Positioning rituximab in the therapeutic strategies for SLE

Systemic lupus erythematosus (SLE) is one of the most challenging diseases to manage due to its high heterogeneity and unpredictable course. Rituximab is an off-label, widely administered treatment in severe, refractory SLE. Observational and real-world evidence studies have been highly heterogeneous, featuring differences not only in patient numbers and follow-up periods, but also in evaluation timepoints, ranging from 6 months to longer than 10 years. Despite such methodological issues, rituximab treatment has demonstrated significant efficacy among different disease manifestations, with an acceptable toxicity profile. Therefore, it has become common practice to administer rituximab in patients with SLE after conventional treatments have extensively failed; in such refractory patients, this approach has produced encouraging results. Current evidence suggesting early rituximab introduction is limited; however, preliminary results are promising. In this review, we discuss when, how, and in which patient subgroups rituximab treatment may represent a reasonable approach.