原文

譯文

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

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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

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Presentation Number: 2233

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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.

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比較常規治療登記中阿巴西譜、阿達木單抗、依那西普和英夫利昔單抗治療類風濕關節炎的療效和起效時間

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Yusuf Yazici, ?et al. ACR 2011. Present No: 2233

背景/目的:目前已有多種作用機制不同的生物制劑，但它們之間缺乏頭對頭研究，因而比較這些藥物在實際應用中的療效非常有價值，它可以給臨床醫生提供RA治療時如何應用藥物的信息。

方法:關節炎登記監測數據庫(ARMD) 前瞻性收集了自2005年以來一直在紐約大學常規就診的所有病患資料。本研究摘取生物制劑阿巴西普、阿達木單抗、依那西普和英夫利昔單抗應用時的自我評價疾病活動度和臨床指標。計算首次起效時間，療效定義為RAPID3(臨床重要變化)改善至少3.6; 評估生物制劑應用到首次起效時的自我評價疾病活動度和臨床指標的變化。應用Cox相對危險模型估計各生物制劑間首次起效時間。

結果:本研究回顧了3574例患者。共確定385個療程。其中272個療程為1例患者只用1種生物制劑，40例患者在不同階段用過2種生物制劑，另外11例患者用過3種。相比而言，以RAPID減少3.6為療效標準，阿巴西普有效患者比例較多(65%), 高于阿達木單抗(64%),依那西普(62%)或英夫利昔單抗(45%)。在未矯正的Cox模型中，阿巴昔普比英夫利昔單抗治療患者有效的機率增加82％(HR = 1.82,95%可信區間為(1.00,3.32),p = 0.050);其它治療組間未發現統計學差異。但對年齡和病程矯正后的Cox模型中，阿巴昔普與英夫利昔單抗間的差異不明顯。病程越長達到RAPID3療效的機率越低。各生物制劑間起效時間無差異（圖）。

結論:我們的數據顯示,阿巴昔普、阿達木單抗、依那西普和英夫利昔單抗的總體療效相似。同時，它們治療RA的起效時間無差別。鑒于臨床療效和起效時間無差異,治療RA時大部分的治療決定是基于這些藥物的便利性、安全性和長期藥物存活情況的綜合考慮。

Table 1. Demographics and Outcome Measures at Initiation and Follow-up by Biologic Medication

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