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类风湿关节炎一线肿瘤坏死因子α抑制剂的八年生存研究:来自大学中心登记处的真实世界数据。

Eight-year survival study of first-line tumour necrosis factor α inhibitors in rheumatoid arthritis: real-world data from a university centre registry.

作者信息

Papadopoulos Christos G, Gartzonikas Ilias K, Pappa Tatiani K, Markatseli Theodora E, Migkos Michael P, Voulgari Paraskevi V, Drosos Alexandros A

机构信息

Department of Internal Medicine, Rheumatology Clinic, Medical School, University of Ioannina, Ioannina, Greece.

出版信息

Rheumatol Adv Pract. 2019 Mar 14;3(1):rkz007. doi: 10.1093/rap/rkz007. eCollection 2019.

Abstract

OBJECTIVE

This study aimed to investigate the efficacy, safety and survival of TNF-α inhibitors in patients with RA.

METHODS

A total of 178 patients >18 years of age were treated with TNF-α inhibitors. A total of 74 patients were treated with infliximab, 75 with adalimumab and 29 with etanercept. Each patient was followed-up for a period of 8 years.

RESULTS

Anti-TNF-α therapy resulted in rapid clinical improvement. The rate of good/moderate response according to EULAR response criteria for the index 28-joint DAS with CRP in the first 6 months was 82% for infliximab, 89.6% for adalimumab and 95.6% for etanercept. The rate of withdrawal in 8 years was 80% for patients on infliximab, 61.4% for patients on adalimumab and 47.6% for patients on etanercept. The main reasons for discontinuation were allergic reactions for infliximab (rate of discontinuation 25.7%) and inefficacy for adalimumab and etanercept (17.5% and 23.8%, respectively). Systemic allergic reactions and infections were significantly more frequent in the infliximab group ( < 0.05 and  < 0.001, respectively). However, there was no significant difference among the three drugs concerning serious infections. According to Kaplan-Meier survival analysis, a significantly faster withdrawal for infliximab patients was depicted compared with adalimumab ( = 0.003) and etanercept ( = 0.019), while adalimumab and etanercept were not statistically different ( = 0.089).

CONCLUSIONS

TNF-α inhibitors establish an effective therapeutic option in RA showing an acceptable safety profile. Infections and allergic reactions appear more often with infliximab, while serious infections did not differ among them. RA patients treated with infliximab are more likely to discontinue treatment earlier compared with the other alternatives.

摘要

目的

本研究旨在调查肿瘤坏死因子-α(TNF-α)抑制剂治疗类风湿关节炎(RA)患者的疗效、安全性及生存率。

方法

共178例年龄大于18岁的患者接受了TNF-α抑制剂治疗。其中74例患者接受英夫利昔单抗治疗,75例接受阿达木单抗治疗,29例接受依那西普治疗。每位患者随访8年。

结果

抗TNF-α治疗使临床症状迅速改善。根据欧洲抗风湿病联盟(EULAR)反应标准,在前6个月中,英夫利昔单抗治疗28个关节疾病活动评分(DAS28)联合C反应蛋白(CRP)的良好/中度反应率为82%,阿达木单抗为89.6%,依那西普为95.6%。8年时,英夫利昔单抗治疗患者的停药率为80%,阿达木单抗治疗患者为61.4%,依那西普治疗患者为47.6%。停药的主要原因是英夫利昔单抗的过敏反应(停药率25.7%)以及阿达木单抗和依那西普的无效(分别为17.5%和23.8%)。全身过敏反应和感染在英夫利昔单抗组中明显更频繁(分别P<0.05和P<0.001)。然而,三种药物在严重感染方面无显著差异。根据Kaplan-Meier生存分析,与阿达木单抗(P=0.003)和依那西普(P=0.019)相比,英夫利昔单抗治疗患者的停药明显更快,而阿达木单抗和依那西普在统计学上无差异(P=0.089)。

结论

TNF-α抑制剂为RA提供了一种有效的治疗选择,安全性可接受。感染和过敏反应在英夫利昔单抗治疗时更常见,而严重感染在三种药物之间无差异。与其他药物相比,接受英夫利昔单抗治疗的RA患者更有可能更早停药。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d27/6649942/35df6f4a5bb9/rkz007f1.jpg

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