Meaningful Clinical Improvement in Serum Uric Acid (sUA) Levels with Concomitant Use of Low-Dosage Mycophenolate Mofetil (MMF) and Pegloticase in Patients with CKD and Uncontrolled Gout

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Background: Pegloticase is approved for treatment of uncontrolled gout and coadministration with MMF can mitigate immunogenicity, improving safety and efficacy. In the RECIPE study (NCT03303989), administering pegloticase 8mg biweekly with MMF 1000mg BID vs placebo showed a higher percentage of patients(pts) achieving target sUA <6mg/dL (86% vs 40%), less infusion reactions (0% vs 30%) and similar adverse events (AEs). Since MMF has potential for gastrointestinal intolerance and infection we aim to describe the effectiveness and tolerability of lower daily dose MMF (≤500mg BID) in combination with pegloticase. Methods: Demographics (ethnicity/race, gender, age, BMI, comorbidities [hypertension, diabetes mellitus/metabolic syndrome, coronary artery disease/peripheral vascular disease]), renal and gout parameters were collected to understand the population and track outcomes. Deidentified data were collected from community nephrology clinics. Results: 15 pts with chronic kidney disease (CKD) received pegloticase and MMF (14 received MMF 500mg BID and 1 received MMF 500mg QD). Based on CKD severity, 6 pts had Stage 2-3A (eGFR ≥45 mL/min/1.73 m2) and 9 had Stage 3B-5 (eGFR <45 mL/min/1.73 m2). At baseline, tophi were present in 66% with Stage 2-3A and 89% with Stage 3B-5. Stage 2-3A pts received a median(range) of 19(2-21) doses of pegloticase over 188(147-317) days. Stage 3B-5 pts received a median(range) of 12(4-34) doses of pegloticase over 287(37-610) days. sUA rapidly decreased to less than 0.2mg/dL, and levels were maintained throughout treatment for all pts except one with CKD Stage 2 who discontinued pegloticase. eGFR was stable or increased in 3/6(50%) with Stage 2-3A and 7/9(78%) with Stage 3B-5 (Figures 1,2). Conclusion: This small, retrospective study evaluating a lower daily dose of MMF ≤500mg BID concomitantly with pegloticase led to rapid sUA reduction, clinical improvement in gout symptoms, with both low AEs and discontinuation rate. Kidney function showed stability in most patients with both less severe and more severe stages of CKD. Funding: Commercial Support - Amgen, Inc.

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