Atopic Dermatitis News From EADV Congress

poster EADVPhase 3 Dupilumab Data 

Positive results were presented in a late-breaking news session from the phase 3 CAFÉ study of dupilumab (Dupixent) in adults with moderate to severe AD who are inadequately controlled with or intolerant to the broad immunosuppressant drug cyclosporine A (CSA), or when this treatment is medically inadvisable.1 Dupilumab is a human monoclonal antibody that is designed to simultaneously inhibit overactive signaling of IL-4 and IL-13 cytokines.

In the study, dupilumab with topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearing, itching, and patient-reported quality of life measures. CSA is approved for the treatment of AD in most European countries and Japan; it is not approved in the United States for this use. 

The study’s primary endpoint was the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index (EASI 75) score at 16 weeks from baseline. A total of 325 patients in Europe were randomized into 3 treatment arms in the 16-week study to either dupilumab 300 mg weekly with TCS, dupilumab 300 mg every 2 weeks with TCS, or placebo with TCS. A total of 59% of patients who received dupilumab weekly with TCS, and 63% of patients who received dupilumab every 2 weeks with TCS achieved EASI 75 compared with 30% of those patients who received placebo with TCS (P <.0001).

The mean percent change improvement in EASI from baseline at 16 weeks (a secondary endpoint) was 78% and 80% for patients who received dupilumab weekly or every 2 weeks with TCS, respectively, compared with 47% for those who received placebo plus TCS (P< .0001).

“In moderate-to-severe atopic dermatitis, some patients stop cyclosporine therapy due to intolerance or lack of efficacy, or are not candidates because of other medical conditions or contraindicated medications,” explained Marjolein De Bruin-Weller, MD, PhD, dermatologist with the National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht in Utrecht, Netherlands. “In the CAFÉ study, dupilumab with topical corticosteroids significantly improved overall measures of disease severity including lesions, itch, quality of life measures, and symptoms of anxiety and depression in these patients. The safety profile in this study was consistent with 3 previous positive dupilumab phase 3 studies in moderate-to-severe atopic dermatitis.” 

Other secondary endpoints of the study included measures of the impact of dupilumab on the persistent itch caused by the disease, quality of life measures, and symptoms of anxiety and depression. The results for these secondary endpoints at 16 weeks showed that the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the pruritus Numerical Rating Scale, was 52% and 54% in patients who received dupilumab weekly or every 2 weeks with TCS, respectively, compared with 25% for those who received placebo plus TCS (P <.0001). 

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