Pegloticase is effective in achieving a sustained decrease in serum urate (SU) levels in kidney transplant recipients (KTRs) with uncontrolled gout, investigators reported at the American Society of Nephrology’s Kidney Week 2021.

In the phase 4 open-label PROTECT trial, nearly 89% of patients treated with the drug for 6 months were responders, defined as achieving and maintaining SU levels less than 6 mg/dL for at least 80% of the time during month 6, Abdul Abdellatif, MD, of Baylor College of Medicine in Houston, Texas, and colleagues reported in a poster presentation. Pegloticase was associated with a decline in gout flares over the treatment period so that by month 6 no patient experienced them.

The investigators explained that gout in KTRs can be severe and particularly challenging to manage because of high residual urate burden from decreased renal urate excretion caused by reduced glomerular filtration rate, calcineurin inhibitors, and diuretic use.

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The study enrolled 20 kidney transplants (85% male) who had serum urate levels of 7 mg/dL or higher during screening and prior to the treatment period, inability to maintain an SU level less than 6 mg/dL on other urate-lowering therapies or intolerable side effects, and 1 or more of the following: tophi, 2 or more gout flares in the past 12 months, and/or presence of gouty arthritis. The patients also needed to be able to tolerate low-dose prednisone (10 mg/d or less).

At baseline, the study population had a mean age of 53.9 years and SU levels of 9.4 mg/dL. The mean baseline estimated glomerular filtration rate (eGFR) was 45.8 mL/min/1.73 m2, and the mean urine albumin-to-creatinine ratio (UACR) was 734.1 mg/g. All patients were on stable doses of 2 or more immunosuppressants.

Of the 20 patients, 2 discontinued therapy prior to month 6 and were not included in the analysis. Of the remaining 18 patients, 16 (88.9%) were responders. From month 1 to month 6, the proportion of patients with gout flares declined from 35% to 0%. Adverse events occurred in 80% of patients and were mild to moderate in intensity in the majority of patients. Further, eGFR values at 6 months (44.8 mL/min/1.73 m2) remained similar to baseline. The investigators observed no trend in reduction or increase in UACR over time relative to baseline.

“The PROTECT trial demonstrated that utilizing pegloticase to treat kidney transplant patients with uncontrolled gout was effective in producing a sustained decrease in SU levels, associated with clinically meaningful improvement in pain and disability, without a worsening of key kidney function markers,” Dr Abdellatif’s team concluded.

This research was supported by Horizon Therapeutics. Please see the original reference for a full list of disclosures.

Reference Abdellatif A, Zhao L, Pelosos PM, et al. Pegloticase for uncontrolled gout in kidney transplant recipients: Provisional data report of a multicenter, open-label, efficacy and safety study