250-μg patch produces significant treatment response compared with placebo after 12 months
WEDNESDAY, Nov. 15, 2017 (HealthDay News) — A 250-μg peanut patch produces a significant treatment response in peanut-allergic patients treated for a year, according to a study published online Nov. 14 in the Journal of the American Medical Association.
Hugh A. Sampson, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted a multicenter phase 2b trial to determine the optimal dose, adverse events (AEs), and efficacy of a peanut patch for treatment of peanut-allergic patients (aged 6 to 55 years). Patients were randomly assigned to receive an epicutaneous peanut patch containing 50, 100, or 250 μg of peanut protein (n = 53, 56, and 56, respectively) or a placebo patch (n = 56). After 12 months of daily patch application, patients underwent a placebo-controlled food challenge to determine an eliciting dose.
The researchers found that a significant absolute difference in response rates was seen at month 12 between the 250-μg patch and the placebo patch (50 versus 25 percent), but no significant difference was seen between the placebo patch and the 100-μg patch. The only significant interaction by age group was for the 250-μg patch; the response rate difference in the 6- to 11-year stratum was 34.2 percent between the 250-μg patch and placebo. There were no dose-related serious adverse events reported.
“In this dose-ranging trial of peanut-allergic patients, the 250-μg peanut patch resulted in significant treatment response versus placebo patch following 12 months of therapy. These findings warrant a phase 3 trial,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including DBV Technologies, which funded the study.
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