WEDNESDAY, July 10, 2024 (HealthDay News) -- For patients with moderate-to-severe atopic dermatitis (AD), sustained safety and efficacy are seen for long-term dupilumab treatment, according to a study published online July 10 in JAMA Dermatology.
Lisa A. Beck, M.D., from the University of Rochester Medical Center in New York, and colleagues examined the safety and efficacy of dupilumab treatment for up to five years in adults with moderate-to-severe AD in an open-label extension study conducted at 550 sites in 28 countries. A total of 2,677 patients were enrolled and treated in the extension study; 334 patients (12.5 percent) completed treatment up to week 260.
The researchers found that the most common reasons for withdrawal were regulatory approval of dupilumab in compliance with the study protocol, patient withdrawal, and adverse events (58.7, 18.0, and 8.4 percent, respectively). Throughout the study, exposure-adjusted rates of treatment-emergent adverse events (TEAEs) were generally stable or declined. Nasopharyngitis, worsening AD, upper respiratory tract infection, conjunctivitis, conjunctivitis allergic, headache, oral herpes, and injection-site reaction were common TEAEs (incidence of ≥5 percent). Overall, 67.5 and 88.9 percent of patients achieved an Investigator's Global Assessment score of 0 or 1 and 75 percent or greater improvement in the Eczema Area and Severity Index, respectively, at week 260.
"Dupilumab showed acceptable safety and sustained efficacy with improvements in AD signs, symptoms, and quality of life in adults with moderate-to-severe AD," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Sanofi and Regeneron, which manufacture dupilumab and funded the study.
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