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
The overall study cohort had a median age of 7.0 years and 56% of the participants were boys. Investigators highlighted the trial population is representative of patients with multiple food allergies except for a lower percentage of Hispanic participants than in the general population. Investigators noted the analysis population included 177 individuals aged 1 to 17 years.2
Upon analysis, the primary outcome was achieved among 67% (79 of 118) of patients receiving omalizumab. In contrast, this occurred among just 7% (4 of 59) patients receiving placebo therapy (P < .001). Analysis off secondary outcomes of interest revealed a similar trend, with a greater rate of patients in the omalizumab group able to consume at least 1000 mg of cashew (41% v 3%), milk (66% vs 10%), and egg (68% vs 0) than their counterparts receiving placebo (P for all < .001).2
Analysis of safety outcomes in the trial revealed the incidence and severity of adverse events were similar between the study arms, except for injection site-related events, which were more common among the omalizumab group. Of note, a single serious adverse event occurred in a 1-year-old participant within the omalizumab group. In this child, liver enzyme levels became elevated during the first stage of the trial, but, after discontinuing treatment and a complete evaluation, investigators concluded that omalizumab was unlikely to be the cause.2
Chinthrajah noted, although this breakthrough adds a much-needed tool to the armamentarium of clinicians, the results of the trial provoke additional questions surrounding optimal management as well as the pathophysiology of food allergies.3
“We have a lot of unanswered questions: How long do patients need to take this drug? Have we permanently changed the immune system? What factors predict which people will have the strongest response?” Chinthrajah added.3“We don’t know yet.”
References:
- Campbell P. Robert Wood, MD: Impact of omalizumab approval on management of Pediatric Food Allergy. HCP Live. February 22, 2024. Accessed February 25, 2024. https://www.hcplive.com/view/robert-wood-md-impact-of-omalizumab-approval-on-management-of-pediatric-food-allergy.
- Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024. DOI: 10.1056/NEJMoa2312382
- Stanford Medicine. Drug limits dangerous reactions to allergy-triggering foods, Stanford Medicine-led study of kids finds. EurekAlert. February 25, 2024. Accessed February 25, 2024. https://www.eurekalert.org/news-releases/1035148
