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Open Access Highly Accessed Research

Phase 1 results of safety and tolerability in a rush oral immunotherapy protocol to multiple foods using Omalizumab

Philippe Bégin1, Tina Dominguez1, Shruti P Wilson1, Liane Bacal1, Anjuli Mehrotra1, Bethany Kausch1, Anthony Trela1, Morvarid Tavassoli1, Elisabeth Hoyte1, Gerri O’Riordan1, Alanna Blakemore1, Scott Seki1, Robert G Hamilton2 and Kari C Nadeau1*

Author Affiliations

1 Allergy, Immunology, and Rheumatology Division, Stanford University, 269 Campus Drive, CCSR3215c, Stanford, CA 94305, USA

2 Dermatology, Allergy and Clinical Immunology Reference Laboratory, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

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Allergy, Asthma & Clinical Immunology 2014, 10:7  doi:10.1186/1710-1492-10-7

Published: 27 February 2014

Abstract

Background

Up to 30% of patients with food allergies have clinical reactivity to more than one food allergen. Although there is currently no cure, oral immunotherapy (OIT) is under investigation. Pilot data have shown that omalizumab may hasten the ability to tolerate over 4 g of food allergen protein.

Objective

To evaluate the safety and dose tolerability of a Phase 1 Single Site OIT protocol using omalizumab to allow for a faster and safe desensitization to multiple foods simultaneously.

Methods

Participants with multiple food allergies received OIT for up to 5 allergens simultaneously with omalizumab (rush mOIT). Omalizumab was administered for 8 weeks prior to and 8 weeks following the initiation of a rush mOIT schedule. Home reactions were recorded with diaries.

Results

Twenty-five (25) participants were enrolled in the protocol (median age 7 years). For each included food, participants had failed an initial double-blind placebo-controlled food challenge at a protein dose of 100 mg or less. After pre-treatment with omalizumab, 19 participants tolerated all 6 steps of the initial escalation day (up to 1250 mg of combined food proteins), requiring minimal or no rescue therapy. The remaining 6 were started on their highest tolerated dose as their initial daily home doses. Participants reported 401 reactions per 7,530 home doses (5.3%) with a median of 3.2 reactions per 100 doses. Ninety-four percent (94%) of reactions were mild. There was one severe reaction. Participants reached their maintenance dose of 4,000 mg protein per allergen at a median of 18 weeks.

Conclusion

These phase 1 data demonstrate that rush OIT to multiple foods with 16 weeks of treatment with omalizumab could allow for a fast desensitization in subjects with multiple food allergies. Phase 2 randomized controlled trials are needed to better define safety and efficacy parameters of multi OIT experimental treatments with and without omalizumab.

Keywords:
Food allergy; Oral immunotherapy (OIT); Specific Oral Tolerance Induction (SOTI); Multiple food allergy; Safety; Efficacy; Omalizumab; Desensitization