Pediatrics

The American Academy of Pediatrics has updated its recommendations on risk assessment, terminology, and other care components for children who are deaf or hard of hearing. The update is the first since 2009.

The AAP’s clinical report was published online in Pediatrics.

Charles Bower, MD, with the department of otolaryngology at Arkansas Children’s Hospital in Little Rock, led the research team representing AAP’s Committee on Practice and Ambulatory Medicine, section on otolaryngology and head and neck surgery.

The report details how primary care clinicians can detect changes in hearing status by age.
 

Eliminating terms such as ‘failed’ or ‘impairment’

A key change in this report is that it no longer uses terms such as “loss,” “failed,” or “impairment,” “to reflect that children who are deaf or hard of hearing (D/HH) are equal, healthy, and whole,” the authors wrote.

The report’s recommendations are based on the literature and engagement with deaf and hard of hearing professionals and partner organizations, such as the National Association of the Deaf, working with the AAP Early Hearing Detection and Intervention program.
 

Birth to 5 a critical time

The authors noted that early medical support for hearing is especially important between birth and 5 years of age. That span is a critical time for brain and language development.

Parents and caregivers are often the first to notice a child’s inattention or erratic responses to sound, they wrote, and it’s important to address these concerns with a pediatrician even if the child has passed a newborn hearing test after birth.

Among recommendations in the update:

• All children should have an objective, evidence-based risk assessment for changes in hearing.
• Children at all ages should have prompt screening if there is clinical or caregiver concern about hearing.
• A child who screens positive for atypical hearing in one or both ears should be referred to an audiologist for diagnostic consultation and testing.
• Because standard testing for children with developmental or behavioral health conditions may be impossible or inaccurate, referral may be more appropriate to audiology for electrophysiological hearing testing using auditory brainstem response (ABR) with sedation.
• To prevent false negatives and to avoid delays in identification, access to language, and support, screening tests should not be repeated more than once before referral to audiology.

Additional recommendations

The report authors pointed out that genetic causes may affect hearing and may show up beyond the newborn period.

They wrote that congenital cytomegalovirus (cCMV) infection is the most common infectious cause of childhood sensorineural hearing change and accounts for 25% of deaf and hard of hearing children at age 4.

Meningitis and otitis media also are leading causes of a change in hearing.

Judith E.C. Lieu, MD, MSPH, professor, program director and vice-chair for education in the department of otolaryngology and head and neck surgery at Washington University in St. Louis, who was not part of the research team, said screening recommendations have not changed much in the update, but she highlighted some points.

She noted that tympanometry is not listed as a method of hearing screening in primary care.

“I agree that tympanogram is not a hearing screening. It is an adjunct to look at middle ear function, but that doesn’t necessarily mean it looks for hearing,” she said.

Dr. Lieu says she does take issue with the stated length of one of the tests in the paper. She said she is concerned that the pure-tone audiometry test for ages 4 through adolescence is listed as taking 30 minutes in a primary care setting. She said she worries that pediatricians will be put off by reading that it is a 30-minute test.

“Honestly, in my experience, it doesn’t take 30 minutes. Maybe 10 minutes,” she said. “I don’t know any pediatrician who could devote 30 minutes to one screening test.”
 

Development milestones have been adjusted

Also different in these recommendations are the developmental and speech milestones updated according to the most recent AAP information, Dr. Lieu said. Though the new milestones don’t change by much, they are important to note, she said, such as updated guidance on when to be concerned about speech delay.

She said she wished the guidance included more about hearing loss in older children.

The report authors stated that about 1 to 3 per 1,000 children have atypical hearing at birth and similar numbers become deaf or hard of hearing later in childhood.

But Dr. Lieu says that statistic may give the wrong impression about frequency of atypical hearing.

“Hearing loss increases during childhood,” she pointed out. “By the time they hit about age 18, about 15% of kids have some kind of hearing loss.”

“I don’t think it’s made clear to pediatricians that this is not 1 or 2 in a thousand children – this happens much more frequently,” she said.

The report authors and Dr. Lieu report no relevant financial relationships.

The American Academy of Pediatrics has updated its recommendations on risk assessment, terminology, and other care components for children who are deaf or hard of hearing. The update is the first since 2009.

The AAP’s clinical report was published online in Pediatrics.

Charles Bower, MD, with the department of otolaryngology at Arkansas Children’s Hospital in Little Rock, led the research team representing AAP’s Committee on Practice and Ambulatory Medicine, section on otolaryngology and head and neck surgery.

The report details how primary care clinicians can detect changes in hearing status by age.
 

Eliminating terms such as ‘failed’ or ‘impairment’

A key change in this report is that it no longer uses terms such as “loss,” “failed,” or “impairment,” “to reflect that children who are deaf or hard of hearing (D/HH) are equal, healthy, and whole,” the authors wrote.

The report’s recommendations are based on the literature and engagement with deaf and hard of hearing professionals and partner organizations, such as the National Association of the Deaf, working with the AAP Early Hearing Detection and Intervention program.
 

Birth to 5 a critical time

The authors noted that early medical support for hearing is especially important between birth and 5 years of age. That span is a critical time for brain and language development.

Parents and caregivers are often the first to notice a child’s inattention or erratic responses to sound, they wrote, and it’s important to address these concerns with a pediatrician even if the child has passed a newborn hearing test after birth.

Among recommendations in the update:

• All children should have an objective, evidence-based risk assessment for changes in hearing.
• Children at all ages should have prompt screening if there is clinical or caregiver concern about hearing.
• A child who screens positive for atypical hearing in one or both ears should be referred to an audiologist for diagnostic consultation and testing.
• Because standard testing for children with developmental or behavioral health conditions may be impossible or inaccurate, referral may be more appropriate to audiology for electrophysiological hearing testing using auditory brainstem response (ABR) with sedation.
• To prevent false negatives and to avoid delays in identification, access to language, and support, screening tests should not be repeated more than once before referral to audiology.

Additional recommendations

The report authors pointed out that genetic causes may affect hearing and may show up beyond the newborn period.

They wrote that congenital cytomegalovirus (cCMV) infection is the most common infectious cause of childhood sensorineural hearing change and accounts for 25% of deaf and hard of hearing children at age 4.

Meningitis and otitis media also are leading causes of a change in hearing.

Judith E.C. Lieu, MD, MSPH, professor, program director and vice-chair for education in the department of otolaryngology and head and neck surgery at Washington University in St. Louis, who was not part of the research team, said screening recommendations have not changed much in the update, but she highlighted some points.

She noted that tympanometry is not listed as a method of hearing screening in primary care.

“I agree that tympanogram is not a hearing screening. It is an adjunct to look at middle ear function, but that doesn’t necessarily mean it looks for hearing,” she said.

Dr. Lieu says she does take issue with the stated length of one of the tests in the paper. She said she is concerned that the pure-tone audiometry test for ages 4 through adolescence is listed as taking 30 minutes in a primary care setting. She said she worries that pediatricians will be put off by reading that it is a 30-minute test.

“Honestly, in my experience, it doesn’t take 30 minutes. Maybe 10 minutes,” she said. “I don’t know any pediatrician who could devote 30 minutes to one screening test.”
 

Development milestones have been adjusted

Also different in these recommendations are the developmental and speech milestones updated according to the most recent AAP information, Dr. Lieu said. Though the new milestones don’t change by much, they are important to note, she said, such as updated guidance on when to be concerned about speech delay.

She said she wished the guidance included more about hearing loss in older children.

The report authors stated that about 1 to 3 per 1,000 children have atypical hearing at birth and similar numbers become deaf or hard of hearing later in childhood.

But Dr. Lieu says that statistic may give the wrong impression about frequency of atypical hearing.

“Hearing loss increases during childhood,” she pointed out. “By the time they hit about age 18, about 15% of kids have some kind of hearing loss.”

“I don’t think it’s made clear to pediatricians that this is not 1 or 2 in a thousand children – this happens much more frequently,” she said.

The report authors and Dr. Lieu report no relevant financial relationships.

The American Academy of Pediatrics has updated its recommendations on risk assessment, terminology, and other care components for children who are deaf or hard of hearing. The update is the first since 2009.

The AAP’s clinical report was published online in Pediatrics.

Charles Bower, MD, with the department of otolaryngology at Arkansas Children’s Hospital in Little Rock, led the research team representing AAP’s Committee on Practice and Ambulatory Medicine, section on otolaryngology and head and neck surgery.

The report details how primary care clinicians can detect changes in hearing status by age.
 

Eliminating terms such as ‘failed’ or ‘impairment’

A key change in this report is that it no longer uses terms such as “loss,” “failed,” or “impairment,” “to reflect that children who are deaf or hard of hearing (D/HH) are equal, healthy, and whole,” the authors wrote.

The report’s recommendations are based on the literature and engagement with deaf and hard of hearing professionals and partner organizations, such as the National Association of the Deaf, working with the AAP Early Hearing Detection and Intervention program.
 

Birth to 5 a critical time

The authors noted that early medical support for hearing is especially important between birth and 5 years of age. That span is a critical time for brain and language development.

Parents and caregivers are often the first to notice a child’s inattention or erratic responses to sound, they wrote, and it’s important to address these concerns with a pediatrician even if the child has passed a newborn hearing test after birth.

Among recommendations in the update:

• All children should have an objective, evidence-based risk assessment for changes in hearing.
• Children at all ages should have prompt screening if there is clinical or caregiver concern about hearing.
• A child who screens positive for atypical hearing in one or both ears should be referred to an audiologist for diagnostic consultation and testing.
• Because standard testing for children with developmental or behavioral health conditions may be impossible or inaccurate, referral may be more appropriate to audiology for electrophysiological hearing testing using auditory brainstem response (ABR) with sedation.
• To prevent false negatives and to avoid delays in identification, access to language, and support, screening tests should not be repeated more than once before referral to audiology.

Additional recommendations

The report authors pointed out that genetic causes may affect hearing and may show up beyond the newborn period.

They wrote that congenital cytomegalovirus (cCMV) infection is the most common infectious cause of childhood sensorineural hearing change and accounts for 25% of deaf and hard of hearing children at age 4.

Meningitis and otitis media also are leading causes of a change in hearing.

Judith E.C. Lieu, MD, MSPH, professor, program director and vice-chair for education in the department of otolaryngology and head and neck surgery at Washington University in St. Louis, who was not part of the research team, said screening recommendations have not changed much in the update, but she highlighted some points.

She noted that tympanometry is not listed as a method of hearing screening in primary care.

“I agree that tympanogram is not a hearing screening. It is an adjunct to look at middle ear function, but that doesn’t necessarily mean it looks for hearing,” she said.

Dr. Lieu says she does take issue with the stated length of one of the tests in the paper. She said she is concerned that the pure-tone audiometry test for ages 4 through adolescence is listed as taking 30 minutes in a primary care setting. She said she worries that pediatricians will be put off by reading that it is a 30-minute test.

