Schmidt W A, Schicke B, Krause A, Wernicke D
Rheumaklinik Berlin-Buch, Immanuel Krankenhaus GmbH, Lindenberger Weg 19, 13125, Berlin, Deutschland.
Z Rheumatol. 2010 Jun;69(4):349-55. doi: 10.1007/s00393-009-0474-y.
Does experience with rituximab treatment of rheumatoid arthritis (RA) in daily clinical practice confirm the results of controlled randomized studies?
This is a retrospective data-analysis of the first 50 patients from one center with rituximab treatment for RA. The patients received at least one cycle of 2 rituximab infusions (1000 mg, respectively) within 2 weeks. Clinical assessment was performed 3-5 months after the first infusion.
The patients were older (mean age, 59 years) as compared to previously published controlled studies. The DAS28 was lower (5.5). The mean prednisolone dose was high (13.4 mg/d). The rheumatoid factor was positive in 88% of patients. Only six patients would have fulfilled inclusion criteria for controlled studies such as prednisolone dose <or=10 mg/d, concomitant methotrexate treatment, previous TNF-inhibitor treatment, or absence of malignancy. Nevertheless, indications were compatible with recently published German Rheumatology Society recommendations on rituximab treatment. A total of 62% of patients achieved EULAR response, 20% good response and 10% remission. Response was greater in patients with concomitant methotrexate treatment (88% versus 53%). The results were independent of sex, presence of anti-CCP antibodies, ANA, and previous TNF-inhibitor treatment. Only three patients had pathologic infusion reactions at the first infusion and one patient at the second infusion.
Rituximab proved to be effective, particularly when combined with methotrexate. Most patients differed considerably from those who had entered randomized controlled studies. Recently published German Rheumatology Society recommendations proved to be feasible as they reflect daily clinical practice. Results of controlled studies could be confirmed.
在日常临床实践中，使用利妥昔单抗治疗类风湿关节炎（RA）的经验是否能证实对照随机研究的结果？
这是对来自一个中心的首批50例接受利妥昔单抗治疗RA患者的回顾性数据分析。患者在2周内接受至少一个周期的2次利妥昔单抗输注（每次1000 mg）。在首次输注后3 - 5个月进行临床评估。
与先前发表的对照研究相比，这些患者年龄更大（平均年龄59岁）。疾病活动度评分（DAS28）更低（5.5）。泼尼松龙平均剂量较高（13.4 mg/d）。88%的患者类风湿因子呈阳性。只有6例患者符合对照研究的纳入标准，如泼尼松龙剂量≤10 mg/d、同时接受甲氨蝶呤治疗、先前接受过肿瘤坏死因子抑制剂治疗或无恶性肿瘤。然而，适应证与德国风湿病学会最近发表的关于利妥昔单抗治疗的建议相符。共有62%的患者达到欧洲抗风湿病联盟（EULAR）反应，20%为良好反应，10%为缓解。同时接受甲氨蝶呤治疗的患者反应更好（88%对53%）。结果与性别、抗环瓜氨酸肽（CCP）抗体的存在、抗核抗体（ANA）以及先前的肿瘤坏死因子抑制剂治疗无关。只有3例患者在首次输注时有病理性输注反应，1例患者在第二次输注时有反应。
利妥昔单抗被证明是有效的，特别是与甲氨蝶呤联合使用时。大多数患者与纳入随机对照研究的患者有很大差异。德国风湿病学会最近发表的建议被证明是可行的，因为它们反映了日常临床实践。对照研究的结果可以得到证实。
