Open Label Maintenance Following Milk Oral Immunotherapy (MOIT) for IgE Mediated Cow's Milk Allergy

Abstract

RATIONALE: To determine the safety and efficacy of continued milk intake after oral immunotherapy for children with severe IgE-mediated cow's milk allergy. METHODS: Patients who had completed the double blind portion of MOIT study were continued on daily dietary milk intake, with doses based on post-treatment challenge. Only those who could tolerate >2,540 mg in their post-MOIT challenge were eligible. Gradual dose escalations were determined by the investigators and follow-up challenge with a cumulative dose of 16,000 mg was performed. RESULTS: 15 subjects aged 6-16 years were included. Initial milk doses ranged from 500 to 4,000 mg (median 1,000). 9 patients were able to escalate their daily doses by 2-15-fold (median 5-fold). After 13 to 52 weeks (median 16) of dosing, challenges were conducted on 13 patients. 6 tolerated 16,000 mg with no reaction and 7 reacted at 3,000 mg to 16,000 mg. In the 1,938 total doses recorded (median per child 148, range 95-364), 407 local reactions were reported (21% of doses, median 30, range 2-105). Other reactions included 74 gastrointestinal (3.8%, median 5, range 1-38); 20 respiratory (1%, median 3, range 1-8); 20 cutaneous (1%, median 6, range 1-7); and 143 multi-system (7.4%, median 2, range1-76). Treatment included diphenhydramine for 68 (3.5%) reactions, albuterol in 12 (0.6%), epinephrine 6 (0.3%) and prednisone 3 (0.2%). CONCLUSIONS: In highly milk allergic children, MOIT led to the ability to tolerate 1,000 to 16,000 mg of milk daily with about 25% tolerating unlimited intake. However, reactions were common and largely unpredictable, with several systemic reactions occurring at previously tolerated doses.