Interaction Between Baseline Participant Factors and Treatment Effects Following Peanut Oral Immunotherapy

To evaluate factors associated with remission and health related quality of life (HRQL) among children with peanut allergy treated with probiotic peanut oral immunotherapy (PPOIT) or oral immunotherapy (OIT) alone.

Children (n = 201) aged 1 to 10 years with challenge-confirmed peanut allergy.

In a post hoc analysis of the Probiotic Peanut Oral Immunotherapy 003 multicenter randomized, double-blind, clinical trial authors evaluated children who were randomized to 18 months of treatment (target maintenance dose of 2 grams of peanut protein) with PPOIT, OIT, or placebo (with 12-month post-treatment observation). Baseline characteristics (eg, age, sex, skin prick test diameter, sIgE, additional food allergies, atopic comorbidities, eliciting dose) were evaluated using regression models, with remission defined as tolerating a cumulative 4950 mg of peanut protein (double-blind placebo-controlled food challenge, 8 weeks after treatment without intervening peanut consumption). HRQL was assessed via caregiver completion of the Food Allergy Quality of Life Questionnaire.

Factors significantly associated with remission included: age < 6 years, skin prick test ≤ 10 mm, peanut sIgE < 40 kU/L, <2 food allergies, and absence of anaphylaxis or asthma. Remission likelihood was similar between PPOIT and OIT, except for those with a history of anaphylaxis (odds ratio 3.03, OIT versus PPOIT, P = .05). Surprisingly, when compared with placebo, HRQL was worse as reported by caregivers of female children receiving OIT.

Baseline patient characteristics may inform likelihood of benefit in children receiving food oral immunotherapy.

The study reinforces the concept of early immune plasticity, highlighting that early intervention with food oral immunotherapy may have incremental value in children who have yet to accumulate high levels of disease severity. Notably, improvements in HRQL can be variable, highlighting the key role of shared decision-making where a pediatric allergist-immunologist provides clinical expertise in concert with patients and families, serving as content experts in their values, preferences, and treatment goals. Given treatment goals may be accomplished at lower maintenance doses of OIT (eg, 300 mg) with lower adverse event rates, it is possible HQRL responses may vary in more diverse settings.