Objective: To investigate the efficacy and safety of rituximab (RTX) maintenance therapy compared with traditional immunosuppressive agent (ISA) maintenance therapy in patients with relapsing or refractory SLE.
Methods: It is a prospective observational non-randomized cohort study. The study enrolled SLE patients in four centres who had received at least one course of RTX induction treatment. Patients with a clinical response to RTX were divided into two groups based on their maintenance therapy in the first 12 months: the RTX group and the ISA group. The relapse-free survival times were compared between the two groups. Univariate and multivariate analyses were conducted to identify predictive factors for disease relapse.
Results: Among the 82 patients included in the cohort, 67 (81.7%) patients had a clinical response at 6 months. RTX maintenance therapy was applied in 34 (50.7%) patients and ISA maintenance therapy was applied in the remaining 33 (49.3%) patients. After a median follow-up of 24 months, a total of 13 (19.4%) patients had experienced disease relapse, comprising three in the RTX group and 10 in the ISA group. Patients in the RTX group had a higher relapse-free survival rate than patients in the ISA group. Multivariate analysis identified hydroxychloroquine use, RTX maintenance therapy and haematological system involvement as independent predictors for sustained remission.
Conclusion: This multicentre prospective cohort study demonstrated that long-term RTX maintenance therapy has high efficacy and acceptable safety in relapsing or refractory SLE patients who had a clinical response to RTX induction therapy.
Keywords: Systemic lupus erythematosus; maintenance therapy; prospective; rituximab.
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