Background: Kidney transplant (KT) recipients have a high gout incidence due to reduced eGFR and medication use associated with hyperuricemia. 1 Oral urate-lowering therapies in KT patients are further limited by residual chronic kidney disease and potential drug-drug interactions. Pegloticase rapidly lowers serum urate in uncontrolled gout patients, 2-3 but efficacy for monotherapy is limited in ≥50% of treated patients by anti-drug antibodies that cause loss of urate-lowering effect and can lead to infusion reactions in some patients. 4-5 Anti-rejection medications are ubiquitously used after organ transplantation and are known to reduce the development of anti-drug antibodies, 6 but published data of pegloticase use in KT recipients is limited.
Objectives: This claims-based analysis examined real-world pegloticase use in KT patients to determine the number of administered infusions compared to non-transplanted patients.
Methods: Patients in the IQVIA database (2015-2020) who had ≥1 CPT or ICD9/10 code for KT and ≥1 pegloticase claim following KT were identified. Patients who returned to dialysis due to graft failure/rejection prior to pegloticase use were excluded. Patient characteristics and pegloticase therapy parameters were examined.
Results: 91 KT recipients with pegloticase use were identified. Of 85 patients with demographics, 81% were male, mean(±SD) age at first transplant was 55.0±10.7 years, and 67% had tophaceous gout. The most common comorbidities were hypertension (84%), hyperlipidemia (48%), anemia (46%), type 2 diabetes (40%), and heart failure (34%). First transplant and gout codes occurred 2.6±1.7 and 2.1±1.7 years, respectively, before first pegloticase claim. Among 67 patients with medication codes, immunosuppressive medications used <3 months before and/or during pegloticase included tacrolimus (51%), mycophenolate mofetil (49%), and/or cyclosporine (37%). Patients received 13±16 pegloticase infusions (median: 8 [Q1, Q3: 4, 15]), with 38% receiving ≥12 and 20% receiving ≥20 infusions.
Conclusion: This study showed a higher median number of pegloticase infusions than reported in prior claims-based studies of non-KT patients. 7 Real world data from KT patients support the hypothesis that transplant immunosuppression may allow more patients to receive a longer course of pegloticase therapy, presumably via anti-drug antibody attenuation. This is of particular importance for this vulnerable patient group that is at a high risk for developing uncontrolled gout.
REFERENCES:
[1]Clive DM, et al. J Am Soc Nephrol 2000; 11: 974.
[2]Keenan RT, et al. Sem Arth Rheum 2021; 51: 347-52.
[3]Botson JK and Peterson J . J Clin Rheum 2020 [Epub].
[4]Sundy JS, et al. JAMA 2011; 306(7): 711-20.
[5]Lipsky PE, et al. Arthritis Res Ther 2014; 16(2): R60.
[6]Hershfield MS, et al. Arthritis Res Ther 2014; 16: R63.
[7]Chen SK, et al. BMJ Open 2020; 10(12): e041167.
Disclosure of Interests: Craig Shadur: None declared, Brad Marder Shareholder of: Horizon Therapeutics, Employee of: Horizon Therapeutics, Claudia Vesel Shareholder of: Horizon Therapeutics, Employee of: Horizon Therapeutics, Brian LaMoreaux Shareholder of: Horizon Therapeutics, Employee of: Horizon Therapeutics