Top-Line phase III results for oral JAK inhibitor Baricitinib, plus topical corticosteroids in patients with moderate to severe atopic dermatitis

Eli Lilly and Company and Incyte Corporation announced that baricitinib met the primary endpoint in BREEZE-AD7, the third pivotal Phase III trial in the BREEZE-AD program to be completed in 2019. BREEZE-AD7, an investigational study evaluating the efficacy and safety of baricitinib, an oral JAK inhibitor, to treat moderate to severe atopic dermatitis (AD) in adults met its primary endpoint.

Adding baricitinib to standard-of-care topical corticosteroids significantly improved 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 study at 16 weeks.

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.

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 III trials will be announced later this year or early next year.