Study Reports Positive Patient Response to Oral Treatment for Atopic Dermatitis

According to the findings of a randomized clinical trial, treatment with oral abrocitinib combined with topical therapy was more effective than placebo with topical therapy in adolescents with moderate-to-severe atopic dermatitis (AD).

“In this article, we report the efficacy and safety of abrocitinib, 200 mg and 100 mg, vs placebo combined with topical therapy in adolescents with moderate-to-severe AD in JADE TEEN,” the researchers explain.

To better understand and examine the efficacy and safety of oral abrocitinib plus topical therapy in adolescents with moderate-to-severe AD, a phase 3, randomized, double-blind, placebo-controlled study JADE TEEN was conducted. The study included patients ranging from 12 to 17 years of age who had an inadequate response to four consecutive weeks or longer of topic medication or a need for systemic AD therapy. Finally, the study authors randomly assigned patients 1:1:1 to receive once-daily oral abrocitinib, 200 mg or 100 mg, or placebo for 12 weeks in combination with topical therapy.

“Coprimary end points were achievement of an Investigator’s Global Assessment (IGA) response of clear (0) or almost clear (1) with improvement of 2 or more grades from baseline (IGA 0/1) and 75% or greater improvement from baseline in Eczema Area and Severity Index (EASI-75) response at week 12,” they explained.

The study authors identified 285 adolescents with moderate-to-severe AD (145 boys [50.9%] and 140 girls [49.1%]), with a median age of 15 years.

According to the findings of the study, more patients treated with abrocitinib (200 mg or 100 mg) vs placebo achieved an IGA response of 0/1 (46.2%; 41.6% vs 24.5%; P<.05 for both), EASI-75 (72.0%; 68.5% vs 41.5%; P<.05 for both), and PP-NRS4 (55.4%; 52.6% vs 29.8%; P<.01 for 200 mg vs placebo) at week 12.

As for the reported adverse events (AEs)—59 (62.8%), 54 (56.8%), and 50 (52.1%) patients in the 200 mg, 100 mg, and placebo groups experienced AEs. The most commonly reported AE was nausea among the patients treated with 59 (62.8%), 54 (56.8%), and 50 (52.1%) patients in the 200 mg, 100 mg, and placebo groups. Finally, among the 200 mg, 100 mg, and placebo groups, serious AEs occurred in 1 (1.1%), 0, and 2 (2.1%) patients.

“Considering all data presented, the study results suggest that abrocitinib, 200 mg or 100 mg, combined with medicated topical therapy was efficacious and well-tolerated in adolescents with moderate-to-severe AD, with a favorable benefit-risk profile,” the authors concluded.

Reference:
Eichenfield LF, Flohr C, Sidbury R, et al. Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: The JADE TEEN randomized clinical trial [published online ahead of print, 2021 Aug 18]. JAMA Dermatol. 2021;10.1001/jamadermatol.2021.2830. doi:10.1001/jamadermatol.2021.2830