Impact of Participant Baseline Factors on Exposure-Adjusted Incidence of Treatment-Related Adverse Events During Peanut Oral Immunotherapy.

Abstract

Oral immunotherapy (OIT) causes frequent treatment-related adverse events (AEs), particularly during dose escalation, which can cause treatment withdrawal. To determine whether patient characteristics influenced the frequency of treatment-related AEs during dose escalation. We obtained data from a multicenter randomized trial (PPOIT-003) involving 201 children aged 1 to 10 years who received probiotic peanut oral immunotherapy (PPOIT), peanut OIT alone (OIT), or placebo. Frequency of AEs was expressed as the exposure-adjusted incidence rate (EAIR). We used multivariable Poisson regression models with interaction terms to explore whether baseline participant factors modified the effect of treatment on EAIR of treatment-related AEs during dose escalation. The EAIR of AE in PPOIT and OIT groups was threefold higher compared with placebo, with no difference comparing PPOIT and OIT (PPOIT vs placebo: rate ratio [RR] = 3.62, 95% CI, 2.92-4.48, P < .001; OIT vs placebo: RR = 3.62, 95% CI, 2.93-4.48, P < .001; and PPOIT vs OIT: RR = 1.00, 95% CI, 0.90-1.10; P = .98). Older children (aged ≥6 years) and females had a higher EAIR in all treatment groups. Allergic sensitivity and preexisting allergic conditions modified the effect of treatment on EAIR (likelihood ratio test all P < .001). Children with a skin prick test result of 15 mm or greater, peanut-specific IgE of 40 kU/L or greater, reaction dose threshold less than 320 mg for peanut protein, or history of asthma, allergic rhinitis, or anaphylaxis were more likely to report frequent treatment-related AEs when receiving PPOIT or OIT, but not placebo. Children with higher allergic sensitivity or allergic comorbidities are more likely to experience frequent treatment-related AEs during peanut OIT dose escalation and may benefit from more intensive monitoring and support to optimize treatment success.