Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults - 19/04/17
, Scott H. Sicherer, MD b, A. Wesley Burks, MD c, Donald Y.M. Leung, MD d, Robert W. Lindblad, MD e, Peter Dawson, PhD e, Alice K. Henning, MS e, M. Cecilia Berin, PhD b, David Chiang, MSc b, Brian P. Vickery, MD c, Robbie D. Pesek, MD a, Christine B. Cho, MD e, Wendy F. Davidson, PhD f, Marshall Plaut, MD f, Hugh A. Sampson, MD b, Robert A. Wood, MD gfor the
Consortium of Food Allergy Research
Abstract |
Background |
Peanut allergy is common, life-threatening, and without therapeutic options. We evaluated peanut epicutaneous immunotherapy (EPIT) by using Viaskin Peanut for peanut allergy treatment.
Objective |
We sought to evaluate the clinical, safety, and immunologic effects of EPIT for the treatment of peanut allergy.
Methods |
In this multicenter, double-blind, randomized, placebo-controlled study, 74 participants with peanut allergy (ages 4-25 years) were treated with placebo (n = 25), Viaskin Peanut 100 μg (VP100; n = 24) or Viaskin Peanut 250 μg (VP250; n = 25; DBV Technologies, Montrouge, France). The primary outcome was treatment success after 52 weeks, which was defined as passing a 5044-mg protein oral food challenge or achieving a 10-fold or greater increase in successfully consumed dose from baseline to week 52. Adverse reactions and mechanistic changes were assessed.
Results |
At week 52, treatment success was achieved in 3 (12%) placebo-treated participants, 11 (46%) VP100 participants, and 12 (48%) VP250 participants (P = .005 and P = .003, respectively, compared with placebo; VP100 vs VP250, P = .48). Median change in successfully consumed doses were 0, 43, and 130 mg of protein in the placebo, VP100, and VP250 groups, respectively (placebo vs VP100, P = .014; placebo vs VP250, P = .003). Treatment success was higher among younger children (P = .03; age, 4-11 vs >11 years). Overall, 14.4% of placebo doses and 79.8% of VP100 and VP250 doses resulted in reactions, predominantly local patch-site and mild reactions (P = .003). Increases in peanut-specific IgG4 levels and IgG4/IgE ratios were observed in peanut EPIT-treated participants, along with trends toward reduced basophil activation and peanut-specific TH2 cytokines.
Conclusions |
Peanut EPIT administration was safe and associated with a modest treatment response after 52 weeks, with the highest responses among younger children. This, when coupled with a high adherence and retention rate and significant changes in immune pathways, supports further investigation of this novel therapy.
Le texte complet de cet article est disponible en PDF.Key words : Peanut hypersensitivity, food allergy, immunotherapy, IgE, desensitization, epicutaneous
Abbreviations used : CoFAR, CPE, DSMB, EPIT, IQR, kUA, OFC, OIT, SCD, SPT, VP100, VP250
Plan
| This study is registered with ClinicalTrials.gov with ID NCT01904604. The study is 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 NIH/National Center for Advancing Translational Sciences (NCATS) grant nos. UL1 TR0001082 (Colorado), 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. Support for this trial was also provided by DBV Technologies (Montrouge, France) through funds provided to the Consortium of Food Allergy Research (CoFAR). Protocol development, study conduct, data analysis, and manuscript development were conducted independently of DBV. |
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| Disclosure of potential conflict of interest: S. M. Jones receives grant support form FARE, Aimmune Technologies, DBV Technologies, the National Peanut Board, and the National Institutes of Health (NIH)/National Institutes of Allergy and Infectious Diseases (NIAID); serves as a consultant for Stallergenes; and receives payment for lectures from the Kansas City Allergy Society, Mercy Children's Hospital, Riley Children's Hospital, Southwestern Medical School–Children's Medical Center, the European Academy of Allergy and Clinical Immunology, the New York Allergy & Asthma Society, the University of Iowa-Seebohm Lectureship in Allergy, and the Iowa Society of Allergy, Asthma & Immunology. S. H. Sicherer receives grant support from the NIAID and FARE and royalties from UpToDate and serves as an Associate Editor of the Journal of Allergy and Clinical Immunology: In Practice. A. W. Burks receives grant funding from the NIH, Wallace Foundation and Food Allergy & Anaphylaxis; serves on the board for FARE, the NIH AITC Review Panel, the NIH HAI Study Section, Stallergenes, the World Allergy Organization, and the American Academy of Allergy, Asthma & Immunology; serves as a consultant for ActoGeniX, Adept Field Solutions, Dow AgroSciences, ExploraMed Development, Genentech, GLG Research, Insys Therapeutics, Merck, Regeneron Pharmaceuticals, Sanofi-Aventis US, SRA International, Valeant Pharmaceuticals North America, and Epiva Biosciences; manuscript preparation from the American Society for Microbiology; and holds stock in Allertein and Mastcell Pharmaceuticals. D. Y. M. Leung receives grant funding from the NIH. R. W. Lindblad receives grant funding from the NIH. P. Dawson receives grant funding from the NIH. A. K. Henning receives grant funding from the NIH. D. Chiang receives grant funding from the NIH. B. P. Vickery receives grant support from the NIAID, is an employee of Aimmune Therapeutics, and holds stock options in Aimmune Therapeutics. R. D. Pesek receives grant funding from the NIH, Kedrion, AstraZeneca, Parrigo Nutritionals, and Danone Research. H. A. Sampson receives grant support from the NIAID and DBV Technologies; serves as a consultant for Allertein therapeutics, Genentech/Roche, Sanofi, Stallergenes, Sanone, and Merck; is a part time employee of DBV Technologies; receives royalties from UpToDate and Elsevier; and received stock from DBV Technologies. R. A. Wood receives grant support from the NIAID, DBV Aimmune, Astellas, and HAL-Allergy; serves as a consultant for Stallergenes and Sanofi; and received royalties from UpToDate. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 139 - N° 4
P. 1242 - avril 2017 Retour au numéro
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