A maximum-use trial of ruxolitinib cream in adolescents and adults with atopic dermatitis

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• TRuE-AD1 and TRuE-AD2 were identically designed, double-blind, randomized, vehicle-controlled trials.
• Methods: Eligible patients aged ≥ 12–65 years with atopic dermatitis, an Investigator’s Global Assessment score ≥ 2, and ≥ 25% affected body surface area were enrolled in an open-label, maximum-use phase I study conducted in the USA and Canada. Patients applied 1.5% ruxolitinib cream twice daily to lesions identified at baseline for the first 28 days and continued use only on active lesions for an additional 28 days (extension period). Safety was assessed by frequency, duration, and severity of treatment-emergent adverse events. Plasma concentrations of ruxolitinib and pharmacokinetic parameters were assessed as secondary endpoints.
• Study Limitations: This study used an open-label design and therefore lacked a vehicle control. The limited sample size precluded the ability to draw firm conclusions for efficacy outcomes; however, this sample size has conventionally been adequate for establishing PK information. The small number of patients and the short duration of the study did not allow for the capture of potential rare long-term AEs.
• Incyte Corporation conducted a comprehensive literature search at time of publication and did not identify any publications with contrary results.