Background and aims B cells play a crucial role in pathogenesis of Systemic Lupus Erythematosus(SLE). We examined the efficacy of B cell depletion therapy rituximab for refractory patients with SLE.
Methods 63 eligible study subjects since 2002 until 2015 were men and women, who met the American College of Rheumatology criteria in 1987 or SLICC2012 for the classification of SLE. The protocols were approved by the Institutional Review Board of our university. Treatment protocol: 2 or 4 weekly doses of 500 mg/body, 2 biweekly doses of 1000 mg/body or 4 weekly doses of 1000 mg/body.
Results Baseline characteristics; gender M:F=6:57, age 33.9 years, disease duration 87.2 months, organ failure NPSLE:35, lupus nephritis:46, treated with IVCY 34/63. The 60/63 patients were trailable at 1 year. Primary endpoint; disease activity scores were significantly improved (SLEDAI 17.3→3.0, BAILAG 17.8→2.2; LOCF). The achievement ratio of major clinical response (MCR) defined as no BILAG A and/or B score was 61.7%. Secondary endpoint; dose of corticosteroid was decreased from 43.2 to 8.4 mg/day. Nephritis score originally designed (total 10 points; protein 3, occult blood 3, cast 4) was decreased (3(before)→2.3 (1month)→0.8 (1year)). The 37/50 patients were trailable at 5 years. Primary failure: 3 (8%), secondary failure (flare) : 12 (32.8%, duration: 23.8 months), MCR: 18 (48.6%), corticosteroid discontinued: 5 among 37 patients.
Conclusions Rituximab showed short-term and long-term efficacy in refractory patients with SLE, although some of patients had a relapse. Rituximab could be considered as a therapeutic strategy for refractory patients with SLE.
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