比较常规治疗登记中阿巴西谱、阿达木单抗、依那西普和英夫利昔单抗治疗类风湿关节炎的疗效和起效时间...

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Comparative Effectiveness and Time to Response Among Abatacept, Adalimumab, Etanercept and Infliximab for the Treatment of Rheumatoid Arthritis in a Real World Routine Care Registry     Yusuf Yazici, Division of Rheumatology, New York University School of Medicine and NYU Hospital for Joint Diseases, New York, NY, Maria T. Filopoulos, NYU Hospital for Joint Diseases, New York, NY and Christopher J. Swearingen, University of Arkansas for Medical Sciences, Little Rock, AR   Presentation Number: 2233   Background/Purpose: With the availability of multiple biologic agents with different modes of action, and no head to head trials, it is of use to examine comparative effectiveness of these agents in real world registries to inform physicians how they might be used for the treatment of rheumatoid arthritis (RA). Method: Arthritis Registry Monitoring Database (ARMD) has been collecting prospective patient data since 2005 in all patients seen in routine care at New York University. For this analysis usage of the biologic medications abatacept, adalimumab, etanercept and infliximab along with self-reported disease activity and clinic measures were abstracted. Time to first response defined as an improvement in RAPID3 of at least 3.6 (clinically important difference) was calculated; change from biologic medication initiation to first response for self-reported disease activity and clinic measures was estimated. Differences in time to first response between biologic medications were estimated using Cox proportional hazards model. Results: 3574 encounters were reviewed for this analysis.  A total of 385 treatment courses were determined. 272 of the 385 courses represent the only biologic medication used by an individual; 40 individuals used two biologic medications at different times, while 11 had used three biologics. Abatacept had more patients achieve response (65%) characterized by a reduction in RAPID of 3.6 points or greater than adalimumab (64%), etanercept (62%) or infliximab (45%).  Those patients treated with abatacept had 82% increased likelihood than those treated with infliximab to achieve response (HR=1.82, 95% CI: (1.00, 3.32), p=0.050) in an unadjusted Cox model; no other statistically significant differences between treatments were found.  The difference between abatacept and infliximab was not maintained in a Cox model adjusting for age and duration.  Increased duration of disease was associated with decreased likelihood of achieving a RAPID3 response.  No difference in time to response among biologics was seen (Figure) Conclusion: Our data suggest that overall efficacy of abatacept, adalimumab, etanercept and infliximab was similar. In addition no differences in time to response was shown among these biologic agents when treating RA patients. With no difference in clinical outcomes or response time, most treatment decisions may be based on ease of use, safety data and longterm survival of respective biologics agents when they are being considered for RA treatment.	