Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial
This Phase III study (n=901) met its co-primary endpoints, with more patients randomised to treatment with upadacitinib (oral JAK inhibitor; 15mg or 30mg) than placebo, both used in addition to topical corticosteroids, achieving an EASI-75 and vIGA-AD response at week 16.
Source:
The Lancet
SPS commentary:
At week 16, at least a 75% improvement in EASI score from baseline (EASI-75 response) was achieved in 65% of the upadacitinib 15mg group, 77% of the upadacitinib 30mg group and 26% of the placebo group (adjusted difference vs placebo of 38.1% [95% CI 30.8–45.4] for the 15mg group and 50.6% [43.8–57.4] for the 30mg group; p<0.0001 for both).
A vIGA-AD response (validated Investigator's Global Assessment for Atopic Dermatitis score of 0 [clear] or 1 [almost clear] with ≥2 grades of reduction from baseline) was achieved at week 16 in 40% of the upadacitinib 15mg group, 59% of the 30mg group and 11% with placebo (adjusted difference vs placebo of 28.5% [22.1–34.9] for the 15mg group and 47.6% [41.1–54.0] for the 30mg group; p<0·0001 for both doses).
The results of the Measure Up 1 and Measure Up 2 studies of upadacitinib versus placebo (without concomitant topical corticosteroids) in adolescents with moderate to severe atopic dermatitis have also been published separately.