INTRODUCTION AND AIMS: The efficacy of rituximab (RTX) in Systemic Lupus Erythematosus (SLE) is debated, and there is a lack of data on its role in relapse prevention. We describe our experience in a European cohort of SLE patients with an emphasis on RTX use as a maintenance agent.
METHODS: All the patients with SLE receiving RTX across 7 centers were included. Disease activity was assessed by the ECLAM score. RTX maintenance treatment (RMT) was defined as at least 3 RTX cycles with an interval between administrations of 3-12 months. A negative response (NR) 6 months after the first RTX and a flare during the follow-up were defined as an increase of disease activity and immunesuppressors. The evolution of damage and severe adverse events (SAEs) were collected during follow-up.
RESULTS: 148 patients were identified: at 6 months 39(27%) experienced a NR. 80 received RMT with a median duration of 24.5 months and a median overall dose of RTX of 6g. ECLAM reduced from 3.5 (mean, 95%CI 3.1-3.9) to 1.86 (95%CI 1.5-2.2) after the first RTX (p<0.01) and remained stable (figure below) during RMT despite 52 patients experienced 85 relapses (1.06 per patient). During the RMT the proportion of patients off steroids increased from 14% to 41%, the median prednisolone dose reduced from 10mg (IQR 5-15) to 5 (IQR 0-6.75). By the last RTX administration 84% of the patients were in remission with an ECLAM of 1 (mean, 95%CI 0-2).After the RMT the relapse free survival was 17 months with no difference compared to patients that received only one RTX cycle (figure below). Among the patients treated with RMT, 28 were “good responders” not flaring during RMT; these patients had less increase in damage compared to the rest of the population (0.17 vs 0.25). At the multivariate analyses, the only factor associated to risk of flares during the RMT was active articular disease at the moment of the first RTX (OR 2.89, 95%CI 1.04-8-03,p=0.042).The SAEs in the overall population were 0.30 per patient per year; in the subgroup treated with RMT course 0.24.
CONCLUSIONS: RMT may contribute to the control of the disease in SLE while allowing steroid sparing. Relapse risk after the RMT remains high and the same as after a single RTX course. Having active articular disease at the moment of the first RTX is risk factor for a flare during the RMT.
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