Effect of ketotifen premedication on adverse reactions during peanut oral immunotherapy

Allergy, Asthma & Clinical Immunology

Amanda Jagdis⁴  Noam Berlin¹  Carly Barron²  Mohana Giruparajah²  Nathan Leader⁵  Sean Maclachlan³  Gordon L Sussman⁴ 

[1] Faculty of Medicine, University of Toronto, Toronto, ON, Canada

[2] Gordon Sussman Clinical Research Inc., Toronto, ON, Canada

[3] Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada

[4] Division of Clinical Immunology and Allergy, Department of Medicine, University of Toronto, 202 St Clair Ave W, Toronto, ON M4V 1R2, Canada

[5] Melbourne Medical School, University of Melbourne, Melbourne, Australia

关键词: Adverse reactions;    Desensitization;    Ketotifen;    Antihistamine premedication;    Oral immunotherapy;    Peanut allergy;   

Others  :  1082142
DOI  :  10.1186/1710-1492-10-36

 received in 2014-04-07, accepted in 2014-06-27,  发布年份 2014

【 摘 要 】

Background

Oral immunotherapy (OIT) has shown promise in inducing desensitization for food allergy. However, there are safety concerns regarding the frequency and severity of adverse events during food OIT.

Objective

To evaluate the effect of Ketotifen premedication on adverse reactions during peanut OIT.

Methods

A randomized single blind placebo controlled pilot study was performed. Peanut OIT was performed using a previously published protocol. Ketotifen was up-titrated to 2 mg twice daily over two weeks (week -2 to 0), followed by a peanut OIT initial escalation day (day 1). Ketotifen was administered from week 0–4 of peanut OIT; reactions to peanut OIT doses were recorded by clinic staff and subject diary.

Results

Six subjects (median age 10 years, peanut IgE >100kU_A/L) were enrolled, 4 randomized to Ketotifen, 2 to placebo. The most common side effect of Ketotifen was fatigue (9% during up-titration). The rate of reaction per peanut OIT dose was lower for subjects on ketotifen (K) compared to placebo (P) during initial escalation on day 1 (K: 22% (8/36) vs. P: 67% (12/18)); week 0–4 build-up doses (K: 75% (3/4) vs. P: 100% (2/2)); and week 0–4 home doses (K: 50% (54/108) vs. P: 82% (27/33)). The rate of gastrointestinal symptoms per peanut OIT dose was also lower for subjects on ketotifen during initial escalation on day 1 (K: 17% (6/36) vs. P: 61% (11/18)); week 0–4 build-up doses (K: 75% (3/4) vs P: 100% (2/2)); and week 0–4 home doses (K: 46% (50/108) vs. P: 82% (27/33)).

Conclusions

Ketotifen premedication is well tolerated and reduces the rate of gastrointestinal symptoms during peanut OIT. These findings require confirmation in a larger study of Ketotifen premedication used throughout peanut OIT.

Trial registration

Clinical Trials number: NCT0162515

【 授权许可】

   
2014 Jagdis et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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