Rituximab as maintenance therapy following remission induction in relapsing or refractory systemic lupus erythematosus.

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.