Abstract
BackgroundPeanut allergy is an increasingly common health problem. Current treatment guidelines are based on strict avoidance. However, in the last few years, oral immunotherapy protocols have shown promising results yielding increased tolerance to peanut in allergic children. Adolescence is particularly at risk.Methods/DesignWe have designed a randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of peanut oral escalating immunotherapy in a 12- to 18–year-old population with proved allergy to peanut. Patients are selected when the threshold of peanut intake is over 100 mg and 2 cumulated g on the first double-blind, placebo-controlled oral food challenge (DBPCOFC).During the build-up placebo-controlled blinded phase, doses containing peanut or placebo will be administered by gradual up-dosing from 10 mg to 2 g with 2-weekly increments. After this first randomized phase, the desensitized participants will continue to intake native peanut in an unblinded process during 13 or 37 weeks following a second randomization. Adverse events are picked up and managed throughout the entire protocol.The main endpoint is the percentage of patients with negative DBPCOFC at the threshold of 2 g of cumulative peanut at the end of the build-up phase of 24 weeks.Secondary endpoints include: (1) desensitization 6 weeks and 6 months after the end of the maintenance phase; (2) adverse effects during the build-up phase; (3) immunological profile confirming peanut desensitization. Immunologic assays will be carried out at every DBPCOFC and at the middle of the build-up phase to evaluate the peanut immunologic profile modifications.DiscussionThis double-blind, placebo-controlled study will be, to our knowledge, the first evaluation of a peanut oral immunotherapy protocol in teenagers in the purpose to reduce severe reactions after unexpected intake and to improve quality of life.Trial registrationClinicalTrial.gov: NCT02046083 (23 January 2014).
Highlights
Peanut allergy is an increasingly common health problem
Specific oral immunotherapy is an interesting way of modifying the natural history of peanut allergy
Since 2009, peanut-specific oral immunotherapy protocols have been implemented with the aim of inducing desensitization, which was achieved in 61% [8] to 84% of cases [9]
Summary
Peanut allergy is an increasingly common health problem. Current treatment guidelines are based on strict avoidance. Peanut allergy is one of the most common forms of food allergy encountered in clinical pediatric practice especially in children above 3 years old. In a Cochrane review published in 2012 by Sheikh and Nurmatov [10], only one doubleblind, placebo-controlled study [9] validated the concept of oral immunotherapy for peanut allergy in children. This trial involved only children aged less than 10 years, and nothing is known about desensitization in adolescents with high-level peanut specific IgE. Anagnostou et al demonstrated the interest of tolerance induction versus strict avoidance [11]
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