Adding the oral JAK inhibitor baricitinib to standard-of-care topical corticosteroids significantly improved atopic dermatitis disease severity, measured by the validated Investigator's Global Assessment for AD (vIGA) score of "clear or almost clear" skin (vIGA 0, 1), the primary endpoint of the Phase 3 study at 16 weeks, the Companies report.
The study, BREEZE-AD7, conducted outside of the United States, is the third of five placebo-controlled trials in the Phase 3 program and recruited patients from Asia, Europe, South America and Australia.
Safety data were consistent with the known safety profile of baricitinib. The most common treatment-emergent adverse events observed were nasopharyngitis, upper respiratory tract infection and folliculitis. One pulmonary embolism was reported in the baricitinib group. One opportunistic infection was reported in the placebo group. No malignancies, major adverse cardiovascular events (MACE), or deaths were reported in the study.
"Despite recent scientific advances, moderate to severe atopic dermatitis remains a disease with significant unmet treatment needs. Atopic dermatitis is a chronic, relapsing condition that can vary greatly from person to person, and yet there are few medicines to address the different signs and symptoms in each patient," says Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly, in a news release. "Today's baricitinib results in combination therapy reveal important additional clinical information in a chronic disease where patients currently have limited oral treatment options."
Baricitinib 4 mg and 2 mg both met the primary endpoint on BREEZE-AD1 and BREEZE-AD2 clinical trials disclosed earlier this year. Lilly plans to share the detailed 16-week data and analyses from BREEZE-AD7 at future scientific venues and in peer-reviewed journals later this year. Top-line data from the remaining two Phase 3 trials will be announced later this year or early next year.
Baricitinib is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 60 countries, including the U.S., member states of the EU and Japan, and is marketed as OLUMIANT.