No serious adverse events associated with the use of 1.5% ruxolitinib cream were reported in a long-term study of 461 children with atopic dermatitis (AD) presented at the American Academy of Allergy, Asthma & Immunology 2026 Annual Meeting.

Topical ruxolitinib (Opzelura), a JAK inhibitor, has shown effectiveness and tolerability in children with AD as young as 2 years, according to lead author Dareen Siri, MD, of the Sneeze, Wheeze, and Itch Clinical Research Center, Springfield, Illinois, and colleagues. The topical treatment was approved in September 2025 for children aged 2-11 years with AD. It was first approved for treating AD in people aged 12 or older in 2021.

However, like other JAK inhibitors, the medication has a boxed warning regarding the potential for serious infections, mortality, malignancy, major adverse cardiac events (MACE), and thrombosis, prompted in part by studies of oral JAK inhibitors in older patients with rheumatoid arthritis, and safety concerns have persisted the researchers noted.

In the new study, the researchers reviewed long-term data from eight clinical trials. The study population included 461 children and adolescents aged 2-17 years AD who were treated with ruxolitinib cream applied twice daily for up to 1 year, for a total of 304.98 patient-years. Adverse events were assessed in terms of exposure-adjusted incidence rates (EAIRs), the number of patients who experienced the event per 100 patient-years.

No incidents of MACE, thromboembolic events, malignancies, or fatalities, adverse events that have been associated with systemic JAK inhibition, were reported. Other adverse events were infrequent and deemed unrelated to treatment and the EAIR for serious infections was determined to be 0.66.

Overall, EAIRs remained low over time, and EAIRs associated with other topical AD treatments or AD itself were low, the investigators reported.

Overall, the results indicate that events associated with systemic JAK inhibition among children and adolescents treated with ruxolitinib cream for AD were not reported or rare and considered unrelated to the treatment, the researchers concluded.

Results Addressed Safety Concerns

Additional monitoring of long-term safety with any JAK inhibitor is important, as the treatments are still relatively new, said Brian S. Kim, MD, Professor of Dermatology, Vice Chair of Research, and Director of the Mark Lebwohl Center for Neuroinflammation and Sensation at the Icahn School of Medicine at Mount Sinai, New York City.

“Given that very few have been used in children this young, the topic is even more relevant,” said Kim, who was not involved in the study. The new study findings were not unexpected, given the demonstrated safety of ruxolitinib in postmarket research and in clinical practice, he told Medscape Medical News.

Kim stated that while the results addressed safety concerns related to topical ruxolitinib, he added that more long-term surveillance is needed in all populations to continue to inform practice.

The study was funded by Incyte, and one author declared being employed by Incyte. The other researchers disclosed having no financial conflicts of interest. Kim disclosed previously consulting for Incyte but was not involved in the current research.