Lilly and Incyte announced positive top-line results from two Phase 3 clinical trials evaluating baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis.
Results from the BREEZE-AD1 and BREEZE-AD2 placebo-controlled trials showed that treatment with baricitinib monotherapy led to a statistically significant proportion of patients achieving Investigator’s Global Assessment for Atopic Dermatitis score of clear or almost clear at 16 weeks, the primary endpoint of both studies.
With regard to safety, the most common treatment-emergent adverse events reported were nasopharyngitis and headache; the incidence of treatment-emergent or serious adverse events was found to be similar between the baricitinib and placebo groups.
Commenting on the study results, Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly said, “We are encouraged that baricitinib met the primary endpoints in these 2 studies, and look forward to seeing the collective results of all 5 studies.”
Baricitinib, a Janus kinase inhibitor, is currently approved under the brand name Olumiant for the treatment of moderately-to-severely active rheumatoid arthritis in adults who have had an inadequate response to 1 or more tumor necrosis factor (TNF) antagonists.
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