This is part of the third installment of a series on biologics and dermatology, exploring the impact of biologics on the treatment of dermatologic diseases.

The FDA’s 2019 approval of dupilumab for moderate-to-severe atopic dermatitis (AD) in children aged 12-17 years created a turning point whose momentum continues today as dermatologists await pediatric approvals of additional biologics and JAK inhibitors, which are already approved for AD in adults.

Additional biologic approvals are expected within the next year, experts told Medscape Medical News. Meanwhile, research has shown that targeting interleukin (IL)-4 and IL-13, as dupilumab does, provides efficacy even in the presence of comorbidities such as asthma and allergic rhinitis — and may modify both the development of such comorbidities and the course of AD itself.

“Biologics have revolutionized our care of children and adolescents with atopic dermatitis,” Amy S. Paller, MD, MS, said in an interview, “because the vast majority can now go from having moderate or severe disease to having very little itch and a much better life.” Paller is chair of the Department of Dermatology and professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine in Chicago.

Before biologics, Lawrence Eichenfield, MD, said, “We probably undertreated patients with more serious atopic dermatitis because the systemic choices were problematic.”

Traditional systemic therapies, including oral steroids, methotrexate, cyclosporine, and others, carried concerns for side effects and toxicities, along with limitations on duration of use, explained Eichenfield, distinguished professor of dermatology and pediatrics at the UC San Diego School of Medicine, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego.

“Unfortunately,” added Paller, “there were many people using systemic steroids to treat children — which we almost never want to do.” Even among children with severe AD, Eichenfield said, only a small subset received other conventional immunosuppressants.

Now, “we have new medicines coming out, and insurers accept approved biologics as first-line AD therapies,” Paller said. The biologics tralokinumab, lebrikizumab, and nemolizumab are FDA-approved for ages 12 and up. Two JAK inhibitors, upadacitinib and abrocitinib, are also approved for that age group. 

Presently, the only biologic or JAK inhibitor approved for treating AD in children younger than 2 years is dupilumab. The 2022 FDA approval for AD in children ages 6 months to 5 years extended dupilumab’s benefits to young children who are truly suffering at a crucial developmental juncture, Paller said.

Poor sleep can affect linear growth and neuropsychiatric development, she noted. “Not being able to focus in school sets you up for a lifetime of setbacks,” Paller added. “So the earlier we can get atopic dermatitis under control and change the life of both the child and the parents, the better. Atopic dermatitis involves a huge time, financial, and emotional burden — it affects everybody in the family.”

That being the case, Eichenfield told Medscape Medical News that physicians are acutely aware that children and teenagers with AD welcome fewer injections. To that end, 8-week lebrikizumab maintenance dosing approved by the FDA in June for patients aged 12 years or older who weigh at least 88 pounds can cut the number of maintenance doses roughly in half.

Phase 3 data that Eichenfield presented at the Society for Pediatric Dermatology (SPD) 2026 Annual Meeting, from children aged 6 months to 17 years, showed that roughly half of the treated patients were clear or almost clear at week 16 compared with 15% of those on placebo. Regarding tralokinumab, a phase 3 study in children aged 6 months to 11 years with moderate-to-severe AD is scheduled for primary completion in October.

Phase 2 nemolizumab data in children aged 2 to 11 years presented at the American Academy of Dermatology (AAD) 2026 Annual Meeting showed Eczema Area and Severity Index reductions of 85%-90% with treatment at 1 year. However, Eichenfield said it remains unclear whether these data will suffice for FDA approval because the study design was based on matching serum drug levels used in adolescent and adult studies to show similar exposure levels in an open-label (vs a placebo-controlled) setting.

New Guidelines

None of the above medications existed when previous AAD guidelines for treating AD in adults and children were published in 2014. New pediatric AD guidelines published by the AAD in April strongly recommend all these therapies for moderate-to-severe AD — with the caveats that nemolizumab be used with topical therapy (which traditionally is continued early in the course of systemic agents) and that the JAK inhibitor baricitinib is approved by the European Medicines Agency for treating AD in children aged 2 years or older but not by the FDA. (Paller and Eichenfield are among the authors of the guidelines.)

The new guidelines give physicians alternatives to dupilumab, Paller told Medscape Medical News. For example, she said that if a patient has a safety or efficacy issue with dupilumab, physicians can select another systemic drug, at least for adolescent patients.

Additionally, Paller said there may be reasons to choose an alternative agent as first-line. “If I have a 14-year-old with alopecia areata,” she explained, “I might consider a JAK inhibitor first-line to combat both the AD and the alopecia.” Or if a patient has severe seasonal AD, she said, “A JAK inhibitor might act more quickly and be easier to stop when they don’t need it.”

