Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: The JADE TEEN randomized clinical trial
JAMA Aug 23, 2021
Eichenfield LF, Flohr C, Sidbury R, et al. - According to this multicenter, international, phase 3, randomized, placebo-controlled, parallel-group study (JADE TEEN), oral abrocitinib plus topical therapy was found to be considerably more efficacious than placebo plus topical therapy in adolescents with moderate-to-severe atopic dermatitis (AD), with an acceptable safety profile.
There were 285 adolescents with moderate-to-severe AD in this study (145 boys [50.9%] and 140 girls [49.1%]]), 160 (56.1%) of whom were White and 94 (33.0%) of whom were Asian; the median age was 15 years (interquartile range 13-17 years).
At week 12, significantly more patients treated with abrocitinib (200 mg or 100 mg) compared with placebo had an IGA response of 0/1, 75% or greater improvement from baseline in Eczema Area and Severity Index, and 4 points or more in Peak Pruritus Numerical Rating Scale.
In the 200 mg, 100 mg, and placebo groups, adverse events were recorded by 59 (62.8%), 54 (56.8%), and 50 (52.1%) patients, respectively; nausea was more common with abrocitinib, 200 mg (17 [18.1%]) and 100 mg (7 [7.4%]).
Herpes-related AEs were uncommon; only 1 (1.1%), 0 (0%), and 2 (2.1%) patients suffered serious AEs.
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