Biologic Shows Promise in Ongoing Food Allergy Trial

LOUISVILLE, Ky. — Omalizumab (Xolair) may be an effective therapy for patients with multiple food allergies, according to an ongoing phase III trial.

Most of the first 60 patients with multiple food allergies enrolled in stage one of the OUtMATCH clinical trial were able to tolerate serving-sized portions of those foods a year after receiving 4 months of treatment with the anti-IgE antibody biologic drug, reported Robert A. Wood, MD, of Johns Hopkins University School of Medicine in Baltimore.

All patients who have so far advanced to the later stage of the study were exposed to the foods they were allergic to following treatment with the biologic, either through oral immunotherapy (OIT) or clinic-administered food challenges, he said in a presentation at the American College of Allergy, Asthma & Immunology (ACAAI) annual meeting.

There are currently no biologic therapies with FDA approval for the treatment of food allergy; omalizumab has been granted FDA breakthrough designation status for the food-allergy indication. Wood said developer Genentech/Novartis plans to seek full approval for the drug as a food allergy monotherapy once the OUtMATCH study is completed and if the findings warrant it.

He noted that while the plan is to seek approval for the drug as a monotherapy, the trial is also exploring the impact of the add-on omalizumab to increase safety, and possibly improve the efficacy, of OIT.

OUtMATCH is a 10-center, randomized, double-blind, placebo-controlled trial, and eligible patients (ages 1 year-55) include those diagnosed with peanut allergy, or those with allergies to at least two of the following:

• Milk
• Egg
• Wheat
• Cashew
• Hazelnut
• Walnut

Stage one of the trial consists of 16 weeks of therapy with injections of omalizumab as monotherapy given every 2 to 4 weeks versus placebo. Stage two will compare a short course of omalizumab combined with multi-allergen OIT versus a longer course of omalizumab. Stage three will explore the treatment’s duration in participants who will be followed for up to 56 months. The primary endpoint result — number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the food challenge done at the end of stage one treatment — are expected to be reported in 2023. The estimated study completion date is August 2026. To date, 467 patients have been enrolled and 179 have been randomized, including 68 participants ages <6 years, Wood said.

“We believe the study findings will help to inform the optimal use of this treatment, as well as future anti-IgE medications and possibly other biologics, for the treatment of food allergy,” he said.

Wood added that moving forward, the goal is to have many treatment options available for patients with single and multiple food allergies, including biologics, OIT, patches, sublingual immunotherapy (SLIT), and avoidance.

“There are many very novel therapies in the pipeline, but most are 5 to 10 years away if they prove to be safe and efficacious,” he said.

Wood told ACAAI attendees that while OIT is an effective treatment for many patients, it is not right for every patient. “I would suggest to you that if you are not practicing OIT don’t worry about that,” he said. “It is not a perfect therapy and many patients do very well practicing avoidance. They may actually have a better quality of life than many patients on OIT.”

At the same ACAAI session, David R. Stukus, MD, of Nationwide Children’s Hospital in Columbus, Ohio, discussed the evolving knowledge about food allergy testing, treatment, and risks. He noted that it is established that food avoidance is potentially detrimental to young children with eczema who have an elevated risk for developing food allergies. Yet many parents of children with elevated food-specific IgE are still being told to withdrawal or not introduce certain foods, he said.

“I think we need to recognize that we can cause harm,” he said. “If you have a child with atopic dermatitis and they are eating the food without having acute onset reactions, and they have elevated food-specific IgE, they are sensitized but tolerant.”

“If you take that food out of their diet for a period of time, there is a potential that they then could have a IgE reaction the next time they eat it,” Stukus cautioned. “That’s us collectively causing harm by testing in the first place and telling them [parents] to take food out of the child’s diet. We have to evolve with the evidence.”