clinical associate director of neurology at Allegheny Medical Center, Pittsburgh, he has overseen the care of several hundred patients with generalized MG, as well as participated in clinical trials. “Many physicians use steroids for very quick responses in their patients. I love steroids and I hate steroids. I’ve helped save people’s lives with them, but I’ve also probably hastened their demise, unfortunately, because of the long-term side effects of the medications. Many neurologists in the community will over-utilize steroids because they don’t have access to these more expensive therapies. I look forward to both using these medications more as they become FDA approved and being an advocate for them, because it is my belief that they help decrease the use of steroids,” said Dr. Small in an interview.

Even if new medications do reduce steroid use, there remains a hurdle with insurance companies. “I’ve felt I’ve been forced to use treatments that I know may not be efficacious in the short term in order to get authorization for more expensive therapies that I use now. I’ve had patients admitted to the hospital as I’ve tried to jump through hoops that the insurance companies demanded,” said Dr. Small.
 

Clinical improvements seen

In the MycarinG study, patients received weekly injections of 7 mg/kg, 10 mg/kg rozanolixizumab, or placebo over a 6-week period. Both treatment groups had reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo.

MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were consistent across treatment cycles. The mean MG-ADL score dropped by about 4 points at week 6. At around week 10, the mean improvement declined to 2 points, and then by week 14 it increased to 3 points, where it remained consistent out to 50 weeks. A similar pattern was seen in QMG scores, with an approximate 5-point drop at 6 weeks, then about a 1.5-point improvement at 10 weeks, then a mean decrease of around 4 points that stayed stable out to 50 weeks.

Over all cycles of treatment, 89.9% of patients experienced a treatment-emergent adverse event, including 22.3% who had a serious TEAE; the study dropout rate because of TEAEs was 15.4%.

In the ADAPT-SC study, 110 patients were randomized to 10 mg/kg intravenous efgartigimod or 1,000 mg efgartigimod PH20, which is formulated with recombinant human hyaluronidase to allow for rapid administration of larger volumes. After completion of ADAPT-SC, 105 patients from both groups and an additional 79 patients entered the open-label extension study with 1,000 mg efgartigimod PH20.

The study included 141 patients who were AChR-Ab positive and 38 who were AChR-Ab negative. In the first cycle, 34.6% experienced an injection-site reaction, which steadily dropped to 11.5% by the sixth cycle. After each cycle of treatment, the mean change in MG-ADL from study baseline at week 4 was between 4.1 and 4.7 points. The mean change in Myasthenia Gravis Quality of Life 15-Item Questionnaire revisited from study baseline at week 4 was between 5.1 and 6.5 points. The mean change in EuroQoL 5-dimension, 5-level visual analog scale was between 12.3 and 16.0 points at week 4.

MyCarinG was funded by UCB Pharma. ADAPT-SC was funded by Argenx SE. Dr. Bril has financial relationships with Behring, Argenyx, Alexion, Immunovant, Alnylam, Akcea, Takeda, Sanofi, Ionis, Roche, Novo Nordisk, Octapharma, Momenta, Pfizer, CSL Behring, Grifols, Powell Mansfield, UCB, and Viela Bio. Dr. Small is on the speaker’s bureau for Alexion.

Additional data from the phase 3 EASE study conducted in patients with epidermolysis bullosa (EB) show that regular application of the topical gel Oleogel-S10 (Filsuvez) is associated with a reduced need for daily dressing changes when compared with a control gel.

In a final, post hoc analysis to come from the trial, 15 of 45 (33%) patients treated with Oleogel-S10 versus 5 of 48 (10.4%) treated with the control gel were reported as no longer needing daily dressing changes at 45 days of follow-up.

Moreover, the effect was sustained, with similar percentages of patients no longer requiring daily dressing changes at 60 days (34% vs. 13%, respectively) and 90 days (36% vs. 11%) of follow-up.

The mean reduction in daily dressing changes was 1.36 for Oleogel-S10 and 0.41 for the control gel (P = .005).

