Omalizumab Associated With Less Toxicity Compared to MOIT Among Patients With Food Allergies
Key Takeaways:
- In Stage 2 of the Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults With Food Allergy (OUTMATCH) clinical trial, 117 patients were randomized to receive either omalizumab or multiallergen oral immunotherapy (MOIT).
- Patients in the MOIT cohort had higher rates of study discontinuation, which were primarily driven by increased adverse events (AEs) compared to the omalizumab cohort.
- Omalizumab initially demonstrated superior efficacy compared to MOIT, but this data should be interpreted with caution due to the large number of patients in the MOIT cohort who ended the study early.
Omalizumab (brand name Xolair) and oral immunotherapy (OIT) are the only medications approved by the US Food and Drug Administration (FDA) to treat patients with food allergies. While studies have evaluated the impact of combining OIT with omalizumab, there has been no research directly comparing the therapies.
FDA approval for omalizumab was based on the findings from the OUTMATCH trial. Stage 2 of this trial compared omalizumab with MOIT.
Study Methods and Outcomes
The OUTMATCH trial was a multicenter, double-blind, placebo-controlled, randomized study of patients with an allergy to peanuts and at least 2 other specific foods, including milk, eggs, wheat, cashews, hazelnuts, or walnuts.
In the second stage of the trial, patients were randomized to receive omalizumab-facilitated MOIT with placebo omalizumab or omalizumab with placebo MOIT.
All participants received open-label omalizumab for 16 weeks. At week 8, patients began receiving active or placebo MOIT. At week 16, patients began receiving blinded omalizumab or placebo injections for 44 weeks.
The primary outcome was a cumulative tolerated dose (CTD) of 4044 mg or greater for all 3 foods. Secondary outcomes included CTDs of 1044, 2044, 4044, 6044, or 8044 mg for 1, 2, or all 3 foods.
Researchers conducted 2 statistical analyses, first with an intention-to-treat (ITT) population and then with a per-protocol (PP) population. The ITT population included patients who received at least 1 open-label omalizumab injection. The PP population included all patients who completed stage 2 of the trial.
Omalizumab vs MOIT
The study included 117 patients, of whom 58 received active MOIT and 59 received active omalizumab. Only half (51%) of the patients in the MOIT cohort completed the study compared to the 88% in the omalizumab cohort.
In the ITT analysis, omalizumab had higher rates of success than MOIT, 36% vs 19%, respectively. In addition, patients in the omalizumab cohort were more likely to achieve CTDs of 4044 mg or greater than those in the MOIT cohort.
Patients receiving MOIT had more study discontinuations than those receiving omalizumab, with 22% discontinuing due to AEs. Approximately 31% of MOIT patients experienced a serious AE while omalizumab patients did not experience any serious AE.
Implications for Managed Care
While these findings may suggest omalizumab has a superior efficacy to MOIT, this superiority is mainly the result of high rate of study discontinuations within the MOIT cohort. Discontinuations were largely driven by AEs, indicating omalizumab as a safer treatment option compared to MOIT.
According to the authors, “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.”
Reference
Wood RA, Togias A, Burk CM, et al. Treatment of multifood allergy with omalizumab or multiallergen oral immunotherapy. JAMA Pediatr. 2026;180(10):1067-1075. doi:10.1001/jamapediatrics.2026.2910.
