Efficacy and Safety of Abatacept Versus Placebo During Peanut Oral Immunotherapy for Adults With Severe Peanut Allergy
Abstract
BACKGROUND: Unmet needs remain for disease-modifying interventions for the treatment of severe persistent food allergies. In mice models, abatacept, a cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) immunoglobulin fusion protein, promotes immune tolerance to food proteins, and suppresses the initial allergen-related induction of specific immunoglobulin E (IgE) when used as an adjuvant to allergen immunotherapy. METHODS: In this Phase 2a placebo-controlled clinical trial, 14 peanut-allergic participants (14-50 years old) with specific IgE > 50 kU/L were randomized 1:1 to adjuvant abatacept vs. placebo to peanut oral immunotherapy (OIT) for 24 weeks, followed by 12 weeks of OIT alone. With the hypothesis that abatacept suppresses the transient OIT-induced increase in specific IgE, the primary outcome was the relative change from baseline of the peanut-specific/total IgE ratio at 24 weeks. Sustained unresponsiveness was assessed as a secondary outcome with repeated oral food challenges (OFCs) following incremental periods of peanut avoidance. RESULTS: No significant difference in the relative change in peanut-specific/total IgE ratio from baseline was observed between groups (placebo group 87.9% vs. abatacept group 48.2%, p-value 0.26). Median minimal reactive doses on repeated OFCs were similar in both groups (3000 mg) after 4 weeks of peanut avoidance. Lower adverse event rates including anaphylaxis were observed in the abatacept group (5.9 vs. 10 per participant, p-value 0.006). CONCLUSION: Compared to placebo, abatacept did not suppress the allergen-related induction of peanut-specific IgE relative to their total at 24 weeks, but improved OIT tolerability in this severely allergic adult population. Independently of abatacept, most participants achieved sustained unresponsiveness with OIT.
Related
- Safety and efficacy of levacetylleucine in ataxia-telangiectasia: a phase 3, randomised, double-blind, placebo-controlled crossover trial
- Clinical Outcomes in Placebo-Injection and Injection-Free Cohorts in Birch Pollen Allergy: An Exploratory Cross-Study Comparison
- Rationally Engineered Self-Assembling Protein Nanoparticles for Allergen-Specific Peanut Allergy Immunotherapy
- Efficacy of sound therapy in chronic tinnitus patients with mild hearing loss: a multicentre, double-blind, placebo-controlled randomized clinical trial
- Efficacy of Starting Very-Low-Dose Cow's Milk Intake in Children Aged 1-12 Years With Severe Cow's Milk Allergy: A Retrospective Study.
BibTeX
@article{simard2026efficacy,
title = {{Efficacy and Safety of Abatacept Versus Placebo During Peanut Oral Immunotherapy for Adults With Severe Peanut Allergy}},
author = {Marie‐lee Simard and Camille Braun and Éloise Antony and Émilie Roy and Marie‐ève Gingras and François Graham and Anne Des Roches and Louis Paradis and Kathryn Samaan and Florence Gingras-Lessard and Roxane Labrosse and Thomas Eiwegger and Philippe Bégin},
journal = {Allergy},
year = {2026},
month = sep,
doi = {10.1111/all.70531},
url = {https://hal.science/hal-05795471v1},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Efficacy and Safety of Abatacept Versus Placebo During Peanut Oral Immunotherapy for Adults With Severe Peanut Allergy
AU - Marie‐lee Simard
AU - Camille Braun
AU - Éloise Antony
AU - Émilie Roy
AU - Marie‐ève Gingras
AU - François Graham
AU - Anne Des Roches
AU - Louis Paradis
AU - Kathryn Samaan
AU - Florence Gingras-Lessard
AU - Roxane Labrosse
AU - Thomas Eiwegger
AU - Philippe Bégin
PY - 2026
DA - 2026/09/30
JO - Allergy
DO - 10.1111/all.70531
UR - https://hal.science/hal-05795471v1
AB - BACKGROUND: Unmet needs remain for disease-modifying interventions for the treatment of severe persistent food allergies. In mice models, abatacept, a cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) immunoglobulin fusion protein, promotes immune tolerance to food proteins, and suppresses the initial allergen-related induction of specific immunoglobulin E (IgE) when used as an adjuvant to allergen immunotherapy. METHODS: In this Phase 2a placebo-controlled clinical trial, 14 peanut-allergic participants (14-50 years old) with specific IgE > 50 kU/L were randomized 1:1 to adjuvant abatacept vs. placebo to peanut oral immunotherapy (OIT) for 24 weeks, followed by 12 weeks of OIT alone. With the hypothesis that abatacept suppresses the transient OIT-induced increase in specific IgE, the primary outcome was the relative change from baseline of the peanut-specific/total IgE ratio at 24 weeks. Sustained unresponsiveness was assessed as a secondary outcome with repeated oral food challenges (OFCs) following incremental periods of peanut avoidance. RESULTS: No significant difference in the relative change in peanut-specific/total IgE ratio from baseline was observed between groups (placebo group 87.9% vs. abatacept group 48.2%, p-value 0.26). Median minimal reactive doses on repeated OFCs were similar in both groups (3000 mg) after 4 weeks of peanut avoidance. Lower adverse event rates including anaphylaxis were observed in the abatacept group (5.9 vs. 10 per participant, p-value 0.006). CONCLUSION: Compared to placebo, abatacept did not suppress the allergen-related induction of peanut-specific IgE relative to their total at 24 weeks, but improved OIT tolerability in this severely allergic adult population. Independently of abatacept, most participants achieved sustained unresponsiveness with OIT.
SN - 0105-4538
SN - 1398-9995
ER -