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.
Katie Wright, EMJ
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.
