Adults with moderate-to-severe atopic dermatitis who were treated with Dupixent (dupilumab) from Sanofi and Regeneron along with topical corticosteroids experienced improvements in overall disease severity, according to results from phase 3 of the CAFÃ‰ trial.
Adults with moderate-to-severe atopic dermatitis who were treated with Dupixent (dupilumab) from Sanofi and Regeneron along with topical corticosteroids experienced improvements in overall disease severity, according to results from phase 3 of the CAFÉ trial. The findings were presented at the 26th European Academy of Dermatology and Venereology Congress, which met September 13-17 in Geneva, Switzerland.
The study was assessing the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index (EASI-75) score, which is used to measure extent and severity of disease, at 16 weeks from baseline. The study included 325 patients in Europe with moderate-to-severe atopic dermatitis who were inadequately controlled with, or intolerant to, the broad immunosuppressant drug cyclosporine A or for whom the treatment was medically inadvisable.
Patients were randomized into 3 treatment groups and received topical corticosteroids with either a weekly or biweekly treatment with Dupixent or a placebo.
The researchers found that 59% of patients receiving Dupixent weekly with topical corticosteroids and 63% of patients receiving Dupixent every 2 weeks with topical corticosteroids achieved EASI-75. Only 30% of those receiving the placebo achieved EASI-75.
"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," Marjolein De Bruin-Weller, MD, PhD, dermatologist, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, said in a statement. "In the CAFÉ study, Dupixent 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.”
From baseline to 16 weeks, the mean percent change improvement in EASI was 78% for weekly patients and 80% for patients receiving Dupixent every 2 weeks, respectively. Those receiving placebo had a mean percent change improvement of just 47%.
The 3 arms of the study had similar proportions of patients reporting adverse events. However, conjunctivitis was more frequently in patients receiving Dupixent—16% for weekly patients and 28% in patients receiving every 2 weeks—compared with 11% of patients on placebo. In addition, 11% of patients receiving Dupixent weekly and 4% receiving it every 2 weeks reported injection site reactions compared with 5% of patients receiving placebo. However, more patients receiving placebo reported skin infections (8%) compared with patients receiving Dupixent weekly (4%) or every 2 weeks (2%).