PMID- 29092786 OWN - NLM STAT- MEDLINE DCOM- 20191107 LR - 20230211 IS - 2213-2201 (Electronic) VI - 6 IP - 2 DP - 2018 Mar-Apr TI - Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial. PG - 476-485.e3 LID - S2213-2198(17)30742-0 [pii] LID - 10.1016/j.jaip.2017.09.016 [doi] AB - 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 /=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. CI - Copyright (c) 2017 The Authors. Published by Elsevier Inc. All rights reserved. FAU - Bird, J Andrew AU - Bird JA AD - Division of Allergy & Immunology, University of Texas Southwestern Medical Center, Dallas, Tex. Electronic address: drew.bird@utsouthwestern.edu. FAU - Spergel, Jonathan M AU - Spergel JM AD - Division of Allergy & Immunology, Children's Hospital of Philadelphia, Philadelphia, Pa. FAU - Jones, Stacie M AU - Jones SM AD - Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. FAU - Rachid, Rima AU - Rachid R AD - Division of Allergy & Immunology, Boston Children's Hospital, Harvard Medical School, Boston, Mass. FAU - Assa'ad, Amal H AU - Assa'ad AH AD - Division of Allergy & Immunology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. FAU - Wang, Julie AU - Wang J AD - Division of Allergy & Immunology, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Leonard, Stephanie A AU - Leonard SA AD - Department of Pediatrics, University of California, San Diego, Rady Children's Hospital, San Diego, Calif. FAU - Laubach, Susan S AU - Laubach SS AD - Department of Pediatrics, University of California, San Diego, Rady Children's Hospital, San Diego, Calif; Allergy and Asthma Medical Group and Research Center, San Diego, Calif. FAU - Kim, Edwin H AU - Kim EH AD - Department of Pediatrics, University of North Carolina, Chapel Hill, NC. FAU - Vickery, Brian P AU - Vickery BP AD - Department of Pediatrics, University of North Carolina, Chapel Hill, NC; Department of Clinical Development, Aimmune Therapeutics, Brisbane, Calif. FAU - Davis, Benjamin P AU - Davis BP AD - Division of Immunology, Department of Internal Medicine, University of Iowa Hospitals and Clinics, Iowa City, Iowa. FAU - Heimall, Jennifer AU - Heimall J AD - Division of Allergy & Immunology, Children's Hospital of Philadelphia, Philadelphia, Pa. FAU - Cianferoni, Antonella AU - Cianferoni A AD - Division of Allergy & Immunology, Children's Hospital of Philadelphia, Philadelphia, Pa. FAU - MacGinnitie, Andrew J AU - MacGinnitie AJ AD - Division of Allergy & Immunology, Boston Children's Hospital, Harvard Medical School, Boston, Mass. FAU - Crestani, Elena AU - Crestani E AD - Division of Allergy & Immunology, Boston Children's Hospital, Harvard Medical School, Boston, Mass. FAU - Burks, A Wesley AU - Burks AW AD - Department of Pediatrics, University of North Carolina, Chapel Hill, NC. CN - ARC001 Study Group LA - eng GR - UL1 TR000067/TR/NCATS NIH HHS/United States GR - UL1 TR000003/TR/NCATS NIH HHS/United States GR - UL1 TR001111/TR/NCATS NIH HHS/United States PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20171031 PL - United States TA - J Allergy Clin Immunol Pract JT - The journal of allergy and clinical immunology. In practice JID - 101597220 RN - 0 (Allergens) RN - 0 (Plant Proteins) SB - IM MH - Administration, Oral MH - Adolescent MH - Adult MH - Allergens/*administration & dosage MH - *Arachis MH - Child MH - Child, Preschool MH - *Desensitization, Immunologic MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Peanut Hypersensitivity/*therapy MH - Plant Proteins/*administration & dosage MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - AR101 OT - ARC001 OT - Desensitization OT - Double-blind placebo-controlled trial OT - Food allergy OT - OIT OT - Oral immunotherapy OT - Peanut allergy EDAT- 2017/11/03 06:00 MHDA- 2019/11/08 06:00 CRDT- 2017/11/03 06:00 PHST- 2017/05/11 00:00 [received] PHST- 2017/09/06 00:00 [revised] PHST- 2017/09/18 00:00 [accepted] PHST- 2017/11/03 06:00 [pubmed] PHST- 2019/11/08 06:00 [medline] PHST- 2017/11/03 06:00 [entrez] AID - S2213-2198(17)30742-0 [pii] AID - 10.1016/j.jaip.2017.09.016 [doi] PST - ppublish SO - J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):476-485.e3. doi: 10.1016/j.jaip.2017.09.016. Epub 2017 Oct 31.