FRI0216 IGURATIMOD MIGHT BE AN ALTERNATIVE OPTION FOR REFRACTORY LUPUS NEPHRITIS: A PRELIMINARY OBSERVATIONAL STUDY

Abstract

Background: Despite significant advances in the management of patients with lupus nephritis (LN), a significant proportion of patients either do not respond to first-line immunosuppressive drugs, or relapse after initial remission. Iguratimod is a novel disease modifying anti-rheumatic drug that has been approved for treating rheumatoid arthritis in East Asia and has shown benefits in lupus animal model in our previous research.(1) Objectives: The aim of the present study was to make a preliminary observation on the efficacy and safety of iguratimod in treating refractory LN patients. Methods: We have enrolled adult refractory LN patients who were eligible if they experienced at least two times of failure or relapse before enrollment. Failure was defined as no response to one certain immunosuppressive drug for at least six months. After enrollment, we simply switched their previous immunosuppressant to daily iguratimod (25 mg twice per day), while keeping all other medications. Complete/partial remission (PR/CR) was used as the primary outcome. 24h urine protein, blood cell counts, liver and kidney function were routinely monitored. Results: A total of 20 refractory LN patients had been enrolled (18 female and 2 male patients) since 2015. At enrollment, the median proteinuria was 2.588g/24h (range: 0.98-13.79g/24h). None of them had overt extra-renal involvement. All of them had biopsy-proven LN (class III/IV/V) and two patients agreed repeated biopsy before switching to iguratimod. The median prednisone dosage was 10mg/d (range: 5-35mg/d). One patient was lost to follow-up and one withdrew from the study. Of the remaining 18 patients, 16 patients achieved PR/CR and 2 did not respond to iguratimod. Of the 16 patients who achieved remission, 3 had renal relapse after initial PR and 1 had extra-renal flare after initial CR. One PR patient withdrew from the study due to severe anemia and another due to incompliance. For the remaining 10 patients who were still in follow-up, the median follow-up was 84 weeks (range: 28-144 weeks), with 4 having CR and 6 PR. The median response duration (MRD) was 12 weeks. Conclusion: Out study provided preliminary but promising clinical evidence for iguratimod in treating refractory LN patients. A large randomized clinical trial is needed to establish its safety and efficacy for refractory LN.