Abrocitinib effective, well tolerated in adolescent atopic dermatitis

Oral abrocitinib, in combination with topical therapy, was effective and well tolerated in the treatment of moderate to severe atopic dermatitis in adolescents, according to phase 3 study results.

“Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin condition with immune dysfunction that affects up to 20% of children and adolescents,” Lawrence F. Eichenfield, MD, of Rady Children’s Hospital-San Diego’s departments of dermatology and pediatrics at the University of California San Diego, and colleagues wrote. “To our knowledge, an efficacious systemic oral treatment that has a favorable benefit-risk profile for adolescents with moderate to severe AD remains an unmet need.”

The multicenter, international, randomized, placebo-controlled, parallel-group JADE TEEN trial included 285 adolescents (50.9% boys; median age, 15 years) with AD, of which 273 completed the trial. Patients were randomly assigned to receive once-daily oral abrocitinib 200 mg, once-daily oral abrocitinib 100 mg or placebo for 12 weeks, along with topical therapy.

Investigator Global Assessment response of 0/1 (clear or almost clear) occurred in 43 subjects (46.2%) in the 200 mg group, 37 subjects (41.6%) in the 100 mg group and 23 subjects (24.5%) in the placebo group. IGA response rate differences were 20.6% (95% CI, 7.3%-33.9%; P < .05) for the 200 mg group and 16.7% (95% CI, 3.5%-29.9%; P < .05) for the 100 mg group at week 12.

Eczema Area and Severity Index-75 response occurred in 67 subjects (72%) in the 200 mg group, 61 subjects (68.5%) in the 100 mg group and 39 subjects (41.5%) in the placebo group.

In addition, the proportion of subjects who had a four point or greater improvement in Peak Pruritus Numerical Rating Scale was significantly higher in the treatment groups compared with the placebo group.

One patient in the 100 mg treatment group developed cutaneous herpes zoster, while herpes simplex was reported in one patient in the 200 mg treatment group. Oral herpes was reported in two patients in the 200 mg group and one patient in the 100 mg group.

One patient reportedly developed eczema herpeticum in the 100 mg group, and one patient in the placebo group developed conjunctivitis. Acne was reported in five, three and one patients in the 200 mg, 100 mg and placebo groups, respectively.

“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 wrote.