Lilly’s experimental JAK inhibitor Baricitinib in combination with a mid-potency topical corticosteroid (TCS) significantly improved the signs and symptoms of moderate-to-severe atopic dermatitis (AD) compared to TCS alone, with improvements seen as early as first week of treatment.
The results of this Phase 2 trial were presented in an oral presentation today at the European Academy of Dermatology and Venereology Annual Meeting in Geneva, Switzerland. Lilly will initiate a Phase 3 clinical program for moderate-to-severe atopic dermatitis later this year.
Baricitinib was approved in February 2017 for the treatment of adults with moderate-to-severe-active rheumatoid arthritis in the European Union and is marketed as Olumiant. Lilly and Incyte have an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib.
After 16 weeks of treatment, 61 percent of patients treated with 4-mg of baricitinib in combination with TCS (n=38) achieved a 50 percent or greater reduction in their overall disease severity as measured by the Eczema Area and Severity Index (EASI-50), compared to 37 percent of patients treated with TCS alone (n=49), (p<0.05). Among patients treated with 2-mg of baricitinib in combination with TCS (n=37), 57 percent achieved EASI-50, although these results were not statistically different compared to treatment with TCS alone (p=0.065). At four weeks, 68 percent of patients treated with 4-mg baricitinib in combination with TCS and 62 percent of patients treated with 2-mg of baricitinib in combination with TCS achieved EASI-50, compared to 16 percent of patients treated with TCS alone (p<0.001).
“Importantly, in this study, patients had to fail four weeks of supervised therapy with a mid-potency topical corticosteroid before randomization, selecting for a difficult to treat patient population,” says Emma Guttman-Yassky, M.D., Ph.D., Sol and Clara Kest professor of dermatology, vice chair Department of Dermatology, director of the Center for Excellence in Eczema and director of the Laboratory of Inflammatory Skin Diseases in the Department of Dermatology at Icahn School of Medicine at Mount Sinai Medical Center in New York, in a news release. “These new results suggest that baricitinib may have the potential to become an oral treatment option for patients suffering from atopic dermatitis who are unable to achieve adequate control with TCS.”
During the treatment period, treatment-emergent adverse events (TEAE) occurred in 49 percent of patients treated with TCS, 46 percent and 71 percent of the 2-mg and 4-mg baricitinib in combination with TCS groups, respectively. The most common TEAE in the 4-mg baricitinib in combination with TCS group were upper respiratory tract infections and nasopharyngitis, headache, and increases in asymptomatic laboratory changes, namely increases in creatine phosphokinase (CPK).