Patients with atopic dermatitis who received baricitinib 4 mg plus a topical corticosteroid achieved 50% improvement in the Eczema Area and Severity Index score at week 16 at a significantly higher rate than patients who received placebo plus a topical corticosteroid, according to a study.
Out of 187 adult patients with moderate to severe atopic dermatitis involving more than 10% of the body surface area at screening, 124 patients were enrolled in the study, with 104 patients in the U.S. and 20 in Japan.
Forty-nine patients were randomly assigned to receive placebo once daily plus a topical corticosteroid, 37 subjects received 2 mg of baricitinib once daily plus a topical corticosteroid, and 38 subjects received 4 mg of baricitinib once daily plus a topical corticosteroid.
Median Eczema Area and Severity Index (EASI) scores were similar at screening and baseline for all patients.
Patients, investigators and study site personnel were blinded to the treatment arms, and patients discontinued systemic treatment for atopic dermatitis and other prohibited medications.
As early as 4 weeks, the difference between the proportion of patients who received 2 mg or 4 mg of baricitinib and achieved 50% improvement in EASI score and the proportion of patients who received placebo and reached 50% improvement in EASI score was statistically significant.
A higher proportion of patients on baricitinib 4 mg achieved a 50% improvement in EASI score at week 16 compared with those treated with placebo.
Dermatology Life Quality Index improved in both treatment groups compared with placebo and showed significant improvement at week 4.
Additionally, the patients on baricitinib used approximately 30% less topical corticosteroid monthly than those on placebo.
Researchers reported significant improvements based on EASI score as early as week 1. – by Abigail Sutton
Disclosures: Guttman-Yassky reports she receives grants from Eli Lilly and Company, Dermira, Leo Pharma, Novartis, Galderma, Regeneron Pharmaceuticals, Pfizer, Vitae Pharmaceuticals, Glenmark, AbbVie, Celgene, Medimmune, Innovaderm Research, Immune Pharmaceuticals and Asana Biosciences, and personal fees from Regeneron Pharmaceuticals, Sanofi, Stiefel/GSK, Pfizer, Galderma, Celgene, Dermira, Anacor Pharmaceuticals, AnaptysBio, Glenmark, Novartis, AbbVie, Sun Pharmaceutical Industries, Mitsubishi Tanabe, Vitae Pharmaceuticals, Allergan, Almirall, PuriCore, Asana Biosciences, Gilead Sciences, Concert Pharmaceuticals, Immune Pharmaceuticals, Kyowa Kirin Co., Ziarco Group, DS Biopharma, DBV Technologies, Eli Lilly and Company and Escalier Biosciences. Please see the study for all other authors’ relevant financial disclosures.