In a recent interview, Michael Peters, MD, MAS, assistant professor at the University of California, San Francisco School of Medicine, discusses the key role that biomarkers play in asthma in order to potentially monitor patient response to medications and identify new molecular pathways.
“Right now, in the field of asthma, we don’t have great ways of monitoring patients and how they respond to medications,” said Dr. Peters. “Biomarkers have the unique propensity to do that.”
Biomarkers could also be particularly useful in identifying new pathways to molecular mechanisms—an option Dr. Peters said he believes is underappreciated.
“Right now, type 2 inflammation is pretty well-established as being a mechanism in particularly severe asthma, but we don’t have great insights into what other things potentially contribute to disease,” he said.
Importance for Trial Design
He noted that biomarkers could be therefore be useful in identifying how molecular pathways influence disease pathology. Biomarkers have also proven useful in clinical trials, notably as researchers are shifting toward an adaptive trial design—which has shown a twofold benefit.
“We use the biomarker to actually choose which treatments patients get within the trials themselves,” Dr. Peters explained. “Biomarkers can be used both to stratify subjects and to decide which patients are most likely to respond to which therapies.”
These trials not only benefit the patient, but also allow researchers to enroll fewer patients in their trials, which allows for quicker trials and speeds up the testing of therapies. One of the biggest challenges that remains is that while trials have shown the responsiveness of drugs, these are patient-population-centered trials, rather than patient-centered trials. For instance, in a trial where 100 patients receive an asthma drug, all 100 patients will have lower exacerbation rates. This, however, does not shed any light on the patient on an individual level.
“If [your patient] has one exacerbation on the drug, you have no idea if that one exacerbation is less than the three they would’ve had if they weren’t on the drug,” Dr. Peters explained.
Deciding which biomarkers to consider is another challenge. Several exist in the asthma treatment realm—spirometry, immunoglobulin E levels, and simply asking patients how they’re doing—but choosing one is not always an easy choice because there are a lack of data comparing biomarkers and medications.
Overall, Dr. Peters is optimistic about the current trajectory for asthma and biomarkers.
“I think this is a great time in the world of asthma research and of asthma clinical care,” he said. “We have a lot of new drugs coming into market and [it will be] pretty exciting to see how they influence patient care.”