Dupixent improves atopic dermatitis severity in adults

Adult patients with moderate to severe atopic dermatitis demonstrated improvements in overall disease severity after treatment with Dupixent, according to findings from the CAFÉ trial presented at the European Academy of Dermatology and Venereology Congress.

The study included 325 patients randomly assigned Dupixent (dupilumab, Sanofi/Regeneron) 300 mg weekly plus topical corticosteroids, 300-mg dupilumab every 2 weeks plus topical corticosteroids, or placebo with topical corticosteroids.

Eligible participants had inadequately controlled disease or intolerance to cyclosporine A. A 75% or greater improvement in Eczema Area and Severity Index (EASI-75) score at 16 weeks served as the primary endpoint. Secondary endpoints included mean percent change improvement in EASI from baseline to 16 weeks, along with parameters of itching, quality of life, and symptoms of anxiety and depression.

Results indicated that 59% of patients who received the weekly dose of the study drug and 63% of those treated every 2 weeks reached EASI-75 compared with 30% in the placebo arm (P < .0001).

Secondary endpoint data revealed a 78% improvement in EASI in the weekly dupilumab group and an 80% improvement in the group treated every 2 weeks, while the improvement was just 47% in those treated with placebo (P < .0001).

Patient-reported itch, as assessed by the Numerical Rating Scale, improved by 52% in the weekly dupilumab arm and 54% in those treated every 2 weeks compared with a 25% improvement in itch seen in the placebo arm (P < .0001).

Quality of life improvements, as measured by the Dermatology Life Quality Index, were 78% in patients treated weekly and 88% in patients treated every 2 weeks, while the placebo group experienced a 44% improvement in this parameter (P < .0001).

The researchers assessed skin parameters by calculating the proportion of patients who improved by four or more points on the Patient Oriented Eczema Measure. Seventy-six percent of patients treated weekly with dupilumab and 83% of those treated every 2 weeks with the drug reached this endpoint compared with 42% of those in the placebo group (P < .0001).

The researchers observed no new adverse events with dupilumab, with patients in both active treatment arms experiencing similar event rates. Weekly dupilumab yielded a 16% rate of conjunctivitis, while this event occurred in 28% of those treated every 2 weeks and 11% of those in the placebo group. Injection site reaction rates were reported in 11% of those treated weekly, 4% of those treated every 2 weeks and 5% of the placebo group. Four percent of weekly treated patients and 2% of the group treated every two weeks experienced skin infections compared with 8% of those in the placebo group. – by Rob Volansky

Reference:

de Bruin-Weller M, et al. Dupilumab with concomitant topical corticosteroids in adult patients with atopic dermatitis who are not adequately controlled with or are intolerant to cyclosporine A, or when this treatment is medically inadvisable: A placebo-controlled, randomized phase 3 clinical trial (LIBERTY AD CAFÉ). Presented at: European Academy of Dermatology and Venereology Annual Congress; Sept. 13-17, 2017; Geneva.

Disclosure: de Bruin-Weller reports serving as a principal investigator and/or advisory board member for Regeneron and Sanofi-Genzyme, and as a principal investigator, advisory board member and consultant for AbbVie.