Safety and Tolerability of Ruxolitinib Cream in Adolescents with Mild-to-Moderate Atopic Dermatitis: Results From a 1-Year, Phase III, Open-Label Study.

backgroundRuxolitinib cream (1.5%) has demonstrated efficacy and safety in patients aged ≥ 2 years with mild-to-moderate atopic dermatitis.

objectiveWe aimed to further investigate the safety and efficacy of ruxolitinib cream in adolescents with atopic dermatitis in an open-label study.

methodsPatients aged 12-17 years with atopic dermatitis, an Investigator's Global Assessment score of 2/3, and 3-20% affected body surface area applied twice-daily 1.5% ruxolitinib cream for an 8-week continuous treatment period, followed by a 44-week long-term safety period in which ruxolitinib cream was applied twice daily as needed. Safety was the primary endpoint. Secondary endpoints included plasma trough concentrations of ruxolitinib. Affected body surface area, ≥ 75% improvement from baseline in Eczema Area and Severity Index, achievement of Investigator's Global Assessment score of 0/1, and ≥ 4-point improvement from baseline in the itch Numerical Rating Scale were exploratory endpoints.

resultsOf 103 patients, 59.2% had a baseline Investigator's Global Assessment of 3. Mean baseline body surface area and Eczema Area and Severity Index scores were 8.9% and 6.4, respectively. Over 52 weeks, 42 patients (40.8%) had treatment-emergent adverse events, most commonly upper respiratory tract infection (10.7%) and nasopharyngitis (8.7%). Three patients (2.9%) had grade ≥ 3 treatment-emergent adverse events; all were considered unrelated to treatment by the investigator. Steady-state ruxolitinib plasma concentrations during the continuous treatment period were low (geometric mean [geometric coefficient of variation], 14.2 [169] nM), consistent with the lack of observed treatment-emergent adverse events associated with systemic Janus kinase inhibition. Clinical improvements occurred during the continuous treatment period and were maintained or improved with as-needed treatment through the long-term safety period to week 52 (mean affected body surface area, 1.3%; ≥ 75% improvement from baseline in Eczema Area and Severity Index, 87.0%; Investigator's Global Assessment 0/1, 82.6%; ≥ 4-point improvement from baseline in itch Numerical Rating Scale, 41.7%).

conclusionsRuxolitinib cream (1.5%) was well tolerated and efficacious with long-term as-needed use in adolescents with mild-to-moderate atopic dermatitis, consistent with safety and efficacy findings reported in previous phase III studies in adolescents and adults. CLINICAL

trial registrationClinicaltrials.gov identifier, NCT05456529 (registered 13 July, 2022).