“Honestly, in my experience, it doesn’t take 30 minutes. Maybe 10 minutes,” she said. “I don’t know any pediatrician who could devote 30 minutes to one screening test.”
 

Development milestones have been adjusted

Also different in these recommendations are the developmental and speech milestones updated according to the most recent AAP information, Dr. Lieu said. Though the new milestones don’t change by much, they are important to note, she said, such as updated guidance on when to be concerned about speech delay.

She said she wished the guidance included more about hearing loss in older children.

The report authors stated that about 1 to 3 per 1,000 children have atypical hearing at birth and similar numbers become deaf or hard of hearing later in childhood.

But Dr. Lieu says that statistic may give the wrong impression about frequency of atypical hearing.

“Hearing loss increases during childhood,” she pointed out. “By the time they hit about age 18, about 15% of kids have some kind of hearing loss.”

“I don’t think it’s made clear to pediatricians that this is not 1 or 2 in a thousand children – this happens much more frequently,” she said.

The report authors and Dr. Lieu report no relevant financial relationships.

The limited scope and depth of existing literature on childhood eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE) spurred an international group of researchers and clinicians to develop the first clinical practice guidelines for diagnosing and treating these rare conditions.

The consensus-based guidelines also aim to facilitate high-quality randomized controlled trials of various treatment modalities using a standardized nomenclature.

They were developed jointly by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

Non-EoE EGIDs are rare chronic inflammatory disorders of the gastrointestinal tract, estimated at less than 200,000 cases annually in the United States, with unknown long-term consequences, Glenn Furuta, MD, professor of pediatrics at the University of Colorado at Denver and section head of gastroenterology at Children’s Hospital Colorado, both in Aurora, said in an interview 

“There are many unmet needs. Research has been limited and has not progressed at the pace we want it to,” added Dr. Furuta, who is corresponding author of the guidelines.

The guidelines were published online in the Journal of Pediatric Gastroenterology & Nutrition, by lead author Alexandra Papadopoulou, MD, division of gastroenterology and hepatology, first department of pediatrics, University of Athens, and Children’s Hospital Agia Sofia, also in Athens, and colleagues.

With these, we provide guidance for clinicians to better understand the conditions and also how to diagnose and initiate care for patients with these rare diseases, said Dr. Furuta. 
 

Difficult-to-diagnose conditions

Guideline development involved a working group of 26 pediatric gastroenterologists, adult gastroenterologists, allergists/immunologists, and pathologists from 16 countries across five continents. The consensus document includes 34 statements based on available evidence and 41 recommendations based on expert opinion and best clinical practices. In cases where the supporting evidence was weak but agreement was strong, the authors issued conditional recommendations.

The guidelines subdivide the non-EoE EGIDs according to inflammation location: eosinophilic gastritis, eosinophilic duodenitis (EoD), eosinophilic colitis, and eosinophilic enteritis. The latter can be further subdivided into EoD, eosinophilic jejunitis, and eosinophilic ileitis.

Non-EoE EGIDs are hard to diagnose because symptoms are relatively nonspecific and may include abdominal pain, vomiting, diarrhea, and bloody stools, all of which could have any number of underlying causes, Dr. Furuta said.

If you are treating a patient who is not getting better with such symptoms as persisting infections, acid-related problems, significant bleeding leading to anemia, intestinal perforation or obstruction, or low serum protein leading to swelling, then you should think that something else is going on that requires more of an evaluation, Dr. Furuta noted.

Patients with personal or family histories of eosinophilic or allergic disease should raise greater suspicion, Dr. Furuta said. “The next step requires an endoscopy and biopsy.”

Awareness of non-EoE EGIDs has been higher among pediatric gastroenterologists than among those treating adult disease because pediatric gastroenterologists have always obtained biopsies of the intestinal tract, Dr. Furuta noted.

The guidelines recommend that diagnosis of non-EoE EGIDs in children and adolescents must include signs or symptoms of gastrointestinal dysfunction, dense eosinophilic infiltrates found in mucosal or full-thickness biopsies above organ-specific threshold values included in the document, and absence of other diseases associated with GI mucosal eosinophilic inflammation.
 

Individualized treatment

The authors noted that the strength of recommendations varies with the often-modest availability of randomized controlled trial data on treatment efficacy. 

For example, they recommended that systemic steroids be considered to induce remission but only conditionally recommend topical steroids. They conditionally recommend consideration of empiric elimination diets and conditionally recommend against using food allergy testing to guide diet.

The choice of treatment should be individualized on the basis of the affected GI segment, severity of the disease, patient characteristics, and family resources and capabilities, the authors wrote.

“We’ve provided guidance on how to care for patients based on the consensus of experts who have the necessary experience and knowledge base,” Dr. Furuta said. “Our ability to say: ‘Here are the established treatments,’ is lacking, though. We need research studies to verify that our recommended approaches are indeed correct.”

The authors conditionally recommended that treatment goals include achieving symptom resolution, improving gross endoscopic and histologic abnormalities, promoting normal childhood growth and development, and preventing disease complications.

No pediatric study has determined the natural history of non-EoE EGIDs, and no study of maintenance therapy has been conducted, the authors noted. 

For this reason, they conditionally recommended that the clinical decision to continue therapy should be discussed with patients and their parents/caregivers, and those discussions include the benefits and risk of long-term treatment, its cost, and its impact on health-related quality of life.
 

A starting point for patient management

In a comment, Vincent Mukkada, MD, professor of pediatrics at the University of Cincinnati and an attending physician in gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital and Medical Center, observed that, though improved awareness among pediatric gastroenterologists may account for some of the increase in GI eosinophil disease, the incidence is also likely growing. 

“We’re looking for them much more,” said Dr. Mukkada.

“But I also think they’re increasing, just like all other atopic diseases. We’re not sure why,” he added.

“The hope is that these guidelines will allow nonsubspecialized gastroenterologists and allergists feel comfortable to at least start on the journey of managing these patients. And, for pediatricians who learn that their patient has received a non-EoE EGID diagnosis, they can go to the summary figures in this one document and very quickly get an overview of the disease and its course,” Dr. Mukkada said.

Guideline development was funded by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. The authors and Dr. Mukkada reported no relevant financial relationships.

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

The limited scope and depth of existing literature on childhood eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE) spurred an international group of researchers and clinicians to develop the first clinical practice guidelines for diagnosing and treating these rare conditions.

The consensus-based guidelines also aim to facilitate high-quality randomized controlled trials of various treatment modalities using a standardized nomenclature.

They were developed jointly by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

Non-EoE EGIDs are rare chronic inflammatory disorders of the gastrointestinal tract, estimated at less than 200,000 cases annually in the United States, with unknown long-term consequences, Glenn Furuta, MD, professor of pediatrics at the University of Colorado at Denver and section head of gastroenterology at Children’s Hospital Colorado, both in Aurora, said in an interview 

“There are many unmet needs. Research has been limited and has not progressed at the pace we want it to,” added Dr. Furuta, who is corresponding author of the guidelines.

The guidelines were published online in the Journal of Pediatric Gastroenterology & Nutrition, by lead author Alexandra Papadopoulou, MD, division of gastroenterology and hepatology, first department of pediatrics, University of Athens, and Children’s Hospital Agia Sofia, also in Athens, and colleagues.

With these, we provide guidance for clinicians to better understand the conditions and also how to diagnose and initiate care for patients with these rare diseases, said Dr. Furuta. 
 

Difficult-to-diagnose conditions

Guideline development involved a working group of 26 pediatric gastroenterologists, adult gastroenterologists, allergists/immunologists, and pathologists from 16 countries across five continents. The consensus document includes 34 statements based on available evidence and 41 recommendations based on expert opinion and best clinical practices. In cases where the supporting evidence was weak but agreement was strong, the authors issued conditional recommendations.

The guidelines subdivide the non-EoE EGIDs according to inflammation location: eosinophilic gastritis, eosinophilic duodenitis (EoD), eosinophilic colitis, and eosinophilic enteritis. The latter can be further subdivided into EoD, eosinophilic jejunitis, and eosinophilic ileitis.

Non-EoE EGIDs are hard to diagnose because symptoms are relatively nonspecific and may include abdominal pain, vomiting, diarrhea, and bloody stools, all of which could have any number of underlying causes, Dr. Furuta said.

If you are treating a patient who is not getting better with such symptoms as persisting infections, acid-related problems, significant bleeding leading to anemia, intestinal perforation or obstruction, or low serum protein leading to swelling, then you should think that something else is going on that requires more of an evaluation, Dr. Furuta noted.

Patients with personal or family histories of eosinophilic or allergic disease should raise greater suspicion, Dr. Furuta said. “The next step requires an endoscopy and biopsy.”

Awareness of non-EoE EGIDs has been higher among pediatric gastroenterologists than among those treating adult disease because pediatric gastroenterologists have always obtained biopsies of the intestinal tract, Dr. Furuta noted.

The guidelines recommend that diagnosis of non-EoE EGIDs in children and adolescents must include signs or symptoms of gastrointestinal dysfunction, dense eosinophilic infiltrates found in mucosal or full-thickness biopsies above organ-specific threshold values included in the document, and absence of other diseases associated with GI mucosal eosinophilic inflammation.
 

Individualized treatment

The authors noted that the strength of recommendations varies with the often-modest availability of randomized controlled trial data on treatment efficacy. 

For example, they recommended that systemic steroids be considered to induce remission but only conditionally recommend topical steroids. They conditionally recommend consideration of empiric elimination diets and conditionally recommend against using food allergy testing to guide diet.

The choice of treatment should be individualized on the basis of the affected GI segment, severity of the disease, patient characteristics, and family resources and capabilities, the authors wrote.

“We’ve provided guidance on how to care for patients based on the consensus of experts who have the necessary experience and knowledge base,” Dr. Furuta said. “Our ability to say: ‘Here are the established treatments,’ is lacking, though. We need research studies to verify that our recommended approaches are indeed correct.”

The authors conditionally recommended that treatment goals include achieving symptom resolution, improving gross endoscopic and histologic abnormalities, promoting normal childhood growth and development, and preventing disease complications.

No pediatric study has determined the natural history of non-EoE EGIDs, and no study of maintenance therapy has been conducted, the authors noted. 

For this reason, they conditionally recommended that the clinical decision to continue therapy should be discussed with patients and their parents/caregivers, and those discussions include the benefits and risk of long-term treatment, its cost, and its impact on health-related quality of life.
 

A starting point for patient management

In a comment, Vincent Mukkada, MD, professor of pediatrics at the University of Cincinnati and an attending physician in gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital and Medical Center, observed that, though improved awareness among pediatric gastroenterologists may account for some of the increase in GI eosinophil disease, the incidence is also likely growing. 

“We’re looking for them much more,” said Dr. Mukkada.

“But I also think they’re increasing, just like all other atopic diseases. We’re not sure why,” he added.

