New data on the long-term efficacy and safety of dupilumab are very reassuring to patients with asthma, explained J. Allen Meadows, MD, president of the American College of Allergy, Asthma & Immunology.
New data on the long-term efficacy and safety of dupilumab are very reassuring to patients with asthma, explained J. Allen Meadows, MD, president of the American College of Allergy, Asthma & Immunology, a solo community-based practitioner at the Alabama Allergy & Asthma Clinic, and a clinical faculty member at the Alabama College of Osteopathic Medicine.
What was the new data on dupilumab that was released at the European Respiratory Society meeting? What was the purpose of this open-label extension?
Well, the data that was presented the European Respiratory Society meeting on the long-term safety of diplomat was really pretty exciting. What it was it was an extension study of the previous studies that got dupilumab approved in the United States for asthma, and it was primarily, the primary end point was to demonstrate safety, but they also looked secondarily at the efficacy of dupilumab.
And did the results in the open-label extension study match what was found in the previous clinical trial findings or did anything change?
Well, now the study results are pretty cool. The rates of adverse events are similar to those that were observed in the initial intent-to-treat populations. And there were no new safety signals that were identified. And so it was very reassuring that the safety data that we saw in the very short-term studies that got this drug approved, now that we have these much longer-term studies, no new safety signals—the adverse events remain the same over the entire treatment course.
So, you know, it gives when I'm talking to patients about that, it's something very reassuring that we can talk to them about.
How do the findings that dupilumab is safe and effective in the long term add another weapon to the arsenal of providers who are treating patients with asthma?
Well, the long-term findings on dupilumab are really big to me. I may not be like all the doctors, but when I'm starting somebody on a biologic, I draw a laboratory evaluation…I'll look at the total eosinophil count. I'll report those to the patients. But then a month or so later, we come back in for a long visit—which I kind of call my shared decision-making visit—and then based on what their laboratory evaluation is, I tell them which biologics they would be eligible for based on FDA approval, or approval ratings on them. And then I say, “Well, you know, this is the advantage of this one, this is the disadvantage of this one.” And safety is a big thing. How long has it been around?