Pegloticase seen as safe and effective for uncontrolled gout in kidney transplant patients
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Pegloticase decreased serum urate in patients with uncontrolled gout who previously received a kidney transplant and were treated with more than one immunosuppressive therapy to protect against organ rejection.
The study was presented as part of ASN Kidney Week. In their study abstract, co-author Abdul A. Abdellatif, MD, assistant professor of medicine in the department of nephrology at Baylor College of Medicine in Houston, and colleagues described the effects of pegloticase on serum urate (SU) levels as “substantial.”
These findings from the PROTECT trial were similar to previous reports on the efficacy and safety of the use of pegloticase with immunomodulation.
In the phase 4 trial, 20 kidney transplant patients with uncontrolled gout who had received immunosuppressive therapy were treated with 8 mg of pegloticase once every 2 weeks for 24 weeks. A total of 16 of participants met the primary endpoint, which was SU levels of less than 6 mg/dL after 6 months for at least 80% of the time.
All 20 patients had an initial, notable decrease in SU rates, with most sustaining the decrease for the remainder of the study period.
After 24 weeks, the eGFR was unaffected. Serious adverse events considered unrelated to pegloticase, including cellulitis, duodenal ulcer, species, atrial fibrillation, diverticulitis and infection, occurred in five patients.
In addition, health assessment questionnaire outcomes improved in patients who finished treatment.
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Abdellatif AA, et al. Abstract PO2117. Presented at: ASN Kidney Week; Nov. 2-7, 2021 (virtual meeting).
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