Drew Bird, MD: Particularities of Food Allergy Immunotherapy Trials

Food allergy therapies are emerging, but still carry a set of clear benefits and risks like most first-generation treatments do. So as long as there’s an honest understanding of oral or epicutaneous immunotherapy limitations, there can be an embrace of their potential.

In an interview with MD Magazine® at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2019 Annual Meeting in San Francisco, CA, this week, Drew Bird, MD, Associate Professor of Pediatrics and Internal Medicine at the University of Texas Southwestern and Director of the Food Allergies Center, Children’s Medical Center, explained how investigators assessing investigative therapies such as AR-101 or Viaskin Peanut navigated potential adverse effects, what the timeline of improved therapies looks like now that these first therapies have neared the market, and when other food allergies aside from peanut may receive therapy indication.

MD Mag: How much consideration goes into the concern of patient anaphylaxis risk in oral immunotherapy trials?

Bird: Certainly, there is risk associated with the therapy, and the trials were designed in allergists’ offices and by allergists. We feel allergists are best-equipped to recognize anaphylaxis—not only that, but to characterize which patients would benefit from therapy, which ones wouldn't.

There is a high rate of misdiagnosis of food allergies in general, and so the last thing you'd want to do is put someone on a therapy when they didn't have the disease to begin with. We really feel overall that allergists are best-equipped to properly diagnose, and then if treatment is appropriate, to discuss the benefits, the pros and cons of a treatment option—desensitization being perhaps that option. But I think that it is best in the hands of an allergist.

How far out are we from seeing improvements on first-generation immunotherapies for food allergy?

I think number 1, it's a little bit of a misunderstanding to think that every peanut-allergic patient needs to have a therapy—because the majority of allergic patients are successfully avoiding peanut without having life-threatening reactions. And there is some concern that any therapy might actually increase your reaction rate rather than decrease it.

So, I think that's a discussion to be had with the family, when they're considering whether or not they should or should not undergo a therapy at this point. But the therapies that—in the view of most of our minds right now is these are really pioneering therapies—are on the foundation. And the future therapies will build off of what we're learning from these, what we're seeing from these.

But there are many phase 1 trials and phase 2 trials for other investigational therapeutics, and so it's very likely that in 5 or 10 years surely we’ll have an armamentarium of options for patients. And different options might be best suited for different patients, and like you mentioned, combination therapies in my mind are likely. And certainly, that's being investigated to see how can we safely deliver therapy and what's the best way to deliver the outcome we're looking for.

Why is there such a focus on treating peanut allergy, compared to other food allergies?

So peanut allergy itself is rarely outgrown, number 1, and if you look at fatalities related to food allergy, peanut tops the list. And if you look at the latest prevalence data for food allergy, peanut is the most prevalent food allergy in the US right now. And so, because it's rarely outgrown, because it can be life-threatening, and because it has a significant effect on the quality of life of kids and their families, then we've really felt overall it's important to address this growing epidemic of food allergy, starting with peanut.

Now, once some of the therapeutics are on the market for peanut, the expectation is that other foods will follow shortly. I think, while we're starting with peanut, there's certainly plenty of other food allergens and plenty of families that are affected by more than a peanut allergy alone. They may have multiple food allergies. So, addressing 1 allergy and neglecting the others may not be the right fit for everyone.

And again, that's part of the discussion that physicians are really going to need to have for the families—saying, in all practical nature, what house is going to change your life right now? Do you do anything differently than you have been doing, and what does that mean for you? And for some families, it's a positive changer. For others, they're not ready to make that that step.

So it's an honest discussion. It’s an interesting time, and it's exciting for the food allergy community, that we at least have options to talk about, because we haven't up until now.