ABSTRACT Background Oral immunotherapy (OIT) is a management strategy for food allergies, typically one at a time, with maintenance doses ≥ 300 mg 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 ≤ 444 mg protein each nut followed by initiation of an open‐label mix of 4 mg protein/nut with dose increases every 2 months up to a maintenance dose of 30 mg protein/nut. After 18 months, an exit‐OFC assessed allergic threshold changes, with a maximum of 2040 mg 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 10 mg protein/nut (IQR 3–100 mg). 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 1000 mg (IQR 300–1000 mg), 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 ≥ 300 mg ( p < 0.001). No patients required epinephrine during treatment. Conclusions VLOIT led to a significant increase in the tolerated dose to multiple nuts.
Upton et al. (Mon,) studied this question.