ArticleAllergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology2014
Phase 1 results of safety and tolerability in a rush oral immunotherapy protocol to multiple foods using Omalizumab.
Article in Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 98 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
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Who cites it
98 citing papers in PubMed, 1 synthesis or guideline pooled it, 239 citations in OpenAlex.
- Systematic review and meta-analysis of omalizumab for IgE-mediated food allergy in children and young adults.Frontiers in immunology · 2025Pooled it
- HLA-DRAllergy · 2025Trial
- Omalizumab for the Treatment of Multiple Food Allergies.The New England journal of medicine · 2024Trial
- Anti-IgE treatment with oral immunotherapy in multifood allergic participants: a double-blind, randomised, controlled trial.The lancet. Gastroenterology & hepatology · 2018Trial
- Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy.The Journal of allergy and clinical immunology · 2016Trial
- Update on biologic and small molecules treatments in pediatric allergic diseases.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026Review
- Oral Immunotherapy-Induced Changes in IgE, IgG, and IgA: A Review of Antibody Isotype Shifts and Their Clinical Relevance in Food Allergy.Antibodies (Basel, Switzerland) · 2026Review
- Adjuvant Strategies to Improve the Efficacy of Allergen Immunotherapy.Journal of inflammation research · 2026Review
- Socioenvironmental factors associated with shrimp allergy and shrimp sensitization in a large and diverse patient population and cohort study from metropolitan Detroit.The journal of allergy and clinical immunology. Global · 2025Article
- The Role of Omalizumab as an Adjunct to Oral Immunotherapy in Pediatric Food Allergy: A Systematic Review.Cureus · 2025Review
- Adverse reactions of rush subcutaneous immunotherapy using standardized house dust mite allergen extract and its prediction model construction and analysis.Asia Pacific allergy · 2025Article
- Observational
- Omalizumab and Oral Immunotherapy in IgE-Mediated Food Allergy in Children: A Systematic Review and a Meta-Analysis.Pharmaceuticals (Basel, Switzerland) · 2025Review
- The Etiology of IgE-Mediated Food Allergy: Potential Therapeutics and Challenges.International journal of molecular sciences · 2025Review
- ADP101 multifood oral immunotherapy for food-allergic patients: Harmony phase 1/2 randomized clinical trial.The journal of allergy and clinical immunology. Global · 2025Article
- A phase 2 randomized controlled trial using biologics to improve multi OIT outcomes (COMBINE): design, rationale, and methods.Frontiers in allergy · 2025Article
- Bibliometric Analysis of Global Pediatric Research on Cow's Milk Protein Allergy.Journal of asthma and allergy · 2025Article
- Article
- GAClinical and translational allergy · 2024Review
- The Relationship Between Asthma and Food Allergies in Children.Children (Basel, Switzerland) · 2024Review
38 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
14 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUp 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.
objectiveTo 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.
methodsParticipants 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.
resultsTwenty-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.
conclusionThese 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.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.