First Real-World Safety Analysis of Preschool Peanut Oral Immunotherapy

Lianne Soller; Elissa M Abrams; Stuart Carr; Sandeep Kapur; Gregory A Rex; Sara Leo; Per G Lidman; Joanne Yeung; Timothy K Vander Leek; Mary McHenry; Tiffany Wong; Victoria E Cook; Kyla J Hildebrand; Thomas V Gerstner; Raymond Mak; Nicole J Lee; Scott B Cameron; Edmond S Chan

doi:10.1016/j.jaip.2019.04.010

First Real-World Safety Analysis of Preschool Peanut Oral Immunotherapy

J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2759-2767.e5. doi: 10.1016/j.jaip.2019.04.010. Epub 2019 Apr 17.

Authors

Lianne Soller¹, Elissa M Abrams², Stuart Carr³, Sandeep Kapur⁴, Gregory A Rex⁴, Sara Leo⁵, Per G Lidman³, Joanne Yeung⁶, Timothy K Vander Leek³, Mary McHenry⁴, Tiffany Wong⁷, Victoria E Cook⁸, Kyla J Hildebrand⁷, Thomas V Gerstner⁹, Raymond Mak¹⁰, Nicole J Lee⁷, Scott B Cameron⁸, Edmond S Chan⁷

Affiliations

¹ British Columbia Children's Hospital Research Institute, Vancouver, BC, Canada; Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada. Electronic address: lsoller@bcchr.ca.
² Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; Department of Pediatrics, Section of Allergy and Clinical Immunology, University of Manitoba, Winnipeg, MB, Canada; Meadowood Medical Center, Winnipeg, MB, Canada.
³ Pediatric Allergy & Asthma, Department of Pediatrics, University of Alberta, Edmonton, AB, Canada.
⁴ Division of Allergy, Department of Pediatrics, Dalhousie University/IWK Health Centre, Halifax, NS, Canada; Halifax Allergy & Asthma Associates, Halifax, NS, Canada.
⁵ Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; West Coast Allergy and Immunology Clinic, Vancouver, BC, Canada.
⁶ Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; Vancouver Pediatric and Allergy Centre, Vancouver, BC, Canada.
⁷ British Columbia Children's Hospital Research Institute, Vancouver, BC, Canada; Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.
⁸ Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; Community Allergy Clinic, Victoria, BC, Canada.
⁹ Department of Pediatrics, Section of Allergy and Clinical Immunology, University of Manitoba, Winnipeg, MB, Canada; Meadowood Medical Center, Winnipeg, MB, Canada.
¹⁰ Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.

PMID: 31002957
DOI: 10.1016/j.jaip.2019.04.010

Abstract

Background: In 2017, a clinical trial of 37 subjects demonstrated that preschool peanut oral immunotherapy (P-OIT) was safe, with predominantly mild symptoms reported and only 1 moderate reaction requiring epinephrine.

Objectives: We sought to examine whether these findings would be applicable in a real-world setting.

Methods: As part of a Canada-wide quality improvement project, community and academic allergists administered P-OIT to preschool-age children who had (1) skin prick test wheal diameter greater than or equal to 3 mm or specific IgE level greater than or equal to 0.35 kU/L and history of reaction and/or positive baseline oral food challenge, or (2) no ingestion history and specific IgE level greater than or equal to 5 kU/L. Over 16 to 22 weeks, patients had biweekly clinic visits for updosing, and consumed the dose daily at home between visits. Target maintenance dose was 300 mg peanut protein. Symptoms were classified using a modified World Allergy Organization Subcutaneous Immunotherapy Reaction Grading System (1 mildest, 5 fatal).

Results: Of 270 patients who started P-OIT in the period 2017 to 2018, 243 reached maintenance, and 27 dropped out (10.0%); 67.8% of patients experienced reactions during buildup: 36.3% grade 1, 31.1% grade 2, and 0.40% grade 4. Eleven patients (4.10%) received epinephrine (10 patients received 1 dose, 1 patient received epinephrine on 2 separate days), representing 2.23% of reactions (12 of 538) and 0.029% of doses (12 of 41,020).

Conclusions: We are the first group to describe preschool P-OIT in a real-world multicenter setting. The treatment appears to be safe for the vast majority of patients because symptoms were generally mild and very few reactions received epinephrine; however, life-threatening reactions in a minority of patients (0.4%) can still occur.

Keywords: Adverse events; Allergic reactions; Oral immunotherapy; Peanut allergy; Peanut oral immunotherapy; Preschool children; Preschoolers; Real-world; Safety.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Administration, Oral
Allergens / adverse effects
Allergens / immunology
Arachis / adverse effects
Arachis / immunology
Canada
Child, Preschool
Desensitization, Immunologic*
Female
Humans
Immunoglobulin E / blood
Infant
Male
Peanut Hypersensitivity / blood
Peanut Hypersensitivity / therapy*
Skin Tests

Substances

Allergens
Immunoglobulin E