Age and severe comorbidities were among the differences found when real-world data on Medicare patients receiving CAR T-cell therapy was compared to clinical trial outcomes, said Karl Kilgore, PhD, senior research analyst at Avalere Health.
Age and severe comorbidities were among the differences found when real-world data on Medicare patients receiving CAR T-cell therapy was compared to clinical trial outcomes, said Karl Kilgore, PhD, senior research analyst at Avalere Health.
Transcript:
What do we know about real-world use of CAR T-cell therapies and how the outcomes differ from those seen in clinical trials?
We have not compared outcomes in our study. We've not compared the outcomes directly to the trials. A good reason for that, one of our focuses in this study was on healthcare utilization as an outcome, pre versus post. In clinical trials, an awful lot of the utilization is prescribed by the protocol. That's a reason to do real-world analyses with these, so we can see what the decisions the clinicians are making when they're less constrained by the requirements of the protocol. We did, however, see one difference not in the care, but in the type of patients, the characteristics, of the patients that we're seeing. Average age of patients in the pivotal trials was 56 to 58 years of age. In our study, average age was 70, median was 71. Half of the patients in our trials were over 71. Another characteristic was presence of severe comorbidities. Over 50% of our patients had chronic heart disease, kidney disease, chronic obstructive pulmonary disease, and other serious conditions common in the elderly, common in this population. But the kinds of conditions that, in many cases, not in all, we have claims data. We don't always know the severity of these conditions, but they were present. So at least for some of the patients that we saw, again, over 50% of our patients had one of these conditions. These are conditions that, at least for some of the patients, would have led to them being excluded from the clinical trial. And we saw pretty positive outcomes coming from this.