Omalizumab beat multiallergen oral immunotherapy for multiple food allergies, mainly because immunotherapy was hard to tolerate

Design

Double-blind, placebo-controlled randomised trial (OUTMATCH stage 2)

Population

117 people aged 1 to 55 with peanut plus ≥2 other food allergies

Primary outcome

Tolerating ≥4044 mg protein of all 3 foods

Effect

36% omalizumab vs 19% oral immunotherapy; OR 2.6 (95% CI 1.1 to 6.3)

This stage of the OUTMATCH trial randomised 117 people aged 1 to 55 years, median age 7, with peanut allergy plus at least two other food allergies. After 16 weeks of open-label omalizumab, they received either blinded omalizumab or multiallergen oral immunotherapy for 44 weeks, each with a placebo for the other.

Tolerating at least 4044 mg of protein of all three foods was achieved by 36% on omalizumab and 19% on oral immunotherapy (OR 2.6, 95% CI 1.1 to 6.3). But only 51% of the immunotherapy group completed the study against 88% on omalizumab, and per-protocol results did not differ. Serious adverse events (31% vs 0%) and adrenaline-treated reactions (37% vs 7%) were far more common with immunotherapy.

The effect is driven by tolerability rather than potency. For a child with several food allergies, omalizumab may be the more practical option where it is available and affordable, but access in India is limited and cost is high.

• For children with several serious food allergies, omalizumab may be easier to sustain than multi-food oral immunotherapy
• Expect frequent reactions with multiallergen oral immunotherapy; half did not complete it
• Strict avoidance and an adrenaline action plan remain the foundation of care
• Refer to a specialist allergy service for any disease-modifying treatment

Why it matters

It suggests that for multiple food allergies, the treatment a family can keep going may matter more than the one with the highest ceiling.

Don't overread it

Per-protocol analyses showed no difference, so this does not show omalizumab is more effective in those who complete either treatment.

The statistics, in plain English

The intention-to-treat difference reflects dropouts as much as efficacy: among those who stuck with treatment, outcomes were similar. The wide interval (1.1 to 6.3) reflects the small trial.

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