AR101 Oral Immunotherapy for Peanut Allergy Academic Article uri icon

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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; P<0.001). During the exit food challenge, the maximum severity of symptoms was moderate in 25% of the participants in the active-drug group and 59% of those in the placebo group and severe in 5% and 11%, respectively. Adverse events during the intervention period affected more than 95% of the participants 4 to 17 years of age. A total of 34.7% of the participants in the active-drug group had mild events, as compared with 50.0% of those in the placebo group; 59.7% and 44.4% of the participants, respectively, had events that were graded as moderate, and 4.3% and 0.8%, respectively, had events that were graded as severe. Efficacy was not shown in the participants 18 years of age or older. CONCLUSIONS: 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 .).

authors

  • PALISADE Group of Clinical Investigators
  • Vickery, Brian P
  • Vereda, Andrea
  • Casale, Thomas B
  • Beyer, Kirsten
  • du Toit, George
  • Hourihane, Jonathan O
  • Jones, Stacie M
  • Shreffler, Wayne G
  • Marcantonio, Annette
  • Zawadzki, Rezi
  • Sher, Lawrence
  • Carr, Warner W
  • Fineman, Stanley
  • Greos, Leon
  • Rachid, Rima
  • Ibáñez, M Dolores
  • Tilles, Stephen
  • Assa’ad, Amal H
  • Nilsson, Caroline
  • Rupp, Ned
  • Welch, Michael J
  • Sussman, Gordon
  • Chinthrajah, Sharon
  • Blumchen, Katharina
  • Sher, Ellen
  • Spergel, Jonathan M
  • Leickly, Frederick E
  • Zielen, Stefan
  • Wang, Julie
  • Sanders, Georgiana M
  • Wood, Robert A
  • Cheema, Amarjit
  • Bindslev-Jensen, Carsten
  • Leonard, Stephanie
  • Kachru, Rita
  • Johnston, Douglas T
  • Hampel, Frank C
  • Kim, Edwin H
  • Anagnostou, Aikaterini
  • Pongracic, Jacqueline A
  • Ben-Shoshan, Moshe
  • Sharma, Hemant P
  • Stillerman, Allan
  • Windom, Hugh H
  • Yang, William H
  • Muraro, Antonella
  • Zubeldia, José M
  • Sharma, Vibha
  • Dorsey, Morna J
  • Chong, Hey J
  • Ohayon, Jason
  • Bird, J Andrew
  • Carr, Tara F
  • Siri, Dareen
  • Fernández-Rivas, Montserrat
  • Jeong, David K
  • Fleischer, David M
  • Lieberman, Jay A
  • Dubois, Anthony EJ
  • Tsoumani, Marina
  • Ciaccio, Christina E
  • Portnoy, Jay M
  • Mansfield, Lyndon E
  • Fritz, Stephen B
  • Lanser, Bruce J
  • Matz, Jonathan
  • Oude Elberink, Hanneke NG
  • Varshney, Pooja
  • Dilly, Stephen G
  • Adelman, Daniel C
  • Burks, A Wesley

publication date

  • November 22, 2018

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