The Efficacy and Safety of Probiotic and Peanut Oral Immunotherapy for inducing Desensitization and Sustained Unresponsiveness: Results from a Phase 2b Multi-center Randomized Trial (PPOIT-003)

Peanut allergy is the commonest cause of serious food-induced allergic reactions with no effective long-term treatment. Results of a phase 2a randomized trial (PPOIT-001) showed that Probiotic and Peanut Oral Immunotherapy (PPOIT) was highly effective at inducing 2-5 week sustained unresponsiveness (SU) (82.1% PPOIT vs 3.6% placebo, p<0.001) and had a favorable safety profile. PPOIT-003 compares PPOIT with placebo and peanut OIT for induction of 8-week SU. Children aged 1-10 years with double-blind placebo controlled food challenge (DBPCFC) confirmed peanut allergy were randomized 2:2:1 to receive PPOIT, OIT or placebo for 18-months. The primary endpoint is SU evaluated by DBPCFC (cumulative 4950mg peanut protein) at 8-weeks post-treatment in PPOIT vs placebo and PPOIT vs OIT groups. Desensitization is assessed at end of treatment by DBPCFC. Peanut and peanut component sIgE and sIgG4 and peanut skin prick test are measured at screening, end of treatment and 8-weeks post-treatment. The study protocol was approved by the Royal Children’s Hospital Human Research Ethics Committee. 201 subjects were consented and randomized. The median cumulative eliciting dose at study entry DBPCFC was 560 mg (IQR 240–2450). At the time of submission of this abstract, 200 subjects have completed the 8-week post-treatment SU assessment. Efficacy and safety data will be available for presentation at the AAAAI 2020 meeting. The results of PPOIT-003 will provide new information on whether PPOIT is effective at inducing 8-week SU compared to placebo and peanut OIT respectively, and clarify whether addition of the probiotic enhances efficacy and safety of OIT.