TOPLINE
Adding abatacept to peanut oral immunotherapy (OIT) did not significantly suppress the transient rise in peanut-specific immunoglobulin E (IgE) levels in adolescents and adults with severe peanut allergy. Patients who received abatacept had fewer anaphylactic reactions than those on placebo, though the 14-patient trial was small to reliably detect differences in safety.
METHODOLOGY
- Researchers conducted a phase 2a randomized trial in Canada to evaluate whether adding abatacept to peanut OIT could promote immune tolerance in patients with severe peanut allergy.
- They assigned 14 patients (mean age, 21 years; 50% males) with confirmed severe peanut allergy (peanut-specific IgE above 50 kU/L) to receive abatacept (n = 7) or placebo (n = 7) alongside peanut OIT for 24 weeks, followed by 12 weeks of OIT alone.
- Both groups received OIT, with doses raised every 2 weeks to a daily maintenance dose of 300 mg of peanut protein.
- Abatacept was dosed by body weight (500, 750, or 1000 mg); it was given a day before OIT began, then at 2-week intervals for the first three doses, and monthly through week 24 (seven infusions in total). The same infusion schedule was followed for the placebo group.
- The main outcome was the relative change from baseline to week 24 in the ratio of peanut-specific IgE to total IgE. The secondary outcomes included sustained unresponsiveness, which was evaluated through repeat open oral food challenges after 3 days, 1 week, 2 weeks, and 4 weeks of OIT avoidance. Adverse events, including serious adverse events, were tracked throughout the trial.
TAKEAWAY
- At 24 weeks, the ratio of peanut-specific IgE to total IgE rose 87.9% with placebo and 48.2% with abatacept (P = .26). The difference was not significant and did not reach the prespecified 50% reduction.
- After 4 weeks of OIT avoidance, both groups still tolerated a median of 3000 mg of peanut protein, and reactions to OIT doses were similar between groups.
- Adverse events were fewer in patients who received abatacept than in those on placebo (5.9 vs 10.0 per patient; P = .006), including fewer anaphylactic reactions (2 vs 13 events; P = .007).
- No serious adverse events occurred, and none were linked to abatacept. Three patients (one on placebo, two on abatacept) developed treatment-emergent eosinophilic esophagitis confirmed by biopsy. All esophagitis cases were managed with standard treatment, and none of the patients withdrew.
IN PRACTICE
"Although abatacept may have a limited impact on the development of tolerance during OIT in this population, no safety concerns were detected and improved tolerability to peanut OIT was observed in the abatacept group with lower adverse event and anaphylaxis rates compared to placebo," the authors wrote.
SOURCE
Philippe Bégin, with the Centre Hospitalier Universitaire Sainte-Justine, Montréal, Québec, Canada, was the corresponding author of the study, which was published online on September 30 in Allergy.
LIMITATIONS
The study enrolled only 14 patients. Variability in the increase of IgE response was higher than expected, which reduced power and could have masked a true effect. No entry oral food challenge was performed before randomization.
DISCLOSURES
The study was funded by the Centre Hospitalier Universitaire Sainte-Justine Foundation. Several authors reported receiving personal fees, grants, or lecture fees or holding advisory board roles in multiple pharmaceutical companies, including Novartis, Sanofi, ALK, DBV Technologies, and Regeneron.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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