Allergy · 2026
Efficacy and Safety of Abatacept Versus Placebo During Peanut Oral Immunotherapy for Adults With Severe Peanut Allergy.
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Simard Marie-Lee, Braun Camille, Antony Éloise, Roy Émilie, Gingras Marie-Ève, Graham François, Des Roches Anne, Paradis Louis, Samaan Kathryn, Gingras-Lessard Florence, Labrosse Roxane, Eiwegger Thomas, Bégin Philippe
Аннотация
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.
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.