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

Avoidance strategies in patients with cow's milk allergy occasionally fail to protect these patients from inadvertent exposures, leading to life-threatening reactions. To assess the safety and efficacy of milk oral immunotherapy as an alternative therapeutic strategy. 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. 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). 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.