The management of food allergies has undergone a revolution in recent years, with the field propelled into the future by the development of clinical programs and pipeline items, including oral immunotherapy and epicutaneous immunotherapies.
Now, in early 2024, the field welcomed what could be the most significant breakthrough in its history, with the February 16, 2024 US FDA approval of omalizumab (Xolair) for the treatment of multiple food allergies.1
The basis of this approval, the OUtMATCH trial, was presented in full at the 2024 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.2,3
“I’m excited that we have a promising new treatment for multifood allergic patients. This new approach showed really great responses for many of the foods that trigger their allergies,” said senior investigator Sharon Chinthrajah, MD, associate professor of medicine and of pediatrics, and the acting director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford Medicine.3
Key Highlights
Omalizumab (Xolair) received FDA approval for multiple food allergies based on the OUtMATCH trial, presented at the AAAAI Annual Meeting.
The trial demonstrated a significant efficacy of omalizumab, with 67% achieving the primary outcome compared to 7% in the placebo group.
Secondary outcomes also showed promising results, with a greater percentage of patients in the omalizumab group able to consume various allergens without dose-limiting symptoms.
Safety outcomes were generally favorable, although injection site-related events were more common among the omalizumab group, and one serious adverse event occurred in a 1-year-old participant.
Named the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy (OIT) in Food Allergic Children and Adults (OUtMATCH) trial, the study was designed as a double-blind, randomized, placebo-controlled trial with the intent of comparing omalizumab, a monoclonal anti-IgE antibody, against placebo therapy in management of multiple foods allergies. Conducted at 10 sites across the US, the trial screened 462 people aged 1 to 55 years with a history of allergy to peanut and at least 2 other foods from a protocol-specified list, including cashew, milk, egg, walnut, wheat, and hazelnut.2
Of the 462 who underwent screening, 180 were randomized in a 2:1 ratio to receive either omalizumab or placebo administered subcutaneously, with the dose based on weight and IgE levels, every 2 to 4 weeks for 16 to 20 weeks. For inclusion in the trial, participants were required to have a reaction to a food challenge of 100 mg or less of peanut protein and 300 mg or less of 2 of the other aforementioned foods. At the conclusion of the treatment period, the challenges were repeated.2
The primary outcome of interest for the trial was consumption of at least a single dose of at least 600 mg of peanut protein without dose-limiting symptoms at the completion of the first stage of the trial. The trial also included 3 key secondary outcomes of interest: the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms.2