“Patients who, in the beginning, had daily dressing changes had almost three fewer dressing changes every 2 weeks if they were treated with Oleogel-S10,” Dimitra Kiritsi, MD, PhD, of the department of dermatology at the University of Freiburg (Germany), reported at the annual congress of the European Academy of Dermatology and Venereology. By comparison, patients in the control group had just one fewer daily dressing change in 2 weeks.

“You might say okay, but what does this mean in terms of time?” added Dr. Kiritsi. Using historical data on the time required for whole body care (Orphanet J Rare Dis. 2020 Jan 3. doi: 10.1186/s13023-019-1279-y), it was estimated that treatment with Oleogel-S10 was associated with an overall time-saving per week of 11 hours (6.6 hours for the patient and 4.4 hours for the caregiver) and use of the control gel was associated with an overall time-saving of 4 hours (2.4 hours for the patient and 1.6 hours for the caregiver).

“This is, for our patients, important,” said Dr. Kiritsi, as “it is time that they can spend doing something nice with the family” instead, avoiding the pain and distress associated with frequent dressing changes.

Approved in Europe, not in the United States

Oleogel-S10, classified as an herbal product, contains triterpenes derived from birch bark extract, which have been formulated with sunflower oil to form a gel.

Despite being approved for use in Europe, Oleogel-S10 has not yet been approved to treat EB in the United States. The FDA did not approve Amryt Pharma’s new drug application in February 2022. The application had included data from the EASE trial.

EASE included 223 patients with dystrophic or junctional EB, including 156 children, at 58 sites in 28 countries. As such, this makes it the largest treatment study in this rare genetic disease to date.

The trial had consisted of an initial 90-day, double-blind treatment period, during which time 109 patients had used Oleogel-S10 and 114 had used a control gel. This was followed by a 24-month open-label phase, during which time all remaining patients (n = 205) had used Oleogel-S10 on top of their standard of care.

Dr. Kiritsi summarized the main results of the EASE trial as follows.

• Complete healing of target wounds (primary endpoint) in 41.3% of patients treated with Oleogel-S10 and 28.9% of patients treated with the control gel (P = .013).
• Improved total body wound burden measured by both Epidermolysis Bullosa Disease Activity and Scarring Index and Body Surface Area Percentage scores.
• Reduced frequency of dressing changes (1 less per 2 weeks for Oleogel-S10 versus 0 less per 2 weeks for control gel).
• Improved pain among participants aged 4 years and older while their dressings were being changed.
• Reduced rates of wound infection (0.9% Oleogel-S10 vs. 4.4% control gel).
• Similar rates of treatment-emergent adverse events (24.8% vs. 22.8%, respectively), which were mostly deemed to be mild or moderate.

The EASE study – an important trial for EB

EASE is an important trial for EB, the study’s principal investigator Dédée Murrell, MD, DSc, University of New South Wales, Sydney, has pointed out previously.

“This was the first EB study to meet its primary endpoint and demonstrated a statistically significant acceleration of target wound healing by day 45,” Dr. Murrell said in a press release issued by Amryt Pharma to coincide with the online publication of the trial results.

“In addition, the favorable trends we see with key secondary endpoints such as reduced wound burden, pain, and frequency of dressing changes are considered as being very meaningful for patients,” Dr. Murrell said.

The EASE study was funded by Amryt Research Limited. Dr. Kiritsi reported receiving honoraria or consultation fees from Amryt, RHEACELL GmbH, and Fibrx Derm. She also acknowledged grant or research support from DEBRA International, EB Research Partnership, Fritz-Thyssen Foundation, German Research Foundation, and RHEACELL. Dr. Murrell has ties to Amryt and Amicus and is a co-owner of the patent for topical sirolimus for EB simplex.

A version of this article appeared on Medscape.com.

Additional data from the phase 3 EASE study conducted in patients with epidermolysis bullosa (EB) show that regular application of the topical gel Oleogel-S10 (Filsuvez) is associated with a reduced need for daily dressing changes when compared with a control gel.

In a final, post hoc analysis to come from the trial, 15 of 45 (33%) patients treated with Oleogel-S10 versus 5 of 48 (10.4%) treated with the control gel were reported as no longer needing daily dressing changes at 45 days of follow-up.

