Quality of life improvements and clinical assessments in kidney transplant recipients undergoing pegloticase treatment for uncontrolled gout: findings of the phase 4 PROTECT clinical trial

Abdul Abdellatif ¹ Lin Zhao ² Katie Obermeyer ² Zana Vranic ² Brad A. Marder ^2* John D. Scandling ³

• ¹ Baylor College of Medicine, Houston, United States
• ² Amgen (United States), Thousand Oaks, United States
• ³ School of Medicine, Stanford University, Stanford, United States

Gout is 12-times more prevalent in kidney transplant (KT) recipients than in non-transplanted population. We report quality-of-life (QOL) and clinical assessment findings from the PROTECT trial examining pegloticase efficacy and safety in KT recipients with uncontrolled gout (SU≥7mg/dL, oral urate-lowering therapy refractory/intolerant, and ≥2 flares/yr, unresolving tophi, or chronic gouty arthritis), KT>1 yr prior, graft eGFR≥15 ml/min/1.73m 2 , and stable immunosuppression). Pegloticase was administered for 24-weeks. QOL endpoints included the Health Assessment Questionnaire (HAQ; Disability Index, Health, Pain) and Physician Global Assessment of Gout. Key clinical assessments included proportion with resolution of ≥1 tophus and change from baseline in blood pressure (BP) at Week-24. Twenty KT recipients (85.0% male, age: 53.9±10.9 years, BMI: 30.6±7.2kg/m 2 , eGFR: 45.8±11.9ml/min/1.73m 2 , time since kidney transplantgraft age: 14.6±6.9 years) were included. The primary endpoint was achieved with 89% of patients reaching and maintaining a SU of <6 mg/dL atduring Month 6. Meaningful improvements occurred over 24 weeks of treatment in all QOL measures (mean [95% CI] change from baseline: HAQ--