Safety and Efficacy of Very Low-Dose Multi-Nut Oral Immunotherapy in Children

Abstract

Background:

Oral immunotherapy (OIT) is a management strategy for food allergies, typically one at a time, with maintenance doses ≥300mg protein. However, 30% of allergic children have multiple trigger foods, and large maintenance doses are associated with side effects. If efficacious, Very Low-Dose OIT (VLOIT) may enhance safety in multi-OIT.

Methods:

Eighteen children with allergies to 2-5 nuts (tree nuts, peanuts) were enrolled (NCT03799328). Oral food challenge (OFC)-confirmed allergies to their nut mix at </=444mg protein each nut followed by initiation of an open-label mix of 4mg protein/nut with dose increases every 2 months up to a maintenance dose of 30mg protein/nut. After 18 months, an exit-OFC assessed allergic threshold changes, with a maximum of 2040mg protein/nut. Efficacy was evaluated using pre-post treatment and proportional analyses (Wilcoxon signed-ranks, two-tailed Fisher’s test).

Results:

The median age at enrollment was 5.0 years (IQR 3.13-9.62). The baseline median tolerated dose was 10mg protein/nut (IQR 3-100mg). Three withdrew, one did not reach the target maintenance but was invited for the exit OFC, resulting in 15/18 eligible for exit OFC. The median tolerated dose at exit OFC was 1000mg (IQR 300-1000mg), with a significant difference from baseline (p<0.0001). Ten out of 15 participants tolerated the maximum dose (p<0.0001). Intention- to-treat analysis showed that 14/18 children met pre-defined efficacy measures: tolerated 5X their baseline dose or ≥300mg (p<0.001). No patients required epinephrine during treatment.

Conclusions:

VLOIT led to a significant increase in the tolerated dose to multiple nuts.

Authors:

Julia EM Upton, Carmen H Li, Alireza Berenjy, Alana Galper, Xiaojun Yin, Alper Celik, Lucy Duan, Samantha Wong, Christina M Ditlof, Jennifer A Hoang, Moshe Ben-shoshan, Akash Kothari, Lisa Hung, Mikhail Monteiro, Wut Hmone Phue, Theo J Moraes, Thomas

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