Moreover, the effect was sustained, with similar percentages of patients no longer requiring daily dressing changes at 60 days (34% vs. 13%, respectively) and 90 days (36% vs. 11%) of follow-up.

The mean reduction in daily dressing changes was 1.36 for Oleogel-S10 and 0.41 for the control gel (P = .005).

“Patients who, in the beginning, had daily dressing changes had almost three fewer dressing changes every 2 weeks if they were treated with Oleogel-S10,” Dimitra Kiritsi, MD, PhD, of the department of dermatology at the University of Freiburg (Germany), reported at the annual congress of the European Academy of Dermatology and Venereology. By comparison, patients in the control group had just one fewer daily dressing change in 2 weeks.

“You might say okay, but what does this mean in terms of time?” added Dr. Kiritsi. Using historical data on the time required for whole body care (Orphanet J Rare Dis. 2020 Jan 3. doi: 10.1186/s13023-019-1279-y), it was estimated that treatment with Oleogel-S10 was associated with an overall time-saving per week of 11 hours (6.6 hours for the patient and 4.4 hours for the caregiver) and use of the control gel was associated with an overall time-saving of 4 hours (2.4 hours for the patient and 1.6 hours for the caregiver).

“This is, for our patients, important,” said Dr. Kiritsi, as “it is time that they can spend doing something nice with the family” instead, avoiding the pain and distress associated with frequent dressing changes.

Approved in Europe, not in the United States

Oleogel-S10, classified as an herbal product, contains triterpenes derived from birch bark extract, which have been formulated with sunflower oil to form a gel.

Despite being approved for use in Europe, Oleogel-S10 has not yet been approved to treat EB in the United States. The FDA did not approve Amryt Pharma’s new drug application in February 2022. The application had included data from the EASE trial.

EASE included 223 patients with dystrophic or junctional EB, including 156 children, at 58 sites in 28 countries. As such, this makes it the largest treatment study in this rare genetic disease to date.

The trial had consisted of an initial 90-day, double-blind treatment period, during which time 109 patients had used Oleogel-S10 and 114 had used a control gel. This was followed by a 24-month open-label phase, during which time all remaining patients (n = 205) had used Oleogel-S10 on top of their standard of care.

Dr. Kiritsi summarized the main results of the EASE trial as follows.

• Complete healing of target wounds (primary endpoint) in 41.3% of patients treated with Oleogel-S10 and 28.9% of patients treated with the control gel (P = .013).
• Improved total body wound burden measured by both Epidermolysis Bullosa Disease Activity and Scarring Index and Body Surface Area Percentage scores.
• Reduced frequency of dressing changes (1 less per 2 weeks for Oleogel-S10 versus 0 less per 2 weeks for control gel).
• Improved pain among participants aged 4 years and older while their dressings were being changed.
• Reduced rates of wound infection (0.9% Oleogel-S10 vs. 4.4% control gel).
• Similar rates of treatment-emergent adverse events (24.8% vs. 22.8%, respectively), which were mostly deemed to be mild or moderate.

The EASE study – an important trial for EB

EASE is an important trial for EB, the study’s principal investigator Dédée Murrell, MD, DSc, University of New South Wales, Sydney, has pointed out previously.

“This was the first EB study to meet its primary endpoint and demonstrated a statistically significant acceleration of target wound healing by day 45,” Dr. Murrell said in a press release issued by Amryt Pharma to coincide with the online publication of the trial results.

“In addition, the favorable trends we see with key secondary endpoints such as reduced wound burden, pain, and frequency of dressing changes are considered as being very meaningful for patients,” Dr. Murrell said.

The EASE study was funded by Amryt Research Limited. Dr. Kiritsi reported receiving honoraria or consultation fees from Amryt, RHEACELL GmbH, and Fibrx Derm. She also acknowledged grant or research support from DEBRA International, EB Research Partnership, Fritz-Thyssen Foundation, German Research Foundation, and RHEACELL. Dr. Murrell has ties to Amryt and Amicus and is a co-owner of the patent for topical sirolimus for EB simplex.

A version of this article appeared on Medscape.com.

