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At the recent American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, researchers presented the phase III OUtMATCH study, which showed that omalizumab (Xolair) injections increased reaction thresholds for people with multiple common food allergies.

In this third of four exclusive episodes, 乌鸦传媒 brought together three expert leaders in the field -- moderator Michael Wechsler, MD, of National Jewish Health in Denver, is joined by Flavia Hoyte, MD, also of National Jewish Health, and Leonard Bacharier, MD, of Vanderbilt University Medical Center in Nashville, Tennessee -- for a virtual roundtable discussion on the results of the OUtMATCH study.

Click here to watch other episodes in this roundtable series.

Following is a transcript of their remarks:

Wechsler: Welcome back to another AAAAI 2024 roundtable discussion sponsored by 乌鸦传媒. We're back again today with Len Bacharier from Vanderbilt and Flavia Hoyte from National Jewish. I'm Dr. Michael Wechsler, professor of medicine here at National Jewish as well.

One of the most exciting topics that came out of the American Academy of Allergy, Asthma & Immunology that took place in Washington, D.C. last month was the OUtMATCH study, which was concomitantly presented in the . And this was a new advancement in food allergy research. So, Len, why don't you tell us a little bit about the OUtMATCH study first, then we can have a brief discussion about it.

Bacharier: Sure. So this is really sort of one of the most major advances in the management of food allergy, potentially in the history of food allergy. And what these investigators asked was, if you use the medication that promptly and substantially reduces total serum IgE, in this case, the anti-IgE antibody omalizumab, and you gave this to patients who are multiply food allergic, would you be able to reduce their sensitivity to their target foods, such that over time they would be able to eat a greater quantity of the food with or without having a substantial clinical reaction?

And this is really quite important because there are patients who are very sensitive to foods, particularly children, and when they encounter these in very small quantities in real-world accidents, those still are capable of triggering severe reactions. So anything that can be done to increase the amount of food that they can tolerate before developing a reaction would be viewed as a positive advance.

So they did a randomized clinical trial of about 180 children and a few adults, all of whom had peanut allergy at trial onset plus food allergy to at least two more highly relevant foods. So these are children with oral food challenge, confirmed food allergy to multiple foods. They were randomized to receive omalizumab or placebo for 24 weeks in a blinded fashion, and then there was an open-label extension. And the investigators considered a treatment to have been positive if there was a substantial improvement in the amount of the food that could be eaten after treatment compared to the amount that was eaten before treatment that had triggered a reaction.

And what was remarkable is that the vast majority of children, around 80%, experienced this degree of improvement to peanut. The secondary foods that they were required to be allergic to also improved in their amount of food tolerated at the end of the study, not quite to the same substantial amount as was achieved with peanut, but enough to probably protect them from real-world accidents that could turn into severe reactions or anaphylaxis.

So I think the real take-home from this is that this is a therapy that is nonspecific because it is anti-IgE. It is not specific to an individual food allergen, has relatively rapid onset of effect, is with a therapy that we have now had for 20 years for a variety of conditions and understand the side-effect profile, and was demonstrated to be effective in children as young as a year of age. So I think we're at the beginning of the next era of food allergy management where we may have more to offer families than the advice of, "just don't eat that and watch your diet, carry an epinephrine autoinjector and hope that the labels you read are accurate." I think this is a real important step forward.

Wechsler: Flavia, were you surprised by the results? And what do you think are the major clinical implications moving forward with this study?

Hoyte: Yeah, I wouldn't say that the results surprised me. I think that we know that omalizumab is a very potent anti-IgE. And IgE drives food allergy. So I'm not surprised about the impact on these patients. I think that the one thing that surprised me is that the indication for omalizumab based on this data was approved actually for patients of 1 year and older, and that includes our adult patients. So there weren't that many in the trial, and yet this broad indication was approved, which is actually great news. And I think especially since oral immunotherapy is an option for our pediatric patients, but not an FDA-approved option for adult patients, this at least gives us something to offer these adult patients.

I think accidental exposures, to Len's point, are really common and much harder for children in terms of avoidance. But you'd be surprised, our adults get into stuff all the time, even with strict avoidance measures. So I think this is a great kind of background therapy to have to give them that extra level of confidence and protection that they'll do fine even with an accidental [exposure].

Wechsler: Great. Well, I think it's really important. I know that food allergy is a huge issue for kids and adults, and there's a lot of potential morbidity that can result from food allergies. And I think a study like this is really a landmark study that will really have a huge impact for our patients for years to come and will certainly change the guidelines for management of patients with food allergy.

So, again, another important study from the AAAAI 2024 that will have significant clinical implications for our patients. So thanks for joining us today. We look forward to seeing you next time.

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