First Real-World Safety Analysis of Preschool Peanut Oral Immunotherapy.

Authors:
Lianne Soller
Lianne Soller
McGill University Health Center
Canada
Elissa M Abrams
Elissa M Abrams
Section of Allergy and Clinical Immunology
Stuart Carr
Stuart Carr
University of Alberta
Canada
Sandeep Kapur
Sandeep Kapur
Russells Hall Hospital
United Kingdom
Sara Leo
Sara Leo
University of Ferrara
Italy
Joanne Yeung
Joanne Yeung
University of Waterloo
Canada

J Allergy Clin Immunol Pract 2019 Apr 17. Epub 2019 Apr 17.

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.

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.

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Source
http://dx.doi.org/10.1016/j.jaip.2019.04.010DOI Listing
April 2019
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