比较常规治疗登记中阿巴西谱、阿达木单抗、依那西普和英夫利昔单抗治疗类风湿关节炎的疗效和起效时间   Yusuf Yazici,  et al. ACR 2011. Present No: 2233 背景/目的:目前已有多种作用机制不同的生物制剂，但它们之间缺乏头对头研究，因而比较这些药物在实际应用中的疗效非常有价值，它可以给临床医生提供RA治疗时如何应用药物的信息。 方法:关节炎登记监测数据库(ARMD) 前瞻性收集了自2005年以来一直在纽约大学常规就诊的所有病患资料。本研究摘取生物制剂阿巴西普、阿达木单抗、依那西普和英夫利昔单抗应用时的自我评价疾病活动度和临床指标。计算首次起效时间，疗效定义为RAPID3(临床重要变化)改善至少3.6; 评估生物制剂应用到首次起效时的自我评价疾病活动度和临床指标的变化。应用Cox相对危险模型估计各生物制剂间首次起效时间。 结果:本研究回顾了3574例患者。共确定385个疗程。其中272个疗程为1例患者只用1种生物制剂，40例患者在不同阶段用过2种生物制剂，另外11例患者用过3种。相比而言，以RAPID减少3.6为疗效标准，阿巴西普有效患者比例较多(65%), 高于阿达木单抗(64%),依那西普(62%)或英夫利昔单抗(45%)。在未矫正的Cox模型中，阿巴昔普比英夫利昔单抗治疗患者有效的机率增加82％(HR = 1.82,95%可信区间为(1.00,3.32),p = 0.050);其它治疗组间未发现统计学差异。但对年龄和病程矫正后的Cox模型中，阿巴昔普与英夫利昔单抗间的差异不明显。病程越长达到RAPID3疗效的机率越低。各生物制剂间起效时间无差异（图）。 结论:我们的数据显示,阿巴昔普、阿达木单抗、依那西普和英夫利昔单抗的总体疗效相似。同时，它们治疗RA的起效时间无差别。鉴于临床疗效和起效时间无差异,治疗RA时大部分的治疗决定是基于这些药物的便利性、安全性和长期药物存活情况的综合考虑。
Table 1. Demographics and Outcome Measures at Initiation and Follow-up by Biologic Medication Abatacept Etanercept Infliximab Adalimumab Change RAPID3 >= 3.6 Change RAPID3 >= 3.6 Change RAPID3 >= 3.6 Change RAPID3 >= 3.6 Initiation Present Absent Initiation Present Absent Initiation Present Absent Initiation Present Absent N 114 61 (65%) 33 (35%) 148 77 (62%) 48 (38%) 38 13 (45%) 16 (55%) 85 42 (64%) 24 (36%) Age (Years) 52.2 (14.6) 50.6 (13.3) 55.4 (14.9) 52.6 (15.3) Duration (Years) 8.0 (7.8) 5.5 (7.1) 9.4 (12.1) 5.5 (6.0) Education (Years) 13.7 (3.9) 14.0 (3.7) 14.2 (3.5) 13.1 (4.0) Female [N (%)] 102 (90%) 127 (88%) 30 (81%) 66 (80%) Function [0-10] 3.4 (2.1) 2.8 (2.1) 3.9 (2.2) 2.9 (2.3) 2.5 (2.0) 2.9 (2.3) 2.9 (2.2) 2.6 (2.3) 3.0 (2.3) 3.4 (2.6) 2.1 (1.9) 3.8 (2.4) Pain [0-10] 5.6 (2.4) 3.8 (2.4) 6.1 (2.2) 5.6 (2.9) 3.9 (2.5) 5.6 (3.1) 5.4 (2.6) 4.5 (2.6) 5.8 (3.4) 5.8 (2.9) 3.9 (3.0) 6.3 (2.5) Global [0-10] 5.2 (2.1) 3.7 (2.2) 5.8 (2.4) 5.2 (2.8) 3.1 (2.2) 5.8 (3.0) 5.0 (2.9) 3.9 (2.5) 5.5 (3.0) 5.6 (2.8) 3.6 (2.7) 5.8 (2.6) RAPID3 [0-30] 14.3 (5.6) 9.9 (5.5) 15.7 (6.1) 13.6 (7.2) 9.0 (5.4) 14.2 (7.6) 13.2 (6.8) 10.3 (6.9) 14.3 (8.0) 14.8 (7.6) 8.5 (6.5) 15.9 (6.8) Fatigue [0-10] 5.5 (2.9) 4.1 (3.0) 5.6 (2.9) 5.5 (3.0) 4.2 (3.0) 5.6 (3.0) 5.5 (3.0) 4.3 (2.5) 5.6 (3.3) 5.4 (3.2) 4.5 (3.2) 6.1 (2.8) MD Global [0-10] 3.7 (1.3) 2.3 (3.8) 2.3 (1.2) 2.7 (1.6) 1.6 (1.3) 3.4 (2.4) 3.8 (0.9) 3.8 (2.6) 4.0 (3.1) 3.1 (1.9) 2.2 (1.8) 2.7 (1.6) Swollen [0-28] 1.8 (2.9) 0.0 (0.0) 2.3 (3.2) 4.3 (5.7) 1.3 (3.2) 4.0 (6.4) 4.0 (2.2) 0.7 (1.2) 4.3 (4.9) 4.1 (5.8) 2.0 (3.7) 2.7 (3.8) Tender [0-28] 7.4 (3.9) 0.4 (0.9) 4.3 (4.0) 6.8 (5.4) 2.7 (3.8) 7.1 (7.0) 5.5 (0.6) 1.7 (2.9) 6.3 (4.0) 7.6 (5.7) 3.5 (4.8) 5.0 (4.5) ESR (mm/hr) 23.0 (18.3) 27.5 (11.8) 8.0 (1.4) 26.9 (27.2) 27.2 (26.0) 22.6 (25.7) 26.8 (26.1) 20.5 (13.4) 14.0 (15.6) 25.8 (27.5) 20.0 (14.2) 31.3 (29.6) CRP (mg/dL) 8.8 (25.9) 1.6 (2.2) 1.1 (1.1) 5.4 (25.4) 2.3 (6.0) 17.9 (53.3) 1.8 (1.5) 2.1 (3.5) 2.7 (5.4) 2.2 (3.9) DAS28 [0-10] 4.3 (0.7) 4.3 (1.8) 2.4 (1.1) 3.8 (1.9) 4.3 (1.6) 2.9 (2.0) 4.6 (2.6) CDAI [0-76] 19.7 (7.3) 7.1 (4.9) 16.8 (8.5) 19.7 (13.2) 7.0 (6.7) 20.3 (14.6) 18.8 (2.5) 20.9 (13.0) 11.1 (12.3) 16.6 (10.1) Follow-up (Months) 4.7 (6.0) 13.1 (12.9) 6.2 (8.0) 13.2 (18.9)

转载于:https://www.cnblogs.com/T2T4RD/archive/2011/12/14/5464222.html