1. AR101 Oral Immunotherapy for Peanut Allergy
- Author
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Hey Chong, Antonella Muraro, Caroline Nilsson, Julie Wang, Jonathan Matz, Tara F. Carr, Andrea Vereda, Stephanie A. Leonard, Douglas T Johnston, Katharina Blumchen, Moshe Ben-Shoshan, Stanley Fineman, Frank C Hampel, Montserrat Fernandez-Rivas, Michael J Welch, José Manuel Zubeldia, Jay M. Portnoy, Carsten Bindslev-Jensen, Rima Rachid, Leon Greos, Vibha Sharma, Brian P. Vickery, Marina Tsoumani, Dareen Siri, Edwin H. Kim, Lyndon E Mansfield, A. Wesley Burks, J. Andrew Bird, Daniel C. Adelman, Ellen Sher, Robert A. Wood, Thomas B. Casale, Stephen A. Tilles, Annette Marcantonio, Hugh H Windom, Hanneke N G Oude Elberink, Stefan Zielen, Hemant P Sharma, Wayne G. Shreffler, Bruce J. Lanser, Amarjit Cheema, Ned Rupp, Stephen B Fritz, Stacie M. Jones, Allan Stillerman, Gordon Sussman, Frederick E Leickly, Stephen G Dilly, W. Carr, Jay A. Lieberman, Pooja Varshney, David Fleischer, Kirsten Beyer, William H. Yang, Jacqueline A. Pongracic, Morna J. Dorsey, George Du Toit, Jason A. Ohayon, Aikaterini Anagnostou, M Dolores Ibáñez, David K Jeong, Amal Assa'ad, Jonathan O'b Hourihane, Rita Kachru, Anthony E.J. Dubois, Christina E. Ciaccio, Rezi Zawadzki, Sharon Chinthrajah, Lawrence Sher, Georgiana M Sanders, Jonathan M. Spergel, and Groningen Research Institute for Asthma and COPD (GRIAC)
- Subjects
Male ,0301 basic medicine ,Arachis ,Gastrointestinal Diseases ,Peanut allergy ,Administration, Oral ,CHILDREN ,GUIDELINES ,FOOD ALLERGY ,law.invention ,DOUBLE-BLIND ,0302 clinical medicine ,Randomized controlled trial ,law ,Young adult ,Child ,Plant Proteins ,Age Factors ,food and beverages ,General Medicine ,Middle Aged ,PREVALENCE ,Child, Preschool ,SAFETY ,Female ,Adult ,medicine.medical_specialty ,Adolescent ,Dose-Response Relationship, Immunologic ,Placebo ,DIAGNOSIS ,Young Adult ,03 medical and health sciences ,Double-Blind Method ,Food allergy ,Internal medicine ,medicine ,Humans ,Peanut Hypersensitivity ,Adverse effect ,Biological Products ,business.industry ,NATURAL-HISTORY ,Allergens ,medicine.disease ,Clinical trial ,Regimen ,030104 developmental biology ,030228 respiratory system ,Desensitization, Immunologic ,business - Abstract
BACKGROUND: Peanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions.METHODS: In a phase 3 trial, we screened participants 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge. Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic oral immunotherapy drug) or placebo in an escalating-dose program. Participants who completed the regimen (i.e., received 300 mg per day of the maintenance regimen for approximately 24 weeks) underwent a double-blind, placebo-controlled food challenge at trial exit. The primary efficacy end point was the proportion of participants 4 to 17 years of age who could ingest a challenge dose of 600 mg or more, without dose-limiting symptoms.RESULTS: Of the 551 participants who received AR101 or placebo, 496 were 4 to 17 years of age; of these, 250 of 372 participants (67.2%) who received active treatment, as compared with 5 of 124 participants (4.0%) who received placebo, were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge (difference, 63.2 percentage points; 95% confidence interval, 53.0 to 73.3; PCONCLUSIONS: In this phase 3 trial of oral immunotherapy in children and adolescents who were highly allergic to peanut, treatment with AR101 resulted in higher doses of peanut protein that could be ingested without dose-limiting symptoms and in lower symptom severity during peanut exposure at the exit food challenge than placebo. (Funded by Aimmune Therapeutics; PALISADE ClinicalTrials.gov number, NCT02635776 .).
- Published
- 2018
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