Wendler Joerg, Burmester Gerd R, Sörensen Helmut, Krause Andreas, Richter Constanze, Tony Hans-Peter, Rubbert-Roth Andrea, Bartz-Bazzanella Peter, Wassenberg Siegfried, Haug-Rost Iris, Dörner Thomas
Arthritis Res Ther. 2014 Mar 26;16(2):R80. doi: 10.1186/ar4521.
The aim of this study was to evaluate the safety and efficacy of rituximab (RTX) in a large cohort of patients with rheumatoid arthritis in routine care, and to monitor changes in daily practice since the introduction of RTX therapy.
This was a multicentre, prospective, non-interventional study conducted under routine practice conditions in Germany. Efficacy was evaluated using Disease Activity Score in 28 joints (DAS28) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Safety was assessed by recording adverse drug reactions (ADRs). Physician and patient global efficacy and tolerability assessments were also evaluated.
Overall, 2,484 patients (76.7% female, mean age 56.4 years, mean disease duration 11.7 years) received RTX treatment (22.7% monotherapy). The total observation period was approximately six-years (median follow-up 14.7 months). RTX treatment led to improvements in DAS28 and HAQ-DI that were sustained over multiple courses. DAS28 improvements positively correlated with higher rheumatoid factor levels up to 50 IU/ml. Response and tolerability were rated good/very good by the majority of physicians and patients. Mean treatment intervals were 10.5 and 6.8 months for the first and last 400 enrolled patients, respectively. Infections were the most frequently reported ADRs (9.1%; 11.39/100 patient-years); approximately 1% of patients per course discontinued therapy due to ADRs.
Prolonged RTX treatment in routine care is associated with good efficacy and tolerability, as measured by conventional parameters and by physicians' and patients' global assessments. Rheumatoid factor status served as a distinct and quantitative biomarker of RTX responsiveness. With growing experience, physicians repeated treatments earlier in patients with less severe disease activity.
本研究旨在评估利妥昔单抗（RTX）在一大群接受常规治疗的类风湿关节炎患者中的安全性和有效性，并监测自引入RTX治疗以来日常实践中的变化。
这是一项在德国常规实践条件下进行的多中心、前瞻性、非干预性研究。使用28个关节疾病活动评分（DAS28）和健康评估问卷残疾指数（HAQ-DI）评估疗效。通过记录药物不良反应（ADR）来评估安全性。还评估了医生和患者的总体疗效和耐受性评估。
总体而言，2484例患者（76.7%为女性，平均年龄56.4岁，平均病程11.7年）接受了RTX治疗（22.7%为单药治疗）。总观察期约为6年（中位随访14.7个月）。RTX治疗使DAS28和HAQ-DI得到改善，并在多个疗程中持续存在。DAS28的改善与类风湿因子水平高达50 IU/ml呈正相关。大多数医生和患者对反应和耐受性的评价为良好/非常好。首批和最后400名入组患者的平均治疗间隔分别为10.5个月和6.8个月。感染是最常报告的ADR（9.1%；11.39/100患者年）；每个疗程约1%的患者因ADR停止治疗。
通过传统参数以及医生和患者的总体评估衡量，常规护理中延长RTX治疗与良好的疗效和耐受性相关。类风湿因子状态是RTX反应性的一个独特且定量的生物标志物。随着经验的增加，医生在疾病活动较轻的患者中更早地重复治疗。
