Kidney transplant recipients are known to have a higher prevalence and severity of gout compared with the general population. To address the challenges faced by these patients, a recent phase 4 clinical trial has evaluated the safety and efficacy of pegloticase, a pegylated recombinant uricase, in treating uncontrolled gout among kidney transplant recipients.
Per the authors of this study, published in Clinical Transplantation, “The aim of this phase 4, multisite, open-label trial (PROTECT NCT04087720) was to examine the safety and efficacy of pegloticase in kidney transplant participants on immunosuppression with chronic gout refractory to conventional urate lowering therapy.”
The trial included 20 participants who had received a kidney transplant at least 1 year prior to enrollment. The study enrolled individuals who had uncontrolled gout, characterized by a serum uric acid (sUA) level of ≥7 mg/dL, intolerance or inefficacy to urate lowering therapy, and at least 1 of the following criteria: presence of tophi, chronic gouty arthritis, or a history of 2 or more gout flares within the past year. All participants had a functioning kidney transplant, with an estimated glomerular filtration rate of ≥15 mL/min/1.73 m² and were on stable immunosuppression therapy.
The primary endpoint of the study was the response of sUA levels during the sixth month, with the goal of achieving sUA levels consistently below 6 mg/dL for at least 80% of the time. Mean participant age was 53.9±10.9 years, and the average time since kidney transplantation was 14.7±6.9 years. The participants had an average sUA level of 9.4±1.5 mg/dL and a gout duration of 8.4±11.6 years. All participants were receiving at least 2 stable doses of immunosuppression agents.
The administration of pegloticase (8 mg intravenous every 2 weeks) to kidney transplant recipients with uncontrolled gout demonstrated an impressive response rate of 89% (16 out of 18 responders). Two participants discontinued treatment solely due to concerns related to COVID-19 prior to completing 6 months of treatment and were not included in the primary analysis. Notably, pegloticase exposures in this trial were higher than those historically observed with pegloticase monotherapy, indicating a potential benefit of this treatment approach. Moreover, the study reported no incidents of anaphylaxis or infusion reactions during the course of treatment.
The trial had several limitations. According to the authors of the study, “Limitations for this study include its open-label design, lack of a control group, small participant enrollment, and the broad diversity of immunosuppression regimens used among participants.”
Considering the elevated prevalence of gout among kidney transplant recipients and the limitations associated with oral urate lowering medications, these results suggest that pegloticase may offer a promising therapeutic option for managing uncontrolled gout in this specific population. Further studies are warranted to confirm these findings and assess the long-term efficacy and safety of pegloticase in kidney transplant recipients with gout.
Source: Clinical Transplantation
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