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Kidney Week

Abstract: PO2481

Pegloticase for Uncontrolled Gout in Kidney Transplant Recipients: Early Data Report of a Multicenter, Open-Label Efficacy and Safety Study

Session Information

Category: Transplantation

  • 1902 Transplantation: Clinical

Authors

  • Abdellatif, Abdul A., Baylor College of Medicine, Division of Nephrology, Houston, Texas, United States
  • Zhao, Lin, Horizon Therapeutics plc, Lake Forest, Illinois, United States
  • Peloso, Paul M., Horizon Therapeutics plc, Lake Forest, Illinois, United States
  • Cherny, Katya, Horizon Therapeutics plc, Lake Forest, Illinois, United States
  • Marder, Brad Allan, Horizon Therapeutics plc, Lake Forest, Illinois, United States
  • Scandling, John D., Stanford School of Medicine, Division of Nephrology, Stanford, California, United States
  • Saag, Kenneth G., University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, Birmingham, Alabama, United States
Background

Gout is common and more severe in US kidney transplant (KT) recipients, with prevalence >10x higher than in non-transplant patients. The management of gout can be challenging in KT patients due to decreased urate lowering therapy (ULT) clearance and drug-drug interactions. Recent reports suggest that pegloticase, a pegylated uricase approved for treating uncontrolled gout, has improved efficacy and safety when co-administered with immunosuppressive medications (IMM). We conducted the PROTECT trial (NCT04087720) to examine pegloticase use in KT recipients.

Methods

Patients with uncontrolled gout (sUA ≥7 mg/dL, intolerance of or contraindication to ULT, and ≥1 of the following: tophi, chronic gouty arthritis, ≥2 flares in past yr) and functioning KT graft (eGFR ≥15 mL/min/1.73m2) are included (KT>1 yr earlier). Pegloticase (8 mg q2w for 24 wks) safety and efficacy are examined. Primary endpoint is % pegloticase responders during Month 6 (sUA <6 mg/dL for ≥80% of time).

Results

7 patients were enrolled by Apr 30, 2020 (age: 52.0±11.2 yrs, KT 15.3±5.0 yrs ago, sUA: 10.0±1.4 mg/dL, gout duration: 5.9±4.3 yrs; all on stable doses of ≥2 IMM) and received 2-12 infusions. 1 patient discontinued. In the 1 completed and 5 ongoing patients, all central lab sUA levels were <1 mg/dL, indicating treatment response; no infusion reactions occurred. No notable eGFR changes were observed; 2 patients with baseline albuminuria of >300 mg/g showed >35% reduction in UACR by wk 14. 2 SAEs (stomach ulcer, cellulitis) unrelated to pegloticase were reported.

Conclusion

Early data of this ongoing clinical trial are promising and suggest pegloticase is safe and effective for treating uncontrolled gout in KT recipients. Additional efficacy and safety data are planned.

Serum uric acid (sUA) and kidney function parameters
 sUA (mg/dL)eGFR (mL/min/1.73m2)UACR
PatientLast Visit Prior to Data Cut (week)BaselineLast ValueLast Visit with eGFR and UACR values (week)BaselineLast ValueBaselineLast Value
1249.1<12461.251.037656
2†*207.9<11441.645.55640
3*219.3<11441.849.721961406
4210.9<1241.134.9305572
5*69.7<1640.140.12220
6*610.9<1640.832.7317407
7*412.2<1220.423.2407342

*ongoing, †experienced an SAE

Funding

  • Commercial Support