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Baricitinib plus topical steroids improves atopic dermatitis symptoms

Combination treatment with baricitinib and topical corticosteroids was associated with a higher proportion of patients achieving clear or almost clear skin, according to data from the BREEZE-AD7 trial.

Adults with moderate to severe atopic dermatitis were enrolled in the randomized, double-blind, placebo-controlled phase 3 trial and assigned 1:1:1 to daily Olumiant (baricitinib, Eli Lilly) 2 mg (n = 109), 4 mg (n = 111) or placebo (n = 109) for 16 weeks. Topical corticosteroids of low to moderate potency were allowed, according to the abstract of the study, presented at the European Academy of Dermatology and Venereology Congress.

The primary endpoint was the number of patients achieving clear or almost clear skin per the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and an improvement of 2 or more points from baseline to week 16.

A significantly higher proportion of patients in the 4 mg plus corticosteroid group achieved clear or almost clear skin, or a vIGA-AD score of 0 or 1, compared with placebo plus corticosteroids (30.6% vs. 14.7%; P .01); 23.9% of patients in the 2 mg group also achieved vIGA-AD scores of 0 or 1, but the difference was not statistically significant.

Additionally, at week 16, the proportion of patients with Eczema Area and Severity Index-75 was significantly higher in the 4 mg and 2 mg groups compared with placebo (47.7% and 43.1% vs. 22.9%; P .01 for both). Itch significantly improved by week 2 for patients in the 4 mg group and week 3 for those in the 2 mg group. Skin pain, nighttime awakenings, Dermatology Life Quality Index and Patient Oriented Eczema Measure improved by week 1 for the 4 mg group and weeks 1 to 3 for the 2 mg group.

Post hoc analysis revealed that compared with placebo, the number of corticosteroid-free days was significantly higher in patients in the baricitinib groups (17% vs. 33% in the 4 mg group [P .01] and 17% vs. 25% in the 2 mg group [P .05]).

According to the abstract, baricitinib reduced the amount of moderate potency topical corticosteroids used in the study vs. placebo: 39% in the 4 mg group and 28% in the 2 mg group (P .01 for both).

Common adverse events included nasopharyngitis, upper respiratory tract infections and folliculitis and occurred among 38% of patients in the placebo group, 56% of those in the 2 mg group and 58% of those in the 4 mg group. Serious events occurred in 3.7% of patients in the placebo group, 1.8% of those in the 2 mg group and 3.6% of those in the 4 mg group. – by Stacey L. Adams

Reference:

Reich K, et al. 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). Presented at: 28th European Academy of Dermatology and Venereology Congress; Oct. 9-13, 2019; Madrid.

Disclosure: Healio Dermatology was unable to confirm any relevant financial disclosures at the time of publication.