Long-term safety and immunologic outcomes of daily oral immunotherapy for peanut allergy

J. Andrew Bird, Caroline Nilsson, Kari Brown, Trinh Pham, Stephen Tilles, George du Toit, Amal Assa'ad

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

Background: Oral immunotherapy containing peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) (Palforzia [Aimmune Therapeutics, Brisbane, Calif]) for 9 to 12 months resulted in higher tolerated amounts of peanut protein in PTAH-treated individuals aged 4 to 17 years with peanut allergy than in placebo-treated participants. Objective: We aimed to describe additional long-term pooled safety data and changes in peanut sensitization markers from baseline through approximately 5 years of treatment. Methods: The results from 6 clinical trials of PTAH (3 controlled and 3 open-label extension studies [N = 1227]) were pooled, and analysis of safety outcomes and immunologic data was performed. The PTAH doses were administered sequentially as follows: initial dose escalation (dose increased to 6 mg over 2 days), updosing (dose increased every 2 weeks to 300 mg for a minimum of 6 months), and maintenance dosing (300 mg per day). Results: There was a trend toward decreased adverse events (AEs) at years 1 and 2 that was maintained up to 5 years, with 94% of patients experiencing mild or moderate AEs and only 13% discontinuing PTAH use because of AEs overall. Gastrointestinal symptoms were the most commonly reported treatment-related AEs. A downward trend in systemic allergic reactions was also reported. PTAH treatment resulted in reduced levels of peanut-specific IgE after the first year and increased levels of peanut-specific IgG4, with a lowered peanut-specific IgE:IgG4 ratio. A reduction in median peanut skin prick test wheal diameter was observed (11.50 mm at baseline vs 5.75 mm at year 5). Conclusion: Long-term immunomodulation without any new safety signals was reported with PTAH immunotherapy in the largest safety data set and longest treatment duration for oral immunotherapy published to date.

Original languageEnglish (US)
Article number100120
JournalJournal of Allergy and Clinical Immunology: Global
Volume2
Issue number3
DOIs
StatePublished - Aug 2023

Keywords

  • PTAH
  • immunologic outcomes
  • oral immunotherapy
  • peanut (Arachis hypogaea) allergen powder
  • peanut allergy
  • pooled safety

ASJC Scopus subject areas

  • Immunology and Allergy

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