Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy - 06/04/16
, A. Wesley Burks, MD b, Corinne Keet, MD c, Brian P. Vickery, MD b, Amy M. Scurlock, MD a, Robert A. Wood, MD c, Andrew H. Liu, MD d, Scott H. Sicherer, MD e, Alice K. Henning, MS f, Robert W. Lindblad, MD f, Peter Dawson, PhD f, Cecilia Berin, PhD e, David M. Fleischer, MD d, Donald Y.M. Leung, MD d, Marshall Plaut, MD g, Hugh A. Sampson, MD efor the
Consortium of Food Allergy Research (CoFAR)
Abstract |
Background |
We previously reported the results of a randomized placebo-controlled study of egg oral immunotherapy (eOIT) in which 27.5% of subjects achieved sustained unresponsiveness (SU) after 2 years. Here we report the results of treatment through 4 years and long-term follow-up.
Objective |
We sought to evaluate the efficacy and safety of eOIT in participants treated up to 4 years.
Methods |
Children with egg allergy (5-18 years old) received eOIT (n = 40) for up to 4 years or placebo (n = 15) for 1 year or less. The key outcome was the percentage of subjects achieving SU by year 4. Safety and immunologic assessments were performed, and long-term follow-up questionnaires (LFQs) were administered after study conclusion (LFQ-1) and 1 year later (LFQ-2).
Results |
Of 40 eOIT-treated subjects, 20 (50.0%) of 40 demonstrated SU by year 4. For those subjects still dosing during years 3 and 4, mild symptoms were present in 12 (54.5%) of 22 subjects. At the time of the LFQ, more subjects receiving eOIT (LFQ-1, 23/34 [68%]; LFQ-2, 21/33 [64%]) were consuming unbaked and baked egg versus placebo (LFQ-1, 2/11 [18%], P = .006; LFQ-2, 3/12 [25%], P = .04). Of subjects achieving SU, 18 (90%) of 20 completed the LFQ, with 18 (100%) of 18 reporting consumption of all forms of egg. When compared with subjects not achieving SU, subjects achieving SU had higher IgG4 values (P = .001) and lower egg skin prick test scores (P = .0002) over time and a lower median baseline ratio of egg-specific IgE to total IgE (1.1% vs 2.7%, P = .04).
Conclusions |
SU after eOIT is enhanced with longer duration of therapy and increases the likelihood of tolerating unbaked egg in the diet.
Le texte complet de cet article est disponible en PDF.Key words : Egg allergy, food allergy, oral immunotherapy, desensitization, sustained unresponsiveness, immune tolerance, IgE, follow-up
Abbreviations used : AUC, eOIT, IQR, kUA, LFQ, OFC, OIT, OR, SPT, SU
Plan
| Supported by National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID) grants U19AI066738 and U01AI066560. The project was also supported by grants UL1 TR000154 (National Jewish), UL1 TR000067 (Mount Sinai), UL1 TR000039 (Arkansas), UL1 TR000083 (North Carolina), and UL1 TR000424 (Johns Hopkins) from the National Center for Research Resources (NCRR), a component of the NIH. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the NCRR or NIH. |
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| This study is registered with ClinicalTrials.gov with ID NCT00461097. |
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| Disclosure of potential conflict of interest: S. M. Jones receives research funding from Food Allergy Research Education (FARE), the Allergy Research Corporation, DBV Technologies, the National Peanut Board, and the National Institutes of Health (NIH); serves as a consultant for Stallergenes; and has received payments for lectures from Kansas City, Mercy Children's Hospital, Riley Children's Hospital, Southwestern Medical School–Children's Medical Center, the European Academy of Allergy & Clinical Immunology, the New York Allergy & Asthma Society, the Iowa Society of Allergy, Asthma & Immunology, the University of Iowa, and the Paul M. Seebohm Lectureship in Allergy. A. W. Burks receives research funding from the NIH U-19, the NIH, and the Wallace Research Foundation; serves on the board of the American Academy of Allergy, Asthma & Immunology (AAAAI), FARE, the NIH AITC Review Panel and study section, Stallergenes, and the World Allergy Organization; serves as a consultant to ActoGeniX, Adept Filed Solutions, Dow AgroSciences, ExploraMed Development, Genentech, GLG Research, Insys Therapeutics, Merck, Novartis Pharma AG, Nutricia North America, Regeneron Pharmaceuticals, Sanofi-Aventis, SRA International, and Valeant Pharmaceuticals North America; receives payments for lectures from Mylan specialty and the American Society for Microbiology; and has stock options in Allertein and Mastcell Pharmaceuticals. C. Keet receives research support from the NIH. B. P. Vickery receives research support from the NIH. A. M. Scurlock receives research funding from the NIH and receives payment for lectures from Mt Sinai School of Medicine. R. A. Wood receives research funding from the National Institute of Allergy and Infectious Diseases (NIAID), serves as a consultant for Sanofi and Stallergenes, and received royalties from UpToDate. A. H. Liu serves on the board of GlaxoSmithKline and has also received payments for lectures from Merck. S. H. Sicherer receives research support from the NIH, has board membership with the American Board of Allergy Immunology, and receives royalties from UpToDate. A. K. Henning receives research funding from the NIH. R. W. Lindblad receives research funding from the NIH and NIAID. P. Dawson receives research funding from the NIH. D. M. Fleischer serves as a consultant for LabCorp; receives grant funding from Monsanto Company, Nestle Nutrition Institute, and DBV Technologies; receives payment for lectures from Nestle Nutrition Institute; and receives royalties from UpToDate. H. A. Sampson has received research support from the National Institute of Allergy and Infectious Diseases Consortium of Food Allergy Research; has received consultancy fees from Allertein Therapeutics, Genentech, Sanofi, Stallergenes, and Merck; is employed by DBV Technologies; and has stock options in Allertein Therapeutics and DBV Therapeutics. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 137 - N° 4
P. 1117 - avril 2016 Retour au numéro
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