Robert Keenan, MD, an adjunct associate professor at Duke University School of Medicine, Division of Rheumatology and Immunology, and lead investigator on “The effect of immunomodulators on the efficacy and tolerability of pegloticase: a systematic review,” discusses the study’s findings.
DocWire News: What prompted you to undertake this study?
Dr. Keenan: So this study was done, well for a few reasons. One, given the systemic impact of gout, reducing the burden of urate in these patients is critical in improving their quality of life and reducing their disability and morbidity in general. And these patients who we’re treating with pegloticase specifically, a lot of times, this is kind of their last hope, so to speak. In other words, they failed other medications or have been intolerant to the typical gout medications, or they’re just not enough, and they were so far behind, so to speak, as far as how much crystal burden they have.
They’re having a lot of, like I said, just a lot of difficulty with daily quality of life stuff, whether it’s putting shoes on or riding or holding a cup of coffee or anything like that. These patients are having constant flares and missing work and all those kind of things. So we wanted to make sure these patients had the best chance for success and make sure this medication does what it’s supposed to do. And that’s decreased that crystal burden and decrease the uric acid and keep it there.
DocWire News: What are the key takeaways from the study?
Dr. Keenan: Well, there’s a lot of takeaways. I mean, we basically found that there were numerous different types of immunomodulatory therapy or immunosuppressive therapy used, and potentially could be used, to effectively improve outcomes with this medication. We looked at 82 patients from 10 different studies. Two of those studies were actual clinical trials, and the rest were case reports, either case series or case reports of individual patients. And what we found was an overall response rate of 82.9% success with the medication, and that’s just about double of what the pivotal clinical trials showed back with monotherapy, pegloticase. And so this is kind of providing some real world evidence that both patients and providers can be comfortable using immunomodulation or immuno-suppressive therapy with pegloticase, to improve outcomes.
DocWire News: Did any of the study’s findings come as a surprise to you?
Dr. Keenan: I wouldn’t say surprised. I mean, one of the things that was a little bit, I guess, surprising, but the numbers were small, was that the Azithropin probably didn’t do as well as it should do, compared to methotrexate, for example. Now that said, a lot of providers in general, under dose Azithropin for whatever disease state we’re treating, so, that might have something to do with it. But also, I think that this publication emphasizes that gout is not just a disease of intermittent flares, and it’s important to recognize that these patients are kind of in a situation where the disease state has kind of gotten out of hand and it needs to be treated aggressively, and that it’s important to treat these patients to target. Most rheumatologists would kind of maybe scoff, or some rheumatologists will scoff at using immunomodulation therapy, with these patients just given their comorbid diseases they typically have or can have.
But I think if they kind of compare it or use the analogy of a rheumatoid arthritis patient or a psoriatic arthritis patient has severe disease, those patients require more than one therapy and usually it’s a biologic plus a d-mor, or disease modifying anti-rheumatic drug like methotrexate. So really and truly, it’s really no different, and these patients have just as much, if not more, in some cases, morbidity and decreased quality of life as those patients do. So I think it’s important to… And hopefully this other rheumatologists will recognize that this study is hopefully… Well, actually I should say it should become standard of care, in other words, that using more than one therapy is okay in gout, just like it is in other diseases that we treat.
DocWire News: Do you have any future research plans pertaining to this area?
Dr. Keenan: Yeah, right now there’s actually an ongoing randomized clinical trial comparing monotherapy pegloticase with pegloticase plus methotrexate. And so we’re excited about this and the data should be coming out hopefully this year, by the end of the year, if not before.
DocWire News: Any final thoughts you’d like to share?
Dr. Keenan: I want everybody to realize these are real, or at least reinforced real-world, in findings and resources, that kind of been accumulating over the last several years. And it’s important that this co-treatment approach is a good one and a valuable one, and a valuable option to help ensure that these patients get the response they deserve, and we expect from pegloticase. And ultimately we need to maximize response treatment in order to manage the impact and complications associated with severe gout, and improve outcomes in the long run for these patients. And basically kind of get them back to where they should be and where they should never have been, in most cases, where should have never gotten to, to begin with.