Adding baricitinib to topical corticosteroids significantly improved disease severity in adult patients with moderate to severe atopic dermatitis, according to top-line results from BREEZE-AD7 study.
The phase 3 study included 300 patients who had been diagnosed with moderate to severe atopic dermatitis for at least 12 months and had an inadequate response to topical medications. Patients were randomized to receive baricitinib, an oral Janus kinase (JAK) inhibitor, or placebo, in combination with topical corticosteroids. The primary outcome measure was the proportion of patients achieving Investigator’s Global Assessment (IGA) of 0 (clear) or 1 (almost clear) with a ≥2 point improvement at 16 weeks.
Results showed that a significantly greater percentage of patients treated with baricitinib 2mg (23.9%) and 4mg (30.6%) achieved the primary end point compared with those given placebo (14.7%). In addition, 43.1% of the baricitinib 2mg group and 47.7% of the baricitinib 4mg group achieved Eczema Area and Severity Index 75 (EASI75) at 16 weeks (secondary end point), compared with 22.9% of the placebo arm.
With regard to safety, the most common treatment-emergent adverse events included nasopharyngitis, upper respiratory tract infection and folliculitis.
BREEZE-AD7 is part of the BREEZE-AD program that includes multiple trials evaluating baricitinib in the treatment of moderate to severe atopic dermatitis; earlier this year baricitinib 2mg and 4mg both met the primary end point in the BREEZE-AD1 and BREEZE-AD2 studies. Additional information from BREEZE-AD7 will be presented at future medical meetings and publications later this year, according to Lilly.
Baricitinib (Olumiant) is currently approved to treat moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to 1 or more tumor necrosis factor antagonists.