Efficacy and safety of baricitinib in combination with topical corticosteroids in moderate to severe atopic dermatitis: results of a phase 3 randomized, double-blind, placebo-controlled 16-week trial (BREEZE-AD7)
Prof. Kristian Reich
Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing,
University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany
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. 
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.
Key messages/Clinical perspectives
Baricitinib may represent a potential novel treatment option for patients with moderate to severe atopic dermatitis with rapid onset of action.
Presented by: Prof. Kristian Reich, Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany