Allergists Mostly Optimistic About Prescribing Biologics for Food Allergy

While many allergists were enthusiastic about the potential advantages of biologics compared with existing therapies to treat food allergies, others were worried about their novelty and cost, according to a qualitative study.

During interviews with 60 community and academic allergists, four main themes emerged about the use of biologics for food allergies:

• The perceived benefits of biologics, including filling a treatment gap and treating multiple food allergies
• Ideal uses of biologics, including as an adjunct to oral immunotherapy or as monotherapy
• Concerns about biologics, including insufficient evidence, patient or parental resistance, potential for overuse, and cost
• Biologics as the perceived future of food allergy treatment, including optimism about their convenience

“Our findings revealed the overall enthusiasm expressed by community and academic providers about biologics and their perception that biologics are the future of FA [food allergy] treatment,” wrote Jill A. Fisher, PhD, of the University of North Carolina at Chapel Hill, and colleagues in the Annals of Allergy, Asthma & Immunology. “Now that omalizumab [Xolair] has been approved for FA, the future could be said to have arrived.”

Omalizumab injection, the first medication to help reduce allergic reactions to multiple foods after accidental exposure, was approved by the FDA in February for adults and children 1 year and older. Data from the first stage of the randomized OUtMATCH trial showed that regular courses of omalizumab injections increased the amount of peanut and other foods that multi-food-allergic children could consume without experiencing an allergic reaction.

Unlike oral immunotherapy, which aims to build a patient’s tolerance to allergens over time by slow exposure, biologics like omalizumab are designed to interrupt inflammatory immune responses to allergens, and may raise a patient’s reaction threshold for multiple foods, Fisher and team noted. How allergists perceive the risks and benefits of biologics to treat food allergies has remained mostly unknown.

Scott H. Sicherer, MD, of the Icahn School of Medicine at Mount Sinai in New York City, told MedPage Today that since the study was done before omalizumab’s FDA approval for food allergy, it would have been “more interesting to have done the same type of thing after the approval” to ask providers how they are using omalizumab.

He emphasized that the study authors “were specifically going to people who, for example, were [using] oral immunotherapy in their practice, which is not something that the majority of allergists are even doing.”

“I’m actually quite interested more in what allergists across the board, who are not considered the food allergy experts, are going to be doing with this new, only second, thing … that [is] FDA-approved for food allergy,” he added.

In interviews, most providers expressed enthusiasm for biologics over oral immunotherapy, citing the less frequent administration and advantages for younger patients who might have trouble with food allergen avoidance. Some also noted that oral immunotherapy can be challenging to implement for multiple food allergies.

One participant said, “It’s going to get you at least the same benefit [as oral immunotherapy], hopefully, conceptually, increasing your threshold dose. But the ask, the lift, the commitment is much less, and the safety profile is probably better.”

Still, others worried that patients or parents may be hesitant about a new, potentially long-term drug, or even overprescribing compared with oral immunotherapy. They were also concerned about the substantial cost of the drugs — omalizumab can range from $30,000-$60,000 per year.

“The risk is that they’re unaffordable for almost everyone,” one participant said. “So, going down the route of using biologics for the treatment of food allergy will worsen the disparities in care that already exist for patients with food allergy.”

Another said, “I can’t imagine how we can afford to pay … $50- to $60,000 a year in system costs, for really something that should be just managed by avoidance.”

Asked about the future of food allergy treatment, one provider called biologics a “turning point.” Some pointed to the convenience of a shot compared with oral immunotherapy for situations like travel.

For this study, the researchers recruited U.S. physicians through direct solicitation by email using purposive sampling (those who self-identified as food allergy experts, providers with a record of involvement in oral immunotherapy and/or clinical trials, and those with practice websites that identified food allergy as a primary area of interest and/or experience) and snowball sampling (recommendations from providers already interviewed).

Interviews were conducted via telephone or Zoom. The interviewers, two PhD-level qualitative researchers, adjusted questions according to participant experiences. They identified emerging themes using a coding system.

A total of 60 participants from 34 states were included in the study; 53.3% worked in a community practice and 46.7% worked in an academic medical center. About 42% were in their 40s, 56.7% were men, and 60% were white.

Of the interviewed providers, 53.4% had experience with food allergy clinical trials, and 85% offered oral immunotherapy to their patients. All providers regularly prescribed biologics, and 13.3% reported that they had specifically prescribed a biologic — most commonly omalizumab or dupilumab (Dupixent) — off-label to treat food allergies.

Fisher and colleagues acknowledged that their interviews were conducted before omalizumab’s approval for food allergy, so provider responses reflected this. They also noted that the sample of providers offering oral immunotherapy may have been higher than the national average. In addition, their sampling methods may have not captured the views of a broader population of providers who were not as “visible” or whose information was not public.

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