Bang So-Young, Lee Chang Keun, Kang Young Mo, Kim Hyoun-Ah, Suh Chang-Hee, Chung Won Tae, Park Yong-Beom, Choe Jung-Yoon, Kim Tae-Jong, Park Yong-Wook, Yoo Dae-Hyun, Bae Sang-Cheol, Lee Hye-Soon
Division of Rheumatology, Department of Internal Medicine, Hanyang University Guri Hospital, Gyeonggi-do, Guri-si 471-701, Republic of Korea.
Autoimmune Dis. 2012;2012:565039. doi: 10.1155/2012/565039. Epub 2012 Dec 9.
Objective. Although two recent randomized placebo-controlled trials of rituximab (RTX) failed to demonstrate efficacy in systemic lupus erythematosus (SLE), clinicians continue to use off-label RTX for cases refractory to current treatments. We evaluated the effectiveness and safety of rituximab for patients with refractory SLE in Korea. Methods. We retrospectively analyzed multicenter patients treated with RTX in Korea. Results. 39 SLE patients treated with RTX were included in the following manner: lupus nephritis 43.6%, hematologic 33.3%, arthritis 7.8%, myositis 7.8%, and others 7.7%. All patients had responded poorly to at least one conventional immunosuppressive agent (mean 2.5 ± 1.1, cyclophosphamide 43.6%, mycophenolate mofetil 48.7%, and other drugs) before RTX. Clinical improvements (complete or partial remission) occurred in patients with renal disease, hematologic disease, arthritis, myositis, and other manifestations at 6 months after RTX. The SLEDAI score was significantly decreased from 10.8 ± 7.1 at baseline to 6.7 ± 4.0 at 6 months, 6.2 ± 4.1 at 12 months, and 5.5 ± 3.6 at 24 months after RTX (P < 0.05). Among 28 clinical responders, 4 patients experienced a relapse of disease at 25 ± 4 months. Infections were noted in 3 patients (7.7%). Conclusion. RTX could be an effective and relatively safe therapeutic option in patients with severe refractory SLE until novel B-cell depletion therapy is available.
目的。尽管最近两项利妥昔单抗（RTX）的随机安慰剂对照试验未能证明其在系统性红斑狼疮（SLE）中的疗效，但临床医生仍在对当前治疗难治的病例中使用未获批准的RTX。我们评估了RTX对韩国难治性SLE患者的有效性和安全性。方法。我们回顾性分析了在韩国接受RTX治疗的多中心患者。结果。39例接受RTX治疗的SLE患者纳入方式如下：狼疮性肾炎43.6%，血液系统疾病33.3%，关节炎7.8%，肌炎7.8%，其他7.7%。所有患者在RTX治疗前对至少一种传统免疫抑制剂反应不佳（平均2.5±1.1种，环磷酰胺43.6%，霉酚酸酯48.7%，以及其他药物）。RTX治疗6个月后，肾病、血液系统疾病、关节炎、肌炎和其他表现的患者出现临床改善（完全或部分缓解）。RTX治疗后，SLEDAI评分从基线时的10.8±7.1显著降至6个月时的6.7±4.0、12个月时的6.2±4.1和24个月时的5.5±3.6（P<0.05）。在28例临床缓解者中，4例患者在25±4个月时疾病复发。3例患者（7.7%）出现感染。结论。在有新的B细胞清除疗法可用之前，RTX可能是重度难治性SLE患者一种有效且相对安全的治疗选择。
