Dupilumab, an investigational monoclonal antibody directed against interleukin-4 and interleukin-13, was effective for treatment of moderate to severe atopic dermatitis in adults, and higher doses were associated with better outcomes, according to Dr. Diamant Thaçi, and associates.
In the international, randomized, placebo-controlled study, 379 patients were split into six groups and treated for 16 weeks, receiving either 300 mg dupilumab once a week, 300 mg every 2 weeks, 200 mg every 2 weeks, 300 mg every 4 weeks, 100 mg every 4 weeks, or placebo.
Eczema Area and Severity Index (EASI) scores were most improved in the 300-mg-weekly group, with a reduction of 74%, followed by the 300-mg-every-2-weeks group with a 68% reduction. (Dupilumab is administered subcutaneously). EASI scores were similarly improved in the 200-mg-every-2-weeks and 300-mg-every-4-weeks groups, with reductions of 65% and 64%, respectively. The reduction was 45% in the 100-mg-every-4-weeks group and 18% in the placebo group.
Dr. Diamont Thaci
Adverse events related to treatment were similar in both groups, with 80% of the placebo group and 81% of the dupilumab group reporting at least one adverse event. The most common side effect was nasopharyngitis, reported in 28% of the dupilumab group and in 26% of the placebo group.
“The emerging data with dupilumab in multiple atopic diseases provides the first compelling clinical data to support a single unifying hypothesis regarding the drivers of allergic and atopic diseases in general (i.e., that IL-4 and IL-13 are key drivers of signs and symptoms in these clinical settings), and suggests that their blockade might also be effective in other atopic settings,” the investigators concluded.
This was a dose-ranging phase IIb study. Results from phase III studies of dupilumab in adults with moderate to severe atopic dermatitis that is not adequately controlled with topical atopic dermatitis medications are expected in the first half of 2016. Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority, according to a press statement issued by Regeneron Pharmaceuticals and Sanofi, which are developing the drug.
Find the full study in the Lancet (doi: 10.1016/S0140-6736[15]00388-8).
Dr. Thaçi is with the Comprehensive Center for Inflammation Medicine, at University Hospital Schleswig- Holstein, Campus Lübeck (Germany).