Objective Rituximab is a B cell depleting monoclonal anti-CD20 antibody that has been suggested by number of research as a potential Effective agent in Resistant active SLE. however, related clinical trials; ‘Explorer’, ‘lunar’ trials both failed to show clinically significant efficacy of Rituximab compared to placebo.In this uni-centre study, we evaluated the Efficacy and safety of Rituximab in refractory SLE patients.
Method We analysed retrospectively the data of resistant SLE patients who received Rituximab
Results Data included 23 refractory SLE patients that received Rituximab which was indicated for lupus nephritis 26.1%, haematological involvement 21.7%, neuropsychiatric complications 30.4%, cutaneous involvement 13.0%, and combination of lupus nephritis and haematological involvement 8.6%. Mean ±SD of SELENA Modified version – SLEDAI score at baseline was 15.0±8.8 and 9.2±9.0 at 6 months after treatment (p value. 002). Among patients with lupus nephritis Complete renal response was noted in 2 (8.7%) out of 8 patients. Partial response was documented in 3 (13.0%). 3 of 7 patients with haematological involvement responded completely, 2 have responded partially the other 2 did not respond to Rituximab. 5 (21.7%) patients of 7 neuropsychiatric patients showed complete response, and no response was noted in 2 (8.7%) patients. 4 out of 5, who showed complete response undergone remission. Two non-responders eventually died. Only 3 (13.0%) patients showed cutaneous involvement. 2 of them showed partial response and remaining 1 showed complete response. Adverse effects were noted in 8 (34.8%) patients. 2 (8.7%) of them reported acute infusion reaction, 4 (17.4%) showed features of severe infection and 2 (8.7%) patients died due to septic shock and multi organ failure (table 3).
Conclusion Rituximab is an effective and relatively safe agent for refractory SLE, additional well-structured controlled studies are needed to prove efficacy in those patients compared to other conventional therapy.
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