Additional data from the phase 3 EASE study conducted in patients with epidermolysis bullosa (EB) show that regular application of the topical gel Oleogel-S10 (Filsuvez) is associated with a reduced need for daily dressing changes when compared with a control gel.

In a final, post hoc analysis to come from the trial, 15 of 45 (33%) patients treated with Oleogel-S10 versus 5 of 48 (10.4%) treated with the control gel were reported as no longer needing daily dressing changes at 45 days of follow-up.

Moreover, the effect was sustained, with similar percentages of patients no longer requiring daily dressing changes at 60 days (34% vs. 13%, respectively) and 90 days (36% vs. 11%) of follow-up.

The mean reduction in daily dressing changes was 1.36 for Oleogel-S10 and 0.41 for the control gel (P = .005).

“Patients who, in the beginning, had daily dressing changes had almost three fewer dressing changes every 2 weeks if they were treated with Oleogel-S10,” Dimitra Kiritsi, MD, PhD, of the department of dermatology at the University of Freiburg (Germany), reported at the annual congress of the European Academy of Dermatology and Venereology. By comparison, patients in the control group had just one fewer daily dressing change in 2 weeks.

“You might say okay, but what does this mean in terms of time?” added Dr. Kiritsi. Using historical data on the time required for whole body care (Orphanet J Rare Dis. 2020 Jan 3. doi: 10.1186/s13023-019-1279-y), it was estimated that treatment with Oleogel-S10 was associated with an overall time-saving per week of 11 hours (6.6 hours for the patient and 4.4 hours for the caregiver) and use of the control gel was associated with an overall time-saving of 4 hours (2.4 hours for the patient and 1.6 hours for the caregiver).

“This is, for our patients, important,” said Dr. Kiritsi, as “it is time that they can spend doing something nice with the family” instead, avoiding the pain and distress associated with frequent dressing changes.

Approved in Europe, not in the United States

Oleogel-S10, classified as an herbal product, contains triterpenes derived from birch bark extract, which have been formulated with sunflower oil to form a gel.

Despite being approved for use in Europe, Oleogel-S10 has not yet been approved to treat EB in the United States. The FDA did not approve Amryt Pharma’s new drug application in February 2022. The application had included data from the EASE trial.

EASE included 223 patients with dystrophic or junctional EB, including 156 children, at 58 sites in 28 countries. As such, this makes it the largest treatment study in this rare genetic disease to date.

The trial had consisted of an initial 90-day, double-blind treatment period, during which time 109 patients had used Oleogel-S10 and 114 had used a control gel. This was followed by a 24-month open-label phase, during which time all remaining patients (n = 205) had used Oleogel-S10 on top of their standard of care.

Dr. Kiritsi summarized the main results of the EASE trial as follows.

• Complete healing of target wounds (primary endpoint) in 41.3% of patients treated with Oleogel-S10 and 28.9% of patients treated with the control gel (P = .013).
• Improved total body wound burden measured by both Epidermolysis Bullosa Disease Activity and Scarring Index and Body Surface Area Percentage scores.
• Reduced frequency of dressing changes (1 less per 2 weeks for Oleogel-S10 versus 0 less per 2 weeks for control gel).
• Improved pain among participants aged 4 years and older while their dressings were being changed.
• Reduced rates of wound infection (0.9% Oleogel-S10 vs. 4.4% control gel).
• Similar rates of treatment-emergent adverse events (24.8% vs. 22.8%, respectively), which were mostly deemed to be mild or moderate.

The EASE study – an important trial for EB

EASE is an important trial for EB, the study’s principal investigator Dédée Murrell, MD, DSc, University of New South Wales, Sydney, has pointed out previously.

“This was the first EB study to meet its primary endpoint and demonstrated a statistically significant acceleration of target wound healing by day 45,” Dr. Murrell said in a press release issued by Amryt Pharma to coincide with the online publication of the trial results.

“In addition, the favorable trends we see with key secondary endpoints such as reduced wound burden, pain, and frequency of dressing changes are considered as being very meaningful for patients,” Dr. Murrell said.

