负荷剂量英夫利昔单抗治疗强直性脊柱炎的临床疗效及疗效预测因素分析

目的 探讨负荷剂量的抗肿瘤坏死因子(TNF)-α单克隆抗体英夫利昔单抗治疗强直性脊柱炎(AS)的临床疗效和达到临床疗效的预测因素.方法 本研究以一项2个中心的开放性Ⅱ期临床试验为基础,纳入确诊的AS患者,并且处于疾病活动期,即Bath AS疾病活动指数(BASDAI)和脊柱痛评分均≥4.患者分别在试验的第0、2、6周静脉滴注英夫利昔单抗5 mg/kg,在10周时对其临床疗效进行评估,以10周时是否达到ASAS 20,ASAS 40和BASDAI 50为疗效标准,对人口学参数[性别、年龄、病程、人类白细胞抗原(HLA)-B27阳性与否]和基线时疾病活动指标[BASDAI、脊柱炎症、脊柱痛VAS、夜间痛VAS、患者总体评估指数、BASFI、BASMI、肌腱端指数、整体关节肿胀指数、扩胸度、红细胞沉降率(ESR)和C反应蛋白(CRP)和BASRI]17个指标进行Logistic单因素和多因素疗效预测分析.结果 63例患者(男性占79%,平均年龄32岁,平均病程10年,HLA-B27阳性占90%)纳入并完成研究,第10周试验结束时,84%的患者达到ASAS 20改善;.75%的患者达到ASAS 40改善;70%的患者达到BASDAI评分改善＞50%.Logistic单因素和多因素分析显示:人口学参数和基线时疾病活动指标均未显示能预测患者的疗效.结论 英夫利昔单抗治疗AS疗效明显,基线时的人口学参数、疾病活动性的临床和实验室指标不能预测疗效.

Clinical efficacy of loading dose infliximab in the treatment of active ankylosing spondylitis and clinical response predicting factor analysis

Objective To evaluate the efficacy profile of loading dose of anti-tumour necrosis factor (TNF)-α antibody infliximab in the treatment of ankylosing spondylitis (AS) and investigate the parameters that could be used as predicting factors for clinical response to infliximab in AS.Methods This was an open-labeled.mutticenter trial.Subiects eligible for this study were adults with a diagnosis of definite AS.Active disease was a Bath AS disease activity index(BASDAI)≥4 and spinal pain VAS≥4.Infliximab 5 md/kg was infused at weeks 0,2,6.All patients were followed for up to 10 weeks.Logistic regression likelihood ratio tests (univariate and multivariate) were performed to investigate which of the following parameters assessed before treatment were associated with ASAS 20,ASAS 40 and BASDAI 50 response:sex.age.disease duration,HLA-B27,BASDAI,spinal inflammatory (questions 5 and 6 of the BASDAI),spinal pain,night pain,patient global assessment,Bath AS functional index (BASFI),BASMI,enthesis index (EI),presence of peripheral arthritis,chest expansion,ESR,CRP,Bath AS radiology index (BASRI).Results Sixty-three patients (79% were males.90% were HLA-B27 postivie with a median age of 32 years and the median disease duration was 10 years) completed the treatment.The proportion of ASAS 20 responders.ASAS 40 responders and BASDAI 50 at week 10 was 84%,75%,70%,respectively.Univariate and multivariate Logistic regression analysis showed none of the 17 parameters evaluated at week 0 including ESR/CRP,disease duration were predictive for improvement.Conclnsion In this study,a loading regimen of infliximab has demonstrated consistent efficacy and none of the demographic parameters and baseline AS activity parameters are predictors for maior clinical response to infliximab in active AS.