Clinical predictors for favorable outcomes in an oral immunotherapy program for IgE-mediated cow's milk allergy

Background: Avoidance strategies in patients with cow's milk allergy occasionally fail to protect these patients from inadvertent exposures, leading to life-threatening reactions. Objective: To assess the safety and efficacy of milk oral immunotherapy as an alternative therapeutic strategy. Methods: Patients (n = 280, >4 years old) with IgE-mediated cow's milk allergy were enrolled into a milk oral immunotherapy program at a single hospital center. High-risk patients were not excluded. The treatment protocol consisted of 3 rounds of oral induction performed every 4 weeks. On day 1, a patient's reaction threshold was determined. On days 2 and 3, a tolerated starting dose below the threshold was confirmed. Day 4 mimicked the home treatment, which continued until the next induction. Results: The median initial starting dose was 52.5 mg of cow's milk protein. Excluding those whose treatment failed in the first week (n = 5) or are still undergoing treatment (n = 15), 61.5% (160 of 260 patients) achieved 7,200 mg and 85.4% of patients were consuming at least 180 mg of milk protein. Reactions at home requiring the use of injectable epinephrine occurred in 15.7% of patients (44 of 280) and in 0.075% (58 of 77,098) of doses administered. Predictors for achieving a full dose in multivariate analysis included a starting dose higher than 30 mg of milk protein (odds ratio 4.6, P < .001), not requiring epinephrine during induction (odds ratio 5.2, P < .001) or home treatment (odds ratio 2.6, P = .037), and the lack of nonanaphylactic type symptoms (odds ratio 15.6, P < .001). Conclusion: Milk oral immunotherapy, carried out in a highly controlled setting, is successful in protecting the overwhelming majority of patients from accidental exposures to cow's milk protein. (C) 2014 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.