“The hope is that these guidelines will allow nonsubspecialized gastroenterologists and allergists feel comfortable to at least start on the journey of managing these patients. And, for pediatricians who learn that their patient has received a non-EoE EGID diagnosis, they can go to the summary figures in this one document and very quickly get an overview of the disease and its course,” Dr. Mukkada said.

Guideline development was funded by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. The authors and Dr. Mukkada reported no relevant financial relationships.

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

The limited scope and depth of existing literature on childhood eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE) spurred an international group of researchers and clinicians to develop the first clinical practice guidelines for diagnosing and treating these rare conditions.

The consensus-based guidelines also aim to facilitate high-quality randomized controlled trials of various treatment modalities using a standardized nomenclature.

They were developed jointly by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

Non-EoE EGIDs are rare chronic inflammatory disorders of the gastrointestinal tract, estimated at less than 200,000 cases annually in the United States, with unknown long-term consequences, Glenn Furuta, MD, professor of pediatrics at the University of Colorado at Denver and section head of gastroenterology at Children’s Hospital Colorado, both in Aurora, said in an interview 

“There are many unmet needs. Research has been limited and has not progressed at the pace we want it to,” added Dr. Furuta, who is corresponding author of the guidelines.

The guidelines were published online in the Journal of Pediatric Gastroenterology & Nutrition, by lead author Alexandra Papadopoulou, MD, division of gastroenterology and hepatology, first department of pediatrics, University of Athens, and Children’s Hospital Agia Sofia, also in Athens, and colleagues.

With these, we provide guidance for clinicians to better understand the conditions and also how to diagnose and initiate care for patients with these rare diseases, said Dr. Furuta. 
 

Difficult-to-diagnose conditions

Guideline development involved a working group of 26 pediatric gastroenterologists, adult gastroenterologists, allergists/immunologists, and pathologists from 16 countries across five continents. The consensus document includes 34 statements based on available evidence and 41 recommendations based on expert opinion and best clinical practices. In cases where the supporting evidence was weak but agreement was strong, the authors issued conditional recommendations.

The guidelines subdivide the non-EoE EGIDs according to inflammation location: eosinophilic gastritis, eosinophilic duodenitis (EoD), eosinophilic colitis, and eosinophilic enteritis. The latter can be further subdivided into EoD, eosinophilic jejunitis, and eosinophilic ileitis.

Non-EoE EGIDs are hard to diagnose because symptoms are relatively nonspecific and may include abdominal pain, vomiting, diarrhea, and bloody stools, all of which could have any number of underlying causes, Dr. Furuta said.

If you are treating a patient who is not getting better with such symptoms as persisting infections, acid-related problems, significant bleeding leading to anemia, intestinal perforation or obstruction, or low serum protein leading to swelling, then you should think that something else is going on that requires more of an evaluation, Dr. Furuta noted.

Patients with personal or family histories of eosinophilic or allergic disease should raise greater suspicion, Dr. Furuta said. “The next step requires an endoscopy and biopsy.”

Awareness of non-EoE EGIDs has been higher among pediatric gastroenterologists than among those treating adult disease because pediatric gastroenterologists have always obtained biopsies of the intestinal tract, Dr. Furuta noted.

The guidelines recommend that diagnosis of non-EoE EGIDs in children and adolescents must include signs or symptoms of gastrointestinal dysfunction, dense eosinophilic infiltrates found in mucosal or full-thickness biopsies above organ-specific threshold values included in the document, and absence of other diseases associated with GI mucosal eosinophilic inflammation.
 

Individualized treatment

The authors noted that the strength of recommendations varies with the often-modest availability of randomized controlled trial data on treatment efficacy. 

For example, they recommended that systemic steroids be considered to induce remission but only conditionally recommend topical steroids. They conditionally recommend consideration of empiric elimination diets and conditionally recommend against using food allergy testing to guide diet.

The choice of treatment should be individualized on the basis of the affected GI segment, severity of the disease, patient characteristics, and family resources and capabilities, the authors wrote.

“We’ve provided guidance on how to care for patients based on the consensus of experts who have the necessary experience and knowledge base,” Dr. Furuta said. “Our ability to say: ‘Here are the established treatments,’ is lacking, though. We need research studies to verify that our recommended approaches are indeed correct.”

The authors conditionally recommended that treatment goals include achieving symptom resolution, improving gross endoscopic and histologic abnormalities, promoting normal childhood growth and development, and preventing disease complications.

No pediatric study has determined the natural history of non-EoE EGIDs, and no study of maintenance therapy has been conducted, the authors noted. 

For this reason, they conditionally recommended that the clinical decision to continue therapy should be discussed with patients and their parents/caregivers, and those discussions include the benefits and risk of long-term treatment, its cost, and its impact on health-related quality of life.
 

A starting point for patient management

In a comment, Vincent Mukkada, MD, professor of pediatrics at the University of Cincinnati and an attending physician in gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital and Medical Center, observed that, though improved awareness among pediatric gastroenterologists may account for some of the increase in GI eosinophil disease, the incidence is also likely growing. 

“We’re looking for them much more,” said Dr. Mukkada.

“But I also think they’re increasing, just like all other atopic diseases. We’re not sure why,” he added.

“The hope is that these guidelines will allow nonsubspecialized gastroenterologists and allergists feel comfortable to at least start on the journey of managing these patients. And, for pediatricians who learn that their patient has received a non-EoE EGID diagnosis, they can go to the summary figures in this one document and very quickly get an overview of the disease and its course,” Dr. Mukkada said.

Guideline development was funded by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. The authors and Dr. Mukkada reported no relevant financial relationships.

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

ASHEVILLE, N.C. – Treating chronic pediatric skin diseases requires an understanding of the barriers that many children face in obtaining the consistent health care they need, according to a pediatric dermatologist who addressed the annual meeting of the Society for Pediatric Dermatology.

As a general principle for treating chronic skin conditions in children who are not doing well, it is reasonable to draw out information about a patient’s access to adequate housing, nutrition, and other basic needs, George Hightower, MD, PhD, of the division of pediatric and adolescent dermatology, University of California, San Diego, said at the meeting.

“We need conversations about where patients play, learn, and rest their heads at night,” said Dr. Hightower, who conducts research in this area. Fundamental components of well-being, such as stable housing and secure access to nutrition “are inseparable” from a child’s health, he noted.

“What are the stakes?” he asked. For many children, these factors might mean the difference between effective and poor control of the diseases for which the patient is seeking care.

To illustrate the point, Dr. Hightower used hidradenitis suppurativa (HS), a disease that appears to be on the rise among adolescents, as an example of why patient circumstances matter and should be considered. A complex disorder that is more prevalent in resource-poor communities, HS is difficult to control, often requiring extended periods of treatment with medications that can involve complex dosing or regular infusions.

“There is a need for medical providers to help the patient plan for this chronic illness,” said Dr. Hightower, referring to the importance of close follow-up. In adolescents, HS can be sufficiently disruptive from both the physical and psychological perspective that poor control can “derail future aspirations” by complicating educational endeavors and social interactions.

Dr. Hightower acknowledged that simply documenting housing insecurity or other issues does not solve these problems, but he does believe that developing a sensitivity to these obstacles to health care is a first step. It is a process that should permeate into medical training, health care research, and strategies to improve outcomes.

“The connections between fair housing and clinical practice may appear tenuous and inconsequential to the care provided by medical specialists,” Dr. Hightower said, but he emphasized that there are clear consequences when these factors contribute to inadequate control of such diseases as HS. As a source of missed appointments and disjointed care, an unstable home life can be an important barrier to disease control – and because of scarring nodules, fistulae, pain, school absences, and social isolation, complications can be dire.

Solutions to insecure housing are not typically available to an individual clinician, but the awareness that this can be a factor can help both physicians and patients begin to think about the role this plays in impairing recovery and what solutions might be found to modify the impact. Awareness not just among individual clinicians but a broader consortium of those working to improve health care outcomes is needed to “challenge the way we are doing medicine,” he said.

While conversations about the social determinants of health, including access to resources within patients’ neighborhoods, schools, and environment, can demonstrate concern about how to address obstacles, it can also be part of a reorientation to think beyond treatment for the underlying pathology alone. Eliciting trust and emphasizing the importance of environmental barriers to adequate care can be positive steps on the path to solutions.


 

Participatory action research

Relevant to this orientation, Dr. Hightower spoke about participatory action research (PAR), which provides a framework for patients to participate in the planning of clinical studies to effect change, not just serve as subjects in these studies.

The assumption of PAR is that “all people have valuable knowledge about their lives and experiences,” Dr. Hightower said. From this assumption, individuals who have been historically marginalized by race, income, or other factors can help define the problems from the patient’s perspective and, from there, create studies to seek solutions.

PAR is consistent with a patient-centered approach to medical care, which Dr. Hightower called “the future of medicine.” It involves a big-picture approach to look beyond disease pathology and symptoms to factors that might be creating susceptibility to disease and undermining health care.

Organized medicine alone cannot solve the cause of social inequities leading to disparate risks for disease and risks of inadequate health care, but Dr. Hightower argued that these inequities should not be ignored. He believes medical trainees should learn how to elicit information about the barriers to adequate health care and be aware of solutions, such as fair housing policies.

While he believes that PAR is an example of a pathway to problem solving, he suggested that a comprehensive approach requires an effective method of communication between providers and patients that would lead to a collaborative and mutually reinforcing approach.

“How do we ensure that individuals from communities most impacted by health disparities are treated fairly and empowered to address these disparities?” Dr. Hightower asked. He said that this is the direction of his own research and the issues that inhibit adequate treatment of many dermatologic diseases, as well as other types of disease, in childhood.

Craig Burkhart, MD, director of a private pediatric and adolescent dermatology practice in Cary, N.C., said that Dr. Hightower’s message is relevant. The value of considering and addressing the psychological well-being of patients of any age is not a new concept, but he acknowledged that he, for one, has not routinely inquired about obstacles to follow-up care if there is a signal that this might be an issue.

“As dermatologists, we focus on the acute complaints. We want to make the patient better,” said Dr. Burkhart, who moderated the session in which Dr. Hightower spoke. He agreed with Dr. Hightower that environmental factors make a difference on the road to recovery for a patient, and his presentation was a good reminder, he said, to consider the patient’s circumstances when response to treatment is inadequate, particularly in chronic diseases like HS, for which comprehensive care and close follow-up are needed.

Dr. Hightower and Dr. Burkhart report no potential conflicts of interest.

ASHEVILLE, N.C. – Treating chronic pediatric skin diseases requires an understanding of the barriers that many children face in obtaining the consistent health care they need, according to a pediatric dermatologist who addressed the annual meeting of the Society for Pediatric Dermatology.

As a general principle for treating chronic skin conditions in children who are not doing well, it is reasonable to draw out information about a patient’s access to adequate housing, nutrition, and other basic needs, George Hightower, MD, PhD, of the division of pediatric and adolescent dermatology, University of California, San Diego, said at the meeting.

