Edwin H Kim1, Tamara T Perry2, Robert A Wood3, Donald Y M Leung4, M Cecilia Berin5, A Wesley Burks6, Christine B Cho4, Stacie M Jones2, Amy Scurlock2, Scott H Sicherer5, Alice K Henning7, Peter Dawson7, Robert W Lindblad7, Marshall Plaut8, Hugh A Sampson5. 1. Department of Medicine and Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: edwinkim@email.unc.edu. 2. Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. 3. Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Rockville. 4. Department of Pediatrics, National Jewish Health, Denver, Colo. 5. Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York. 6. Department of Medicine and Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC. 7. Emmes, Rockville, Md. 8. National Institutes of Health/National Institutes of Allergy and Infectious Diseases, Bethesda, Md.
Abstract
BACKGROUND: While desensitization and sustained unresponsiveness (SU) have been shown with egg oral immunotherapy (OIT), the benefits of baked egg (BE) therapy for egg allergy have not been well studied. OBJECTIVES: This study sought to evaluate the safety and efficacy of BE ingestion compared with egg OIT in participants allergic to unbaked egg but tolerant to BE. METHODS:Children who are BE-tolerant but unbaked egg reactive ages 3 to 16 years were randomized to 2 years of treatment with either BE or egg OIT. Double-blind, placebo-controlled food challenges were conducted after 1 and 2 years of treatment to assess for desensitization, and after 2 years of treatment followed by 8 to 10 weeks off of treatment to assess for SU. Mechanistic studies were conducted to assess for immune modulation. A cohort of participants who are BE-reactive underwent egg OIT and identical double-blind, placebo-controlled food challenges as a comparator group. RESULTS:Fifty participants (median age 7.3 years) were randomized and initiated treatment. SU was achieved in 3 of 27 participants assigned to BE (11.1%) versus 10 of 23 participants assigned to egg OIT (43.5%) (P = .009). In the BE-reactive comparator group, 7 of 39 participants (17.9%) achieved SU. More participants who are BE-tolerant withdrew from BE versus from egg OIT (29.6% vs 13%). Dosing symptom frequency in participants who are BE-tolerant was similar with BE and egg OIT, but more frequent in participants who are BE-reactive. Egg white-specific IgE, skin testing, and basophil activation decreased similarly after BE and egg OIT. CONCLUSIONS: Among children allergic to unbaked egg but tolerant to BE, those treated with egg OIT were significantly more likely to achieve SU than were children ingesting BE.
RCT Entities:
BACKGROUND: While desensitization and sustained unresponsiveness (SU) have been shown with egg oral immunotherapy (OIT), the benefits of baked egg (BE) therapy for egg allergy have not been well studied. OBJECTIVES: This study sought to evaluate the safety and efficacy of BE ingestion compared with egg OIT in participantsallergic to unbaked egg but tolerant to BE. METHODS:Children who are BE-tolerant but unbaked egg reactive ages 3 to 16 years were randomized to 2 years of treatment with either BE or egg OIT. Double-blind, placebo-controlled food challenges were conducted after 1 and 2 years of treatment to assess for desensitization, and after 2 years of treatment followed by 8 to 10 weeks off of treatment to assess for SU. Mechanistic studies were conducted to assess for immune modulation. A cohort of participants who are BE-reactive underwent egg OIT and identical double-blind, placebo-controlled food challenges as a comparator group. RESULTS: Fifty participants (median age 7.3 years) were randomized and initiated treatment. SU was achieved in 3 of 27 participants assigned to BE (11.1%) versus 10 of 23 participants assigned to egg OIT (43.5%) (P = .009). In the BE-reactive comparator group, 7 of 39 participants (17.9%) achieved SU. More participants who are BE-tolerant withdrew from BE versus from egg OIT (29.6% vs 13%). Dosing symptom frequency in participants who are BE-tolerant was similar with BE and egg OIT, but more frequent in participants who are BE-reactive. Egg white-specific IgE, skin testing, and basophil activation decreased similarly after BE and egg OIT. CONCLUSIONS: Among childrenallergic to unbaked egg but tolerant to BE, those treated with egg OIT were significantly more likely to achieve SU than were children ingesting BE.
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