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March 05, 2014
OIT or OIT Plus Biologic? Allergists, Patients Look to Lessen Food Allergy Woes
Avoid the allergen. For decades, that was the only advice for people with life threatening food allergies. While that is still true, the food allergy community is cautiously, but excitedly, watching research unfold that could help patients tolerate more of the allergen that might otherwise have serious or deadly consequences.
Whether or not the treatment sticks – that is to say, the person has achieved “sustained unresponsiveness”—is not known until the allergen is avoided for some time period, and then an oral food challenge is conducted in a medical setting to see if there is a reaction.
Another factor that Wood said would have to be considered is the knowledge than as with severe asthma, it is expected that someone would have to stay on omalizumab in order to keep the reactions away.
“There is no expectation that omalizumab will keep working for food allergies once the medication is stopped,” he said. Whether or not it is possible to stop the medication and still eat the food safely is a long-term question, he said.
In an email to The American Journal of Managed Care® (AJMC®), a spokeswoman for Genentech, the maker of omalizumab, would not speculate on price and payers could not be reached for comment. When used for asthma and other allergic conditions, omalizumab generally requires prior approval from an insurance company.
“It’s not going to be cheap,” said Wood. But he noted that somewhere between 40% to 70% of people with peanut allergies have other food allergies, which typically are harder to avoid than peanut.
In addition, “about 50% to 90% of people with peanut allergy or other food allergies have other allergic conditions in general. So omalizumab would help all of that.”
Wood said the biggest promise of omalizumab would be its ability to have an effect on multiple food allergies. “Even though peanut oral immunotherapy is being developed, most of my patients are not that excited about it because they’re much more worried about their milk allergy or their egg allergy.”
People with multiple food allergies and multiple allergic conditions may consider the severity of their condition and quality of life issues in any cost-benefit analysis, he said.
OIT, even without the addition of a biologic, is not without risks, some of which can occur during treatment, and some of which may occur with a dose that was previously well-tolerated. Mild adverse effects could involve an itchy mouth, and more moderate ones may involve wheezing and hives. More severe reactions are often linked to exercise, anxiety, or infection. In fact, children undergoing OIT are instructed not to engage in any physical activity for up to 2 hours after a dose.
The 2 peanut desensitization products that are expected to seek FDA approval, and which could be used in conjunction with omalizumab or another biologic, are from Aimmune and DBV Technologies. Aimmune is creating an engineered peanut capsule, and DBV is investigating epicutaneous immunotherapy for both peanut, milk, and egg. It is the peanut skin patch that is farthest along in development.
The pivotal trial for omalizumab will begin in the second quarter of 2019, recruiting patients with multiple food allergies through the clinical sites that are a part of the Consortium of Food Allergy Research (CoFAR), which Wood heads. An application to the FDA is expected in 2021.
In a randomized control trial involving peanut in a pediatric population of 9 months to 36 months, 29 of 32 patients reached sustained unresponsiveness.3
In 1 study, omalizumab or placebo was added to an open-label milk OIT and was found to improve safety, but not efficacy. At the completion of treatment, 88.9% of the omalizumab-treated patients and 71.4% of the placebo-treated patients passed the 10-g "desensitization" OFC (P =.18).
Two months later, SU was demonstrated in 48.1% in the omalizumab group and 35.7% in the placebo group (P =.42).
Patients receiving omalizumab had fewer doses that involved allergic symptoms (2.1% vs 16.1%, P =.0005), dose-related reactions requiring treatment (0.0% vs 3.8%, P =.0008), and doses required to achieve maintenance (198 vs 225, P =.008).
In another study, open-label omalizumab was administered in a placebo-controlled study of peanut OIT. After 12 weeks of treatment with omalizumab, patients underwent a rapid 1-day desensitization of up to 250 mg of peanut protein, followed by weekly increases up to 2000 mg.
Melinda M. Rathkopf, MD, an allergist in Anchorage, Alaska, is one of those allergists who has been doing OIT (but no omalizumab food allergy trials) since the start of the year. She and 5 other allergists have a caseload of 20 patients total trying peanut OIT.
“It’s kind of interesting to talk about this as a breakthrough therapy for a therapy that isn’t really considered a standard of care yet,” she said in an interview with AJMC®.
Her practice is part of a loose association of allergists around the country who have been doing OIT, and they are now sharing information with each other and publishing data to try and get a handle on this growing area.
Allergenic food is “cheap to avoid, but in reality it’s not, because mistakes are made and people still wind up in the ED,” she said.
“It’s those hidden amounts [of food] that you worry about,” she said
Asked what she thinks families with food allergies will weigh into their decision when considering adding the cost of a biologic versus doing OIT alone, Sturner said there still a lot of unknown factors, including “how much insurance currently covers and will continue to cover moving forward. Of course, the amount varies by person and policy.”
“I'm glad to see research progressing in terms of efficacy, though preliminary data looks promising. The time commitment is moot, in my opinion, since patients and parents typically have to miss school and work, respectively, for OIT updose appointments. Hypothetically and per studies, adding omalizumab should significantly reduce the amount of time required. This seems particularly beneficial for concurrently treating multiple allergens," Sturner said in an email to AJMC®.
1. National Academies of Sciences, Engineering, and Medicine. Finding a path to safety in food allergy: Assessment of the global burden, causes, prevention, management, and public policy. http://nap.edu/23658. Published 2017.
2. Wasserman RL, Jones DH, Windom, HH. Oral immunotherapy for food allergy: The FAST perspective. Ann Allergy Asthma Immunol. 2018;(121)3:272-275. doi: 10.1016/j.anai.2018.06.011.
3. Wood RA. Oral immunotherapy for food allergy. J Investig Allergol Clin Immunol 2017. 2017;27(3):151-159. doi: 10.18176/jiaci.0143.