“We need conversations about where patients play, learn, and rest their heads at night,” said Dr. Hightower, who conducts research in this area. Fundamental components of well-being, such as stable housing and secure access to nutrition “are inseparable” from a child’s health, he noted.

“What are the stakes?” he asked. For many children, these factors might mean the difference between effective and poor control of the diseases for which the patient is seeking care.

To illustrate the point, Dr. Hightower used hidradenitis suppurativa (HS), a disease that appears to be on the rise among adolescents, as an example of why patient circumstances matter and should be considered. A complex disorder that is more prevalent in resource-poor communities, HS is difficult to control, often requiring extended periods of treatment with medications that can involve complex dosing or regular infusions.

“There is a need for medical providers to help the patient plan for this chronic illness,” said Dr. Hightower, referring to the importance of close follow-up. In adolescents, HS can be sufficiently disruptive from both the physical and psychological perspective that poor control can “derail future aspirations” by complicating educational endeavors and social interactions.

Dr. Hightower acknowledged that simply documenting housing insecurity or other issues does not solve these problems, but he does believe that developing a sensitivity to these obstacles to health care is a first step. It is a process that should permeate into medical training, health care research, and strategies to improve outcomes.

“The connections between fair housing and clinical practice may appear tenuous and inconsequential to the care provided by medical specialists,” Dr. Hightower said, but he emphasized that there are clear consequences when these factors contribute to inadequate control of such diseases as HS. As a source of missed appointments and disjointed care, an unstable home life can be an important barrier to disease control – and because of scarring nodules, fistulae, pain, school absences, and social isolation, complications can be dire.

Solutions to insecure housing are not typically available to an individual clinician, but the awareness that this can be a factor can help both physicians and patients begin to think about the role this plays in impairing recovery and what solutions might be found to modify the impact. Awareness not just among individual clinicians but a broader consortium of those working to improve health care outcomes is needed to “challenge the way we are doing medicine,” he said.

While conversations about the social determinants of health, including access to resources within patients’ neighborhoods, schools, and environment, can demonstrate concern about how to address obstacles, it can also be part of a reorientation to think beyond treatment for the underlying pathology alone. Eliciting trust and emphasizing the importance of environmental barriers to adequate care can be positive steps on the path to solutions.


 

Participatory action research

Relevant to this orientation, Dr. Hightower spoke about participatory action research (PAR), which provides a framework for patients to participate in the planning of clinical studies to effect change, not just serve as subjects in these studies.

The assumption of PAR is that “all people have valuable knowledge about their lives and experiences,” Dr. Hightower said. From this assumption, individuals who have been historically marginalized by race, income, or other factors can help define the problems from the patient’s perspective and, from there, create studies to seek solutions.

PAR is consistent with a patient-centered approach to medical care, which Dr. Hightower called “the future of medicine.” It involves a big-picture approach to look beyond disease pathology and symptoms to factors that might be creating susceptibility to disease and undermining health care.

Organized medicine alone cannot solve the cause of social inequities leading to disparate risks for disease and risks of inadequate health care, but Dr. Hightower argued that these inequities should not be ignored. He believes medical trainees should learn how to elicit information about the barriers to adequate health care and be aware of solutions, such as fair housing policies.

While he believes that PAR is an example of a pathway to problem solving, he suggested that a comprehensive approach requires an effective method of communication between providers and patients that would lead to a collaborative and mutually reinforcing approach.

“How do we ensure that individuals from communities most impacted by health disparities are treated fairly and empowered to address these disparities?” Dr. Hightower asked. He said that this is the direction of his own research and the issues that inhibit adequate treatment of many dermatologic diseases, as well as other types of disease, in childhood.

Craig Burkhart, MD, director of a private pediatric and adolescent dermatology practice in Cary, N.C., said that Dr. Hightower’s message is relevant. The value of considering and addressing the psychological well-being of patients of any age is not a new concept, but he acknowledged that he, for one, has not routinely inquired about obstacles to follow-up care if there is a signal that this might be an issue.

“As dermatologists, we focus on the acute complaints. We want to make the patient better,” said Dr. Burkhart, who moderated the session in which Dr. Hightower spoke. He agreed with Dr. Hightower that environmental factors make a difference on the road to recovery for a patient, and his presentation was a good reminder, he said, to consider the patient’s circumstances when response to treatment is inadequate, particularly in chronic diseases like HS, for which comprehensive care and close follow-up are needed.

Dr. Hightower and Dr. Burkhart report no potential conflicts of interest.

ASHEVILLE, N.C. – Treating chronic pediatric skin diseases requires an understanding of the barriers that many children face in obtaining the consistent health care they need, according to a pediatric dermatologist who addressed the annual meeting of the Society for Pediatric Dermatology.

As a general principle for treating chronic skin conditions in children who are not doing well, it is reasonable to draw out information about a patient’s access to adequate housing, nutrition, and other basic needs, George Hightower, MD, PhD, of the division of pediatric and adolescent dermatology, University of California, San Diego, said at the meeting.

“We need conversations about where patients play, learn, and rest their heads at night,” said Dr. Hightower, who conducts research in this area. Fundamental components of well-being, such as stable housing and secure access to nutrition “are inseparable” from a child’s health, he noted.

“What are the stakes?” he asked. For many children, these factors might mean the difference between effective and poor control of the diseases for which the patient is seeking care.

To illustrate the point, Dr. Hightower used hidradenitis suppurativa (HS), a disease that appears to be on the rise among adolescents, as an example of why patient circumstances matter and should be considered. A complex disorder that is more prevalent in resource-poor communities, HS is difficult to control, often requiring extended periods of treatment with medications that can involve complex dosing or regular infusions.

“There is a need for medical providers to help the patient plan for this chronic illness,” said Dr. Hightower, referring to the importance of close follow-up. In adolescents, HS can be sufficiently disruptive from both the physical and psychological perspective that poor control can “derail future aspirations” by complicating educational endeavors and social interactions.

Dr. Hightower acknowledged that simply documenting housing insecurity or other issues does not solve these problems, but he does believe that developing a sensitivity to these obstacles to health care is a first step. It is a process that should permeate into medical training, health care research, and strategies to improve outcomes.

“The connections between fair housing and clinical practice may appear tenuous and inconsequential to the care provided by medical specialists,” Dr. Hightower said, but he emphasized that there are clear consequences when these factors contribute to inadequate control of such diseases as HS. As a source of missed appointments and disjointed care, an unstable home life can be an important barrier to disease control – and because of scarring nodules, fistulae, pain, school absences, and social isolation, complications can be dire.

Solutions to insecure housing are not typically available to an individual clinician, but the awareness that this can be a factor can help both physicians and patients begin to think about the role this plays in impairing recovery and what solutions might be found to modify the impact. Awareness not just among individual clinicians but a broader consortium of those working to improve health care outcomes is needed to “challenge the way we are doing medicine,” he said.

While conversations about the social determinants of health, including access to resources within patients’ neighborhoods, schools, and environment, can demonstrate concern about how to address obstacles, it can also be part of a reorientation to think beyond treatment for the underlying pathology alone. Eliciting trust and emphasizing the importance of environmental barriers to adequate care can be positive steps on the path to solutions.


 

Participatory action research

Relevant to this orientation, Dr. Hightower spoke about participatory action research (PAR), which provides a framework for patients to participate in the planning of clinical studies to effect change, not just serve as subjects in these studies.

The assumption of PAR is that “all people have valuable knowledge about their lives and experiences,” Dr. Hightower said. From this assumption, individuals who have been historically marginalized by race, income, or other factors can help define the problems from the patient’s perspective and, from there, create studies to seek solutions.

PAR is consistent with a patient-centered approach to medical care, which Dr. Hightower called “the future of medicine.” It involves a big-picture approach to look beyond disease pathology and symptoms to factors that might be creating susceptibility to disease and undermining health care.

Organized medicine alone cannot solve the cause of social inequities leading to disparate risks for disease and risks of inadequate health care, but Dr. Hightower argued that these inequities should not be ignored. He believes medical trainees should learn how to elicit information about the barriers to adequate health care and be aware of solutions, such as fair housing policies.

While he believes that PAR is an example of a pathway to problem solving, he suggested that a comprehensive approach requires an effective method of communication between providers and patients that would lead to a collaborative and mutually reinforcing approach.

“How do we ensure that individuals from communities most impacted by health disparities are treated fairly and empowered to address these disparities?” Dr. Hightower asked. He said that this is the direction of his own research and the issues that inhibit adequate treatment of many dermatologic diseases, as well as other types of disease, in childhood.

Craig Burkhart, MD, director of a private pediatric and adolescent dermatology practice in Cary, N.C., said that Dr. Hightower’s message is relevant. The value of considering and addressing the psychological well-being of patients of any age is not a new concept, but he acknowledged that he, for one, has not routinely inquired about obstacles to follow-up care if there is a signal that this might be an issue.

“As dermatologists, we focus on the acute complaints. We want to make the patient better,” said Dr. Burkhart, who moderated the session in which Dr. Hightower spoke. He agreed with Dr. Hightower that environmental factors make a difference on the road to recovery for a patient, and his presentation was a good reminder, he said, to consider the patient’s circumstances when response to treatment is inadequate, particularly in chronic diseases like HS, for which comprehensive care and close follow-up are needed.

Dr. Hightower and Dr. Burkhart report no potential conflicts of interest.

For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).

The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.

It’s not a vaccine, but a monoclonal antibody used for prevention. That may cause confusion because a vaccine for RSV was approved just 3 months ago for adults aged 60 and older. And monoclonal antibodies are often used for treatment rather than prevention.

Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.

Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.

It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.

If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?

Specialists say no.

That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.

Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.

“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
 

What’s the difference between vaccines and antibodies?

Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.

Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.

Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.

That means kids at high risk for severe RSV have had to get monthly injections.

But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
 

Vaccines train the body

“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”

Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”

“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.

“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
 

Fast-acting monoclonal antibodies

An advantage for monoclonal antibodies is that they start working almost immediately.

Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”

The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.

By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”

To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”

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

For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).

The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.

It’s not a vaccine, but a monoclonal antibody used for prevention. That may cause confusion because a vaccine for RSV was approved just 3 months ago for adults aged 60 and older. And monoclonal antibodies are often used for treatment rather than prevention.

Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.

Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.

It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.

If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?

Specialists say no.

That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.

Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.

“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
 

What’s the difference between vaccines and antibodies?

Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.

Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.

Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.

That means kids at high risk for severe RSV have had to get monthly injections.

But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
 

Vaccines train the body

“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”

Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”

“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.

“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
 

Fast-acting monoclonal antibodies

An advantage for monoclonal antibodies is that they start working almost immediately.

Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”

The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.

By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”

To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”

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

For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).

The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.

It’s not a vaccine, but a monoclonal antibody used for prevention. That may cause confusion because a vaccine for RSV was approved just 3 months ago for adults aged 60 and older. And monoclonal antibodies are often used for treatment rather than prevention.

Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.

Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.

It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.

If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?

Specialists say no.

That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.

Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.

“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
 

What’s the difference between vaccines and antibodies?

Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.

Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.

Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.

That means kids at high risk for severe RSV have had to get monthly injections.

But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
 

Vaccines train the body

“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”

Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”

“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.

“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
 

Fast-acting monoclonal antibodies

An advantage for monoclonal antibodies is that they start working almost immediately.

Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”

The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.

By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”

To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”

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

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

I’d like to present you today with a case that raised a large amount of discussion and debate. I got involved as an ethics consultant on the case. I think you’ll find it very interesting and I also think there are going to be some differences of opinion about how to manage the case. I’ll be looking forward to getting comments and feedback on this.

The case involved a 14-year-old boy who had been brought into the hospital by his parents, suffering from severe bouts of anxiety that were just almost overwhelming to him. When he was brought in, he was assigned a health care provider who had a West African last name. Prior to meeting the patient, I have to say that the father of this kid told the intake department nurse that he requested someone else. He saw the name – he hadn’t even met the provider – and he said he wanted someone who might be Catholic.

The parents are both from the Dominican Republic. They identified as White, but they appeared to be non-White Latinx to the nurse who was doing some of the initial intake. They got reassigned to a different provider in the department who identified as African American.

The first month of treatment for the young boy went very well, and he seemed to be getting along extremely well with his provider. He was reporting relief to both parents of some of his anxiety, and the provider felt very connected to the child. A good doctor-patient alliance had been formed.

Nevertheless, at the end of the first month, the father connected back to one of the administrators at the hospital and complained, saying he still wanted a different provider. When asked why, he said, “Well, I don’t really want to answer that,” but getting pressed, he basically said he wasn’t comfortable with having an African American doctor take care of his child. He eventually went back to the argument that what he wanted was someone with a Catholic background, although I don’t know that he knew whether this particular provider was religious – Catholic or anything else.

The issue became what to do in the face of these continued demands by the dad for a change. Some people felt that, as the father in charge of the child’s care, if we could accommodate what he wanted in terms of the parents being comfortable, then that’s something we should do. I absolutely did not agree.

My view is that in a situation where a strong provider-patient relationship has been established, where trust is going both ways, where there are no issues coming up between this 14-year-old and the provider, and when a serious mental health issue is being adequately addressed, the patient’s interest must come first.

Once that therapeutic alliance had been established and both the patient and the provider felt satisfied, I don’t think the father’s wishes made any sense. He may have been acting more out of bigotry or just discomfort about difference in terms of who the provider was. I don’t think that’s something that any health system should have to accommodate unless it is getting in the way of patient care.

I hope that we treat all physicians as properly trained to deal with all kinds of patients, regardless of their religion, ethnicity, or skin color. They should have the skills to manage and do well with any patient. There may be situations where it just doesn’t work or where people don’t get along. Yes, I think we then should try, perhaps, to shift the doctor, get a different nurse, or have a different person do an exam. That’s because of the inability to get the patient’s health interests addressed.

Listening to this dad about what he preferred in terms of religion or ethnicity seemed to me to be interfering with medical success. Could I stop him from moving this patient out entirely from the care setting? Probably not, but I think the way to manage this is to try to talk to him – and, by the way, to talk to the mother.

When we did bring the mom into the situation, she was very happy with the health care provider. She didn’t agree with the dad and wanted to have a meeting with the social worker, the dad, and her to get him to get over the worries, concerns, and maybe even biases he was bringing in about the kind of provider he wanted. That’s exactly what we did.

I know that there are many instances where patients may say, “I don’t want a particular doctor or a particular type.” My view is that we shouldn’t accommodate that. We should say that our doctors are trained to help and care for all manner of people. Unless we can think of some reason that there might be a gap or a problem in the actual delivery of the quality of care, we are not going to accommodate racism, bigotry, or bias.

We certainly shouldn’t be accommodating that once a successful therapeutic relationship is established. Even when it’s a child, I would argue that the patient’s best interest has to trump parental desires, parental worries, and parental concerns about the background, ethnicity, and religion of the provider.

Dr. Caplan is director of the division of medical ethics at NYU Langone Medical Center, New York. He disclosed a conflict of interest with Johnson & Johnson.

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

This transcript has been edited for clarity.

I’d like to present you today with a case that raised a large amount of discussion and debate. I got involved as an ethics consultant on the case. I think you’ll find it very interesting and I also think there are going to be some differences of opinion about how to manage the case. I’ll be looking forward to getting comments and feedback on this.

The case involved a 14-year-old boy who had been brought into the hospital by his parents, suffering from severe bouts of anxiety that were just almost overwhelming to him. When he was brought in, he was assigned a health care provider who had a West African last name. Prior to meeting the patient, I have to say that the father of this kid told the intake department nurse that he requested someone else. He saw the name – he hadn’t even met the provider – and he said he wanted someone who might be Catholic.

The parents are both from the Dominican Republic. They identified as White, but they appeared to be non-White Latinx to the nurse who was doing some of the initial intake. They got reassigned to a different provider in the department who identified as African American.

The first month of treatment for the young boy went very well, and he seemed to be getting along extremely well with his provider. He was reporting relief to both parents of some of his anxiety, and the provider felt very connected to the child. A good doctor-patient alliance had been formed.

Nevertheless, at the end of the first month, the father connected back to one of the administrators at the hospital and complained, saying he still wanted a different provider. When asked why, he said, “Well, I don’t really want to answer that,” but getting pressed, he basically said he wasn’t comfortable with having an African American doctor take care of his child. He eventually went back to the argument that what he wanted was someone with a Catholic background, although I don’t know that he knew whether this particular provider was religious – Catholic or anything else.

The issue became what to do in the face of these continued demands by the dad for a change. Some people felt that, as the father in charge of the child’s care, if we could accommodate what he wanted in terms of the parents being comfortable, then that’s something we should do. I absolutely did not agree.

My view is that in a situation where a strong provider-patient relationship has been established, where trust is going both ways, where there are no issues coming up between this 14-year-old and the provider, and when a serious mental health issue is being adequately addressed, the patient’s interest must come first.

Once that therapeutic alliance had been established and both the patient and the provider felt satisfied, I don’t think the father’s wishes made any sense. He may have been acting more out of bigotry or just discomfort about difference in terms of who the provider was. I don’t think that’s something that any health system should have to accommodate unless it is getting in the way of patient care.

I hope that we treat all physicians as properly trained to deal with all kinds of patients, regardless of their religion, ethnicity, or skin color. They should have the skills to manage and do well with any patient. There may be situations where it just doesn’t work or where people don’t get along. Yes, I think we then should try, perhaps, to shift the doctor, get a different nurse, or have a different person do an exam. That’s because of the inability to get the patient’s health interests addressed.

Listening to this dad about what he preferred in terms of religion or ethnicity seemed to me to be interfering with medical success. Could I stop him from moving this patient out entirely from the care setting? Probably not, but I think the way to manage this is to try to talk to him – and, by the way, to talk to the mother.

When we did bring the mom into the situation, she was very happy with the health care provider. She didn’t agree with the dad and wanted to have a meeting with the social worker, the dad, and her to get him to get over the worries, concerns, and maybe even biases he was bringing in about the kind of provider he wanted. That’s exactly what we did.

I know that there are many instances where patients may say, “I don’t want a particular doctor or a particular type.” My view is that we shouldn’t accommodate that. We should say that our doctors are trained to help and care for all manner of people. Unless we can think of some reason that there might be a gap or a problem in the actual delivery of the quality of care, we are not going to accommodate racism, bigotry, or bias.

We certainly shouldn’t be accommodating that once a successful therapeutic relationship is established. Even when it’s a child, I would argue that the patient’s best interest has to trump parental desires, parental worries, and parental concerns about the background, ethnicity, and religion of the provider.

Dr. Caplan is director of the division of medical ethics at NYU Langone Medical Center, New York. He disclosed a conflict of interest with Johnson & Johnson.

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

This transcript has been edited for clarity.

I’d like to present you today with a case that raised a large amount of discussion and debate. I got involved as an ethics consultant on the case. I think you’ll find it very interesting and I also think there are going to be some differences of opinion about how to manage the case. I’ll be looking forward to getting comments and feedback on this.

The case involved a 14-year-old boy who had been brought into the hospital by his parents, suffering from severe bouts of anxiety that were just almost overwhelming to him. When he was brought in, he was assigned a health care provider who had a West African last name. Prior to meeting the patient, I have to say that the father of this kid told the intake department nurse that he requested someone else. He saw the name – he hadn’t even met the provider – and he said he wanted someone who might be Catholic.

The parents are both from the Dominican Republic. They identified as White, but they appeared to be non-White Latinx to the nurse who was doing some of the initial intake. They got reassigned to a different provider in the department who identified as African American.

The first month of treatment for the young boy went very well, and he seemed to be getting along extremely well with his provider. He was reporting relief to both parents of some of his anxiety, and the provider felt very connected to the child. A good doctor-patient alliance had been formed.

Nevertheless, at the end of the first month, the father connected back to one of the administrators at the hospital and complained, saying he still wanted a different provider. When asked why, he said, “Well, I don’t really want to answer that,” but getting pressed, he basically said he wasn’t comfortable with having an African American doctor take care of his child. He eventually went back to the argument that what he wanted was someone with a Catholic background, although I don’t know that he knew whether this particular provider was religious – Catholic or anything else.

The issue became what to do in the face of these continued demands by the dad for a change. Some people felt that, as the father in charge of the child’s care, if we could accommodate what he wanted in terms of the parents being comfortable, then that’s something we should do. I absolutely did not agree.

My view is that in a situation where a strong provider-patient relationship has been established, where trust is going both ways, where there are no issues coming up between this 14-year-old and the provider, and when a serious mental health issue is being adequately addressed, the patient’s interest must come first.

Once that therapeutic alliance had been established and both the patient and the provider felt satisfied, I don’t think the father’s wishes made any sense. He may have been acting more out of bigotry or just discomfort about difference in terms of who the provider was. I don’t think that’s something that any health system should have to accommodate unless it is getting in the way of patient care.

I hope that we treat all physicians as properly trained to deal with all kinds of patients, regardless of their religion, ethnicity, or skin color. They should have the skills to manage and do well with any patient. There may be situations where it just doesn’t work or where people don’t get along. Yes, I think we then should try, perhaps, to shift the doctor, get a different nurse, or have a different person do an exam. That’s because of the inability to get the patient’s health interests addressed.

Listening to this dad about what he preferred in terms of religion or ethnicity seemed to me to be interfering with medical success. Could I stop him from moving this patient out entirely from the care setting? Probably not, but I think the way to manage this is to try to talk to him – and, by the way, to talk to the mother.

When we did bring the mom into the situation, she was very happy with the health care provider. She didn’t agree with the dad and wanted to have a meeting with the social worker, the dad, and her to get him to get over the worries, concerns, and maybe even biases he was bringing in about the kind of provider he wanted. That’s exactly what we did.

