Food allergy is a common condition that significantly impacts patients' quality of life and carries the risk of life-threatening anaphylaxis.^1,2 Until recently, treatment options were largely limited to lifelong allergen avoidance.² However, two Food and Drug Administration (FDA)-approved therapies are now available: oral immunotherapy (OIT) and omalizumab.¹ While both approaches have been used for multi-food allergy treatment, their effectiveness had not been directly compared—until now.³ At the 2025 AAAAI/WAO Joint Congress, Dr. Robert Wood from the Johns Hopkins University School of Medicine presented findings from the OUtMATCH stage 2 study, the first trial to directly compare the efficacy and safety of omalizumab with multi-allergen OIT in children with multi-food allergies.³

The OUtMATCH stage 2 randomized controlled trial randomly assigned participants (n=117) to receive either a double-blind multi-allergen OIT and placebo omalizumab, or omalizumab/placebo OIT.³ Initially, all participants underwent 16 weeks of open-label omalizumab treatment.³ At week 9, OIT or placebo-OIT was introduced and escalated to a maintenance dose of 1,000mg per allergen.³ At week 16, participants transitioned to blinded injection therapy with omalizumab or placebo for 44 weeks.³ The median age of study participants was seven years, and 55% were male.³ Completion rates varied significantly between treatment groups, with 88% (51 out of 58) of those receiving omalizumab completing stage 2, compared to only 51% (30 out of 59) in the OIT group.³ The study concluded with a food challenge, in which participants were exposed to a cumulative dose of 8,044mg of protein per food.³

The primary endpoint of the study was the ability to tolerate at least 2,000mg (cumulative 4,044mg) of all three allergens.³ The intent-to-treat analysis demonstrated that omalizumab was superior to OIT, with a success rate of 36% compared to 19% (odds ratio=2.6, p=0.031).³ Omalizumab also demonstrated higher success rates in tolerating at least two allergens (p=0.004) and in other secondary endpoints.³ However, in the per-protocol analysis, which excluded dropouts, there was no significant difference between the two groups (p=0.66).³ Safety outcomes favored omalizumab significantly.³ No serious adverse events were reported in the omalizumab group, whereas 30.5% of participants in the OIT group experienced serious adverse events.³ Treatment discontinuation due to adverse events occurred in 22.0% of OIT participants, while none of the omalizumab-treated participants discontinued treatment.³ Epinephrine use was also notably higher in the OIT group, with 37.3% requiring treatment compared to only 6.9% in the omalizumab group.³

In conclusion, these findings highlight omalizumab as a more effective and safer alternative to multi-allergen OIT for treating multi-food allergy.³ The high rate of adverse events and treatment discontinuation in the OIT group, despite initial omalizumab therapy, contributed to the observed differences in efficacy and safety.³ This study provides compelling evidence that omalizumab could be a preferred treatment option for multi-food allergy, offering a better balance between efficacy and tolerability than OIT.³