Long-Term Safety Analysis of Ruxolitinib Cream in Pediatric Patients With Atopic Dermatitis: An Integrated Analysis of 8 Clinical Trials

Document Type

Conference Proceeding

Publication Date

2-10-2026

Publication Title

J Allergy Clin Immunol

Keywords

Janus kinase, Janus kinase 2 inhibitor, Janus kinase inhibitor, oclacitinib, ruxolitinib, acne, adolescent, adult, adverse drug reaction, application site reaction, atopic dermatitis, cardiovascular disease, child, conference abstract, contact dermatitis, controlled study, cream, diarrhea, drug therapy, fatality, female, folliculitis, headache, herpes zoster, human, incidence, major clinical study, male, mortality, nausea, pediatric patient, rheumatoid arthritis, safety assessment, side effect, special situation for pharmacovigilance, thromboembolism, topical drug administration, topical treatment

Abstract

Rationale: Ruxolitinib (Janus kinase [JAK]1/JAK2 inhibitor) cream has demonstrated effectiveness and tolerability in patients with atopic dermatitis (AD) as young as 2 years of age. This analysis of ruxolitinib cream safety in pediatric patients with AD investigated concerns arising from a systemic pan-JAK inhibitor in older adults with rheumatoid arthritis (major adverse cardiovascular events [MACE], malignancy, serious infections, thromboembolic events, and mortality), other AD topical therapies (acne, application site reactions, contact dermatitis, diarrhea, folliculitis, headache, and nausea), and AD (herpes zoster). Methods: Exposure-adjusted incidence rates (EAIRs; number of patients experiencing the event per 100 patient years [PY]) over time were determined in pediatric patients (aged 2−17 y) with AD who applied twice-daily ruxolitinib cream for up to 1 year across 8 clinical trials. Results: Of 461 children and adolescents with AD who applied 1.5% ruxolitinib cream over 304.98 PY, adverse events (AEs) associated with systemic JAK inhibition were not reported (no MACE, thromboembolic events, malignancies, or fatalities) or were infrequent and considered by the investigator as not related to treatment (serious infection EAIR, 0.66). EAIRs associated with other topical AD treatments or AD were low (acne, 0.98; application site reactions, 4.59; contact dermatitis, 1.31; diarrhea, 3.61; folliculitis, 0.66; headache, 3.61; herpes zoster, 0.33; and nausea, 0.98). EAIRs generally remained low over time. Conclusions: AEs associated with systemic JAK inhibition were not reported or rare and considered unrelated to ruxolitinib cream. Rates of AEs associated with other topical therapies or AD were low and stable over time.

Volume

157

Issue

2

First Page

AB16

Find It @ Sladen

Share

COinS