I know that there are many instances where patients may say, “I don’t want a particular doctor or a particular type.” My view is that we shouldn’t accommodate that. We should say that our doctors are trained to help and care for all manner of people. Unless we can think of some reason that there might be a gap or a problem in the actual delivery of the quality of care, we are not going to accommodate racism, bigotry, or bias.

We certainly shouldn’t be accommodating that once a successful therapeutic relationship is established. Even when it’s a child, I would argue that the patient’s best interest has to trump parental desires, parental worries, and parental concerns about the background, ethnicity, and religion of the provider.

Dr. Caplan is director of the division of medical ethics at NYU Langone Medical Center, New York. He disclosed a conflict of interest with Johnson & Johnson.

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

An epidemiologic study of children aged 2 months to 5.5 years using data from the French national birth cohort (ELFE) reveals an increased risk of food allergies linked to a delayed introduction of major allergenic foods. These findings were published in Allergy.

Launched in April 2011, the French ELFE study aims to monitor children from birth to adulthood to better understand the factors from the intrauterine period to adolescence that affect their development, health, social skills, and school career. Thanks to this cohort, a team of scientists has reviewed the relationship between complementary feeding practices and allergies in French children.

The study focused on 6,662 children who had no signs of an allergic reaction before 2 months of age. Data on feeding practices were collected monthly from ages 3 months to 10 months. Their age at complementary feeding introduction was calculated, and a food diversity score was determined at 8 and 10 months. The number of major allergenic foods (out of eggs, fish, wheat, and dairy products) not introduced at 8 and 10 months was also determined. Allergic diseases (food allergy, eczema, asthma, and rhinoconjunctivitis) were reported by parents at 2 months and at 1, 2, 3.5, and 5.5 years.

Initially, scientists determined that just 62% of children began complementary feeding in the recommended age window, which is between ages 4 months and 6 months. They then closely studied the link between delayed introduction of major allergenic foods and the risk of food allergies. They saw that for 1 in 10 children, at least two major allergens, from eggs, fish, wheat, and dairy products, had still not been introduced into the diet of infants by the age of 10 months. Now, these children have a risk of developing a food allergy before the age of 5.5 years that is two times greater than that of children in whom the four major allergens were introduced before the age of 10 months.

These findings therefore confirm the importance of not delaying the introduction of major food allergens to prevent the occurrence of childhood allergic diseases. They provide convincing arguments in support of new recommendations made by the French pediatric and allergy societies as well as those issued by Public Health France.
 

ELFE: The first cohort to follow children from birth to adulthood

ELFE is the first longitudinal nationwide French study dedicated to monitoring children from birth to adulthood. More than 18,000 children born in metropolitan France in 2011 were included in this study, which represents 1 in 50 children born in 2011. From the time that researchers first met the families in the maternity ward, the parents who agreed to participate in this great scientific adventure have been questioned at regular intervals to better understand how environment, family members, and living conditions affect the development, health, and socialization of children.

This article was translated from the Medscape French Edition. A version of this article first appeared on Medscape.com.

An epidemiologic study of children aged 2 months to 5.5 years using data from the French national birth cohort (ELFE) reveals an increased risk of food allergies linked to a delayed introduction of major allergenic foods. These findings were published in Allergy.

Launched in April 2011, the French ELFE study aims to monitor children from birth to adulthood to better understand the factors from the intrauterine period to adolescence that affect their development, health, social skills, and school career. Thanks to this cohort, a team of scientists has reviewed the relationship between complementary feeding practices and allergies in French children.

The study focused on 6,662 children who had no signs of an allergic reaction before 2 months of age. Data on feeding practices were collected monthly from ages 3 months to 10 months. Their age at complementary feeding introduction was calculated, and a food diversity score was determined at 8 and 10 months. The number of major allergenic foods (out of eggs, fish, wheat, and dairy products) not introduced at 8 and 10 months was also determined. Allergic diseases (food allergy, eczema, asthma, and rhinoconjunctivitis) were reported by parents at 2 months and at 1, 2, 3.5, and 5.5 years.

Initially, scientists determined that just 62% of children began complementary feeding in the recommended age window, which is between ages 4 months and 6 months. They then closely studied the link between delayed introduction of major allergenic foods and the risk of food allergies. They saw that for 1 in 10 children, at least two major allergens, from eggs, fish, wheat, and dairy products, had still not been introduced into the diet of infants by the age of 10 months. Now, these children have a risk of developing a food allergy before the age of 5.5 years that is two times greater than that of children in whom the four major allergens were introduced before the age of 10 months.

These findings therefore confirm the importance of not delaying the introduction of major food allergens to prevent the occurrence of childhood allergic diseases. They provide convincing arguments in support of new recommendations made by the French pediatric and allergy societies as well as those issued by Public Health France.
 

ELFE: The first cohort to follow children from birth to adulthood

ELFE is the first longitudinal nationwide French study dedicated to monitoring children from birth to adulthood. More than 18,000 children born in metropolitan France in 2011 were included in this study, which represents 1 in 50 children born in 2011. From the time that researchers first met the families in the maternity ward, the parents who agreed to participate in this great scientific adventure have been questioned at regular intervals to better understand how environment, family members, and living conditions affect the development, health, and socialization of children.

This article was translated from the Medscape French Edition. A version of this article first appeared on Medscape.com.

An epidemiologic study of children aged 2 months to 5.5 years using data from the French national birth cohort (ELFE) reveals an increased risk of food allergies linked to a delayed introduction of major allergenic foods. These findings were published in Allergy.

Launched in April 2011, the French ELFE study aims to monitor children from birth to adulthood to better understand the factors from the intrauterine period to adolescence that affect their development, health, social skills, and school career. Thanks to this cohort, a team of scientists has reviewed the relationship between complementary feeding practices and allergies in French children.

The study focused on 6,662 children who had no signs of an allergic reaction before 2 months of age. Data on feeding practices were collected monthly from ages 3 months to 10 months. Their age at complementary feeding introduction was calculated, and a food diversity score was determined at 8 and 10 months. The number of major allergenic foods (out of eggs, fish, wheat, and dairy products) not introduced at 8 and 10 months was also determined. Allergic diseases (food allergy, eczema, asthma, and rhinoconjunctivitis) were reported by parents at 2 months and at 1, 2, 3.5, and 5.5 years.

Initially, scientists determined that just 62% of children began complementary feeding in the recommended age window, which is between ages 4 months and 6 months. They then closely studied the link between delayed introduction of major allergenic foods and the risk of food allergies. They saw that for 1 in 10 children, at least two major allergens, from eggs, fish, wheat, and dairy products, had still not been introduced into the diet of infants by the age of 10 months. Now, these children have a risk of developing a food allergy before the age of 5.5 years that is two times greater than that of children in whom the four major allergens were introduced before the age of 10 months.

These findings therefore confirm the importance of not delaying the introduction of major food allergens to prevent the occurrence of childhood allergic diseases. They provide convincing arguments in support of new recommendations made by the French pediatric and allergy societies as well as those issued by Public Health France.
 

ELFE: The first cohort to follow children from birth to adulthood

ELFE is the first longitudinal nationwide French study dedicated to monitoring children from birth to adulthood. More than 18,000 children born in metropolitan France in 2011 were included in this study, which represents 1 in 50 children born in 2011. From the time that researchers first met the families in the maternity ward, the parents who agreed to participate in this great scientific adventure have been questioned at regular intervals to better understand how environment, family members, and living conditions affect the development, health, and socialization of children.

This article was translated from the Medscape French Edition. A version of this article first appeared on Medscape.com.

The Diagnosis: Neonatal Lupus Erythematosus

A review of the medical records of the patient’s mother from her first pregnancy revealed positive anti-Ro/SSA (Sjögren syndrome A) (>8.0 U [reference range <1.0 U]) and anti-La/SSB (Sjögren syndrome B) antibodies (>8.0 U [reference range <1.0 U]), which were reconfirmed during her pregnancy with our patient (the second child). The patient’s older brother was diagnosed with neonatal lupus erythematosus (NLE) 2 years prior at 1 month of age; therefore, the mother took hydroxychloroquine during the pregnancy with the second child to help prevent heart block if the child was diagnosed with NLE. Given the family history, positive antibodies in the mother, and clinical presentation, our patient was diagnosed with NLE. He was referred to a pediatric cardiologist and pediatrician to continue the workup of systemic manifestations of NLE and to rule out the presence of congenital heart block. The rash resolved 6 months after the initial presentation, and he did not develop any systemic manifestations of NLE.

Neonatal lupus erythematosus is a rare acquired autoimmune disorder caused by the placental transfer of anti-Ro/SSA and anti-La/SSB antibodies and less commonly anti-U1 ribonucleoprotein antinuclear autoantibodies.^1,2 Approximately 1% to 2% of mothers with these positive antibodies will have infants affected with NLE.² The annual prevalence of NLE in the United States is approximately 1 in 20,000 live births. Mothers of children with NLE most commonly have clinical Sjögren syndrome; however, anti-Ro/SSA and anti-LA/SSB antibodies may be present in 0.1% to 1.5% of healthy women, and 25% to 60% of women with autoimmune disease may be asymptomatic.¹ As demonstrated in our case, when there is a family history of NLE in an infant from an earlier pregnancy, the risk for NLE increases to 17% to 20% in subsequent pregnancies^1,3 and up to 25% in subsequent pregnancies if the initial child was diagnosed with a congenital heart block in the setting of NLE.¹

Neonatal lupus erythematosus classically presents as annular erythematous macules and plaques with central scaling, telangictasia, atrophy, and pigmentary changes. It may start on the scalp and face and spread caudally.^1,2 Patients may develop these lesions after UV exposure, and 80% of infants may not have dermatologic findings at birth. Importantly, 40% to 60% of mothers may be asymptomatic at the time of presentation of their child’s NLE.¹ The diagnosis can be confirmed via antibody testing in the mother and/or infant. If performed, a punch biopsy shows interface dermatitis, vacuolar degeneration, and possible periadnexal lymphocytic infiltrates on histopathology.^1,2

Management of cutaneous NLE includes sun protection (eg, application of sunscreen) and topical corticosteroids. Most dermatologic manifestations of NLE are transient, resolving after clearance of maternal IgG antibodies in 6 to 9 months; however, some telangiectasia, dyspigmentation, and atrophic scarring may persist.^1-3

Neonatal lupus erythematosus also may have hepatobiliary, cardiac, hematologic, and less commonly neurologic manifestations. Hepatobiliary manifestations usually present as hepatomegaly or asymptomatic elevated transaminases or γ-glutamyl transferase.^1,3 Approximately 10% to 20% of infants with NLE may present with transient anemia and thrombocytopenia.¹ Cardiac manifestations are permanent and may require pacemaker implantation.^1,3 The incidence of a congenital heart block in infants with NLE is 15% to 30%.³ Cardiac NLE most commonly injures the conductive tissue, leading to a congenital atrioventricular block. The development of a congenital heart block develops in the 18th to 24th week of gestation. Manifestations of a more advanced condition can include dilation of the ascending aorta and dilated cardiomyopathy.¹ As such, patients need to be followed by a pediatric cardiologist for monitoring and treatment of any cardiac manifestations.

