John Botson, MD, discusses his study examining real-world pegloticase plus immunomodulation co-therapy using data from an insurance claims database.
Previous data, including the MIRROR randomized controlled trial (RCT), have supported pegloticase, a US Food and Drug Administration (FDA)-approved treatment for the management of chronic gout refractory to standard treatment, plus immunomodulation co-therapy. In July 2022, the pegloticase label was updated to include concomitant treatment with methotrexate.
In an interview with HCPLive, John Botson, MD, a rheumatologist at Orthopedic Physicians Alaska, discussed his study “Real-world Trends in the Use of Immunomodulation as Co-therapy to Pegloticase: Claims-based Findings Since 2016,” presented at the American College of Rheumatology’s 2023 Convergence in San Diego, California, which examined real-world immunomodulation co-therapy through November 2022 using data from a large insurance claims database.1
Can you tell me a bit about the study design your team utilized?
Basically, this was a claims database that looked at patients who had received at least 1 dose of pegloticase. And then we looked at, surrounding that, what type of immunomodulator they were on. This was looking at everything from 180 days before the pegloticase and up to 60 days afterwards. We were looking at the uptick in the use of immunomodulators with pegloticase around the time of pegloticase.
What were the overall key findings?
The overall key findings were ever since we started to present data on immunomodulation, there has been a further uptick in the use of immunomodulators around pegloticase. Some of the smaller findings were that the methotrexate was the primary immunomodulator used, followed by mycophenolate. We also noticed certain times when the uptick was more. This was around key findings such as the presentation of additional data, the results of the MIRROR RCT trial, and of course with the methotrexate label change that happened in 2022.
What is the clinical significance of these results?
When we put people on pegloticase and an immunomodulator is available, the medication is going to work longer and it's going to work better. By seeing more of the uptick, we know the patients are getting better treatment and are hopefully able to finish their course without any problems.
Were there any strengths or limitations you would like to highlight?
As it's a database study, we just knew the patients received an immunomodulator and pegloticase. So, some patients were probably on multiple agents.
What are the next steps for your team?
It would be interesting to see the trends if we did this again in the future. So far, it has been really encouraging that, as more data has come out, other rheumatologist and prescribers are using this combination for our patients.
How do patient-reported outcomes (PROs) complement other clinical measures and laboratory assessments in evaluating disease progression and treatment efficacy?
PROs are important. We all like objective data and we love measuring serum uric acid, but ultimately what really ensures the patient stays on treatment is how the patient feels and their quality of life. There may not be a perfect lab test, it may just be that the patient feels better, which then translates into them being able to go to work or school, or just feel better in their activities of daily living. It is important to capture those as an additional assessment in these treatments because we may have a treatment that is otherwise is similar on paper, but if the quality of life for the patient is better, that is probably the one we are going to reach for.