Omalizumab outperforms multiallergen oral immunotherapy in multifood allergy trial

Food allergy affects up to 8% to 10% of children and adults, and many patients are allergic to more than one food, making avoidance difficult and increasing the risk of accidental reactions.¹ A new randomized clinical trial suggests that omalizumab may offer a safer path to increasing food tolerance than multiallergen oral immunotherapy (MOIT), although both approaches remain viable options for selected patients.²

The findings, published in JAMA Pediatrics, come from stage 2 of the Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen Oral Immunotherapy in Children and Adults With Food Allergy (OUTMATCH) trial. Investigators enrolled 117 participants aged 1 to 55 years with peanut allergy and at least 2 additional food allergies. Participants were randomly assigned to receive either omalizumab plus placebo MOIT or omalizumab-facilitated MOIT.

How did omalizumab compare with multiallergen oral immunotherapy?

The primary outcome was the ability to tolerate at least 4044 mg of protein from all 3 study foods during a blinded oral food challenge at the end of treatment.

In the intention-to-treat analysis, 36% of participants receiving omalizumab achieved the primary end point compared with 19% of those receiving MOIT (odds ratio [OR], 2.6; 95% CI, 1.1-6.3; P = .03). Omalizumab also demonstrated superiority for tolerating at least 4044 mg of protein from 2 or more foods and for several individual allergens, including peanut, milk, and egg.

Investigators also reported greater success with omalizumab across several secondary analyses. For example, 72% of participants receiving omalizumab tolerated at least 444 mg of all 3 allergens compared with 39% of those receiving MOIT, a threshold that may provide protection against small accidental exposures. Additionally, 24% of participants receiving omalizumab tolerated 8044 mg or more of all 3 foods compared with 10% of those receiving MOIT.

What did the OUTMATCH trial find about treatment success?

The investigators emphasized that differences between the treatment groups largely reflected differences in treatment completion rather than efficacy among participants who completed therapy.

Completion rates differed substantially between groups. Fifty-one of 58 participants (88%) assigned to omalizumab completed the study compared with 30 of 59 participants (51%) assigned to MOIT. In the per-protocol analysis, which included only participants who completed treatment, no significant difference in efficacy was observed between treatment groups.

The authors concluded, “Although the ITT analysis found a higher rate of treatment success in those receiving omalizumab compared with MOIT, results suggest that the difference was largely driven by the high rate of study discontinuation in the participants treated with MOIT, mostly related to adverse events.”

How did the safety profiles differ?

Treatment-related adverse events occurred considerably more often among participants receiving MOIT.

Serious adverse events occurred in 31% of participants receiving MOIT and in none receiving omalizumab. Events leading to treatment discontinuation occurred in 22% of the MOIT group and none of the omalizumab group. Epinephrine-treated reactions occurred in 37% versus 7%, respectively. Investigators also identified 3 biopsy-confirmed cases of eosinophilic esophagitis in the MOIT arm.

What do the findings mean for pediatric allergy practice?

The investigators noted that omalizumab and MOIT should not be viewed as mutually exclusive approaches but rather as options with different benefit-risk profiles.

They concluded, “Both omalizumab and omalizumab-facilitated MOIT represent viable treatment options, each with distinct risk-benefit profiles that must be weighed in the context of individual patient needs and preferences.” They added that additional comparative studies, including cost-benefit analyses, are needed to better define the role of anti-IgE therapy and oral immunotherapy in the management of multifood allergy.

References:

1. Gupta RS, Springston EE, Warrier MR, et al. The prevalence, severity, and distribution of childhood food allergy in the US. Pediatrics. 2011;128(1):e9-e17. doi:10.1542/peds.2011-0204

2. Wood RA, Togias A, Burk CM, et al. Treatment of Multifood Allergy With Omalizumab or Multiallergen Oral Immunotherapy: A Randomized Clinical Trial. JAMA Pediatr. Published online July 27, 2026. doi:10.1001/jamapediatrics.2026.2910