Families ‘thrilled’ with omalizumab in the year since its approval for food allergy
Key takeaways:
- Robert A. Wood, MD, FAAAAI, looks back on the first year of omalizumab’s use for food allergy.
- Patients often are allergic to multiple foods or to foods that are difficult to avoid.
As we approach the first anniversary of omalizumab’s approval for food allergy, its use is “definitely going to grow,” Robert A. Wood, MD, FAAAAI, professor of pediatrics, Johns Hopkins University School of Medicine, told Healio.
“It’s been a very exciting year in the world of food allergy,” said Wood, who also was the lead author of the phase 3 Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults (OUtMATCH) trial.
The results of the trial, presented at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting last February, led to the approval of omalizumab (Xolair; Genentech/Novartis) for food allergy.
Prescription patterns
“Prescriptions started very quickly after it was approved,” Wood said. “In our practice here, we now have about 200 patients receiving regular injections.”
That population represents approximately 10% to 20% of Wood’s food allergy patients, he added, noting that multiple factors are driving treatment and family interest in it.
The first is the number of foods that a patient may be allergic to, as well as how difficult those foods are to avoid.
“That differs from family to family,” Wood said. “If that list includes things that are really hard to avoid, like milk and egg and wheat, there’s been a huge amount of interest.”
Patients with allergies to both peanut and tree nut as well as another food or two such as sesame represent another common profile, Wood added.
Age is another factor, Wood continued. Families with younger children may feel that they have their diets under control and can avoid their allergens successfully. But omalizumab uptake increases with adolescence.
“As kids get older, there’s more foods that are not under the parents’ control. And then eventually there’s college, and nothing is under the parents’ control,” Wood said. “So, age has been a big factor.”
Anxiety is the next factor that Wood cited in omalizumab prescriptions.
“Some people live with the same list of allergens relatively easily, and others are far more affected on a day-to-day basis,” Wood said.
Finally, atopic comorbidities and other allergies prompt many patients and families to elect treatment.
“This turns out to be a very important one, because most of our patients with food allergy do have other allergic conditions,” Wood said. “Omalizumab works extremely well for asthma and allergic rhinitis.”
In fact, Wood called this a “tipping point” for some families.
“If I can get a shot every 2 weeks and be on a lot less of my other medications that weren’t working that well anyway, it can be a very, very big deal,” Wood said. “A lot of the stories we’re getting back from patients are not just related to food allergy. It’s that, ‘Oh my gosh. My environmental allergies have never been controlled like this before.’”
Despite the demand, there have been obstacles.
“With any new medicine, especially medicine that’s on the more expensive side, we were not surprised that there were a lot of denials for our prescriptions,” Wood said. “That led to a lot of dissatisfaction among families and to a lot of work for my staff.”
At this point, Wood said, more than 90% of patients with appropriate prescriptions have been approved.
“But there was a fair amount of pushback,” Wood said. “And I think overall that it has impacted prescriptions.”
Wood also said that other doctors have told him that they do not prescribe omalizumab because of the time it requires. He said he has heard from families who have seen other doctors who have told them the same thing as well.
“The other doctor says, ‘I just don’t have capacity in my office with my staff to do all this prior authorization work,’” Wood said. “Hopefully, that will get better.”
Wood noted that he has seen the process improve for other drugs such as dupilumab (Dupixent; Regeneron, Sanofi) as practices have learned to provide the documentation that payors require to justify the prescription.
“It’s already gotten a little bit easier, but we’re still fairly early in the course,” Wood said, adding that omalizumab is routinely approved for his asthma patients. “As long as they meet the criteria, it never gets denied, because it’s been around a long time. It just seems that the newer medicines get an extra level of scrutiny.”
Early results
Many patients who use omalizumab have seen “dramatic” responses during oral food challenges, Wood said.
“One of the issues that we are discussing with other food allergists across the country is exactly who and when you need to do a food challenge,” he said.
For example, Wood said that he is comfortable saying that omalizumab works well enough to protect most patients with peanut and tree nut allergies who have no desire to eat these foods from small, accidental exposures.
“That is consistent with the package label,” Wood said.
But patients with allergies to foods such as milk, egg and wheat get routine food challenges because they want more than just protection from cross-contamination, he continued.
“There’s often desire to actually incorporate the food, if they could,” Wood said. “There’s even this other possibility that you can introduce the food.”
Omalizumab can be used in conjunction with oral immunotherapy, he explained.
“Most people can actually start eating the food in a dietary form, commonly in serving size portions, build up tolerance fairly quickly, and then have the opportunity to keep the food in their diet and discontinue the medication, as long as things are going smoothly,” Wood said.
“We have a large group of people that are in that process right now, where, especially in younger children, especially with something like a severe milk or egg allergy, there are patients that we are treating above and beyond what is listed on the package insert,” he continued.
In fact, Wood said that he and his colleagues will present further results from the OuTMATCH study examining these processes at the 2025 AAAAI/World Allergy Organization Joint Congress in San Diego, Feb. 28 through March 3.
“Last year, we were very careful to not say anything above and beyond what’s in the package insert,” Wood said. “As these other data are coming forward, we’re going to be able to say more about other approaches to using this drug.”
The researchers also will present results comparing omalizumab with multi-food OIT during the AAAAI/WAO Joint Congress.
Patients and families have been pleased with the results so far, Wood said, especially since the only treatment approved by the FDA has been Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp (Stallergenes Greer) oral immunotherapy.
“Even families that have chosen to not start it at this point in time are thrilled that there’s an option, especially a drug that has a long-term track record of safety,” Wood said. “Even families who are saying ‘I don’t think we’re going to start it yet’ are crying at visits.”
Looking ahead
News about omalizumab’s use in food allergy is spreading, Wood said.
“At least half of families come in with knowledge of the drug and wanting to know more about it,” he said. “There’s probably more word of mouth and chatter on social media having an impact, more so than the commercials.”
In fact, Wood said, the commercials have given some patients and families pause.
“As all these commercials do, they finish with a long list of risks and side effects. People often come in saying, ‘We’ve heard about the drug, but it sounds pretty scary from the commercials,’” he said.
“But that, again, is anecdotal. I can’t say there’s a big trend in that direction, and I’m sure there’s some people that never would have heard about it if they hadn’t seen the TV commercials,” he said.
Wood expects omalizumab to continue to have an impact in food allergy.
“We don’t see any new treatments emerging in the very near future,” he said, adding that he expects that the upcoming results comparing omalizumab with OIT will have an impact on prescribing practices too.
“There will be new information that people have really been anxious to hear, and there’s never been a comparison before like that,” Wood said. “There’s no doubt it’s going to continue to grow.”
Perspective
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I have prescribed omalizumab for food allergy several times. Most of these patients are allergic to more than one food or have had a history of anaphylaxis or anxiety related to food allergy. Several of my patients have come to me through my education on social media and heard about omalizumab that way.
So far, I have had positive feedback from my patients. They feel that they have a safety blanket and have improved their quality of life. However, I have not seen many instances where there has been accidental ingestion. Until another treatment comes along, I believe that the use of omalizumab to treat food allergy will grow.
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