This double-blind, placebo-controlled RCT (OUTMATCH stage 2) compared omalizumab monotherapy vs. omalizumab-facilitated multiallergen OIT (MOIT) in 117 participants aged 1–55 years with allergy to peanuts plus ≥2 other foods, across 10 US academic centers over 60 weeks.
In the ITT analysis, omalizumab was superior to MOIT for tolerating a cumulative dose ≥4044 mg across all 3 foods (36% vs. 19%; OR 2.6; 95% CI 1.1–6.3; P = .03); however, per-protocol analyses showed no difference. MOIT had far more serious adverse events (31% vs. 0%), discontinuations (22% vs. 0%), and epinephrine use (37% vs. 7%).
- The ITT superiority of omalizumab was largely driven by high MOIT discontinuation due to adverse events (49% did not complete), not by greater efficacy in those who tolerated the regimen. - Per-protocol analysis showed no significant difference, raising questions about true comparative efficacy. - Median participant age was 7 years, limiting direct generalizability to adults.
For children and adults with multifood allergy, omalizumab monotherapy offers a safer profile than multiallergen OIT, with fewer serious reactions and near-zero discontinuations — making it a practical first-line option, especially for patients at high risk of OIT-related reactions. Clinicians should counsel that MOIT's high adverse event burden (31% serious, 22% discontinuation) substantially limits its real-world use in this population.
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