The EASE study was funded by Amryt Research Limited. Dr. Kiritsi reported receiving honoraria or consultation fees from Amryt, RHEACELL GmbH, and Fibrx Derm. She also acknowledged grant or research support from DEBRA International, EB Research Partnership, Fritz-Thyssen Foundation, German Research Foundation, and RHEACELL. Dr. Murrell has ties to Amryt and Amicus and is a co-owner of the patent for topical sirolimus for EB simplex.

A version of this article appeared on Medscape.com.

The U.S. Food and Drug Administration has approved ustekinumab-auub (Wezlana) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the first approval for a ustekinumab biosimilar in the United States.

Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider.

“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”

Ustekinumab, manufactured by Johnson & Johnson, targets interleukin-12 and IL-23 and was first approved in 2009. Ustekinumab-auub was developed by Amgen.

Ustekinumab-auub is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. It is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.

The approval was based on “comprehensive review of scientific evidence,” including “comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data,” the FDA said.

Some common side effects of ustekinumab-auub include nasopharyngitis, upper respiratory tract infection, headache, fatigue, and nausea. The most severe side effect of the biosimilar, as with the reference drug ustekinumab, is infection.

The product launch of ustekinumab-auub will be delayed as a part of a settlement of Johnson & Johnson’s lawsuit against Amgen, according to Reuters. The details of the settlement are confidential, but it was stated that the biosimilar would be available by Jan. 1, 2025.

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

The U.S. Food and Drug Administration has approved ustekinumab-auub (Wezlana) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the first approval for a ustekinumab biosimilar in the United States.

Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider.

“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”

Ustekinumab, manufactured by Johnson & Johnson, targets interleukin-12 and IL-23 and was first approved in 2009. Ustekinumab-auub was developed by Amgen.

Ustekinumab-auub is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. It is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.

The approval was based on “comprehensive review of scientific evidence,” including “comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data,” the FDA said.

Some common side effects of ustekinumab-auub include nasopharyngitis, upper respiratory tract infection, headache, fatigue, and nausea. The most severe side effect of the biosimilar, as with the reference drug ustekinumab, is infection.

The product launch of ustekinumab-auub will be delayed as a part of a settlement of Johnson & Johnson’s lawsuit against Amgen, according to Reuters. The details of the settlement are confidential, but it was stated that the biosimilar would be available by Jan. 1, 2025.

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

The U.S. Food and Drug Administration has approved ustekinumab-auub (Wezlana) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the first approval for a ustekinumab biosimilar in the United States.

Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider.

“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”

Ustekinumab, manufactured by Johnson & Johnson, targets interleukin-12 and IL-23 and was first approved in 2009. Ustekinumab-auub was developed by Amgen.

Ustekinumab-auub is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. It is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.

The approval was based on “comprehensive review of scientific evidence,” including “comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data,” the FDA said.

Some common side effects of ustekinumab-auub include nasopharyngitis, upper respiratory tract infection, headache, fatigue, and nausea. The most severe side effect of the biosimilar, as with the reference drug ustekinumab, is infection.

The product launch of ustekinumab-auub will be delayed as a part of a settlement of Johnson & Johnson’s lawsuit against Amgen, according to Reuters. The details of the settlement are confidential, but it was stated that the biosimilar would be available by Jan. 1, 2025.

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

The Food and Drug Administration has approved an expanded indication for abatacept (Orencia) for treatment of psoriatic arthritis (PsA) in pediatric patients aged 2 years and older.

Juvenile psoriatic arthritis (JPsA) is a form of juvenile idiopathic arthritis (JIA). It is a rare condition, and it is estimated that as many as 5% of children with JIA have JPsA.

Olivier Le Moal/Getty Images

“The FDA’s approval of expanding Orencia’s indication adds a much-needed treatment option for children with JPsA, a rare, potentially serious condition characterized by chronic inflammation and joint damage,” said Carlos Dortrait, senior vice president of U.S. immunology at Bristol-Myers Squibb in a statement. BMS is the manufacturer of abatacept.

Abatacept was first approved in 2005 for the treatment of moderate to severe rheumatoid arthritis and was approved for treating active PsA in adults in 2017. In 2008, the drug was the first intravenous biologic approved for patients 6 years old and older to treat moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). In 2017, a subcutaneous administration option was approved for children 2 years old and older with pJIA, according to a BMS press release.

