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Abatacept to induce remission of peanut allergy during oral immunotherapy (ATARI): protocol for a phase 2a randomized controlled trial

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  • Additional Information
    • Contributors:
      Hospices Civils de Lyon (HCL); Immunité de l’épiderme & allergie - Epidermal Immunity and Allergy CIRI (CIRI-EIA); Centre International de Recherche en Infectiologie (CIRI); École normale supérieure de Lyon (ENS de Lyon); Université de Lyon-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure de Lyon (ENS de Lyon); Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); Centre de ressources et Compétences (CRCM) enfant, Hopital Femme Mère Enfant; Service de Pneumologie Pédiatrique Hôpital Femme Mère Enfant - CHU de Lyon; Hôpital Femme Mère Enfant CHU - HCL (HFME); Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL)-lyon
    • Publication Information:
      CCSD
      Frontiers media
    • Publication Date:
      2023
    • Collection:
      Hospices Civils de Lyon (HCL): HAL
    • Abstract:
      International audience ; Context While oral immunotherapy (OIT) has been shown to promote the remission of mild peanut allergy in young children, there is still an unmet need for a disease-modifying intervention for older patients and those with severe diseases. In mice models, abatacept, a cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) immunoglobulin fusion protein, has been shown to promote immune tolerance to food when used as an adjuvant to allergen immunotherapy. The goal of this study is to explore the potential efficacy of abatacept in promoting immune tolerance to food allergens during OIT in humans. Methods In this phase 2a proof-of-concept study (NCT04872218), 14 peanut-allergic participants aged from 14 to 55 years will be randomized at a 1:1 ratio to abatacept vs. placebo for the first 24 weeks of a peanut OIT treatment (target maintenance dose of 300 mg peanut protein). The primary outcome will be the suppression of the OIT-induced surge in peanut-specific IgE/total IgE at 24 weeks, relative to the baseline. Sustained unresponsiveness will be assessed as a secondary outcome starting at 36 weeks by observing incremental periods of peanut avoidance followed by oral food challenges. Discussion This is the first study assessing the use of abatacept as an adjuvant to allergen immunotherapy in humans. As observed in preclinical studies, the ability of abatacept to modulate the peanut-specific immune response during OIT will serve as a proxy outcome for the development of clinical tolerance, given the small sample size. The study will also test a new patient-oriented approach to sustained tolerance testing in randomized controlled trials.
    • Accession Number:
      10.3389/fmed.2023.1198173
    • Online Access:
      https://hal.science/hal-04946312
      https://hal.science/hal-04946312v1/document
      https://hal.science/hal-04946312v1/file/ATARI_protocol.pdf
      https://doi.org/10.3389/fmed.2023.1198173
    • Rights:
      info:eu-repo/semantics/OpenAccess
    • Accession Number:
      edsbas.8CB926CE