Baricitinib Meets Primary Endpoint in Phase 2 Study of Patients with Moderate-to-Severe Atopic Derma

Eli Lilly and Company and Incyte announced new safety and efficacy data from a Phase 2 study of baricitinib in people with moderate-to-severe atopic dermatitis (AD). The results showed that baricitinib in combination with a mid-potency topical corticosteroid (TCS) significantly improved the signs and symptoms of AD compared to TCS alone. The results were presented in an oral presentation today at the European Academy of Dermatology and Venereology (EADV) Annual Meeting in Geneva, Switzerland.

"Atopic dermatitis has a significant impact on the quality of life, including the emotional and social wellbeing of people with the disease," said James McGill, M.D., distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. "Baricitinib demonstrated clinical efficacy in a Phase 2 study in atopic dermatitis. The study was designed to understand the safety and efficacy of baricitinib in patients refractory to topical steroids. In this population, baricitinib was able to achieve improvement in both itch and skin inflammation. Based on these data, we plan to initiate a Phase 3 clinical program for atopic dermatitis later this year."

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," said 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. "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 TEAEs 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).