Journal article
Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial.
Journal of Allergy and Clinical Immunology, Vol.6(2), pp.476-485
03/01/2018
DOI: 10.1016/j.jaip.2017.09.016
PMID: 29092786
Abstract
<p>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.</p>
<p>OBJECTIVE: We performed the first phase 2 multicentered study to assess the safety and efficacy of AR101, a novel oral biologic drug product.</p>
<p>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 was the proportion of subjects in each arm able to tolerate ≥443 mg (cumulative peanut protein) at exit DBPCFC with no or mild symptoms.</p>
<p>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.</p>
<p>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.</p>
Details
- Title: Subtitle
- Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial.
- Creators
- J Andrew Bird - University of Texas Southwestern Medical Center,Jonathan M Spergel - Children's Hospital of PhiladelphiaStacie M Jones - University of Arkansas for Medical Sciences and Arkansas Children's HospitalRima Rachid - Harvard Medical SchoolAmal H Assa'ad - Cincinnati Children's Hospital Medical CenterJulie Wang - Icahn School of Medicine at Mount SinaiStephanie A Leonard - University of California - San DiegoSusan S Laubach - University of California - San DiegoEdwin H Kim - University of North Carolina at Chapel HillBrian P Vickery - University of North Carolina at Chapel HillBenjamin P. Davis - University of IowaJennifer Heimall - Children's Hospital of PhiladelphiaAntonella Cianferoni - Children's Hospital of PhiladelphiaAndrew J MacGinnitie - Harvard Medical SchoolElena Crestani - Harvard Medical SchoolA Wesley Burks - University of North Carolina at Chapel HillARC001 Study Group
- Resource Type
- Journal article
- Publication Details
- Journal of Allergy and Clinical Immunology, Vol.6(2), pp.476-485
- DOI
- 10.1016/j.jaip.2017.09.016
- PMID
- 29092786
- NLM abbreviation
- J Allergy Clin Immunol Pract
- ISSN
- 2213-2201
- Copyright
- © 2017 The Authors
- Language
- English
- Date published
- 03/01/2018
- Academic Unit
- Stead Family Department of Pediatrics; Internal Medicine
- Record Identifier
- 9983557180602771
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