The overall prognosis of infants affected with NLE varies. Cardiac involvement is associated with a poor prognosis, while isolated cutaneous involvement requires little treatment and portends a favorable prognosis. It is critical for dermatologists to recognize NLE to refer patients to appropriate specialists to investigate and further monitor possible extracutaneous manifestations. With an understanding of the increased risk for a congenital heart block and NLE in subsequent pregnancies, mothers with positive anti-Ro/La antibodies should receive timely counseling and screening. In expectant mothers with suspected autoimmune disease, testing for antinuclear antibodies and SSA and SSB antibodies can be considered, as administration of hydroxychloroquine or prenatal systemic corticosteroids has proven to be effective in preventing a congenital heart block.¹ Our patient was followed by pediatric cardiology and was not found to have a congenital heart block.

The differential diagnosis includes other causes of annular erythema in infants, as NLE can mimic several conditions. Tinea corporis may present as scaly annular plaques with central clearing; however, it rarely is encountered fulminantly in neonates.⁴ Erythema multiforme is a mucocutaneous hypersensitivy reaction distinguished by targetoid morphology.⁵ It is an exceedingly rare diagnosis in neonates; the average pediatric age of onset is 5.6 years.⁶ Erythema multiforme often is associated with an infection, most commonly herpes simplex virus,⁵ and mucosal involvement is common.⁶ Urticaria multiforme (also known as acute annular urticaria) is a benign disease that appears between 2 months to 3 years of age with blanchable urticarial plaques that likely are triggered by viral or bacterial infections, antibiotics, or vaccines.⁶ Specific lesions usually will resolve within 24 hours. Annular erythema of infancy is a benign and asymptomatic gyrate erythema that presents as annular plaques with palpable borders that spread centrifugally in patients younger than 1 year. Notably, lesions should periodically fade and may reappear cyclically for months to years. Evaluation for underlying disease usually is negative.⁶

The Diagnosis: Neonatal Lupus Erythematosus

A review of the medical records of the patient’s mother from her first pregnancy revealed positive anti-Ro/SSA (Sjögren syndrome A) (>8.0 U [reference range <1.0 U]) and anti-La/SSB (Sjögren syndrome B) antibodies (>8.0 U [reference range <1.0 U]), which were reconfirmed during her pregnancy with our patient (the second child). The patient’s older brother was diagnosed with neonatal lupus erythematosus (NLE) 2 years prior at 1 month of age; therefore, the mother took hydroxychloroquine during the pregnancy with the second child to help prevent heart block if the child was diagnosed with NLE. Given the family history, positive antibodies in the mother, and clinical presentation, our patient was diagnosed with NLE. He was referred to a pediatric cardiologist and pediatrician to continue the workup of systemic manifestations of NLE and to rule out the presence of congenital heart block. The rash resolved 6 months after the initial presentation, and he did not develop any systemic manifestations of NLE.

Neonatal lupus erythematosus is a rare acquired autoimmune disorder caused by the placental transfer of anti-Ro/SSA and anti-La/SSB antibodies and less commonly anti-U1 ribonucleoprotein antinuclear autoantibodies.^1,2 Approximately 1% to 2% of mothers with these positive antibodies will have infants affected with NLE.² The annual prevalence of NLE in the United States is approximately 1 in 20,000 live births. Mothers of children with NLE most commonly have clinical Sjögren syndrome; however, anti-Ro/SSA and anti-LA/SSB antibodies may be present in 0.1% to 1.5% of healthy women, and 25% to 60% of women with autoimmune disease may be asymptomatic.¹ As demonstrated in our case, when there is a family history of NLE in an infant from an earlier pregnancy, the risk for NLE increases to 17% to 20% in subsequent pregnancies^1,3 and up to 25% in subsequent pregnancies if the initial child was diagnosed with a congenital heart block in the setting of NLE.¹

Neonatal lupus erythematosus classically presents as annular erythematous macules and plaques with central scaling, telangictasia, atrophy, and pigmentary changes. It may start on the scalp and face and spread caudally.^1,2 Patients may develop these lesions after UV exposure, and 80% of infants may not have dermatologic findings at birth. Importantly, 40% to 60% of mothers may be asymptomatic at the time of presentation of their child’s NLE.¹ The diagnosis can be confirmed via antibody testing in the mother and/or infant. If performed, a punch biopsy shows interface dermatitis, vacuolar degeneration, and possible periadnexal lymphocytic infiltrates on histopathology.^1,2

Management of cutaneous NLE includes sun protection (eg, application of sunscreen) and topical corticosteroids. Most dermatologic manifestations of NLE are transient, resolving after clearance of maternal IgG antibodies in 6 to 9 months; however, some telangiectasia, dyspigmentation, and atrophic scarring may persist.^1-3

Neonatal lupus erythematosus also may have hepatobiliary, cardiac, hematologic, and less commonly neurologic manifestations. Hepatobiliary manifestations usually present as hepatomegaly or asymptomatic elevated transaminases or γ-glutamyl transferase.^1,3 Approximately 10% to 20% of infants with NLE may present with transient anemia and thrombocytopenia.¹ Cardiac manifestations are permanent and may require pacemaker implantation.^1,3 The incidence of a congenital heart block in infants with NLE is 15% to 30%.³ Cardiac NLE most commonly injures the conductive tissue, leading to a congenital atrioventricular block. The development of a congenital heart block develops in the 18th to 24th week of gestation. Manifestations of a more advanced condition can include dilation of the ascending aorta and dilated cardiomyopathy.¹ As such, patients need to be followed by a pediatric cardiologist for monitoring and treatment of any cardiac manifestations.

The overall prognosis of infants affected with NLE varies. Cardiac involvement is associated with a poor prognosis, while isolated cutaneous involvement requires little treatment and portends a favorable prognosis. It is critical for dermatologists to recognize NLE to refer patients to appropriate specialists to investigate and further monitor possible extracutaneous manifestations. With an understanding of the increased risk for a congenital heart block and NLE in subsequent pregnancies, mothers with positive anti-Ro/La antibodies should receive timely counseling and screening. In expectant mothers with suspected autoimmune disease, testing for antinuclear antibodies and SSA and SSB antibodies can be considered, as administration of hydroxychloroquine or prenatal systemic corticosteroids has proven to be effective in preventing a congenital heart block.¹ Our patient was followed by pediatric cardiology and was not found to have a congenital heart block.

The differential diagnosis includes other causes of annular erythema in infants, as NLE can mimic several conditions. Tinea corporis may present as scaly annular plaques with central clearing; however, it rarely is encountered fulminantly in neonates.⁴ Erythema multiforme is a mucocutaneous hypersensitivy reaction distinguished by targetoid morphology.⁵ It is an exceedingly rare diagnosis in neonates; the average pediatric age of onset is 5.6 years.⁶ Erythema multiforme often is associated with an infection, most commonly herpes simplex virus,⁵ and mucosal involvement is common.⁶ Urticaria multiforme (also known as acute annular urticaria) is a benign disease that appears between 2 months to 3 years of age with blanchable urticarial plaques that likely are triggered by viral or bacterial infections, antibiotics, or vaccines.⁶ Specific lesions usually will resolve within 24 hours. Annular erythema of infancy is a benign and asymptomatic gyrate erythema that presents as annular plaques with palpable borders that spread centrifugally in patients younger than 1 year. Notably, lesions should periodically fade and may reappear cyclically for months to years. Evaluation for underlying disease usually is negative.⁶

The Diagnosis: Neonatal Lupus Erythematosus

A review of the medical records of the patient’s mother from her first pregnancy revealed positive anti-Ro/SSA (Sjögren syndrome A) (>8.0 U [reference range <1.0 U]) and anti-La/SSB (Sjögren syndrome B) antibodies (>8.0 U [reference range <1.0 U]), which were reconfirmed during her pregnancy with our patient (the second child). The patient’s older brother was diagnosed with neonatal lupus erythematosus (NLE) 2 years prior at 1 month of age; therefore, the mother took hydroxychloroquine during the pregnancy with the second child to help prevent heart block if the child was diagnosed with NLE. Given the family history, positive antibodies in the mother, and clinical presentation, our patient was diagnosed with NLE. He was referred to a pediatric cardiologist and pediatrician to continue the workup of systemic manifestations of NLE and to rule out the presence of congenital heart block. The rash resolved 6 months after the initial presentation, and he did not develop any systemic manifestations of NLE.

Neonatal lupus erythematosus is a rare acquired autoimmune disorder caused by the placental transfer of anti-Ro/SSA and anti-La/SSB antibodies and less commonly anti-U1 ribonucleoprotein antinuclear autoantibodies.^1,2 Approximately 1% to 2% of mothers with these positive antibodies will have infants affected with NLE.² The annual prevalence of NLE in the United States is approximately 1 in 20,000 live births. Mothers of children with NLE most commonly have clinical Sjögren syndrome; however, anti-Ro/SSA and anti-LA/SSB antibodies may be present in 0.1% to 1.5% of healthy women, and 25% to 60% of women with autoimmune disease may be asymptomatic.¹ As demonstrated in our case, when there is a family history of NLE in an infant from an earlier pregnancy, the risk for NLE increases to 17% to 20% in subsequent pregnancies^1,3 and up to 25% in subsequent pregnancies if the initial child was diagnosed with a congenital heart block in the setting of NLE.¹

Neonatal lupus erythematosus classically presents as annular erythematous macules and plaques with central scaling, telangictasia, atrophy, and pigmentary changes. It may start on the scalp and face and spread caudally.^1,2 Patients may develop these lesions after UV exposure, and 80% of infants may not have dermatologic findings at birth. Importantly, 40% to 60% of mothers may be asymptomatic at the time of presentation of their child’s NLE.¹ The diagnosis can be confirmed via antibody testing in the mother and/or infant. If performed, a punch biopsy shows interface dermatitis, vacuolar degeneration, and possible periadnexal lymphocytic infiltrates on histopathology.^1,2

Management of cutaneous NLE includes sun protection (eg, application of sunscreen) and topical corticosteroids. Most dermatologic manifestations of NLE are transient, resolving after clearance of maternal IgG antibodies in 6 to 9 months; however, some telangiectasia, dyspigmentation, and atrophic scarring may persist.^1-3

Neonatal lupus erythematosus also may have hepatobiliary, cardiac, hematologic, and less commonly neurologic manifestations. Hepatobiliary manifestations usually present as hepatomegaly or asymptomatic elevated transaminases or γ-glutamyl transferase.^1,3 Approximately 10% to 20% of infants with NLE may present with transient anemia and thrombocytopenia.¹ Cardiac manifestations are permanent and may require pacemaker implantation.^1,3 The incidence of a congenital heart block in infants with NLE is 15% to 30%.³ Cardiac NLE most commonly injures the conductive tissue, leading to a congenital atrioventricular block. The development of a congenital heart block develops in the 18th to 24th week of gestation. Manifestations of a more advanced condition can include dilation of the ascending aorta and dilated cardiomyopathy.¹ As such, patients need to be followed by a pediatric cardiologist for monitoring and treatment of any cardiac manifestations.

