Omalizumab outperforms oral immunotherapy for patients with multiple food allergies
Key takeaways:
- Patients received omalizumab with placebo oral immunotherapy or vice versa.
- 88% of the omalizumab group and 51% of the OIT group completed treatment.
- There were no serious adverse events with omalizumab.
SAN DIEGO — Patients with three different food allergies who used omalizumab experienced better outcomes than patients who used multi-food oral immunotherapy, driven by lower rates of adverse events, according to an abstract presented here.
Robert A. Wood, MD, FAAAAI, professor of pediatrics, Johns Hopkins University School of Medicine, led the study, presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress.
“Both treatments are used for food allergy but there has never been a study comparing the treatments,” Wood told Healio. “This will help patients and clinicians to be more informed in making treatment decisions.”
In stage 2 of the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults, or OUtMATCH, trial, 117 patients (55% male; median age, 7 years) received omalizumab (Xolair; Genentech, Novartis) for 16 weeks.
At 9 weeks, patients also began receiving multi-food oral immunotherapy or placebo oral immunotherapy, with doses increasing to 1,000 mg of each allergen.
Also, patients continued to receive omalizumab or began receiving a placebo at 16 weeks, which continued through 44 weeks, followed by a challenge with a cumulative dose of 8,044 mg of their allergens.
“Is it complicated? Absolutely,” Wood said during his presentation.
Completion rates in the intent-to-treat analysis included 88% (51/58) of the omalizumab group with placebo OIT and 51% (30/59) of the OIT group with placebo omalizumab.
Wood attributed the high dropout rate in the OIT group with placebo omalizumab to the side effects and frequent symptoms that come with OIT.
Leading causes of discontinuation in the OIT with placebo omalizumab group included OIT symptoms for eight patients, severe adverse events that required epinephrine for four patients and eosinophilic esophagitis for three patients. In the omalizumab with placebo OIT group, six of the seven patients who dropped out did so because of study burden.
“There was a significantly improved outcome for those participants receiving active omalizumab vs. those receiving active OIT,” Wood said.
In the intent-to-treat analysis, 36% of the omalizumab group and 19% of the oral immunotherapy group (OR = 2.6; P = .031) achieved the primary endpoint of tolerating at least 2,000 mg of each of their allergens with a cumulative dose of 4,044 mg.
The researchers said that patients experienced more success for two or more foods with omalizumab than with oral immunotherapy (P = .004). Omalizumab treatment was superior based on many other secondary endpoints as well, the researchers added.
Excluding patients who dropped out of the study, the per-protocol analysis yielded similar results, the researchers said, as 37% of those on OIT with placebo omalizumab (11/30) and 41% of those on omalizumab with placebo OIT (21/51) reached a cumulative doze of 4,044 mg of all three of their allergens.
There were no serious adverse events in the omalizumab group, nor did anyone experience an adverse event that led them to discontinue treatment in the intent-to-treat analysis. But in the oral immunotherapy group, 30.5% had serious adverse events, and 22% discontinued treatment after an adverse event.
Also, in the intent-to-treat analysis, 6.9% of the omalizumab group with placebo OIT and 37.3% of the oral immunotherapy group with placebo omalizumab experienced an adverse event that was treated with epinephrine.
“This is consistent with the excellent safety profile of this medication,” Wood told Healio.
Based on these findings, the researchers concluded that omalizumab yielded better outcomes than oral immunotherapy for multiple allergens, primarily due to the high rate of adverse events leading to study discontinuation in the oral immunotherapy group.
However, there are “many, many ways to look at the data,” Wood said during his presentation.
“When we use the per-protocol analysis, it is really pretty clear from those different graphs and tables, that the output all turned out to be very similar,” he said. “Is there a best approach? The answer is no.”
The similarities between patients on omalizumab with placebo OIT and those on OIT with placebo omalizumab represent an opportunity to discuss benefits and risks with patients, Wood continued.
“We’re bringing data to the field and to take that data to the bedside to have individualized care of patients with detailed discussions about the treatment options,” he said. “For my time in medicine, this is by far the best example of shared decision-making.”
Reference:
- Omalizumab is superior to oral immunotherapy in multi-food allergy treatment study. https://www.aaaai.org/about/news/news/2025/omalizumab. Published Feb. 10, 2025. Accessed Feb. 10, 2025.