To describe the clinical outcome and safety of rituximab (RTX) treatment in systemic lupus erythematosus (SLE) patients with severe manifestations or whose disease is refractory to standard immunosuppressive therapy, treated at a single center.

This was a retrospective analysis of all patients with SLE treated with RTX at 1 center between June 2000 and December 2013. The clinical outcome was assessed by determining British Isles Lupus Assessment Group (BILAG) scores and anti–double‐stranded DNA (anti‐dsDNA) and C3 levels before and 6 months after RTX treatment. For safety analysis, adverse events and deaths were recorded.

Of a total of 115 patients, 93.9% were female, the mean ± SD age at diagnosis was 26.39 ± 11.90 years, and the mean ± SD disease duration at first RTX treatment was 91.96 ± 84.80 months. A BILAG score variation of −11.26 ± 11.38 (P < 0.001) was recorded 6 months after the first RTX treatment; 40% of patients had a complete response and 27% had a partial response; in 36.5% of patients, C3 levels increased more than 25%, and in 33.5% anti‐dsDNA levels decreased more than 50%. Depletion of CD19+ cells was achieved in 94.0% of patients. Hypogammaglobulinemia was detected in 14.9% of patients, with significant reduction for IgM (P < 0.001) and IgG (P = 0.001) levels. Severe infections, infusion‐related reactions, and hypersensitivity reactions occurred in 7%, 3.5%, and 2.6% of patients, respectively. Of the 115 patients, 62 patients had repeated RTX treatments, with an average number of 1.95 ± 1.17 cycles per patient and a mean ± SD interval between infusions of 21.44 ± 20.11 months. At the end of followup, 11 patients were deceased; 6 had cardiovascular events.

RTX treatment was effective in decreasing disease activity, with a low incidence of adverse effects.