This expanded approval was based on controlled studies of abatacept in adults with PsA; pharmacokinetic data from adults with RA, adults with PsA, and children with pJIA; and safety data from clinical studies in patients aged 2-17 years with pJIA.

“Children living with psoriatic arthritis can experience a number of challenging symptoms including swollen and painful joints,” Steven Taylor, president and CEO of the Arthritis Foundation, said in a BMS statement. “The FDA’s approval of Orencia for JPsA in patients 2 years of age and older means another treatment option is available to manage this rare chronic disease, which is exciting news for the arthritis community of young patients, their caregivers, and health care professionals.”

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

The Food and Drug Administration has approved an expanded indication for abatacept (Orencia) for treatment of psoriatic arthritis (PsA) in pediatric patients aged 2 years and older.

Juvenile psoriatic arthritis (JPsA) is a form of juvenile idiopathic arthritis (JIA). It is a rare condition, and it is estimated that as many as 5% of children with JIA have JPsA.

Olivier Le Moal/Getty Images

“The FDA’s approval of expanding Orencia’s indication adds a much-needed treatment option for children with JPsA, a rare, potentially serious condition characterized by chronic inflammation and joint damage,” said Carlos Dortrait, senior vice president of U.S. immunology at Bristol-Myers Squibb in a statement. BMS is the manufacturer of abatacept.

Abatacept was first approved in 2005 for the treatment of moderate to severe rheumatoid arthritis and was approved for treating active PsA in adults in 2017. In 2008, the drug was the first intravenous biologic approved for patients 6 years old and older to treat moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). In 2017, a subcutaneous administration option was approved for children 2 years old and older with pJIA, according to a BMS press release.

This expanded approval was based on controlled studies of abatacept in adults with PsA; pharmacokinetic data from adults with RA, adults with PsA, and children with pJIA; and safety data from clinical studies in patients aged 2-17 years with pJIA.

“Children living with psoriatic arthritis can experience a number of challenging symptoms including swollen and painful joints,” Steven Taylor, president and CEO of the Arthritis Foundation, said in a BMS statement. “The FDA’s approval of Orencia for JPsA in patients 2 years of age and older means another treatment option is available to manage this rare chronic disease, which is exciting news for the arthritis community of young patients, their caregivers, and health care professionals.”

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

The Food and Drug Administration has approved an expanded indication for abatacept (Orencia) for treatment of psoriatic arthritis (PsA) in pediatric patients aged 2 years and older.

Juvenile psoriatic arthritis (JPsA) is a form of juvenile idiopathic arthritis (JIA). It is a rare condition, and it is estimated that as many as 5% of children with JIA have JPsA.

Olivier Le Moal/Getty Images

“The FDA’s approval of expanding Orencia’s indication adds a much-needed treatment option for children with JPsA, a rare, potentially serious condition characterized by chronic inflammation and joint damage,” said Carlos Dortrait, senior vice president of U.S. immunology at Bristol-Myers Squibb in a statement. BMS is the manufacturer of abatacept.

Abatacept was first approved in 2005 for the treatment of moderate to severe rheumatoid arthritis and was approved for treating active PsA in adults in 2017. In 2008, the drug was the first intravenous biologic approved for patients 6 years old and older to treat moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). In 2017, a subcutaneous administration option was approved for children 2 years old and older with pJIA, according to a BMS press release.

This expanded approval was based on controlled studies of abatacept in adults with PsA; pharmacokinetic data from adults with RA, adults with PsA, and children with pJIA; and safety data from clinical studies in patients aged 2-17 years with pJIA.

“Children living with psoriatic arthritis can experience a number of challenging symptoms including swollen and painful joints,” Steven Taylor, president and CEO of the Arthritis Foundation, said in a BMS statement. “The FDA’s approval of Orencia for JPsA in patients 2 years of age and older means another treatment option is available to manage this rare chronic disease, which is exciting news for the arthritis community of young patients, their caregivers, and health care professionals.”

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