Pathway to Peanut Tolerance

Overview

While rigorous clinical trials have established peanut OIT as a promising therapy capable of inducing desensitization and even remission, its transition to routine clinical practice requires robust real-world evidence. Current management relies on strict avoidance, and the lack of reliable biomarkers to predict long-term success remains a significant barrier to the wider, more accessible application of OIT. Therefore, there is a critical need to evaluate peanut OIT in pragmatic, real-world settings. Such studies are essential to understand its effectiveness and safety beyond controlled trial conditions, to identify which patients benefit most, and to develop practical monitoring strategies. Generating this evidence is a crucial step toward making this treatment a viable and optimized option for the growing global population affected by peanut allergy.

This is an open-label, non-randomized, two-arm trial designed to evaluate the real-world efficacy, safety, and tolerability of a pragmatic peanut oral immunotherapy (OIT) protocol for children under 18 in Hong Kong. The study addresses a significant unmet need by providing access to a treatment available overseas and aims to establish a translatable model for future food allergy treatments in the region. The intervention arm (n=100) will undergo 18 months of peanut OIT, while the control arm (n=25) will follow standard care, i.e., strict peanut avoidance for the same duration. Eligible children aged 2-17 with a confirmed peanut allergy will be recruited from the Specialist Outpatient Clinic at the Prince of Wales Hospital and through referral from other public hospitals. Participants will be allocated to the active or control arm in a 4:1 ratio. The primary efficacy measure is the proportion of participants in the OIT group versus the control group who achieve a desensitization level of more than 640 mg of peanut protein, as confirmed by an oral food challenge at the end of the 18-month treatment period. Some of the key secondary objectives include to systematically document the frequency and severity of treatment-related adverse events and the proportion of participants discontinuing OIT due to these events; and to identify distinct pre- and post-treatment plasma protein biomarkers associated with successful OIT.