Early Trial Shows That Pegloticase Is Safe for Kidney Transplant Patients

For kidney transplant patients with gout, the use of anti-inflammatory drugs and urate-lowering therapies typically used to prevent flares and slow the progression disease, are associated with the risk of adverse events.

Now, early results from an ongoing clinical trail suggests that pegloticase (Krystexxa, Horizon), a PEGylated uric acid specific enzyme that is indicated for the treatment of chronic gout in adult patients with refractory disease, may be safe and effective for kidney transplant patients with gout, according to Abdul A. Abdellatif, M.D., of Baylor College of Medicine, who recently presented data at Kidney Week, the annual meeting of the American Society of Nephrology which wrapped this week.

Gout is common and more severe in kidney transplant recipients and is 10 times more common in patients who have had a kidney transplant. But without treatment, gout patients are at risk of dangerous flares.

In this study, called PROTECT, researchers included patients with uncontrolled gout (sUA ≥7 mg/dL, intolerance of or contraindication to urate lowering therapy, and at least one of the following: tophi, chronic gouty arthritis, at least more than two flares in past year) and functioning kidney transplant graft (eGFR ≥15 mL/min/1.73m2) are included (having had a kidney transplant more than one year ago).

The primary endpoint was pegloticase responders at the sixth month (sUA <6 mg/dL for ≥80% of time). Seven patients were enrolled with one dropping out of the study. Of the one patient that completed the trial and five ongoing, all central lab sUA levels were less than 1 mg/dL, indicating treatment response; no infusion reactions occurred. No notable eGFR changes were observed; two patients with baseline albuminuria of greater than 300 mg/g showed greater than 35 percent reduction in UACR by week 14.

There were two serious adverse events (stomach ulcer, cellulitis), which researchers said were not related to treatment with pegloticase.

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REFERENCE

ABSTRACT: PO2481. "Pegloticase for Uncontrolled Gout in Kidney Transplant Recipients: Early Data Report of a Multicenter, Open-Label Efficacy and Safety Study," American Society of Nephrology, Kidney Week 2020. Oct. 22, 2020.