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| |  Egg Oral Immunotherapy Induces Clinical Desensitisation After 44 Weeks in First Multicentre Trial: Presented at AAAAI By Carole VanSickle Ellis NEW ORLEANS -- March 3, 2010 -- Egg oral immunotherapy (OIT) showed promise in terms of safety, clinical effectiveness, and immunological effects after the first multicentre trial of the protocol, according to a study reported here on March 2 at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. After 44 weeks of testing, Stacey M. Jones, MD, Professor and Chief, Pediatric Allergies and Immunology, University of Arkansas for Medical Sciences/Arkansas Children’s Hospital Research Institute, Little Rock, Arkansas, said that the OIT process had resulted in induced clinical desensitisation and “significant decreases in egg IgE [immunoglobulin E] and egg-specific basophil and mast cell responses.” The researchers conducted a randomised, double-blind, placebo-controlled trial, including multiple locations. Subjects received egg white solid OIT (eOIT) (n = 40) or a placebo (n = 15) during 3 study phases: initial escalation, build-up, and maintenance. At 44 weeks, they underwent an oral food challenge (OFC) to determine how many had achieved desensitisation, which was indicated by the ability to ingest 5 grams of egg. Initially, 55 subjects enrolled. However, 7 withdrew before OFC. At the original time of OFC, 21 of the 40 eOIT members and none of the placebo members passed the 5-gram test. However, during OFC, 33 eOIT members and 1 placebo member ingested >2,750 mg of the egg white solid. During the dosing phases, participants reported symptoms of mild to moderate severity. In the eOIT group, 74.87% had symptom-free dosing, whereas 96.14% of the placebo reported symptom-free dosing. The reactions to eOIT were predominantly oropharyngeal; respiratory, gastrointestinal, and skin symptoms were less common. In the eOIT groups, egg-IgE levels decreased significantly, with a mean of -12.66 (P = .02). Egg percutaneous skin testing was measured at -6.5 mm (P = .001). Also, at the time of the OFC, significant (P < .001) reductions in basophil activation were observed in eOIT. The team concluded that eOIT induced clinical desensitisation after 44 weeks, along with significant decreases in egg IgE and egg-specific basophil and mast cell responses. However, Dr. Jones pointed out that the results of the study also show that “10% to 15% of patients will not tolerate OIT in this protocol.” She added that the study indicated that the protocol and testing procedures were “safe at home, generally under supervision, but more study is needed before consideration of clinical practice.” The researchers continue to monitor immune profiles and long-term tolerance in the remaining study participants. [Presentation title: Egg Oral Immunotherapy (OIT) Induces Clinical Desensitization in a Double-Blind, Placebo-Controlled (DBPC) Trial in Egg Allergic Children From the Consortium of Food Allergy Research (CoFAR). Abstract L6]
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