TOPLINE:

Baseline characteristics such as high peanut-specific immunoglobulin E levels, large skin prick test (SPT) wheals, and a history of allergic conditions were associated with an increased incidence of adverse events during peanut oral immunotherapy (OIT).

METHODOLOGY:

• Researchers conducted a phase 2 trial of 201 children with peanut allergy who were randomly assigned to receive probiotic peanut OIT (n = 79; 62% boys), peanut OIT with a placebo probiotic (n = 83; 66% boys), or a placebo (n = 39; 64% boys) for 18 months.
• All participants underwent a dose-escalation phase lasting ≥ 16 weeks to reach the target maintenance dose of 2000 mg peanut protein.
• Researchers analyzed the exposure-adjusted incidence rate of adverse events, calculated as the number of treatment-related adverse events per patient-year of treatment exposure.

TAKEAWAY:

• During the dose-escalation phase, children in the active treatment groups had a 3.6-fold higher exposure-adjusted incidence of adverse events than those in the placebo group (adjusted rate ratio [aRR], 3.62; P < .001 for both probiotic peanut OIT and OIT).
• Children with an SPT wheal size ≥ 15 mm had higher adverse event rates than those with < 15 mm (aRR, 1.48; 95% CI, 1.34-1.63; P < .001), and rates were higher in children with a history of asthma/wheeze than in those without (aRR, 1.47; 95% CI, 1.32-1.63; P < .001).
• Children aged 6 years or older had higher adverse event rates than those younger than 6 years (aRR, 1.47; 95% CI, 1.33-1.63; P < .001), and rates were higher in girls than in boys (aRR, 1.25; 95% CI, 1.13-1.38; P < .001).
• Children with peanut-specific immunoglobulin E levels ≥ 40 kU/L had twofold higher rates of adverse events than those with lower levels (aRR, 2.00; P < .001).

IN PRACTICE:

“Identification of groups with both high and low risk of AEs [adverse events] during treatment can assist clinicians and patients to assess risk and consider appropriate mitigation strategies,” the authors of the study wrote.

SOURCE:

Melanie Lloyd, PhD, with Murdoch Children’s Research Institute, Parkville, Australia, was the corresponding author of the study, which was published online on September 19, 2025, in The Journal of Allergy and Clinical Immunology.

LIMITATIONS:

Study participants were recruited from various Australian sites, limiting the generalizability of the findings to global populations. Parent-reported outcomes for reaction symptoms and cofactors outside dose-escalation visits may have introduced inconsistencies in data capture. Additionally, the subjectivity of parent-reported measures may have influenced the strength of observed associations.

DISCLOSURES:

One author reported receiving consultant fees from Pfizer, holding share interest/options in Prota Therapeutics, and serving on multiple medical advisory boards.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.