Lilly Announces Top-Line Phase 3 Results for Baricitinib Trial

Eli Lilly and Company and Incyte announced baricitinib met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase 3 studies evaluating the efficacy and safety of baricitinib monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis (AD). In both investigational trials, compared to patients treated with placebo, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint at Week 16 defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear (IGA 0,1). These are two of five studies that will be part of the placebo-controlled data program intended to support global registrations.

In the 16-week placebo-controlled phase of BREEZE-AD1 and BREEZE-AD2, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment was similar to placebo, and the most common treatment-emergent adverse events observed were nasopharyngitis and headache. No venous thromboembolic events (VTEs), major adverse cardiovascular events (MACE), or deaths were reported.

"Atopic dermatitis is a chronic inflammatory skin disease that can negatively impact the quality of life for patients, and unfortunately there are limited treatment options, particularly oral medications," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We are encouraged that baricitinib met the primary endpoints in these two studies, and look forward to seeing the collective results of all five studies."

Lilly plans to share the full data results from both the BREEZE-AD1 and BREEZE-AD2 studies at future scientific venues and in peer-reviewed journals, as well as the topline data from other ongoing Phase 3 trials later this year.

Baricitinib is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 50 countries, including the U.S., member states of the EU and Japan, and is marketed as OLUMIANT.

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