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

Allergy, Asthma & Clinical Immunology

Philippe Bégin²  Tina Dominguez²  Shruti P Wilson²  Liane Bacal²  Anjuli Mehrotra²  Bethany Kausch²  Anthony Trela²  Morvarid Tavassoli²  Elisabeth Hoyte²  Gerri O’Riordan²  Alanna Blakemore²  Scott Seki²  Robert G Hamilton¹  Kari C Nadeau² 

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

[2] Allergy, Immunology, and Rheumatology Division, Stanford University, 269 Campus Drive, CCSR3215c, Stanford, CA 94305, USA

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

Others  :  791885
DOI  :  10.1186/1710-1492-10-7

 received in 2013-12-06, accepted in 2014-01-14,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Bégin et al.; licensee BioMed Central Ltd.

【 图 表 】

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