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Abstract: PO1166

A USRDS Database Study on the Use of Pegloticase in Patients Undergoing Dialysis

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Bleyer, Anthony J., Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
  • Zhang, Yi, Medical Technology and Practice Patterns Institute, Bethesda, Maryland, United States
  • Kshirsagar, Onkar S., Medical Technology and Practice Patterns Institute, Bethesda, Maryland, United States
  • Marder, Brad Allan, Horizon Therapeutics plc, Lake Forest, Illinois, United States
  • LaMoreaux, Brian, Horizon Therapeutics plc, Lake Forest, Illinois, United States
Background

Gout is a common co-morbidity of chronic kidney disease, but prevalence in dialysis patients is not precisely known. Oral urate-lowering therapy use is limited in patients with advanced renal disease, particularly end-stage. Pegloticase (PEGylated uricase) rapidly lowers serum uric acid, but phase 3 trials did not include dialysis patients. However, a phase 1 trial in non-gout patients showed that pegloticase efficacy and pharmacokinetics are not affected by dialysis. Beyond this, pegloticase use in dialysis-dependent patients is not reported in the literature. This United States Renal Data System (USRDS) study sought to better quantify and understand real-world use of pegloticase in patients undergoing dialysis.

Methods

Patients with advanced renal disease, who are dialysis-dependent, or who have undergone renal transplant are in the USRDS. USRDS patients who were administered pegloticase and undergoing dialysis were identified in 2012-2017 Standard Analytical Files. Parameters examined included demographics, comorbidities, dialysis type, number of pegloticase infusions, and time between pegloticase infusions.

Results

58 dialysis centers reported on 136 patients. Pegloticase was most prescribed by rheumatologists (68%) and internal medicine physicians (7%). The majority of patients were white (61%) and male (73%) and patient age averaged 56.9 ± 16.8 years; all adult age groups were represented (18-44 years: 27%, 45-64 years: 35%, ≥65 years: 39%). Hypertension (74%) and diabetes (46%) were the most reported comorbidities. 9 patients (7%) were donor kidney recipients. More patients were undergoing hemodialysis (108 patients [79%]) than peritoneal dialysis (23 [17%]). Patients received 13.4 ± 19.1 pegloticase infusions (median: 7, 46 [34%] patients ≥12) and median time between doses was 14 days (mean: 21 days). This treatment schedule reflected that of pegloticase labeling (biweekly infusions).

Conclusion

The literature contains few reports of pegloticase use in dialysis patients. Our real-world data suggest that pegloticase is well-tolerated in dialysis patients, as indicated by a median of 7 infusions per patient and the expected treatment schedule. Further research is needed to verify these findings.

Funding

  • Commercial Support