Omalizumab monotherapy is a safe and effective option that allows many children and adults with multiple food allergies to consume foods they are allergic to, with effects comparable to omalizumab-facilitated multi-food oral immunotherapy (mOIT), according to data from stage 3 of the OUtMATCH trial presented at the AAAAI meeting.
Up to 12 months after stopping either treatment, success rates of dietary consumption (DC) plans for peanuts and other allergenic foods were statistically similar when comparing the approaches, exceeding 60% overall. There were no differences in adverse events.
“The findings suggest that both mOIT and omalizumab can promote successful introduction and continued dietary consumption of allergenic foods for at least 12 months using participant-specific, individualized dietary consumption plans,” OUtMATCH investigator Amy Scurlock, MD, a pediatric allergist/immunologist at the University of Arkansas for Medical Sciences and Arkansas Children’s Hospital in Little Rock, told Doximity via email.
The OUtMATCH trial, conducted at 10 US centers, had three stages. In Stage 1, investigators randomized individuals ages 1 to 55 who were allergic to peanuts and at least two other foods to omalizumab or placebo, showing the superiority of the monoclonal anti-IgE antibody for increasing reaction thresholds. In Stage 2, omalizumab topped multi-allergen OIT for treating patients with multiple food allergies, primarily due to a higher rate of adverse events (AEs) leading to discontinuation in the OIT arm.
All but one of the 81 patients who completed Stage 2 qualified for DC plans for the introduction of peanuts and other allergenic foods at home following about 1 year of treatment with either mOIT (n=29) or omalizumab (n=51) and entered Stage 3 of the trial. DC plan success was defined as eating a median of ≥300 mg/day of allergenic food at 3 and 6 months based on daily diaries and through up to 12 months based on assessments by the study team.
Success rates did not differ between the mOIT and omalizumab groups at either 3 months (77% vs 66%; P=0.10) or 6 months (65% vs 63%; P=0.77) according to daily diaries. The findings were similar when success was evaluated by the study team at 3, 6, 9, and 12 months and in analyses examining response to individual food allergens.
Safety was assessed among 52 individuals who remained on their DC plans for 12 months, with no difference between the mOIT and omalizumab groups in overall AEs (86% vs 93%). There were two serious AEs reported during open feeding transition from mOIT to dietary consumption and one case of eosinophilic esophagitis that occurred in a patient who had been treated with omalizumab.
“These findings highlight the importance of awareness of potential treatment side effects and the need for individualized approaches that carefully consider the potential risks and benefits,” Dr. Scurlock said.
According to Kartik Shenoy, MD, a pulmonologist at Temple Health in Philadelphia, Pennsylvania, the results suggest that treatment for patients with multiple food allergies can be streamlined.
“Oral immunotherapy can be complex and time-intensive, requiring gradual dose escalation and frequent monitoring,” he commented to Doximity. “If omalizumab alone can achieve similar outcomes, it could offer a much simpler and potentially safer pathway to expanding patients’ diets.”
Todd Neale has no conflicts of interest to report.
Illustration by Jennifer Bogartz