The overall prognosis of infants affected with NLE varies. Cardiac involvement is associated with a poor prognosis, while isolated cutaneous involvement requires little treatment and portends a favorable prognosis. It is critical for dermatologists to recognize NLE to refer patients to appropriate specialists to investigate and further monitor possible extracutaneous manifestations. With an understanding of the increased risk for a congenital heart block and NLE in subsequent pregnancies, mothers with positive anti-Ro/La antibodies should receive timely counseling and screening. In expectant mothers with suspected autoimmune disease, testing for antinuclear antibodies and SSA and SSB antibodies can be considered, as administration of hydroxychloroquine or prenatal systemic corticosteroids has proven to be effective in preventing a congenital heart block.¹ Our patient was followed by pediatric cardiology and was not found to have a congenital heart block.

The differential diagnosis includes other causes of annular erythema in infants, as NLE can mimic several conditions. Tinea corporis may present as scaly annular plaques with central clearing; however, it rarely is encountered fulminantly in neonates.⁴ Erythema multiforme is a mucocutaneous hypersensitivy reaction distinguished by targetoid morphology.⁵ It is an exceedingly rare diagnosis in neonates; the average pediatric age of onset is 5.6 years.⁶ Erythema multiforme often is associated with an infection, most commonly herpes simplex virus,⁵ and mucosal involvement is common.⁶ Urticaria multiforme (also known as acute annular urticaria) is a benign disease that appears between 2 months to 3 years of age with blanchable urticarial plaques that likely are triggered by viral or bacterial infections, antibiotics, or vaccines.⁶ Specific lesions usually will resolve within 24 hours. Annular erythema of infancy is a benign and asymptomatic gyrate erythema that presents as annular plaques with palpable borders that spread centrifugally in patients younger than 1 year. Notably, lesions should periodically fade and may reappear cyclically for months to years. Evaluation for underlying disease usually is negative.⁶

Children exposed to physical assault were twice as likely to be diagnosed with mental illness in the years following the assault than those who weren’t exposed, a new population-based study shows.

The greatest risk was found in the first year following the assault, increasing to three times the risk of being diagnosed with mental illness, compared with children not assaulted. Mood and anxiety disorders were the most common diagnoses.

“From a clinical and policy perspective, our study highlights that there is a critical opportunity for health care clinicians to support children in the first year following physical assault,” Natasha Saunders, MD, MSc, of the Hospital for Sick Children, Toronto, and colleagues wrote. “There is a need to develop and implement targeted mental illness prevention, screening, and treatment programs for assaulted children.”

The findings were published online in JAMA Network Open.

While it has been well established that children exposed to assault have an increased risk for subsequent mental illness, Dr. Saunders and coinvestigators noted that using an age-matched, population-based cohort study would enable them to obtain detailed information on the patterns and timing of subsequent psychiatric diagnoses.

To that end, the researchers used several medical databases in Ontario to find 5,487 children (infants to age 13 years) who required an ED visit or hospitalization for a physical assault in Ontario between 2006 and 2014.

These children were matched on a 1:4 basis with 21,948 children not exposed to physical assault. The children were followed until their 18th birthday or until the study ended in March 2019.

The researchers found that more than a third of the children (39%) who were exposed to assault received a mental health diagnosis, according to health records, compared with 23% of unexposed children.

Mood and anxiety disorders were the most common diagnoses among children exposed to assault (16.2% vs. 10.6%, respectively); followed by select childhood behavior disorders, such as ADHD, oppositional defiant disorder, or conduct disorder (9.9% vs. 5.2%); and substance use disorders (2.4% vs. 0.4%).
 

Triple risk of mental illness in first year

The researchers found that the children exposed to assault were nearly twice as likely to be diagnosed with a mental illness over a median follow-up of 7 years, compared with those not exposed to assault (adjusted hazard ratio, 1.96; 95% confidence interval, 1.85,2.08).

In the year following the assault, children exposed to assault bore three times the risk of being diagnosed with a mental illness, compared with unexposed children (aHR, 3.08; 95% CI, 2.68,3.54).

In addition, the children who had been assaulted were more likely to be diagnosed in an acute care setting than those who were not assaulted (14% vs. 2.8%).

The children who had been assaulted were an average age of 7 years and were more often boys (55% vs. 45%). Children who were assaulted were also more likely to have mothers with mental illness (35% vs. 19%).

The investigators noted that the study likely underestimated the number of children exposed to assault, as many do not end up in the ED.

In addition to highlighting the need for medical personnel to support children in the first year following assault, the investigators wrote that “our results also advocate for accessible mental health care outside of the acute setting and for care that addresses the social and health needs of mothers, who themselves have high social and health risks.”

This study received funding from the National Foundation to End Child Abuse and Neglect and the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Saunders reported receiving personal fees from The BMJ Group, Archives of Diseases in Childhood outside the submitted work.

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

Children exposed to physical assault were twice as likely to be diagnosed with mental illness in the years following the assault than those who weren’t exposed, a new population-based study shows.

The greatest risk was found in the first year following the assault, increasing to three times the risk of being diagnosed with mental illness, compared with children not assaulted. Mood and anxiety disorders were the most common diagnoses.

“From a clinical and policy perspective, our study highlights that there is a critical opportunity for health care clinicians to support children in the first year following physical assault,” Natasha Saunders, MD, MSc, of the Hospital for Sick Children, Toronto, and colleagues wrote. “There is a need to develop and implement targeted mental illness prevention, screening, and treatment programs for assaulted children.”

The findings were published online in JAMA Network Open.

While it has been well established that children exposed to assault have an increased risk for subsequent mental illness, Dr. Saunders and coinvestigators noted that using an age-matched, population-based cohort study would enable them to obtain detailed information on the patterns and timing of subsequent psychiatric diagnoses.

To that end, the researchers used several medical databases in Ontario to find 5,487 children (infants to age 13 years) who required an ED visit or hospitalization for a physical assault in Ontario between 2006 and 2014.

These children were matched on a 1:4 basis with 21,948 children not exposed to physical assault. The children were followed until their 18th birthday or until the study ended in March 2019.

The researchers found that more than a third of the children (39%) who were exposed to assault received a mental health diagnosis, according to health records, compared with 23% of unexposed children.

Mood and anxiety disorders were the most common diagnoses among children exposed to assault (16.2% vs. 10.6%, respectively); followed by select childhood behavior disorders, such as ADHD, oppositional defiant disorder, or conduct disorder (9.9% vs. 5.2%); and substance use disorders (2.4% vs. 0.4%).
 

Triple risk of mental illness in first year

The researchers found that the children exposed to assault were nearly twice as likely to be diagnosed with a mental illness over a median follow-up of 7 years, compared with those not exposed to assault (adjusted hazard ratio, 1.96; 95% confidence interval, 1.85,2.08).

In the year following the assault, children exposed to assault bore three times the risk of being diagnosed with a mental illness, compared with unexposed children (aHR, 3.08; 95% CI, 2.68,3.54).

In addition, the children who had been assaulted were more likely to be diagnosed in an acute care setting than those who were not assaulted (14% vs. 2.8%).

The children who had been assaulted were an average age of 7 years and were more often boys (55% vs. 45%). Children who were assaulted were also more likely to have mothers with mental illness (35% vs. 19%).

The investigators noted that the study likely underestimated the number of children exposed to assault, as many do not end up in the ED.

In addition to highlighting the need for medical personnel to support children in the first year following assault, the investigators wrote that “our results also advocate for accessible mental health care outside of the acute setting and for care that addresses the social and health needs of mothers, who themselves have high social and health risks.”

This study received funding from the National Foundation to End Child Abuse and Neglect and the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Saunders reported receiving personal fees from The BMJ Group, Archives of Diseases in Childhood outside the submitted work.

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

Children exposed to physical assault were twice as likely to be diagnosed with mental illness in the years following the assault than those who weren’t exposed, a new population-based study shows.

The greatest risk was found in the first year following the assault, increasing to three times the risk of being diagnosed with mental illness, compared with children not assaulted. Mood and anxiety disorders were the most common diagnoses.

“From a clinical and policy perspective, our study highlights that there is a critical opportunity for health care clinicians to support children in the first year following physical assault,” Natasha Saunders, MD, MSc, of the Hospital for Sick Children, Toronto, and colleagues wrote. “There is a need to develop and implement targeted mental illness prevention, screening, and treatment programs for assaulted children.”

The findings were published online in JAMA Network Open.

While it has been well established that children exposed to assault have an increased risk for subsequent mental illness, Dr. Saunders and coinvestigators noted that using an age-matched, population-based cohort study would enable them to obtain detailed information on the patterns and timing of subsequent psychiatric diagnoses.

To that end, the researchers used several medical databases in Ontario to find 5,487 children (infants to age 13 years) who required an ED visit or hospitalization for a physical assault in Ontario between 2006 and 2014.

These children were matched on a 1:4 basis with 21,948 children not exposed to physical assault. The children were followed until their 18th birthday or until the study ended in March 2019.

The researchers found that more than a third of the children (39%) who were exposed to assault received a mental health diagnosis, according to health records, compared with 23% of unexposed children.

Mood and anxiety disorders were the most common diagnoses among children exposed to assault (16.2% vs. 10.6%, respectively); followed by select childhood behavior disorders, such as ADHD, oppositional defiant disorder, or conduct disorder (9.9% vs. 5.2%); and substance use disorders (2.4% vs. 0.4%).
 

Triple risk of mental illness in first year

The researchers found that the children exposed to assault were nearly twice as likely to be diagnosed with a mental illness over a median follow-up of 7 years, compared with those not exposed to assault (adjusted hazard ratio, 1.96; 95% confidence interval, 1.85,2.08).

In the year following the assault, children exposed to assault bore three times the risk of being diagnosed with a mental illness, compared with unexposed children (aHR, 3.08; 95% CI, 2.68,3.54).

In addition, the children who had been assaulted were more likely to be diagnosed in an acute care setting than those who were not assaulted (14% vs. 2.8%).

The children who had been assaulted were an average age of 7 years and were more often boys (55% vs. 45%). Children who were assaulted were also more likely to have mothers with mental illness (35% vs. 19%).

The investigators noted that the study likely underestimated the number of children exposed to assault, as many do not end up in the ED.

In addition to highlighting the need for medical personnel to support children in the first year following assault, the investigators wrote that “our results also advocate for accessible mental health care outside of the acute setting and for care that addresses the social and health needs of mothers, who themselves have high social and health risks.”

This study received funding from the National Foundation to End Child Abuse and Neglect and the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Saunders reported receiving personal fees from The BMJ Group, Archives of Diseases in Childhood outside the submitted work.

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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