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AR101 Oral Immunotherapy for Peanut Allergy.
- Source :
-
The New England journal of medicine [N Engl J Med] 2018 Nov 22; Vol. 379 (21), pp. 1991-2001. Date of Electronic Publication: 2018 Nov 18. - Publication Year :
- 2018
-
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.<br />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.<br />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.<br />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 .).
- Subjects :
- Administration, Oral
Adolescent
Adult
Age Factors
Allergens adverse effects
Biological Products adverse effects
Biological Products immunology
Child
Child, Preschool
Desensitization, Immunologic adverse effects
Dose-Response Relationship, Immunologic
Double-Blind Method
Female
Gastrointestinal Diseases etiology
Humans
Male
Middle Aged
Plant Proteins adverse effects
Plant Proteins immunology
Young Adult
Allergens administration & dosage
Arachis adverse effects
Biological Products administration & dosage
Desensitization, Immunologic methods
Peanut Hypersensitivity therapy
Plant Proteins administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 379
- Issue :
- 21
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 30449234
- Full Text :
- https://doi.org/10.1056/NEJMoa1812856