Rituximab as maintenance treatment for systemic Lupus Erythematosus: a multicentre observational study of 147 patients

INTRODUCTION: The efficacy of rituximab (RTX) in Systemic Lupus Erythematosus (SLE) is debated. We describe the outcomes of a European SLE cohort treated with RTX, with emphasis on its role as a maintenance agent. METHODS: All patients with SLE receiving RTX as induction across four centres were included, follow-up post RTX was collected including the subgroup treated with RTX as maintenance treatment (RMT). Disease flares during the follow-up were defined as an increase in disease activity and immunosuppressive drugs. RESULTS: Of 147 patients, at 6 months 27% experienced treatment failure (TF), in a multivariate analysis, a low number of previous immunosuppressive therapies (p=0.034) and low C4 levels (p=0.008) reduced the risk of TF. Eighty patients received RMT over a median of 24.5 months during which 85 relapses, mainly musculoskeletal, were recorded (1.06 per patient), at the last RTX course, 84% of the patients were in remission. 28/80 (35%) patients never flared during the RMT with low damage accrual, active articular disease at the time of the first RTX course was associated with risk of flare during RMT (p=0.010). After RMT, relapse free survival was similar to patients receiving a single-RTX course (p=0.72). CONCLUSIONS: RMT is a potential treatment option in difficult to treat patients. Relapses occur during RMT and are more likely in those with active articular disease at the time of the first RTX. Relapse risk after RMT remains high and apparently comparable to the one seen after a single-RTX course.