Published: Mar 5, 2014
By Crystal Phend, Senior Staff Writer, MedPage Today
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SAN DIEGO -- The novel monoclonal antibody dupilumab dramatically cut the severity of moderate-to-severe adult atopic dermatitis, a phase II trial showed.
Eczema Area Severity Index scores dropped by a mean 74% by 12 weeks on weekly injections compared with a 23% reduction on placebo (P<0.0001), Diamant Thaci, MD, of the Universitat zu Lubeck, Germany, and colleagues found.
The anti-IL-4 and IL-13 drug halved severity for 86% of patients and cleared it up almost entirely for 40% (versus 35% and 7% on placebo, respectively, both P<0.0001), they reported here at the American Academy of Allergy, Asthma, and Immunology meeting.
Wesley Burks, MD, of the University of North Carolina at Chapel Hill and a past AAAAI president, called the findings "dramatic" and the lack of rebound worsening after discontinuation, as seen with other treatments, "good."
Patients treated in the trial represent the worst 1% or 2% of patients with atopic dermatitis and a population with onset in the teenage years, instead of in childhood as is more common, noted Robert Wood, MD, of Johns Hopkins.
"In that 2% who are untreatable, it's a horrible disease," he told MedPage Today. "Even though this drug might only apply to a few percent of patients, it could be a lifesaver for them."
He predicted that biologics like dupilumab would work their way down, as shown safe and effective, from adults to teens to children.
Serious adverse events and skin infections were reduced with the drug compared with placebo in the 109-patient phase IIa randomized trial. No infection-related serious events or eczema herpeticum occurred on the biologic.
The study was sponsored by Regeneron and Sanofi.
Thaci disclosed relevant financial relationships with Astellas, Novartis, Regeneron, Celgene, Abbott, Pfizer, Janssen-Cilag, MSD, and Leo-Pharma.
Wood disclosed no relevant financial relationships with industry.
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Primary source: American Academy of Allergy, Asthma, and Immunology
Source reference: Bieber TRM, et al "supilumab monotherapy in adults with moderate-to-severe atopic dermatitis: a 12-week, randomized, double-blind, placebo-controlled study" AAAAI 2014; Abstract L20.