Outcome of rituximab therapy in patients with systemic lupus erythematosus

Abstract

Purpose: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting multiple organs. Rituximab (RTX) is an anti-CD20 monoclonal antibody that is an approved treatment for various autoimmune diseases. However, no randomized controlled trial (RCT) has proved the benefit of RTX for patients with lupus nephritis (LN). We conducted a retrospective study to evaluate the effectiveness of RTX as an immunosuppressive treatment for SLE and LN. Methods: Subjects were selected by reviewing medical records from January 2004 to July 2020 in the rheumatology departments of two hospitals in Saudi Arabia. Patients were included if they were >16 years of age with a diagnosis of SLE that fulfilled the 2019 European League Against Rheumatism and the American College of Rheumatology criteria and had received RTX for SLE. Clinical and laboratory data, SLE disease activity index (SLEDAI) score and adverse events before and 3, 6, and 12 months after starting RTX were collected. Statistical analysis was conducted comparing median baseline values with those at various times after starting RTX. Results: 40 patients with SLE were included in the study. The indications for RTX were arthritis (37.5%) and LN (32.5%), with LN varying in severity. Over the 12 months from starting RTX, there were significant improvements in SLEDAI score, and anti-dsDNA antibody, C3, and C4 levels (P<0.001, P=0.048, P<0.001, and P=0.005, respectively). Steroid dose was also significantly reduced (P<0.001) post-RTX. Meanwhile, serum creatinine at 6 and 12 months did not differ significantly from the baseline. Proteinuria in patients receiving RTX for LN showed a significant reduction from median baseline value to that at 12 months (P=0.028). Conclusions: RTX effectively controlled multiple manifestations of SLE in a Saudi population and exhibited a steroid-sparing effect in this population. Larger RCTs should be conducted to determine the patients that could benefit from such treatment.