Shifting the Treatment Paradigm of Severe Asthma With Novel Biologics - Episode 15
A discussion on the future of emerging therapies and whether they will have an impact on improving lung function in patients with severe asthma.
Reynold Panettieri, Jr, MD: We’ve seen a lot of development and a lot of new drugs coming to market in this space. But I think as we move forward, we have to think of the trifecta for drugs that will be approved. We have very effective therapies that improve the efficacy, exacerbation rates, and patient-reported outcomes. I think as we move forward—and of course, we’re all on corticosteroids—they are a burden. But as we move forward, new drugs have to hit at least 3, if not all 4 of those aspects for them to really surface as a viable benefit to patients with severe asthma. Do you see drugs coming out that are acquiring 2 of those 4 metrics? Or are you in unison with my thought process that you need all 4 metrics to move forward? What’s your sense, Sid?
Sidney Braman, MD: My sense is the same as yours but I would like to add the fifth. As we’ve already discussed earlier today, many patients, especially patients who were either poorly controlled having exacerbations or perhaps didn’t get their therapy early enough, have an excess of the client of lung function. We call this airway remodeling and understand that it involves a lot of cell types, such as smooth muscle and so forth. Do we have anything that’s effective in blocking this decline and improving? Let’s say we have the decline to improve it. So I would say that I’d like to add a fifth criteria for drugs in the future. I think, so far, we don’t have any of that.
Reynold Panettieri, Jr, MD: Those are great points. You’re right, that’s going to compel phRMA [Pharmaceutical Research and Manufacturers of America] to do 15- and 20-year-long studies.
Nicola Hanania, MD, MS: I think the bar is very high for clinical trials. As you said, we have good, novel therapies that have been shown, at least in selected population, if we select them right, to improve outcomes. So to come and put in another new agent and to compare it with an existing agent, you have a very high ceiling effect of the ones already available. Clinical trials may be very hard to do because it may be unethical to give a placebo to a patient with severe asthma for a long period of time because we have existing drugs that work. That’s another issue. Another issue I’m going to bring up, and it may be controversial—at least in the era of COPD [chronic obstructive pulmonary disease] now—, is that we may be shifting from phenotyping to tapping into what we call treatable traits. We always like to sort of— and I am from that school—have a cut of this asthma; this is an affiliate of an allergic disease. Maybe we may be too strict in doing this in the COPD arena, for example, we’re shifting to what we call treatable traits: treating traits that the patient presents with. Some of them have cough and shortness of breath. Others have exercised limitation. A third group have more emotional distress, anxiety, and the psychiatric aspect. These are things that have been talked about in the asthma world now. Should we shift to treatable traits and look at interventions based on how the patient presents and what his or her symptoms are? I think it’s all up in the air right now. But I think, from the biologic point of view, it’s very hard to beat drugs that we already have. For the non-T2 [type 2] asthma, we still need a lot. It gets a bit more complicated than it was in that era.
Reynold Panettieri, Jr, MD: Yeah. I agree with you. We stand on case definitions for everything, but we recognize that case definitions must be dynamic. They must be refined: what we call asthma, and congestive heart failure are really syndromes. Within that syndrome, we must have better approaches that give us insight.
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Transcript Edited for Clarity