Baricitinib 2 mg shows positive phase 3 results in atopic dermatitis
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Patients with moderate to severe atopic dermatitis experienced statistically significant improvement with baricitinib 2 mg, according to a phase 3 study.
“Janus kinase (JAK) inhibitors are effective potential therapeutics for atopic dermatitis (AD) because of their potential to target several cytokine axes across AD phenotypes,” Eric L. Simpson, MD, of Oregon Health and Science University, and colleagues wrote in the Journal of the American Academy of Dermatology. “Baricitinib, an oral, selective JAK1/JAK2 inhibitor, is indicated in the EU and studied elsewhere for the treatment of moderate to severe AD in adults who are candidates for systemic therapy.”
The BREEZE-AD5 double-blinded, parallel-controlled study included 440 patients from 81 locations in the U.S. and Canada. Subjects were randomly assigned to receive 1 mg or 2 mg of baricitinib or placebo.
After 16 weeks of treatment, a 75% or greater reduction in the Eczema Area and Severity Index was achieved by 30% of those taking baricitinib 2 mg, 13% of those taking baricitinib 1 mg and 8% of those taking placebo (P < .001 for 2 mg vs. placebo). Patients treated with baricitinib 2 mg achieved validated Investigator Global Assessment for Atopic Dermatitis score of 0/1 at a rate of 24% compared with 13% for those in the baricitinib 1 mg group and 5% for those in the placebo group (P < .001 for 2 mg vs. placebo).
A 4-point or greater improvement on the Itch Numeric Rating Scale was reached by 25% in the baricitinib 2 mg group, 16% in the baricitinib 1 mg group and 6% in the placebo group.
“In BREEZE-AD5, adults with moderate to severe AD receiving baricitinib 2 mg monotherapy experienced improvements in skin inflammation, skin pain, itch, sleep disturbance due to itch and quality of life versus placebo-treated patients,” the authors wrote.
Treatment-emergent adverse events were similar across the three treatment groups, with upper respiratory tract infection, nasopharyngitis and diarrhea being the most common.
“BREEZE-AD5 is the fifth positive phase 3 baricitinib AD trial. When treated with monotherapy baricitinib 2 mg once daily, adults with moderate to severe AD achieved statistically significant improvements over placebo in week 16 EASI-75 responses,” the authors wrote. “Baricitinib-treated patients reported improvements with other secondary efficacy endpoints. No new safety concerns were reported.”