Rheumatology Department, CHU, Clermont-Ferrand, France.
Rheumatology (Oxford). 2011 Dec;50(12):2283-9. doi: 10.1093/rheumatology/ker305. Epub 2011 Oct 22.
To assess the efficacy and safety of rituximab (RTX) in patients with refractory idiopathic inflammatory myopathies (IIMs).
RTX efficacy was based on improvement in three criteria: creatine phosphokinase (CPK) level, daily CS dose and physicians' opinion. A decrease in CPK level or CS dose was significant if it was >25%.
Thirty patients were studied (21 women; age 52.5 years, disease duration 6.1 years). All had previously received immunosuppressors (ISs). Twenty-five patients received 1 g of RTX twice 2 weeks apart and five received 4 weekly RTX infusions (375 mg/m(2)). RTX was given in association with IS in 21 patients. Twenty-eight patients received CS (mean dose 21.2 mg/day). Mean follow-up was 17.2 months. Thirteen adverse events were reported, including seven infections and one serious infection (pyelonephritis). RTX was effective in 16 patients. Duration of efficacy was 15.5 months. Of the 20 patients with baseline CPK level ≥2 × upper limit of normal (ULN), 11 (55%) improved. The main level fell from 20.7 to 11 × ULN. CS decreased in 15 patients, stopped in 4, remained stable in 8 and increased in the remaining 3. The CS dose decreased from 21.2 to 9.9 mg/day. The physicians' opinion was favourable in 21 patients. Manual muscle testing was performed in only five patients: it increased from 87 to 91/100 at 6 months.
RTX was well tolerated and had some beneficial effects on patients with IIM, the main limitation of this study resulted in a lack of manual muscle testing.
评估利妥昔单抗（RTX）治疗难治性特发性炎性肌病（IIM）的疗效和安全性。
RTX 疗效基于以下三个标准的改善：肌酸磷酸激酶（CPK）水平、每日皮质类固醇（CS）剂量和医生意见。如果 CPK 水平或 CS 剂量下降>25%，则认为有显著改善。
研究了 30 名患者（21 名女性；年龄 52.5 岁，病程 6.1 年）。所有患者之前均接受过免疫抑制剂（IS）治疗。25 名患者接受了 2 次 1g RTX 治疗，间隔 2 周，5 名患者接受了 4 次每周 RTX 输注（375mg/m2）。21 名患者在接受 RTX 的同时还接受了 IS。28 名患者接受 CS（平均剂量 21.2mg/天）。平均随访时间为 17.2 个月。报告了 13 例不良事件，包括 7 例感染和 1 例严重感染（肾盂肾炎）。RTX 在 16 名患者中有效。疗效持续时间为 15.5 个月。在基线 CPK 水平≥2×正常值上限（ULN）的 20 名患者中，11 名（55%）患者改善。主要水平从 20.7 降至 11×ULN。15 名患者 CS 减少，4 名患者 CS 停止，8 名患者 CS 稳定，其余 3 名患者 CS 增加。CS 剂量从 21.2 降至 9.9mg/天。21 名患者的医生意见为有利。仅对 5 名患者进行了徒手肌力测试：6 个月时从 87 增加到 91/100。
RTX 耐受性良好，对 IIM 患者有一定的疗效，但本研究的主要局限性在于缺乏徒手肌力测试。
