OMALIZUMAB and oral immunotherapy (OIT) are both used for treating multi-food allergy, yet their effectiveness has never been directly compared.
The OUtMATCH Stage 2 study aimed to assess the efficacy and safety of omalizumab compared to multi-allergen OIT in children with multi-food allergies. Participants were randomly assigned to receive either double-blind multi-allergen OIT with placebo omalizumab or omalizumab with placebo OIT. Initially, all participants underwent 16 weeks of open-label omalizumab treatment. At Week 9, OIT or placebo-OIT was introduced and escalated to a maintenance target of 1000 mg per allergen. At Week 16, participants transitioned to blinded injection therapy with omalizumab or placebo for 44 weeks before undergoing a food challenge, with a cumulative dose of 8044 mg of protein per food. The primary endpoint was defined as tolerance of at least 2000 mg (cumulative 4044 mg) for all three allergens.
A total of 117 participants were enrolled, with a median age of seven years, and 55% were male. Completion rates varied significantly between the groups, with 88% (51/58) of the omalizumab group completing Stage 2 compared to 51% (30/59) in the OIT group. The intent-to-treat analysis demonstrated that omalizumab was superior to OIT, with a success rate of 36% versus 19% (OR 2.6, P=0.031). Superiority was also observed in the success rate for at least two allergens (P=0.004) and other secondary endpoints. However, in the per-protocol analysis, which excluded dropouts, there was no significant difference between the groups (P=0.66). Safety outcomes strongly favoured omalizumab, with serious adverse events occurring in 0% of the omalizumab group compared to 30.5% in the OIT group. Adverse events leading to treatment discontinuation were observed in 22.0% of OIT participants but not in the omalizumab group. Additionally, epinephrine use was higher in the OIT group (37.3%) compared to the omalizumab group (6.9%).
These findings indicate that omalizumab is a more effective and safer option than multi-allergen OIT for treating multi-food allergy. The high rate of adverse events and treatment discontinuation in the OIT group, despite initial omalizumab treatment, contributed to the observed differences in efficacy and safety.
Reference
Wood R et al. Treatment of multi-food allergy with omalizumab compared to omalizumab-facilitated multi-allergen OIT. J Allergy Clin Immunol. 2025;155(2):AB444.
