Rahman Proton, Choquette Denis, Bensen William G, Khraishi Majed, Chow Andrew, Zummer Michel, Shaikh Saeed, Sheriff Maqbool, Dixit Sanjay, Sholter Dalton, Psaradellis Eliofotisti, Sampalis John S, Letourneau Vincent, Lehman Allen J, Nantel François, Rampakakis Emmanouil, Otawa Susan, Shawi May
Department of Medicine & Rheumatology, Memorial University, St. John's, Newfoundland, Canada.
Institut de Rhumatologie de Montréal, Montreal, Quebec, Canada.
BMJ Open. 2016 Apr 5;6(4):e009661. doi: 10.1136/bmjopen-2015-009661.
To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world.
46 primary care rheumatology practices across Canada.
303 biological-naïve patients with AS or patients previously treated with a biological for <6 months and who were eligible for infliximab treatment as per routine care within the Biologic Treatment Registry Across Canada (BioTRAC).
Not applicable (non-interventional study).
Effectiveness was assessed with changes in disease parameters (AS Disease Activity Score (ASDAS), Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Health Assessment Questionnaire Disease Index (HAQ-DI), physician global assessment of disease activity (MDGA), patient global disease activity (PtGA), back pain, C-reactive protein, erythrocyte sedimentation rate (ESR), morning stiffness). Safety was assessed with the incidence of adverse events (AEs).
Of the 303 patients included, 44.6% were enrolled in 2005-2007 and 55.4% in 2008-2013. Patients enrolled in 2005-2007 had significantly higher MDGA and ESR at baseline while all other disease parameters examined were numerically higher with the exception of PtGA. Treatment with infliximab significantly (p<0.001) improved all disease parameters over time in both groups. At 6 months, 56% and 31% of patients achieved clinically important (change≥1.1) and major (change≥2.0) improvement in ASDAS, respectively; at 48 months, these proportions increased to 75% and 50%, respectively. Among patients unemployed due to disability at baseline, 12.1% returned to work (mean Kaplan-Meier (KM)-based time=38.8 months). The estimated retention rate at 12 and 24 months was 78.3% and 60.1%, respectively. The profile and incidence of AEs were comparable to data previously reported for tumour necrosis factor-α inhibitors.
Characteristics of patients with AS at infliximab initiation changed over time towards lower disease activity and shorter disease duration. Infliximab treatment significantly reduced disease activity independent of treatment initiation year, although patients enrolled in recent years achieved lower disease activity over 48 months.
NCT00741793.
描述加拿大常规治疗中接受英夫利昔单抗治疗的强直性脊柱炎（AS）患者的概况，并评估英夫利昔单抗在现实世界中的有效性和安全性。
加拿大46家初级保健风湿病诊疗机构。
303例初治生物制剂的AS患者或先前接受生物制剂治疗<6个月且根据加拿大生物治疗登记处（BioTRAC）的常规护理符合英夫利昔单抗治疗条件的患者。
不适用（非干预性研究）。
通过疾病参数变化（AS疾病活动评分（ASDAS）、巴斯强直性脊柱炎疾病活动指数（BASDAI）、巴斯强直性脊柱炎功能指数（BASFI）、健康评估问卷疾病指数（HAQ-DI）、医生对疾病活动的整体评估（MDGA）、患者对疾病活动的整体评估（PtGA）、背痛、C反应蛋白、红细胞沉降率（ESR）、晨僵）评估有效性。通过不良事件（AE）发生率评估安全性。
纳入的303例患者中，44.6%于2005 - 2007年入组，55.4%于2008 - 2013年入组。2005 - 2007年入组的患者基线时MDGA和ESR显著更高，而除PtGA外，所有其他检查的疾病参数在数值上更高。英夫利昔单抗治疗使两组患者的所有疾病参数随时间均有显著改善（p<0.001）。6个月时，分别有56%和31%的患者在ASDAS中实现了具有临床意义的改善（变化≥1.1）和显著改善（变化≥2.0）；48个月时，这些比例分别增至75%和50%。基线时因残疾失业的患者中，12.1%恢复了工作（基于Kaplan-Meier法的平均时间=38.8个月）。12个月和24个月时的估计留存率分别为78.3%和60.1%。AE的情况和发生率与先前报道的肿瘤坏死因子-α抑制剂的数据相当。
英夫利昔单抗起始治疗时AS患者的特征随时间向疾病活动度降低和病程缩短转变。英夫利昔单抗治疗显著降低了疾病活动度，与治疗起始年份无关，尽管近年来入组的患者在48个月内疾病活动度更低。
NCT00741793。
