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Investigators from multiple institutions conducted a randomized controlled trial assessing the efficacy and safety of epicutaneous immunotherapy with a peanut patch in young children with peanut allergy. Study participants were children 1-3 years old with documented peanut allergy. At baseline, participants underwent a double-blind food challenge; peanut protein at doses of 1, 3, 10, 30, 100, and 300 mg were administered. The minimum dose that elicited pre-specified symptoms was considered the eliciting dose. Study children were randomized 2:1 to receive daily patches containing 250 μg of peanut protein or placebo patches, applied to the interscapular area. After a 12-month treatment period, the double-blind food challenge was repeated, with additional doses of 1,000 and 2,000 mg of peanut protein added to the challenge. The primary outcome was a positive response to treatment, defined as an eliciting dose ≥1,000 mg at follow-up in participants whose baseline eliciting dose was >10 mg, or ≥300 mg in those with an eliciting dose ≤10 mg. Secondary endpoints included change in eliciting dose from baseline to follow-up and follow-up eliciting dose ≥1,000 mg. Differences and 95% confidence intervals (CI) between participants in the intervention and placebo groups were compared. Adverse events, including those related to patching and systemic events, also were recorded.
A total of 362 participants, including 244 randomized to epicutaneous immunotherapy with peanut patches and 118 assigned to the placebo group, were enrolled in the study. The median age of study children was 2.5 years. After 12 months of treatment, 67.0% of children in the intervention group and 33.5% of those randomized to placebo met the positive response to treatment criteria (difference, 33.4 percentage points; 95% CI, 22.4, 44.5; P <0.001). The median change in eliciting dose among those in the intervention group was 900 mg vs 0 mg for placebo recipients (P <0.001). A total of 62.4% of participants randomized to the intervention and 29.6% of those in the placebo group had follow-up eliciting doses ≥1,000 mg (difference, 34.7 percentage points; 95% CI, 23.6, 45.7). Adverse events related to patching occurred in 98.0% and 90.7%, respectively, of children in the intervention and placebo groups. Serious adverse events occurred in 8.6% of those receiving epicutaneous immunotherapy and 2.5% of placebo recipients. Anaphylaxis was reported in 7.8% of children in the intervention group and 3.4% of those randomized to placebo.
The authors conclude that among children 1-3 years old with peanut allergy, epicutaneous immunotherapy was superior to placebo in desensitizing children to peanuts and increasing the dose that triggered allergic symptoms.
Dr Doolittle has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
Peanut allergy, which affects approximately 2% of children in the United States, is a common...
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