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Dupilumab produces dramatic improvement in atopic dermatitis


 

FROM THE NEW ENGLAND JOURNAL OF MEDICINE

References

The monoclonal antibody dupilumab, which blocks the action of the type 2 helper T-cell (Th2) cytokines interleukin-4 and interleukin-13, produced rapid and significant improvement in all signs, symptoms, and biomarkers of atopic dermatitis in four industry-sponsored randomized clinical trials. The data were reported online July 9 in the New England Journal of Medicine.

In particular, once-weekly subcutaneous injections of dupilumab quickly yielded substantial reductions in pruritus, "a major contributor to reduced quality of life experienced by patients with atopic dermatitis," said Dr. Lisa A. Beck of the department of dermatology, University of Rochester (N.Y.) Medical Center, and her associates.

These findings "extend the potential benefit of this new biologic therapy beyond asthma to a second atopic disorder" and suggest that the treatment may be beneficial for other atopic disorders as well, they noted (N. Engl. J. Med. 2014;371:130-9 [doi:10.1056/NEJMoa1314768]).

The four double-blind, placebo-controlled trials involved a total of 207 adults aged 18 years and older in the United States and Europe who had poorly controlled moderate to severe atopic dermatitis of at least 2 years’ duration. Two studies assessed 4 weeks of monotherapy with dupilumab, one assessed 12 weeks of monotherapy, and the fourth assessed 4 weeks of dupilumab added to topical glucocorticoids.

In all four studies, dupilumab induced rapid, dose-dependent improvements in an investigator’s global assessment score, a measure of the percentage of affected body-surface area, scores on the Eczema Area and Severity Index, and scores on both the 5-D pruritus scale and an additional numerical-rating scale of pruritus. In the 12-week trial, for example, 85% of patients given dupilumab achieved at least a 50% reduction in EASI scores, and mean scores on the pruritus rating scale declined by 56%.

Adverse events in all study groups were generally mild and transient: Nasopharyngitis and headache were reported more frequently in the active-treatment groups than in the placebo groups. However, serious adverse events and adverse events leading to treatment withdrawal – chiefly skin infections and exacerbations of the underlying dermatitis – were more common in the placebo groups and were related to lack of efficacy.

This study was funded by Regeneron Pharmaceuticals and Sanofi, which also performed data analysis and assisted with writing the report. Dr. Beck reported other ties to Regeneron; her associates reported ties to numerous industry sources.

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