Sanofi and Regeneron Pharmaceuticals said Wednesday that a Phase III study of Dupixent (dupilumab) in adolescents with moderate-to-severe atopic dermatitis met its primary and key secondary endpoints. The companies noted that a US regulatory submission seeking approval of the therapy for patients ages 12 to 17 is planned for the third quarter.
In the trial, 251 patients who were aged 12 to 17 with moderate-to-severe atopic dermatitis, whose disease could not be adequately controlled with topical medications or for whom topical treatment was medically inadvisable, were randomised to receive placebo or Dupixent administered every two or four weeks. The study's main goal was the proportion of patients with an Investigator's Global Assessment (IGA) score, which measures the overall severity of skin lesions, of 0 or 1 at week 16. A co-primary endpoint outside of the US, and a key secondary endpoint in the US, was the proportion of patients who achieved 75 percent or greater skin improvement as measured by the EASI-75 at week 16.
Results showed that treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching and certain health-related quality of life measures. Sanofi and Regeneron said that Dupixent, which inhibits IL-4 and IL-13, "is the first and only biologic to show positive results in this patient population."
Specifically, data showed that 24 percent of patients who received Dupixent every two weeks and 18 percent of those given the drug every four weeks achieved the primary endpoint, compared with 2 percent for placebo. Further, 41.5 percent of patients who received Dupixent every two weeks and 38 percent administered the therapy every four weeks achieved EASI-75, versus 8 with placebo.
"Current treatment options for these adolescent patients such as topical steroids, oral steroids and non-steroidal immunosuppressants can have significant side effects," remarked Elias Zerhouni, Sanofi's president of global R&D. The companies noted that in the study, Dupixent's safety profile was consistent with that seen in adults, with the overall rate of adverse events being 72 percent in patients given the drug every two weeks, 64 percent for those dosed every four weeks and 69 percent for placebo. Detailed results from the trial are expected to be presented at a future medical meeting.
Dupixent is currently approved in the US, Europe and a number of other countries for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. In addition, filings seeking clearance of Dupixent for the treatment of certain adults and adolescents with inadequately controlled moderate-to-severe asthma are currently under review in the US and EU.
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