Thomas Casale, MD: Expanding Biologics


For what other indications, and in what regimens, are investigators assessing the drug class?

The benefit of biologic therapy has been understood to be in conditions with severe inflammation—from asthma to eczema, and comorbid conditions in between. But its true potential, and its presence in the US therapy market, is still being developed.

In an interview with MD Magazine® while at the American College of Allergy, Asthma & Immunology (ACAAI) 2019 Scientific Meeting in Houston, Thomas Casale, MD, professor of medicine at USF Health Morsani College of Medicine, detailed where individual biologic therapies have benefitted patients most, and where monotherapy options may be considered.

MD Mag: Beyond its current indications, what else are biologics being considered for?

Casale: A lot of these drugs are being used to treat other diseases. The anti-IgE molecule, the paradigm for treating chronic spontaneous or chronic idiopathic urticaria has markedly changed since omalizumab got approved for chronic urticaria.

About 50% of patients are antihistamine-resistant. So you could throw up to 4 times or more of the licensed dose of an antihistamine to treat a patient, but they're still having a lot of problems. Omalizumab has been shown to help a pretty large percentage of those patients.

If you look comorbid conditions that track with asthma—nasal polyps, chronic rhinosinusitis with nasal polyps, you're likely to have that same Th2-driven inflammation. That's why dupilumab, which was first originally approved for atopic dermatitis, also recently got approved for nasal polyps.

Omalizumab at this meeting is going to detail the results of their phase 3 trials, but from the press release, it looks like they hit their endpoints. The IL-5 blockers are going after nasal polyps, as well.

For atopic dermatitis, right now, the best one is probably dupilumab. And the other disease that often tracks would be food allergy, and omalizumab is being trialed for food allergy as a standalone. It's also being studied in conjunction with immunotherapy. And there are a number of other biologics being looked at for food therapy, but they are in early development.

MD Mag: Do they have potential as monotherapies?

Casale: Yeah. So, most of the smaller studies have done combination—the other one that's doing the same thing is dupilumab. Dupilumab is being studied in combination with peanut immunotherapy, and also as a standalone. We'll have to see what happens.

It was 2003 that the predecessor of omalizumab, produced by Tanox, was an anti-IgE molecule. And they did the very first study that showed that it worked pretty well in patients with peanut allergy. It was published in the New England Journal of Medicine.

But there was a big problem in the development of standalone therapies, because to get into the study, you had to have a positive food challenge. So, I have to give you enough food to cause you to have an acute allergic reaction. That sort of stopped the development process for awhile.

And what we're really interested in now is a diagnostic that will replace that food challenge, because that's a big burden on patients and patient families.

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