Severe Patients and Final Thoughts

Peter L. Salgo, MD: Let me throw this out there because other disease states—hypertension, heart disease, lots of other diseases—come back, and they tell you the same thing. People who practice in those specialty areas—about X percent, which is a small percent, of these folks use all the resources. You know, let’s say 5% use 80% of our resources. Is that what we’re looking at here with the biologics? We’re looking for that really small tip of the iceberg that biologics are going to knock down.

John J. Oppenheimer, MD: Well, before we go there, Peter, the data are quite clear. The patients with severe asthma, people say 5% to 10% consume 50%.

Peter L. Salgo, MD: That’s what I’m talking about.

John J. Oppenheimer, MD: So we know that. That’s been shown.

Peter L. Salgo, MD: Right. Is that where we’re going with biologics right now?

Louis Christos, RPh: I would say yes. I just don’t know how small that number is—what that percentage is.

John J. Oppenheimer, MD: I think this is where we need to work as a team. Managed care, the companies making these medicines, and physicians. We need to better stratify whether it be phase IV studies or doing really good meta-analyses of the data that are out there. Can you help me figure out a responder analysis? And then No. 2, once I’m on the therapy, what should be the tip-off for successful or not successful? Because I would argue the cost-effectiveness analysis is certainly much better if, at 6 months, I know it’s a nonresponder, than if I go for 2 years looking for exacerbations.

Louis Christos, RPh: Absolutely.

John J. Oppenheimer, MD: We have to work together to uncover this.

Don A. Bukstein, MD: And that is the key. We have to work together to really try to engage in each individual; every one is a clinical study of 1. And it’s not a final exam. You get to see the patient back again over and over, and you really have to decide: Are they a responder, or are they not a responder? And sometimes it takes just trying the medication, if they fit into the FDA requirements, or often they may be a little outside them. Is somebody with an eosinophil account of 280 going to respond better or worse than somebody at 300? Or if they have an IgE [immunoglobulin E] level that’s 10 over the upper limit or 10 below the lower limit, does that mean that patient isn’t going to respond as well? Probably not, and studies have shown that that’s not true. So again, I think we have to work together, and that’s the key message.

Peter L. Salgo, MD: I want to get 1 final thought from each of our panelists. You’ve each got 15, 20, 30 seconds. A nice pithy thought. Dr. Bukstein, do you want to start?

Don A. Bukstein, MD: My pithy thought is I think we have to start talking, really talking, to patients. We have to establish their goals of therapy, their perception of their illness. And then we have to go 1 step further and constantly evaluate every patient with asthma and determine whether they feel they have good control or not. And all the different parts of their life that asthma impacts. And to do that, we have to do something very simple that will improve their adherence of any medication or anything we do, whether it’s environmental control or anything else. And that’s shared decision making. And it’s easier with shared decision-making tools. There are great shared decision-making tools at many websites, the Allergy and Asthma Network; the American College of Allergy, Asthma and Immunology. They have great shared decision-making tools for severe asthma. They have them for adults and will soon have one for children. And going through these aids with the patient really helps establish whether it’s the right therapy for the right patient at the right time.

Peter L. Salgo, MD: Dr. Oppenheimer.

John J. Oppenheimer, MD: It’s an exciting time. I mean, we’re really talking about understanding the mechanism of the disease. The problem is we’re talking about medicines that cost a whole factor more than we’re used to doing. So we have to try to find the right person. Precision medicine really has to be our mantra.

Louis Christos, RPh: Well, I think it’s still, from what I heard today, a complicated disease. We’re still struggling with definitions for the severity of asthma. I think we’re still struggling with definitions, whether it’s unmanaged, poorly controlled, or uncontrolled, and I do appreciate that we have better tools now to help identify some of these patients, especially for getting them to targeted therapies. I still think we have a little ways to go because when you look at the IL-5, IL-4, and IL-13, I don’t know that I heard that there was any real, as you said, pathway, but a direction of which patient goes in the direction of the IL-5 versus the IL-4, the IL-13. I still think that we’re a lot better than we were years ago, but I still think we have a ways to go.

Peter L. Salgo, MD: Dr. Cox, you’ve got the last word.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: Oh, that’s terrible. I remember when I was sitting on one of the FDA advisory committees, and we’d been waiting and waiting and waiting for sublingual immunotherapy to come to market. And I remember saying there’s compelling evidence that this is effective just to prove it, and let us clinicians work through which patients are most appropriate for it. Because the occlusion trial, the eosinophils, the eNO [exhaled nitric oxide], it’s always the bigger picture, the complete patient. I might be bragging about us, but I think the only person who can really identify that is the patient and the physician caring for them. And I think that’s extremely important.

Peter L. Salgo, MD: Well, I want to thank all of you here on this panel for a great discussion. It’s terrific. And I want to thank you at home for joining us. I hope you found this Peer Exchange discussion to be both useful and informative. I’m Peter Salgo, and I’ll see you next time.