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A “real world” multi-site safety analysis of peanut oral immunotherapy for preschool age children

Published online: April 16, 2019

In early 2017, a seminal paper published by Vickery et al. demonstrated for the first time that peanut oral immunotherapy (P-OIT) was very effective and safe in preschool-aged children (9-36 months of age), with only mild to moderate reactions and one moderate reaction requiring epinephrine. In addition, there is evidence that infants may be less fearful of their food allergens and their immune systems may be more easily altered than older children. This has led some allergists who had reservations about offering P-OIT outside of a research setting to consider it as a treatment option for preschool children in their clinics.

Following publication of the Vickery et al. trial, a group of community and academic allergists from across Canada initiated a quality improvement project entitled Canadian Preschool Peanut Oral Immunotherapy (CPP-OIT) to determine the safety of preschool P-OIT outside of a research setting and provide practitioners with guidance more relevant to their clinical practices. In a recent article published by The Journal of Allergy and Clinical Immunology: In Practice, Soller et al. describe the first real-world safety data on 270 preschool-aged children as part of CPP-OIT.

Following one of 3 protocols, allergists administered P-OIT to preschool-aged children (9 months to 5 years of age) who fulfilled specific entry criteria starting with a very small amount of peanut, and increasing the dose in the allergy clinic every two weeks, up to a maintenance dose of 300mg peanut protein. The child ate the peanut dose every day at home between clinic visits, and allergists collected information from the parents about symptoms and treatment of allergic reactions, including administration of epinephrine, while on P-OIT.  

Of 270 patients who started P-OIT in 2017-18, 243 reached maintenance, and 27 dropped out (10.0%). Although 67.8% of patients experienced allergic reactions on P-OIT, only one patient (0.40%) experienced a severe reaction, and only 12 doses of epinephrine were administered out of over 40,000 peanut doses (0.03%).  

The authors are the first group to describe preschool P-OIT in a real-world multi-center setting. They concluded that the treatment appears to be safe for the vast majority of preschoolers as symptoms were generally mild, and very few reactions received epinephrine; however, they note that life-threatening reactions in a minority of patients (0.4%) can still occur.

The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.