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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 851-862.e10 |
| Journal | Journal of Allergy and Clinical Immunology |
| Volume | 146 |
| Issue number | 4 |
| DOIs | |
| State | Published - Oct 2020 |
Funding
Supported by National Institutes of Health – National Institute of Allergy and Infectious Diseases ( U19AI066738 and U01AI066560 ). The project was also supported by grants from the National Center for Research Resources , a component of the National Institutes of Health : UL1 TR-002535 ( National Jewish Health ), UL1 TR-000067 ( Icahn School of Medicine at Mount Sinai ), UL1 TR-003107 ( University of Arkansas for Medical Sciences ), UL1 TR-000083 ( University of North Carolina School of Medicine ), and UL1 TR-000424 ( Johns Hopkins University School of Medicine ). The contents are solely the responsibility of the authors and do not necessarily represent the official view of National Center for Research Resources or National Institutes of Health. Supported by National Institutes of Health–National Institute of Allergy and Infectious Diseases (U19AI066738 and U01AI066560). The project was also supported by grants from the National Center for Research Resources, a component of the National Institutes of Health: UL1 TR-002535 (National Jewish Health), UL1 TR-000067 (Icahn School of Medicine at Mount Sinai), UL1 TR-003107 (University of Arkansas for Medical Sciences), UL1 TR-000083 (University of North Carolina School of Medicine), and UL1 TR-000424 (Johns Hopkins University School of Medicine). The contents are solely the responsibility of the authors and do not necessarily represent the official view of National Center for Research Resources or National Institutes of Health. Disclosure of potential conflict of interest: E. H. Kim reports clinical medical advisory board membership with DBV Technologies; consultancy with Aimmune Therapeutics, DBV Technologies, AllerGenis, Allakos, Ukko, and Vibrant America; and receives grant support to his institution from the National Institute of Allergy and Infectious Diseases (NIAID), National Center for Complementary and Integrative Health, Food Allergy Research and Education (FARE), and the Wallace Research Foundation. T. T. Perry receives grant support to her institution from National Institute of Nursing Research; National Heart, Lung, and Blood Institute; and National Center for Advancing Translational Sciences. R. A. Wood reports royalty payments from UpToDate and receives grant support to his institution from the NIH/NIAID, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, and Sanofi. D. Y. M. Leung receives grant support to his institution from the NIH/NIAID and National Institute of Arthritis and Musculoskeletal and Skin Diseases and is chairman of the DSMC for Aimmune Therapeutics. M. C. Berin reports scientific advisory board membership with Prota Therapeutics. A. W. Burks reports being a minority stock holder in Allertein and Mastcell pharmaceuticals; scientific advisory board membership with Aimmune Therapeutics, Consortia TX Inc, and Prota therapeutics; consultancy for DBV technologies, N-fold LLC, kaleo, and Ukko Inc; royalties with UpToDate; and receives grant support to his institution from the NIH/NIAID, NIH/National Center for Complementary and Integrative Health, FARE, and the Wallace Research Foundation. S. M. Jones reports research advisory board membership with FARE; reports consultancy with Aimmune Therapeutics and Astellas Pharma Global Development, Inc; has received grant support to her institution from the NIH/NIAID, Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, Genentech, and FARE; and has performed corporate social responsibility (CSR) review/preparation for DBV Technologies on behalf of Emmes. A. M. Scurlock reports clinical medical advisory board membership with DBV Technologies and receives grant support to her institution from NIH/NIAID, Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, and FARE. S. H. Sicherer reports royalty payments from UpToDate and the American Academy of Allergy, Asthma and Immunology, and receives grant support to his institution from the NIH/NIAID and HAL Allergy. A. K. Henning is employed by Emmes, which received support for this work via grant from the NIH/NIAID through Johns Hopkins University. P. Dawson is employed by Emmes, which received support for this work via grant from the NIH/NIAID through Johns Hopkins University. R. W. Lindblad is employed by Emmes, which received support for this work via grant from the NIH/NIAID through Johns Hopkins University. H. A. Sampson reports being a part-time employee of DBV Technologies; receiving consultant fees from N-Fold LLC, and royalties for various textbooks; holding stock options in DBV Technologies and N-Fold; and receives grant support to his institution from the NIH/NIAID. The rest of the authors declare that they have no relevant conflicts of interest. Disclosure of potential conflict of interest: E. H. Kim reports clinical medical advisory board membership with DBV Technologies; consultancy with Aimmune Therapeutics, DBV Technologies, AllerGenis, Allakos, Ukko, and Vibrant America; and receives grant support to his institution from the National Institute of Allergy and Infectious Diseases (NIAID), National Center for Complementary and Integrative Health, Food Allergy Research and Education (FARE), and the Wallace Research Foundation. T. T. Perry receives grant support to her institution from National Institute of Nursing Research; National Heart, Lung, and Blood Institute; and National Center for Advancing Translational Sciences. R. A. Wood reports royalty payments from UpToDate and receives grant support to his institution from the NIH/NIAID, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, and Sanofi. D. Y. M. Leung receives grant support to his institution from the NIH/NIAID and National Institute of Arthritis and Musculoskeletal and Skin Diseases and is chairman of the DSMC for Aimmune Therapeutics. M. C. Berin reports scientific advisory board membership with Prota Therapeutics. A. W. Burks reports being a minority stock holder in Allertein and Mastcell pharmaceuticals; scientific advisory board membership with Aimmune Therapeutics, Consortia TX Inc, and Prota therapeutics; consultancy for DBV technologies, N-fold LLC, kaleo, and Ukko Inc; royalties with UpToDate; and receives grant support to his institution from the NIH/NIAID, NIH/National Center for Complementary and Integrative Health, FARE, and the Wallace Research Foundation. S. M. Jones reports research advisory board membership with FARE; reports consultancy with Aimmune Therapeutics and Astellas Pharma Global Development, Inc; has received grant support to her institution from the NIH/NIAID, Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, Genentech, and FARE; and has performed corporate social responsibility (CSR) review/preparation for DBV Technologies on behalf of Emmes. A. M. Scurlock reports clinical medical advisory board membership with DBV Technologies and receives grant support to her institution from NIH/NIAID, Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, and FARE. S. H. Sicherer reports royalty payments from UpToDate and the American Academy of Allergy, Asthma and Immunology, and receives grant support to his institution from the NIH/NIAID and HAL Allergy. A. K. Henning is employed by Emmes, which received support for this work via grant from the NIH/NIAID through Johns Hopkins University. P. Dawson is employed by Emmes, which received support for this work via grant from the NIH/NIAID through Johns Hopkins University. R. W. Lindblad is employed by Emmes, which received support for this work via grant from the NIH/NIAID through Johns Hopkins University. H. A. Sampson reports being a part-time employee of DBV Technologies; receiving consultant fees from N-Fold LLC, and royalties for various textbooks; holding stock options in DBV Technologies and N-Fold; and receives grant support to his institution from the NIH/NIAID. The rest of the authors declare that they have no relevant conflicts of interest.
Keywords
- Egg allergy
- baked egg
- desensitization
- extensively heated egg
- oral immunotherapy
- sustained unresponsiveness
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
