
A retrospective study published in Rheumatology and Therapy demonstrated further support to the previously published literature regarding the administration of immunomodulation as cotherapy to pegloticase (PEG). While the evidence has been increasingly positive, there a very few published studies from real-world practices. The current study reported on the treatment response rates, effect on kidney function, and safety signals in patients with uncontrolled gout who underwent treatment with pegloticase in addition to immunomodulation cotherapy at two community rheumatology practices.
In total, 34 patients with uncontrolled gout were included in the analysis. The majority of patients were male (79%) and White (74%) with a mean age of 62 years. There were several comorbidities common in the study population, including hypertension, obesity, osteoarthritis, chronic kidney disease (CKD), and cardiovascular disease. Baseline estimated glomerular filtration rate (eGFR), a measurement of kidney function, was 65.4 mL/min/1.73m2. Patients were enrolled on a standard gout flare prophylaxis regimen during PEG, plus immunomodulation cotherapy over a mean duration of 28 weeks. The main outcome measurements included patient demographics, adverse events, gout characteristics, eGFR, and the proportion of patients who were considered to be PEG responders (defined as >12 PEG infusions received and SU<6 mg/dl just prior to infusion 12).
Overall, the response rate of patients treated with PEG plus immunomodulation was 89%, a significant increase from the previously established 42% in patients treated with PEG alone. Comparing the response rates among the different types of immunomodulators used, mycophenolate mofetil was the most effective at 100%, followed by subcutaneous methotrexate at 93%, oral methotrexate at 89%, and azathioprine at 50%. There were no infusion reactions or infections recorded; however, 19 patients experienced gout flares at some point during treatment. There were no novel safety concerns emerged for immunomodulation cotherapy. Additionally, mean eGFR improved 10.3 mL/min/1.73m2 and 85% of patients had stable or improved CKD for the duration of the study.
The authors of the study emphasized the importance of their findings, saying, “Case series highlights experiences with pegloticase plus immunomodulation cotherapy in a real-world clinical setting.” They suggested that several immunomodulation agents may be effective for increasing treatment response rates in patients with uncontrolled gout, though further study is needed.