P0342A STUDY OF TREATMENT WITH RITUXIMAB IN REFRACTORY LUPUS NEPHRITIS

Background and Aims SLE patients have 40% to 70% life time risk of developing lupus nephritis (LN). In LN patients rate of end-stage renal disease is 10%, remaining constant in the last 30 years, even after the emergence of various immunosuppressive therapy. SLE is an example of classical antibody-mediated disease and hence treatment with B cell depleting agent (like the use of Rituximab ) appears to be a promising approach for this unwinnable disease from the Roman era. The aim of this study was to analyze the outcome in terms of - no renal response (NRR), complete renal response (CRR) or partial renal response (PRR) at week 24 after rituximab treatment initiation in refractory LN. CRR considered, if serum creatinine (S Cr) level returned to baseline, with a decline in the 24 hour urinary protein to < 500 mg/day. PRR defined as stabilization (+/-25%), or improvement of S Cr, plus a 50% decrease in 24 hour urinary protein (which was < 3.5 gm/day). NRR considered, if participant did not achieve either a CRR or PRR. Method It is a single center prospective observational study, comparing short term (24 week) outcomes in resistant lupus nephritis patients of >18 year age group with weekly (total 4) dose of rituximab therapy. The study was conducted on 25 refractory lupus nephritis patients admitted in Nephrology Department (not responding to conventional immunosuppressive drugs like cyclophosphamide, MMF). Repeat renal biopsy was performed, all baseline investigations were done. Injection Rituximab 375 mg/m2 weekly 0,1,2,3 week along with premedication treatment were given to every patient. The clinical outcome was assessed monthly post-treatment. Results In the study maximum patients were of class IV, n=21 (84 %). Sustained (6 months post treatment) CRR was achieved in n=6 (24%) patients, n=7 (28%) patients achieved PRR, rest n=12 (48%) patients had NRR. Mean blood absolute CD-19 count was significantly negatively correlated with response to rituximab treatment ( p< 0.001) .Mean absolute CD-19 count was 2.33/microliter in CRR, 2.14/microliter in PRR group and 21.25 / microliter in NRR group . No significant side effects of rituximab were observed. Limitations –Small sample size, single center study, long term follow up not considered. Conclusion In refractory LN patients, 24 weeks after Rituximab treatment