Dupilumab promising in treatment of atopic dermatitis

The human monoclonal antibody dupilumab has shown promising results in treating moderate-to-severe atopic dermatitis in a series of phase 2 studies as both monotherapy and in combination with topical glucocorticoids.

The antibody blocks interleukin-4 (IL-4) and interleukin-13 (IL-13), which drive inflammation. It is also under parallel investigation for treating severe asthma.

The most extensive atopic dermatitis (AD) study - conducted by Lisa A. Beck, M.D., of University of Rochester Medical Center, Rochester, New York, and colleagues - randomized 109 patients 1:1 to receive either 300 mg dupilumab administered subcutaneously once a week or placebo. Maximum beneficial effect was achieved at about 30 days and was maintained through to the end of the 12-week study.

The primary endpoint was a 50 percent reduction in EASI score, which was achieved in 85 percent of patients receiving dupilumab and 35 percent of those receiving placebo. Patients receiving dupilumab (40 percent vs. 7 percent) were more likely to achieve a 0 to 1 EASI score indicating clearing or near-clearing of lesions. This confirmed and extended what was seen in earlier, shorter studies.

Next: Side effects from dupilumab

“We are encouraged by the consistent findings across these studies, which show that patients treated with dupilumab had a marked improvement in disease activity and itch,” Dr. Beck said in a news release. “At this point, dupilumab appears to be remarkably effective for adults with severe AD, although larger studies are needed to confirm its safety and efficacy.”

Most side effects were mild or moderate and transient. Patients receiving placebo were more likely to discontinue the study (five vs. one), generally because of a worsening of their atopic dermatitis.

Interim findings at week four found that half of patients (5/10) receiving only topical glucocorticoids achieved EASI-50, while all patients (21/21) receiving dupilumab in combination with glucocorticoids achieved that endpoint.

A long-term phase 3 study is under way, with results anticipated in 2016.

The study findings were published online July 10 in the New England Journal of Medicine.

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