Persistent clinical response to the anti-TNF-α antibody infliximab in patients with ankylosing spondylitis over 3 years
Persistent clinical response to the anti-TNF-α antibody infliximab in patients with ankylosing spondylitis over 3 years
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DOI：
10.1093/rheumatology/keh584
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发表时间：
2005-05-01
期刊：
影响因子：
5.5
通讯作者：
Sieper, J
中科院分区：
文献类型：
--
作者：
Braun, J;Baraliakos, X;Sieper, J
目标。英夫利昔单抗是一种抗肿瘤坏死因子-α的单抗，在欧洲被批准用于治疗对常规治疗反应不足的活动期强直性脊柱炎(AS)患者。这份报告提供了一项为期3年的扩展研究的分析，作为最初为期3个月的英夫利昔单抗在AS患者中的随机对照试验的1年和2年开放标签扩展的后续。在完成第二年研究的49名AS患者中，46人每6周继续服用英夫利昔单抗5 mg/kg，直到第156周。采用Bath AS疾病活动指数(BASDAI)、Bath AS功能指数、Bath AS计量学指数、患者和医生的总体评估、生活质量(简明36)、C反应蛋白(CRP)和血沉等指标进行评定。大多数患者在第一年和第二年观察到的体征和症状的改善持续到研究的第三年。43名患者(基线登记的69名患者中的62%和开始第三年的患者中的93%)完成了第156周。在意向治疗分析中，分别有46%和50%的患者得到了5分(满分6分)和40%的反应。其他疗效评估的得分与第54周和第102周观察到的值相似。C反应蛋白水平中位数仍然较低(第156周时为1.5 mg/L)。在研究的第三年期间，没有相关的副作用，也没有因药物相关的不良事件而停药。接受英夫利昔单抗治疗3年的AS患者显示出持久的临床反应，且没有失去疗效。在这项研究中，患者对英夫利昔单抗的长期耐受性良好。
Objective. Infliximab, a monoclonal antibody against tumour necrosis factor alpha (TNF-alpha), is approved in Europe for the treatment of patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. This report provides analyses from a 3-yr extension study, as a follow-up to both the 1- and 2-yr open label extensions of the original 3-month randomized controlled trial of infliximab in patients with AS.Methods. Of the 49 patients with AS who completed the second year of the study, 46 continued treatment with infliximab 5 mg/kg every 6 weeks up to week 156. The Bath AS Disease Activity Index (BASDAI), the Bath AS Functional Index, the Bath AS Metrology Index, patient's and physician's global assessments, quality of life (Short Form-36), C-reactive protein (CRP) and erythrocyte sedimentation rate were assessed throughout the study period.Results. The improvement of signs and symptoms observed in the majority of the patients during the first and second year was sustained throughout the third year of the study. Forty-three patients (62% of the 69 patients enrolled at baseline and 93% of the patients who started the third year) completed week 156. In the intention-to-treat analysis, an ASAS '5 out of 6' and ASAS 40% response was seen by 46% and 50% of the patients, respectively. The scores for other efficacy assessments were similar to the values observed at weeks 54 and 102. Median CRP levels remained low (1.5 mg/l at week 156). There were no relevant side-effects and no discontinuation because of drug-related adverse events during the third year of the study.Conclusions. Patients with AS receiving infliximab for 3 yr showed a durable clinical response without loss of efficacy. Long-term infliximab treatment was well tolerated by patients in this study.