Efficacy of rituximab versus cyclophosphamide in lupus patients with severe manifestations. A randomized and multicenter study

There are no controlled studies that compare the efficacy of RTX with standard treatment, such as cyclophosphamide, in patients with systemic lupus erythematosus (SLE). Objective: The objective of this study was to compare the efficacy of rituximab to that of cyclophosphamide in patients with severe manifestations of SLE. Materials and method: This is a multicenter, randomized open and controlled trial in adults with a diagnosis of active SLE. Patients were randomized into two groups; group 1: treated with RTX and group 2: cyclophosphamide pulses with the same steroid scheme. We registered MEX-SLEDAI, steroid requirements and adverse events for 12 months. Descriptive and comparative statistic analysis was performed. Results: 19 patients were included, 17 females, mean age 35.7 +/- 12.1 years and duration of disease 5.6 years (range 0.35 to 30.8 years). There were no differences at baseline regarding gender, age, duration of disease, previous treatments or disease activity between both groups. MEX-SLEDAI was reduced from 12 to 3 in group 1 and from 9 to 2 in group 2 (p=0.80). Nevertheless, patients treated with RTX had a faster improvement. There was no difference in the cumulative steroid dose. Both groups had significant reduction in antinuclear antibody levels and similar increase in C3 levels. Adverse events were similar in both groups. Conclusion: This comparative clinical study in patients with SLE shows that rituximab can be as useful as cyclophosphamide for severe manifestations, maybe showing a faster response. Adverse events were no different. Rituximab should be considered as an adequate alternative for this group of patients. (C) 2009 Elsevier Espana, S.L. All rights reserved.