Baricitinib is an oral selective Janus kinase (JAK) 1 and 2 inhibitor that effectively reduced disease severity in moderate to severe atopic dermatitis in two phase III monotherapy studies BREEZE-AD1 and BREEZE-AD2. [1]

• The phase III study BREEZE-AD7 investigated the efficacy and safety of baricitinib in combination with topical corticosteroid (TCS) therapy in adults with moderate to severe atopic dermatitis.

Type of study, patients, and inclusion criteria

• BREEZE-AD7 was a randomised, double-blind, placebo-controlled phase III trial.
• Randomisation was 1:1:1 to placebo, baricitinib 2-mg, or 4-mg daily for 16 weeks.
• The use of low-to-moderate potency TCS was allowed.
• 329 patients were enrolled.

Primary outcome measure

• The primary endpoint was the proportion of patients achieving Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline at week 16.

• The proportion of patients who achieved vIGA-AD score of 0 or 1, the primary endpoint, was significantly higher in the baricitinib 4-mg + TCS group than in the placebo + TCS group (30.6% versus 14.7%, P ≤0.01) (Figure).
• There was also improvement in the primary outcome measure for the baricitinib 2-mg group (23.9%, P = 0.08), but this was not statistically significant.
• Significantly more patients achieved an Eczema Area and Severity Index (EASI)-75 on 4-mg (47.7%, P ≤0.01) and 2-mg (43.1%, P ≤0.01) compared to placebo (22.9%) at week 16.
• Significant improvement in itch was detected as early as week 2 for 4-mg and week 3 for 2-mg.
• Improvements in night-time awakenings, skin pain, Dermatology Life Quality Index (DLQI), and Patient Oriented Eczema Measure (POEM) were observed by week 1 for 4-mg and by weeks 1 to 3 for 2-mg, and were maintained through week 16.
• Baricitinib also resulted in a significant reduction in the amount of moderate potency TCS used during the study (39% and 28% (P ≤0.01) for 4-mg and 2-mg, respectively, compared to placebo).
• Treatment-emergent adverse events were reported in 38%, 56% and 58% of patients, and serious adverse events in 3.7%, 1.8%, and 3.6% of patients on placebo, 2-mg, and 4-mg, respectively.
• The most common adverse events were nasopharyngitis, upper respiratory tract infections, and folliculitis.

• Baricitinib in combination with background TCS therapy significantly improved the signs and symptoms of moderate to severe atopic dermatitis compared to placebo, with a safety profile consistent with prior findings from baricitinib clinical development in atopic dermatitis.