Department of Rheumatology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium.
Arthritis Res Ther. 2010;12(3):R77. doi: 10.1186/ar2997. Epub 2010 May 6.
This study is based on the results from a Belgian expanded access program in which patients with active refractory and erosive rheumatoid arthritis (RA) were treated with intravenous infusions of infliximab in combination with methotrexate. The objectives of this study were to evaluate the continuation rate of infliximab and its clinical effect over a 7-year period and to document the reasons for discontinuation.
Between 2000 and 2001, 511 patients with severe and refractory RA were enrolled and treated with infliximab. After 7 years, apart from routine clinical follow-up, treating rheumatologists were asked to complete a questionnaire designed specifically for the present study to evaluate the current therapy with infliximab, the level of disease activity (Disease Activity Score in 28 joints [DAS28]) and the reasons for infliximab discontinuation.
After 7 years, 160 of 511 patients (31%) were still on infliximab treatment. The major reasons for infliximab discontinuation included lack of efficacy (104 patients), adverse events (107 patients) and elective change of therapy (70 patients). The majority of cases of treatment discontinuation for safety reasons occurred during the first 2 years. In contrast, discontinuation due to ineffectiveness showed a more constant rate over the 7-year period. Mean DAS for patients still on treatment with infliximab decreased from 5.7 (standard error [SE] 0.1) at baseline to 3.0 (SE 0.1) at year 4 and remained that low until year 7 (3.0 [SE 0.1]). Low disease activity (defined as DAS28<3.2) was present in 60.9% of patients, and 45.5% achieved remission (DAS28<2.6). DAS28 at the time of treatment discontinuation due to ineffectiveness decreased over the 7-year period from 5.6 (SE 0.3) in 2001 to 4.8 (SE 0.3) in 2008.
This observational study revealed that patients who continue to receive infliximab experience sustained clinical benefit. The majority of safety issues occurred during the first 2 years of infliximab therapy. We observed that the DAS at the time of therapy discontinuation showed a trend to decrease over time.
本研究基于一项比利时扩大准入计划的结果，该计划中，患有活动期难治性和侵蚀性类风湿关节炎（RA）的患者接受了英夫利昔单抗静脉输注联合甲氨蝶呤治疗。本研究的目的是评估英夫利昔单抗的延续率及其 7 年的临床疗效，并记录停药的原因。
2000 年至 2001 年，共纳入 511 例严重和难治性 RA 患者接受英夫利昔单抗治疗。7 年后，除常规临床随访外，还要求治疗风湿病医生填写一份专门为本次研究设计的问卷，以评估当前英夫利昔单抗治疗、疾病活动度（28 个关节疾病活动评分[DAS28]）和停药原因。
511 例患者中有 160 例（31%）在 7 年后仍接受英夫利昔单抗治疗。英夫利昔单抗停药的主要原因包括疗效不佳（104 例）、不良事件（107 例）和择期改变治疗方案（70 例）。大多数因安全性原因停药的病例发生在治疗的前 2 年。相比之下，由于无效而停药的比例在 7 年期间保持相对稳定。仍接受英夫利昔单抗治疗的患者的平均 DAS 从基线时的 5.7（标准误差[SE]0.1）降至第 4 年时的 3.0（SE 0.1），并一直保持到第 7 年（3.0[SE 0.1]）。60.9%的患者存在低疾病活动度（定义为 DAS28<3.2），45.5%的患者达到缓解（DAS28<2.6）。由于无效而停药时的 DAS28 在 7 年期间从 2001 年的 5.6（SE0.3）降至 2008 年的 4.8（SE0.3）。
这项观察性研究表明，继续接受英夫利昔单抗治疗的患者可获得持续的临床获益。大多数安全性问题发生在英夫利昔单抗治疗的前 2 年。我们观察到，治疗结束时的 DAS 随时间呈下降趋势。
