دورية أكاديمية
Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results.
| العنوان: | Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results. |
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| المؤلفون: | Pongracic JA; Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill. Electronic address: JPongracic@luriechildrens.org., Gagnon R; Clinique Spécialisée en Allergie de la Capitale, Québec, QC, Canada., Sussman G; Gordon Sussman Clinical Research, Toronto, ON, Canada., Siri D; Midwest Allergy Sinus Asthma SC/SWIA Clinical Research Center, Normal, Ill., Oriel RC; Division of Allergy and Immunology, Department of Pediatrics, the Elliot and Roslyn Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY., Brown-Whitehorn TF; Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa., Green TD; DBV Technologies SA, Montrouge, France; UPMC Children's Hospital of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pa., Campbell DE; DBV Technologies SA, Montrouge, France., Anvari S; Texas Children's Hospital, Houston, Tex; Baylor College of Medicine, Houston, Tex., Berger WE; Allergy and Asthma Associates of Southern California, Mission Viejo, Calif., Bird JA; University of Texas Southwestern Medical Center, Dallas, Tex., Chan ES; Division of Allergy & Immunology, Department of Pediatrics, British Columbia Children's Hospital, University of British Columbia, Vancouver, BC, Canada., Cheema A; Cheema Research Inc, Mississauga, ON, Canada., Chinthrajah RS; Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, Calif., Chong HJ; UPMC Children's Hospital of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pa., Dowling PJ; Division of Allergy and Immunology, Children's Mercy Hospital Kansas City, Kansas City, Mo., Fineman SM; Department of Pediatrics, Emory University School of Medicine, Atlanta Allergy & Asthma, Atlanta, Ga., Fleischer DM; Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo., Gonzalez-Reyes E; South Texas Allergy & Asthma Medical Professionals, San Antonio, Tex., Kim EH; University of North Carolina School of Medicine, Chapel Hill, NC., Lanser BJ; National Jewish Health, Denver, Colo., MacGinnitie A; Division of Immunology, Boston Children's Hospital and Department of Pediatrics, Harvard Medical School, Boston, Mass., Mehta H; Allergy and Asthma Specialists, PA, Minneapolis, Minn., Petroni D; Seattle Allergy & Asthma Research Institute, Seattle, Wash., Rupp N; National Allergy and Asthma Research, North Charleston, SC., Schneider LC; Division of Immunology, Boston Children's Hospital and Department of Pediatrics, Harvard Medical School, Boston, Mass., Scurlock AM; Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark., Sher LD; Peninsula Research Associates, Rolling Hills Estates, Calif., Shreffler WG; Massachusetts General Hospital, Boston, Mass., Sindher SB; Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, Calif., Stillerman A; Allergy and Asthma Specialists, PA, Minneapolis, Minn., Wood R; Johns Hopkins Hospital, Baltimore, Md., Yang WH; Ottawa Allergy Research Corporation and Department of Medicine, University of Ottawa Medical School, Ottawa, ON, Canada., Bois T; DBV Technologies SA, Montrouge, France., Sampson HA; Division of Pediatric Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York, NY., Bégin P; Section of Allergy, Immunology and Rheumatology, Department of Pediatrics, CHU Sainte-Justine, Montréal, QC, Canada. |
| المصدر: | The journal of allergy and clinical immunology. In practice [J Allergy Clin Immunol Pract] 2022 Jul; Vol. 10 (7), pp. 1864-1873.e10. Date of Electronic Publication: 2021 Nov 27. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Inc Country of Publication: United States NLM ID: 101597220 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-2201 (Electronic) NLM ISO Abbreviation: J Allergy Clin Immunol Pract Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, NY : Elsevier Inc., [2013]- |
| مواضيع طبية MeSH: | Anaphylaxis*/etiology , Peanut Hypersensitivity*/drug therapy, Administration, Oral ; Allergens/therapeutic use ; Arachis ; Child ; Desensitization, Immunologic/methods ; Humans ; Immunologic Factors/therapeutic use |
| مستخلص: | Background: Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-μg peanut protein (Viaskin Peanut 250 μg [VP250]) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children. Objective: To examine the safety of VP250 in children, using a study design approximating potential real-world use. Methods: REAL LIfe Use and Safety of EPIT (REALISE) is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment. Children aged 4 to 11 years with physician diagnosis of peanut allergy received daily treatment with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, randomized, controlled phase of REALISE are reported. Results: Three hundred ninety-three children were randomized 3:1 to receive VP250 (n = 294) or placebo (n = 99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. According to parent diary, all participants receiving VP250 and 83.8% receiving placebo reported at least 1 episode of local skin reaction, with frequency decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued because of adverse events (AEs). Epinephrine was administered for allergic reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the study; none involved severe anaphylaxis. Overall, AE rates were similar among participants with and without a history of peanut anaphylaxis. Conclusions: In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 studies. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.) |
| التعليقات: | Comment in: J Allergy Clin Immunol Pract. 2022 Jul;10(7):1874-1875. (PMID: 35809991) |
| معلومات مُعتمدة: | UL1 TR001422 United States TR NCATS NIH HHS |
| فهرسة مساهمة: | Keywords: Children; Desensitization; Epicutaneous immunotherapy (EPIT); Food allergy; Immunotherapy; Peanut allergy; Real-world setting |
| المشرفين على المادة: | 0 (Allergens) 0 (Immunologic Factors) |
| تواريخ الأحداث: | Date Created: 20211201 Date Completed: 20220712 Latest Revision: 20220727 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1016/j.jaip.2021.11.017 |
| PMID: | 34848381 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 2213-2201 |
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| DOI: | 10.1016/j.jaip.2021.11.017 |