Dr Nicola Hanania: Exacerbation Improvement Is an Important Indicator of Patient Response to Biologics

When evaluating a patient’s response to biologics, factors to consider include patient preference; safety, specifically the risk of anaphylaxis; symptoms; asthma control test; and lung fuction, explained Nicola Hanania, MD, MS, pulmonary critical care physician and director, Airway Clinical Research Center, Baylor College of Medicine, Houston, Texas.

Transcript

How is biologic agent effectiveness evaluated in patients?

In clinical trials, we've tested these agents on their effect on exacerbation. So almost all these drugs were approved based on whether they reduce exacerbation. So it means large trials, and not only large, but long, 1-year trials. And in real life in my clinic, I can't wait for a year to know if the patient is responding, so I look at other things.

I look at how the patient is feeling. I look at asthma control. Lung function can sometimes improve dramatically with some of the agents, like anti-IL-4 [interleukin-4], for example. Lung function may not be affected dramatically by others. We look at exacerbation, it’s important. But because you need a long time to look to capture exacerbation, we look at other surrogates and patient satisfaction.

We obviously look at safety. In general, these agents are safe, but if one of them causes anaphylaxis, we have to stop. So there are some safety issues that we should consider as well. Although it's rare, it's been reported that some of them may be associated with anaphylaxis. We look at symptoms, asthma control test, and lung function.