#426 Antiproteinuric effects of dapagliflozin in lupus nephritis

Abstract Background and Aims SGLT2 inhibitors are effective at slowing the progression of kidney disease, reducing heart failure, and lowering the risk of kidney failure and death in CKD. Our aim is to assess the effect and safety of dapagliflozin in patients with systemic lupus erythematosus (SLE) with proteinuria. Method We include adult patients with lupus nephritis (LN) class III, IV with proteinuria >500 mg/daily, in the maintenance treatment with a RAAS and MMF<2 g/day in stable a dose for at least 6 weeks. We excluded patients with other etiologies of CKD, use of induction therapy in the last 12 months. Those included were randomized to receive dapagliflozin 10 mg on top of standard of care therapy (SOC)or not. Primary endpoint is reduction of proteinuria compared to baseline at 6 months. The sample size was calculated for 42 patients enrolled providing 80% power to detect a 25% relative risk reduction in proteinuria. Results We included 42 patients that were randomized 23 to start the treatment with dapagliflozin on top of SOC and 19 to remain with the usual therapy for 24 weeks. We analyzed the data of 23 patients in the initial dapa+SOC and 19 patients in the initial SOC group after 3 and 6 months. Patients in initial dapagliflozin group had a significant decrease in proteinuria after 6 months (1123 to 588 mg/day; P = 0.015) but increased to 1095 mg/day 6 months after the drug withdrawal. This preliminary analysis shows a significant reduction in the proteinuria of −47.6% in patients after 6 months of dapagliflozin as opposed to a 12.1% for those in the SOC therapy at the end of a 6 months period, P = 0.035. Conclusion These preliminary findings demonstrate a significant reduction in proteinuria in patients with LN with dapagliflozin without an increase in infections. These results are from single medical center and multicenter randomized controlled trials are required to obtain more detailed findings.

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