Pegloticase May Improve Uncontrolled Gout in Kidney Transplant Recipients

Investigators report findings from the PROTECT study assessing the efficacy and safety of pegloticase for uncontrolled gout among kidney transplant recipients.

The following article is a part of conference coverage from the American College of Rheumatology (ACR) Convergence 2021, being held virtually from November 3 to 10, 2021. The team at Rheumatology Advisor will be reporting on the latest news and research conducted by leading experts in rheumatology. Check back for more from the ACR Convergence 2021.


Pegloticase has shown promise as a treatment for uncontrolled gout among kidney transplant recipients, according to research recently presented at the American College of Rheumatology (ACR) Convergence 2021, held November 3-10, 2021.

This ongoing phase 4, open-label, multicenter efficacy and safety study (Study of Pegloticase in Patients With Uncontrolled Gout Who Have Had a Kidney Transplant [PROTECT]; Identifier: NCT04087720) included 20 kidney transplant recipients with uncontrolled gout (mean age, 53.9±10.9 years; estimated glomerular filtration rate [eGFR], ≥15 mL/min/1.73m2; gout duration, 8.4±11.6 years; mean time since kidney transplant, 14.7±6.9 years; serum urate, 9.4±1.5 mg/dL), all of whom were being treated with at least 2 immunosuppressive medications. Of these individuals, 10 completed treatment, 3 met criteria for serum urate monitoring (nonresponse for 2 consecutive visits), and 5 received ongoing treatment.

Pegloticase 8 mg was administered via intravenous infusion every 2 weeks. Uncontrolled gout was defined as serum urate level of 7 mg/dL and greater; contraindication to urate-lowering therapy; and at least 2 flares in the past year, chronic gouty arthritis, or tophi. The study’s primary endpoint was the proportion of participants experiencing response to pegloticase during month 6, with response defined as a serum urate level less than 6 mg/dL for at least 80% of the time. Health Assessment Questionnaire (HAQ) disability/pain scores and eGFR were additional endpoints.

All treated participants experienced notable reductions in serum urate, and the majority of these reductions were sustained. Changes in eGFR were not found to be significant. The 10 participants who completed treatment showed improvements in HAQ disability (0.2±0.5) and pain (26.7±30.3) scores at week 24. Serious adverse events including diverticulitis, atrial fibrillation, localized infection, duodenal ulcer, sepsis, and cellulitis were reported by 5 patients, although none were found to be a result of treatment with pegloticase. No occurrences of infusion reaction or anaphylaxis were reported.

The study authors conclude that “on-going results from the PROTECT trial demonstrate promising outcomes treating uncontrolled gout in [kidney transplant] recipients with pegloticase.”

Disclosure: Two study authors report being employed by Horizon Therapeutics. Please see the original reference for a full list of authors’ disclosures.


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Abdellatif A, Zhao L, Peloso P, et al. Pegloticase treatment for uncontrolled gout in kidney transplanted patients: results of an on-going multicenter, open-label, efficacy and safety study. Poster presented at ACR Convergence 2021; November 3-10, 2021. Abstract 665.