Eli Lilly and Incyte announced topline data from the phase 3 BREEZE-AD4 study of baricitinib in combination with topical corticosteroids (TCS) for the treatment of moderate to severe atopic dermatitis (AD) in adult patients who were inadequate responders, intolerant or had contraindication to treatment with cyclosporine.
In the 16-week, multicenter, double-blind, placebo-controlled study, 463 adult patients with moderate to severe AD were randomized to receive either 1mg (n=93), 2mg (n=185), or 4mg (n=92) doses of baricitinib or placebo (n=93), plus TCS. The primary end point was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI75) at week 16.
Results showed that the 4mg dose of baricitinib plus TCS met the primary end point, with 31.5% of patients achieving EASI75 compared with 17.2% of patients in the placebo plus TCS group (P ≤.05). Additionally, the 4mg dose of baricitinib plus TCS met key secondary end points including Investigator’s Global Assessment of 0 (clear) or 1 (almost clear) and 4-point improvement in Itch Numeric Rating Scale at week 16. With regard to safety, the most common treatment-emergent adverse events reported included nasopharyngitis, headache, and influenza.
Full study results will be disclosed at future scientific venues and in peer-reviewed journals.
“There is a high need for additional treatment options for patients living with moderate to severe AD, particularly those who failed conventional systemic treatments like cyclosporine,” said Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly. “As we look to progress our treatment portfolio for chronic skin conditions, the continued insights from the development program in AD further the potential of baricitinib to pursue this indication and to reach patients.”
Baricitinib, an oral Janus kinase (JAK) inhibitor, is already approved under the brand name Olumiant for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to 1 or more tumor necrosis factor (TNF) antagonist therapies.
Lilly plans to submit baricitinib for regulatory review as a treatment for AD to the Food and Drug Administration in 2020.