Journal
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE
Volume 6, Issue 2, Pages 476-+Publisher
ELSEVIER
DOI: 10.1016/j.jaip.2017.09.016
Keywords
AR101; ARC001; Desensitization; Double-blind placebo-controlled trial; Food allergy; Oral immunotherapy; OIT; Peanut allergy
Categories
Funding
- Aimmune Therapeutics, Inc.
- Harvard Catalyst \ The Harvard Clinical and Translational Science Center (National Center for Research Resources, National Institutes of Health)
- Harvard Catalyst \ The Harvard Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health) [UL1 TR001102]
- University of North Carolina Clinical and Translational Science Center, National Institutes of Health [UL1TR001111]
- Icahn School of Medicine Clinical and Translational Science Center, National Institutes of Health [UL1TR000067]
- Children's Hospital of Philadelphia Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health) [UL1TR000003]
- NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES [UL1TR001102, UL1TR001111] Funding Source: NIH RePORTER
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BACKGROUND: Peanut oral immunotherapy, using a variety of approaches, has been previously shown to induce desensitization in peanut-allergic subjects, but no products have been approved for clinical use by regulatory agencies. OBJECTIVE: We performed the first phase 2 multicentered study to assess the safety and efficacy of AR101, a novel oral biologic drug product. METHODS: A randomized, double-blind, placebo-controlled trial was conducted at 8 US centers. Eligible subjects were 4 to 26 years old, sensitized to peanut, and had dose-limiting symptoms to <= 143 mg of peanut protein in a screening double-blind, placebo-controlled food challenge (DBPCFC). Subjects were randomized 1: 1 to daily AR101 or placebo and gradually up-dosed from 0.5 to 300 mg/day. The primary endpoint wasthe proportion of subjects in each arm able to tolerate >= 443 mg (cumulative peanut protein) at exit DBPCFC with no or mild symptoms. RESULTS: Fifty-five subjects (29 AR101, 26 placebo) were enrolled. In the intention-to-treat analysis, 23 of 29 (79%) and 18 of 29 (62%) AR101 subjects tolerated >= 443 mg and 1043 mg at exit DBPCFC, respectively, versus 5 of 26 (19%) and 0 of 26 (0%) placebo subjects (both P < .0001). Compared with placebo, AR101 significantly reduced symptom severity during exit DBPCFCs and modulated peanut-specific cellular and humoral immune responses. Gastrointestinal (GI) symptoms were the most common treatment-related adverse events (AEs) in both groups, with 6 AR101 subjects (21%) withdrawing, 4 of those due primarily to recurrent GI AEs. CONCLUSIONS: In this study, AR101 demonstrated an acceptable safety profile and demonstrated clinical activity as a potential immunomodulatory treatment option in peanut-allergic children over the age of 4, adolescents, and young adults. (C) 2017 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology.
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