Baricitinib, an oral JAK inhibitor, in combination with topical corticosteroids in adult patients with moderate to severe atopic dermatitis
Baricitinib ( Olumiant ) has met the primary endpoint in BREEZE-AD7, the third pivotal phase 3 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. ( Xagena )
Source: Eli Lilly, 2019