PURPOSE OF THE STUDY.
To evaluate the efficacy, safety, and feasibility of early oral immunotherapy (E-OIT) for treatment of peanut-allergic children.
The study included 40 infants and preschool children (9–36 months of age) with either a known peanut allergy or peanut sensitization (peanut-specific immunoglobulin E (IgE) >5kUA/L but no history of reaction). Matched data from a control cohort of 154 participants was retrospectively obtained from a database at Johns Hopkins and compared with study participants.
In this randomized active treatment study, each enrolled subject underwent an open oral food challenge to 4 g of peanut protein at study entry. Subjects with IgE-mediated allergic reactions were randomized 1:1 to receive either low-dose (300 mg/d) or high-dose (3000 mg/d) blinded maintenance dosing of peanut protein. Each participant had an initial-day escalation and an ∼42-week buildup phase to the goal maintenance dose. Participants in the low-dose arm consumed their peanut protein product mixed with oat flour to maintain blinding. After the study subjects either met specific criteria or had undergone 36 months of maintenance dosing, subjects underwent two double-blinded, placebo-controlled food challenges to assess desensitization and sustained unresponsiveness 4 weeks after cessation of E-OIT. After passing both food challenges, subjects consumed one additional serving of peanut openly and, if tolerated, were allowed to reintroduce peanut ad lib. Peanut-specific IgE levels were followed over time.
Thirty-two subjects had evaluable outcomes, 81% were desensitized (low dose: 76%, high dose: 85%), and 78% achieved 4-SU (low dose: 85%, high dose: 76%, P = .43) over a median treatment period of 29 months. The median (IQR) peanut-specific IgE levels declined significantly in the study group (1.6 kUA/L [0.5–4.9 kUA/L]) while increasing in the matched control group (57.4 kUA/L [9–101 kUA/L]). The proportion of the control group who successfully introduced peanut in their diet was 4%, compared with 78% in the study group (RR, 19.42; 95% CI, 8.7–43.7; P < .001). E-OIT was overall safe and well tolerated with no serious adverse events. Although adverse events were noted in 95% of subjects, all were of mild to moderate severity and only required an antihistamine for treatment.
Early oral immunotherapy with peanut protein at both high- and low-maintenance dosing is very effective for inducing sustained unresponsiveness and accelerating the introduction of peanut in the diet of preschool, peanut-allergic children when compared with a natural history control cohort of peanut-allergic children. Furthermore, this study demonstrated that E-OIT is relatively safe, with no serious adverse events noted in this young age group.
This is the first study to demonstrate effectiveness and safety of OIT in young children, suggesting an advantageous window of time to induce immunomodulation and impact allergic status in young children. Results from ongoing and future studies with placebo-controlled treatment in young children will provide additional information about the potential benefit of early intervention for peanut allergy using oral immunotherapy.
- Copyright © 2017 by the American Academy of Pediatrics