Department of Immunology, Schering-Plough nv, 73 Rue de Stalle, Brussels 1180, Belgium.
Arthritis Res Ther. 2010;12(3):R121. doi: 10.1186/ar3058. Epub 2010 Jun 22.
The objective was to describe the prevalence, types, and predictors of adverse events (AEs) in rheumatoid arthritis (RA) patients treated with infliximab and methotrexate in a daily clinical setting.
This was a prospective, multi-center, open-label, 74-week observational study in patients with active RA despite treatment with methotrexate and at least one other disease-modifying anti-rheumatic drug. Patients were treated with 3 mg/kg infliximab at weeks 0, 2, and 6 and then every 8 weeks. At weeks 0, 6, 26, 50, and 74, patients answered a health assessment questionnaire, a swollen joint count was made, and adverse events (AEs) occurring during the previous period were registered.
Five hundred and seventy-five patients were treated with infliximab, of which 346 were still on infliximab at the study end, 158 discontinued treatment, and 71 were lost to follow-up. Reasons for discontinuation included safety (n=74), elective reasons (n=43), and inefficacy (n=41). Infusion reactions (n=33) and infections (n=20) were the most common AEs causing discontinuation and the most common AEs overall. There were four cases of tuberculosis, all of which occurred in patients negative at screening. Total AEs, serious AEs, and infusion reactions as well as discontinuations for AEs were most frequent during the first 26 weeks. Higher age was a predictor of serious adverse events (SAEs), infection, and discontinuation due to an SAE, but odds ratios were close to one.
AEs and discontinuations due to AEs occur most frequently during the first half year of infliximab treatment in refractory RA patients. The main reasons for discontinuing treatment are infections and infusion reactions. Tuberculosis and other infections remain an important concern in these patients.
本研究旨在描述在常规临床环境下，接受英夫利昔单抗联合甲氨蝶呤治疗的类风湿关节炎（RA）患者的不良事件（AE）的发生率、类型和预测因素。
这是一项前瞻性、多中心、开放标签、74 周观察性研究，纳入了尽管接受甲氨蝶呤和至少一种其他改善病情抗风湿药物治疗但仍处于活动期的 RA 患者。患者接受 3mg/kg 英夫利昔单抗治疗，分别在第 0、2 和 6 周给药，之后每 8 周给药一次。在第 0、6、26、50 和 74 周，患者回答健康评估问卷，记录肿胀关节数，并登记前一时期发生的不良事件（AE）。
共 575 例患者接受了英夫利昔单抗治疗，其中 346 例患者在研究结束时仍在接受英夫利昔单抗治疗，158 例患者停药，71 例患者失访。停药原因包括安全性（n=74）、选择性原因（n=43）和无效（n=41）。输注反应（n=33）和感染（n=20）是导致停药的最常见 AE，也是最常见的总体 AE。有 4 例结核病，均发生在筛查阴性的患者中。总 AE、严重 AE 和输注反应以及因 AE 而停药在最初 26 周最为常见。较高的年龄是严重不良事件（SAE）、感染和因 SAE 停药的预测因素，但优势比接近 1。
在难治性 RA 患者接受英夫利昔单抗治疗的前半年，AE 和因 AE 而停药最常见。停药的主要原因是感染和输注反应。结核病和其他感染仍然是这些患者的一个重要关注点。