Currently approved JAK inhibitors have a boxed warning regarding serious infections, mortality, malignancy, major cardiac events, and thrombosis, although real-world and other evidence have been reported since a rheumatoid arthritis study involving tofacitinib prompted the addition of the warning in 2021.

Dermatologists in the US now have more extended experience and safety data with the JAK inhibitors upadacitinib and abrocitinib in adolescents, said Eichenfield. Boxed warnings notwithstanding, he said, the risk in a generally healthy population aged 12 to 17 years appears to be “very low.”

Although FDA-required labeling recommends these drugs as second-line AD therapies, he said, “shared decision-making between patients and doctors allows us to figure out what’s the right therapy for each individual.”

Comorbidities and Disease Modification

Meanwhile, researchers continue to learn more about dupilumab’s capabilities in special situations and populations. In the LIBERTY AD PRESCHOOL study, dupilumab provided similar AD improvement in children aged 6 months to 5 years with and without asthma, allergic rhinitis, and food allergies. Also FDA-approved for asthma, dupilumab has been shown to reduce the incidence of asthma and allergic rhinitis in early childhood. 

Probably the major question in pediatric AD, Eichenfield told Medscape Medical News, is how earlier treatment might modulate the overall course of disease and potentially impact development of comorbidities such as asthma and environmental allergies. In his clinical experience, he said, children with pet allergies can tolerate pets while on dupilumab. It is premature to make similar statements about disease modification with other biologics in younger children, he added, because these drugs have had limited use in this age group. “We’ll be eager to see if they can work similarly and/or differentially in younger children.”

Paller said, “We know that some children with severe AD can take dupilumab for as little as 4 to 6 months, then space out or even stop dupilumab and remain in control.” However, she added, the percentage of patients who remain in control off medication for at least 1 year, which is the current definition of remission, has not yet been reported in any study. Given dupilumab’s ability to mitigate other allergic disorders and early evidence of reducing the risk of developing other allergies, she said, physicians are wondering about the potential benefit of keeping patients on dupilumab longer to reduce the risk for development or the severity of allergic disorders.

Promising Pipeline

All biologics approved for adult AD that are not yet approved for pediatric AD are being studied in younger age groups, said Paller, who expects additional pediatric approvals within the next year. In addition, she said, “JAK inhibitors are in trials for children as young as 6 years in the United States and even younger globally.”

Other biologics being studied in adult AD target IL-18. Treatments in phase 2 studies include EVO301 and camoteskimab. Additionally, the investigational IL-13 antibody zumilokibart has shown the ability to maintain efficacy with three or six injections per year. Also in development are new technologies that will allow biologic dosing once or twice yearly, she told Medscape Medical News.

The oral STAT6 degrader KT-621, which Paller said she hopes proves to be efficacious and safe, is in phase 2 trials as well. Moving into early trials, she added, are bispecific and trispecific antibodies that attack multiple inflammatory AD pathways simultaneously. 

The arrival of new biologic and systemic agents for AD parallels psoriasis treatment 10 years ago, Paller said. The delay in pediatric approvals is unsurprising, she added. “Safety is incredibly important for the pediatric population,” she added, “and we want to make sure that the testing is done appropriately because many pediatric patients will be on biologics for years.”

Paller reported being an investigator or consultant for AbbVie, Abeona Therapeutics, Aegle Therapeutics, Apogee Therapeutics, Applied Pharma Research, Arcutis Biotherapeutics, BioCryst, BioMendics, BioRay Pharmaceutical, Bluefin Biomedicine, Chiesi Farmaceutici, Dermavant Sciences, Eli Lilly, Galderma, Gedeon Richter, Genzyme, Incyte, Johnson & Johnson Innovative Medicine, Kamari (Orvida) Pharma, Kymera Therapeutics, LEO Pharma, MoonLake Immunotherapeutics, Novartis, Palvella Therapeutics, Pelthos Therapeutics, Pfizer, Quoin Pharmaceuticals, Regeneron, Sanofi, Sato, Thera-Clean, TWi Pharmaceuticals, and UCB.

Eichenfield reported serving as a consultant, advisor, or investigator for AbbVie, Abeona Therapeutics, Acrotech Biopharma, Almirall, Amgen, ApogeeTherapeutics, Arcutis Biotherapeutics, Attovia Therapeutics, Bristol Myers Squibb, Castle Biosciences, Chiesi Farmaceutici, CorEvitas, Dermavant Sciences, Formation Bio, Forte Biosciences, Galderma, Incyte, Janssen, Kenvue, Krystal Biotech, LEO, Lilly, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Takeda, Target RWE, TRex Bio, UCB, and Verrica.

John Jesitus is a Denver-based freelance medical writer and editor.