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.
David M. Fleischer, MD, 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 µg peanut protein (238 children) or placebo (118 children) for 12 months.
The researchers found that the responder rate was 35.3 and 13.6% with peanut-patch treatment and placebo, respectively (difference, 21.7%; 95% confidence interval, 12.4 to 29.8%; P < 0.001). This response did not meet the prespecified lower bound of the confidence interval threshold. Overall, 95.4 and 89% 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% in the peanut-patch and placebo groups, respectively.
“Despite the statistical significance in the proportion of responders, the lower bound of the 95% confidence interval of the difference between peanut-patch and placebo-patch treatment groups (12.4%) missed equaling or exceeding the 15% prespecified margin,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry, including DBV Technologies.