Oral abrocitinib monotherapy once daily is effective and well tolerated in adolescents and adults with moderate to severe atopic dermatitis (AD), according to study results published in the Lancet.
The double-blind, randomized phase 3 trial (JADE MONO-1) of abrocitinib, an oral selective Janus kinase 1 inhibitor, enrolled patients aged ≥12 years with moderate to severe AD from 69 sites in Australia, Canada, Europe, and the United States. A total of 387 patients (mean age, 32.6; 58% men) were randomly assigned to receive oral abrocitinib once daily or placebo for 12 weeks—156 received abrocitinib 100 mg, 154 received abrocitinib 200 mg, and 77 were given a placebo.
The researchers found that the percentage of patients who achieved an Investigator Global Assessment response (score of 0 [clear] or 1 [almost clear] with a ≥2-grade improvement from baseline) at 12 weeks was significantly higher in the abrocitinib 100-mg group (37 patients, 24%) than in the placebo group (6 patients, 8%; P = .0037) and in the abrocitinib 200-mg group (67 patients, 44%) compared with the placebo group (6 patients, 8%; P < .0001). In addition, at week 12, the percentage of patients in the abrocitinib 100-mg and 200-mg groups who had achieved 75% improvement in Eczema Area and Severity Index score was significantly higher than in the placebo group.
Abrocitinib had a favorable safety profile, and no cases of venous thromboembolism, malignancy, major adverse cardiovascular events or deaths observed, the researchers found.
The study was limited by the 12-week treatment period, and it did not compare the efficacy of abrocitinib with the current standard of care in moderate to severe AD, noted the investigators.
“Our results suggest that abrocitinib was well tolerated and could present an efficacious oral systemic drug for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older,” the researchers concluded.
Disclosures: This clinical trial was supported by Pfizer. Several of the study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of disclosures.
Simpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): A multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396:255-266.