Safety of a peanut oral immunotherapy protocol in children with peanut allergy
Received 14 October 2008; received in revised form 30 March 2009; accepted 31 March 2009. published online 28 May 2009.
Background
Oral immunotherapy (OIT) offers a promising therapeutic option for peanut allergy. Given that during OIT an allergic patient ingests an allergen that could potentially cause a serious reaction, the safety of OIT is of particular concern.
Objective
The purpose of this study was to examine safety during the initial escalation day, buildup phase, and home dosing phase in subjects enrolled in a peanut OIT study.
Methods
Skin, upper respiratory tract, chest, and abdominal symptoms were recorded with initial escalation day and buildup phase dosings. Subjects also maintained daily diaries detailing symptoms after each home dosing. A statistical analysis of these data was performed.
Results
Twenty of 28 patients completed all phases of the study. During the initial escalation day, upper respiratory tract (79%) and abdominal (68%) symptoms were the most likely symptoms experienced. The risk of mild wheezing during the initial escalation day was 18%. The probability of having any symptoms after a buildup phase dose was 46%, with a risk of 29% for upper respiratory tract symptoms and 24% for skin symptoms. The risk of reaction with any home dose was 3.5%. Upper respiratory tract (1.2%) and skin (1.1%) symptoms were the most likely after home doses. Treatment was given with 0.7% of home doses. Two subjects received epinephrine after 1 home dose each.
Conclusions
Subjects were more likely to have significant allergic symptoms during the initial escalation day when they were in a closely monitored setting than during other phases of the study. Allergic reactions with home doses were rare.
aDivision of Allergy and Immunology, Department of Pediatrics, Duke University Medical Center, Durham, NC
bDivision of Allergy and Immunology, Department of Pediatrics, University of Arkansas, Little Rock, Ark
cDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC
Reprint requests: Wesley Burks, MD, Division of Allergy and Immunology, Duke University Medical Center, Box 2644, Durham, NC 27710.
Supported by the Food Allergy and Anaphylaxis Network, the Gerber Foundation, the Food Allergy Project, and the Dorothy and Frank Robins Family Foundation. The project described was supported by grant no. 1 UL1 RR024128-01 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH) and NIH Roadmap for Medical Research, and its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH.
Disclosure of potential conflict of interest: A. M. Hofmann has received research support from the Pediatric Scientist Development Program. A. M. Scurlock has received research support from Genocea Biosciences and NIH. S. M. Jones has received research support from the National Peanut Board, the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and Dyax Corp and is on the Medical Advisory Board for the Food Allergy and Anaphylaxis Network. A. W. Burks is a consultant for ActoGeniX NV, Novartis, McNeil Nutritionals, and Mead Johnson; is a minority stockholder with Allertein and MastCell, Inc; is on the Advisory Board of Dannon Co Probiotics; is on the speakers' bureau for EpiPen/Dey, LP; is on the Data Monitoring Committee for Genentech; is on the Expert Panel for Nutricia; has received research support from the National Institutes of Health, the Food Allergy and Anaphylaxis Network, Gerber, and Mead Johnson; has provided legal consultation regarding food allergy; is on the Medical Board of Directors for the Food Allergy and Anaphylaxis Network; is a Dermatological Allergy Committee member of the American College of Allergy, Asthma & Immunology; is a study section member at the National Institutes of Health Hypersensitivity, Autoimmune, Immune-mediated Diseases; and is on the Journal of Allergy and Clinical Immunology reviewer board. The rest of the authors have declared that they have no conflict of interest.
ABSTRACT