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

BACKGROUND

Oral immunotherapy (OIT) causes frequent treatment-related adverse events (AEs), particularly during dose escalation, which can cause treatment withdrawal.

OBJECTIVE

To determine whether patient characteristics influenced the frequency of treatment-related AEs during dose escalation.

METHODS

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.

RESULTS

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.

CONCLUSION

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.