Long-term clinical outcomes and safety of rituximab in refractory neuropsychiatric systemic lupus erythematosus: a real-world single-center study.

Publication date: May 12, 2026

To evaluate the efficacy of rituximab therapy in patients with refractory neuropsychiatric systemic lupus erythematosus (NPSLE). Seventeen patients with refractory NPSLE who received rituximab therapy at Ruijin Hospital between July 2016 and August 2025 were enrolled. Clinical manifestations and laboratory parameters were collected before and after treatment. Treatment response was evaluated using predefined manifestation-based clinical criteria, and paired longitudinal changes in laboratory parameters were analyzed using the Wilcoxon matched-pairs signed-rank test where data were available. Sixteen of 17 patients (94. 1%) achieved significant clinical improvement, while one patient showed partial improvement with reduced seizure frequency. During a follow-up period of 3 to 102 months (median 45 months), none of the surviving patients experienced relapse of neuropsychiatric manifestations. Daily prednisone dose was reduced to a median of 5 mg/day at last follow-up. Rituximab-based treatment was associated with marked depletion of circulating CD19⁺ B cells, reductions in anti-dsDNA antibody titers and SLEDAI-2000 scores, and improvement in complement levels. Two patients died from COVID-19 pneumonia during follow-up, and one patient developed severe Pneumocystis jirovecii and cytomegalovirus pneumonia. Rituximab was associated with favorable outcomes in refractory NPSLE and may represent an alternative therapeutic option, particularly for patients who are refractory to conventional treatment with glucocorticoids and/or immunosuppressive agents. Key Points • Rituximab-based treatment was associated with clinical improvement in refractory NPSLE. • Sustained relapse-free remission was observed during long-term follow-up after rituximab therapy in patients with refractory NPSLE. • Rituximab was generally well tolerated, though infection risk requires careful monitoring.

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