Experts share their thoughts on the omalizumab OUtMATCH phase 3 data

At the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting phase 3 data of the OUtMATCH study (NCT03881696) published in The New England Journal of Medicine for recently FDA-approved omalizumab was presented, revealing the monotherapy increased reaction thresholds for people with multiple common food allergies.¹

The data revealed 67% of individuals aged 1 to 55 years included in the study achieved the primary endpoint—ingestion of peanut protein in a single dose of 600mg or more without dose-limiting symptoms—compared to 7% of participants who received placebo.¹

Secondary outcomes included consumption of cashew, milk, and of egg in single doses of at least 1000 mg each, without dose-limiting symptoms, wrote the study investigators.¹

Click here to read more about the phase 3 trail and full results.

Authors of The New England Journal of Medicine article titled "Omalizumab for the Treatment of Multiple Food Allergies," Robert Wood, MD, director, Eudowood Division of Pediatric Allergy, Immunology, and Rheumatology, Johns Hopkins Children’s Center; professor of pediatrics, Johns Hopkins University School of Medicine and Scott Sicherer MD, FAAP, director, Jaffe Food Allergy Institute, Ichan School of Medicine, Mount Sinai, New York, New York, provided their comments regarding the data and approval of omalizumab.²

Robert Wood, MD | Image Credit: Hopkinsmedicine.org

Robert Wood, MD: The biggest takeaway is that we were able to use an old medication – with a long track record of safety – to treat food allergy. The results of the study are very convincing and should make a huge change in the lives of patients with food allergy, in reducing reactions and reaction severity. In addition, and maybe even more important, it will help to reduce the high level of stress, fear and anxiety that patients and their families experience on a daily basis.

The drug is specifically targeted to reduce reactions to small accidental exposures. These sorts of exposures (e.g. a cross-contaminated cookie) are common and can lead to severe, life-threatening reactions in a large proportion of patients with food allergy. There are some who are less allergic – for example a child who may be on their way to outgrowing a milk allergy – for whom the treatment will make less difference.

Most peanut allergy is lifelong and capable of causing severe reactions, so this should be very relevant for patients with peanut allergy at all ages. There is currently one approved treatment for peanut allergy, Palforzia, an oral immunotherapy product, but this is limited to individuals 4-17 years of age and is a burdensome therapy with a high risk of allergic reactions to the treatment itself.

We are especially pleased that this drug has been approved across a wide range of ages and applies to all foods.

Scott Sicherer, MD

Scott Sicherer, MD, FAAP:

The results of the study and the FDA approval are very exciting and provide a needed option for so many people with severe and multiple food allergies. The drug was able to provide an increase in reaction threshold to multiple foods for most of the people treated. Many had substantial increases. This means that for most people treated, there is safety at least for small accidental ingestions that could have otherwise caused reactions.

This is “huge” because there are many people who have reacted to small exposures and this causes anxiety, poses risks at every meal, snack and social activity with food, and ends up limiting quality of life. Families and people with food allergies are often looking to be “bite safe” from accidents and most people have multiple food allergies. So, this approval of an effective treatment is truly life-changing.

Having said that, it is important to understand it did not work for everyone, and the effect varied. Right now, we do not have an easy way to know how much protection an individual has and the instructions are to maintain the food avoidance and be prepared to treat any reactions as before. In the study, medically supervised feeding tests (oral food challenges) were used to determine the change in threshold of reaction. Potential patients must also understand that this is not a cure and the effect of the drug wears off if it is stopped.

Assuming a patient has qualifying laboratory tests and allergies to be a potential candidate for treatment, allergists will be having detailed discussions with their patients and families for shared decision-making to determine those who are a good fit for this treatment.

They will be discussing the severity of their past reactions, success of avoidance, impact on daily life, the foods they are avoiding, and many other factors. Whether the patient has asthma or respiratory allergy that [could also] benefit from this treatment may be part of the assessment.

There will also be a lot of counseling about what is or is not different for them being on this treatment. For example, still carrying epinephrine and avoiding the food, still informing the restaurant of the allergies but knowing that the restaurant meal is likely less risky should there be an error. Or, telling the school to have very careful supervision of the child with food allergies, but knowing if the young child accidentally grabbed food from another child and took a bite, the risk is reduced, [but not eliminated]. The treatment may be more or less meaningful depending upon many factors.

It is interesting that many had very substantial increases in their threshold. More studies are needed to understand about options beyond continued avoidance while being treated with omalizumab (and the OUtMATCH study has stages 2 and 3 looking at these questions. The studies are still underway).

References:

1. Fitch J. Omalizumab increases reaction threshold for multiple common food allergies. Contemporary Pediatrics. February 26, 2024. Accessed February 29, 2024. https://www.contemporarypediatrics.com/view/omalizumab-increases-reaction-threshold-for-common-food-allergies

2. Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the treatment of multiple food allergies. N Engl J Med. Published online February 25, 2024:NEJMoa2312382. doi:10.1056/NEJMoa2312382