Abstract: PUB317
Claims-Based Evaluation of Pegloticase Use in Gout Patients with a History of Kidney Transplant
Session Information
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Shadur, Craig Alan, Kidney Physicians, PC, Des Moines, Iowa, United States
- Masri, Karim Richard, Bon Secours Mercy Rheumatology Center, Richmond, Virginia, United States
- Marder, Brad, Horizon Therapeutics plc, Deerfield, Illinois, United States
- Vesel, Claudia Corina, Horizon Therapeutics plc, Deerfield, Illinois, United States
- LaMoreaux, Brian, Horizon Therapeutics plc, Deerfield, Illinois, United States
Background
Kidney transplant (KT) recipients have a high occurrence of gout due to reduced GFR and medications associated with hyperuricemia. Impaired renal function and drug interaction concerns can make it challenging to effectively lower urate in this population. Pegloticase (pegylated recombinant uricase) rapidly metabolizes urate and has known efficacy for managing uncontrolled gout. However, clinical trials excluded organ transplant recipients and few cases of use in transplant recipients have been reported. This study examined pegloticase use in KT patients with uncontrolled gout in a large claims database.
Methods
The IQVIA database was used to identify pts with a history of KT (≥1 CPT or ICD 9/10 code) receiving ≥1 pegloticase infusion. The number and type of concomitant immunosuppression (IMS) prescriptions within 3 mo prior to/during pegloticase use were collected and the number of pegloticase infusions was evaluated. Pts were excluded if they returned to dialysis before the first pegloticase infusion because of graft failure or rejection.
Results
91 pts were identified between 2015 and 2020. Pts with reported demographics (n=85) were predominately male (81%) and 58±11 yrs old at the time of first pegloticase infusion. The most common comorbidities were hypertension (84%), hyperlipidemia (48%), anemia (46%), type 2 diabetes mellitus (40%), and heart failure (34%). Compared to 1st pegloticase claim, the 1st transplant code was 2.6±1.7 yrs (mean ± SD) earlier and 1st gout code was 2.1±1.7 yrs earlier. 61 pts (67%) had a tophaceous gout code. Transplant IMS medication codes were available for 67 pts (74%), with the majority receiving tacrolimus (n=34), mycophenolate mofetil (n=33), and/or cyclosporine (n=29). Pts received a mean of 13±16 pegloticase infusions (median: 8; Q1, Q3: 4, 15), with 38% receiving ≥12 infusions and 20% receiving ≥20 infusions.
Conclusion
This real-world dataset demonstrated that KT patients with uncontrolled gout are being treated with pegloticase. A main consideration with pegloticase efficacy is potential development of anti-drug antibodies (ADAs). Given that solid-organ transplant patients are on IMS medications to preserve their grafted organ, this likely contributed to prevention of ADAs indicated by the longer average duration of therapy compared to other real-world pegloticase datasets.
Funding
- Commercial Support – Horizon Therapeutics plc