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TUESDAY, March 5, 2019 (HealthDay News) — For peanut-allergic children, use of epicutaneous immunotherapy with a peanut patch is associated with a statistically significant increase in the percentage of responders (meeting a defined eliciting dose to a peanut challenge) at 12 months, according to a study published online Feb. 22 in the Journal of the American Medical Association<\/i>.<\/p>\n
David M. Fleischer, M.D., from the University of Colorado Denver School of Medicine in Aurora, and colleagues conducted a phase 3 randomized trial at 31 sites in five countries. A total of 356 peanut-allergic children were enrolled and randomly assigned to daily treatment with a peanut patch containing 250 \u00b5g peanut protein (238 children) or placebo (118 children) for 12 months.<\/p>\n
The researchers found that the responder rate was 35.3 and 13.6 percent with peanut-patch treatment and placebo, respectively (difference, 21.7 percent; 95 percent confidence interval, 12.4 to 29.8 percent; P < 0.001). This response did not meet the prespecified lower bound of the confidence interval threshold. Overall, 95.4 and 89 percent of the active and placebo groups, respectively, had treatment-emergent adverse events, mainly patch application site reactions. The all-causes rates of discontinuation were 10.5 and 9.3 percent in the peanut-patch and placebo groups, respectively.<\/p>\n
“Despite the statistical significance in the proportion of responders, the lower bound of the 95 percent confidence interval of the difference between peanut-patch and placebo-patch treatment groups (12.4 percent) missed equaling or exceeding the 15 percent prespecified margin,” the authors write.<\/p>\n
Several authors disclosed financial ties to the biopharmaceutical industry, including DBV Technologies.<\/p>\n
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