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.
BACKGROUND: Oral immunotherapy (OIT) offers a promising therapeutic option for peanutallergy. Given that during OIT an allergicpatient 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.
Authors: Ariana D Buchanan; Todd D Green; Stacie M Jones; Amy M Scurlock; Lynn Christie; Karen A Althage; Pamela H Steele; Laurent Pons; Rick M Helm; Laurie A Lee; A Wesley Burks Journal: J Allergy Clin Immunol Date: 2006-10-27 Impact factor: 10.793
Authors: Donald Y M Leung; Hugh A Sampson; John W Yunginger; A Wesley Burks; Lynda C Schneider; Cornelis H Wortel; Frances M Davis; John D Hyun; William R Shanahan Journal: N Engl J Med Date: 2003-03-10 Impact factor: 91.245
Authors: Corinne A Keet; Pamela A Frischmeyer-Guerrerio; Ananth Thyagarajan; John T Schroeder; Robert G Hamilton; Stephen Boden; Pamela Steele; Sarah Driggers; A Wesley Burks; Robert A Wood Journal: J Allergy Clin Immunol Date: 2011-11-30 Impact factor: 10.793