Jeff Peterson, MD, discusses his study determining the complete response rate of pegloticase in conjunction with methotrexate.
Rheumatology Network interviewed Jeff Peterson, MD, President of Washington Rheumatology Alliance, and Director at Northwest Rheumatism Society and Western Washington Medical Group Arthritis Clinic's clinical research department. He discusses his study, MIRROR Randomized Controlled Trial Meets Primary Endpoint and Shows 71% of Patients Achieved a Complete Response Rate Using KRYSTEXXA® (pegloticase injection) with Methotrexate.
Rheumatology Network: Can you tell me a little bit about the study design?
Jeff Peterson, MD: So, the study design was to determine whether or not methotrexate was going to give better efficacy in patients with Krystexxa versus placebo alone. Wwe enrolled 152 adult patients with uncontrolled gout and randomized them 2:1 into a methotrexate arm or a placebo arm. And the results were then tallied after 6 months.The primary endpoint was the proportion of serum uric acid responders, defined as a serum uric acid less than 6 milligrams per deciliter at least 80% of the time during month 6, and that was done to copy the original trials so that we can compare the data.
RN: What were the results of the study?
JP: After the results, the primary endpoint was met: 71% of patients who were receiving methotrexate in combination with Krystexxa showed that they met the primary endpoint, whereas only 40% of the placebo group met the primary endpoint. And that was similar to what we saw in the initial trials with the placebo group.
RN: Were you surprised by the results of this study?
JP: No, these are actually going along with what we have been seeing in our clinical trial. We did an open label clinical trial and we've done several case series that have shown this similar efficacy. Also just recently published is another placebo-controlled, double-blind trial that was done using mycophenolate, which showed about 80% improvement as well. So, I think all what we're seeing is all the immunomodulators are working equally well.
RN What is the clinical significance of these results?
JP: Well, for patients with uncontrolled gout, it can be debilitating and disabling. So, this is a big step for patients who cannot take oral therapy, the use of Krystexxa is definitely helping them. Not only is it getting them better efficacy and getting rid of their tophi and getting them back to life, but it also is reducing their cardiovascular risk. Patients who have untreated gout have the same cardiovascular risk as untreated diabetes, and everybody knows that that's bad.
RN: Is there anything else that you would like our audience to know before we wrap up?
JP: Well, I think that our studies are showing that the use of immunomodulation, in conjunction with Krystexxa is showing dramatic improvements in the outcomes. We're able to get the tophi on these patients with chronic gout and make it go away completely in a very short amount of time. This is life changing for these patients. Gout can be quite miserable. They can they can have episodes lasting a week or so of miserable pain. They can't get out of bed, and it can eventually leads to full disability. I think we can reverse that and prevent that from happening. We cause patients a lot of good by getting them on this therapy and getting rid of their chronic gout. Gout is more than just in the joints. We're finding that it's going a lot of places. But with the new imaging studies, we're seeing that tophi are really appearing in a lot of different areas and that might be a huge thing in the future.