Distinguishing biologic-eligible patients may still need further biomarker and disease severity research.
The introduction of biologics to allergic care did not end with their approval by the US Food and Drug Administration (FDA). In fact, most clinicians are still looking for means to navigate the decision-making process behind marketed biologic use.
In an interview with MD Magazine® while at the American College of Allergy, Asthma & Immunology (ACAAI) 2019 Scientific Meeting in Houston, Tina Sindher, MD, a clinical assistant professor with Stanford University, discussed the current knowledge surrounding biologics in allergic care—and what gaps still need to be filled.
MD Mag: How have new therapy options affected allergy care clinics?
Sindher: In our allergy clinic, we see eczema, we see asthma, we see food allergies, and we see environmental allergies. And in the past, I feel like each of those disease processes were almost thought of as individual entities, and now what we're seeing is that it's all—like someone's atopic and they have one disease, they're just more prone to have the other. And because of that realization, we're actually using some of the medications that are approved for one indication and trying it out in another indication.
MD Mag: Is the benefit of biologics reserved for more severe cases of disease state?
Sindher: You know, that is a really good point. And this is a discussion I actually had with Dr. Casale recently. The problem is, how do you decide who gets the biologic, and who doesn't? Biologics are really, really expensive, and if you then start saying everyone with food allergies can have biologics, that's cost prohibitive. It becomes very expensive.
So, these are kind of things that I think the medical community has to decide upon—when you offer biologics, do they have to go through certain steps before we offer it, or do you just offer it at the get-go? For some of these biologics in the food allergy space, because it's still new, our inclusion criteria is really to make sure that the person actually has the disease we're checking them for—but not so severe that the study might actually be a safety issue.
So it really is not basing it on severity at the moment. But I think the worry is because—and I'll use omalizumab as an example because there are lots of trials out there—we found decreased adverse events on Xolair. We see that the time to reaching the maintenance dose for foods is quicker with Xolair, so then it becomes really difficult to decide which patient to use it for. So severity would be a great way to make it known.
MD Mag: Are there any more discoveries that need to be made to help define biologic decision-making?
Sindher: Yeah so, in terms of omalizumab, it is currently approved for asthma, and that's the data we have. It's approved for chronic urticaria, that's the data we have. We have basic understanding of how it works in food allergy, but we don't understand everything. It seems quite safe—we haven't seen too many kinds of adverse events with Xolair, specifically.
It's been out there the longest, so a lot of those concerns have actually been answered and looked at, and we have data from the asthma trials going way back. But some of the newer drugs like dupilumab, we just don't have the data, we don't know long-term effects. We know that it's an IL-4 and IL-13 blocker, but how that affects cytokines down the line, we don't know.