Jeff Peterson, MD, explains the importance of the recent FDA announcement granting priority review of the Supplemental Biologics License Application for concomitant use of pegloticase injection (KRYSTEXXA) plus methotrexate for patients with uncontrolled gout.
Rheumatology Network interviewed Jeff Peterson, MD, to discuss the recent FDA announcement granting priority review of the Supplemental Biologics License Application (sBLA) for concomitant use of pegloticase injection (KRYSTEXXA) plus methotrexate for patients with uncontrolled gout. Peterson is President of Washington Rheumatology Alliance, and Director at Northwest Rheumatism Society and Western Washington Medical Group Arthritis Clinic's clinical research department.
Pegloticase is an enzyme that works by transforming gout crystals into a chemical that is easily excreted by the kidneys. “Typically, uric acid crystals and uric acid are only excreted about 10% by the kidneys, and that's why it collects in certain patients, which leads to gout. In this case, we're essentially making the gout crystals dissolve,” Peterson explained.
While pegloticase is a relatively older drug, new data from the recent MIRROR open label trial has shown promise in treating this patient population. As such, the FDA is fast-tracking reviewing the drug to potentially update the label.
“I think this is going to show much better promise for patients in the long run,” Peterson hypothesized. “Prior to using immunomodulation with KRYSTEXXA, we were getting about a 40% success rate of getting patients all the way through the treatment protocols. Fifty-eight percent of the patients were failing, having infusion reactions, and just [exhibiting] a lack of efficacy from the drug. Since we have been using immunomodulation, that number has essentially doubled. We're now in around the 80% range. That's just amazing.”
In addition to greater efficacy, infusion reactions, such as anaphylaxis, have been significantly reduced.
This approval will ultimately help clinicians feel more comfortable using immunomodulation and treat their patients more effectively.
Peterson urges both rheumatologists and patients to take the treatment of gout seriously. “We're coming out with some new data and [seeing] that gout crystals can go really anywhere in the body, and they can cause lots of problems. Patients with untreated gout have basically the same cardiovascular risk as untreated diabetes,” Peterson emphasized. “That means you can have 5-to-6-fold increased risk of heart attacks and strokes if you don't treat your gout. We can do a lot of good if we can get patients to recognize that it's a chronic disease. It's a systemic disease, and it needs to be treated with oral or IV medications to get to uric acid levels down.”
Watch the full interview below: