Background: Clinical response in patients with rheumatoid arthritis
(RA) using biologics is well-known. However, there is no direct
comparison between biologics in cohorts of patients with RA in
real-life settings, which could have implications in treatment
decisions and health economics.

背景：生物制剂治疗RA的临床疗效众所周知。但尚无现实世界直接对比生物制剂治疗RA的疗效研究，这样的研究可以影响治疗选择及健康经济学。

Objectives: The aim of this study was to describe a direct comparison
in effectiveness between two classical antiTNF biologics
(Adalimumab, Infliximab) and one Etanercept biosimilar in patients
with long-standing RA in a cohort of
real-life.

目的：在现实队列研究中直接比较两种经典生物制剂（阿达木单抗、英夫利西单抗）与一种依那西普生物类似药（益赛普）治疗长病程RA的疗效。

Methods: A descriptive cross-sectional study was performed. Were
included 158 patients with at least 6 visits to rheumatologist in
last 24 months in a specialized in RA center. Clinical follow-up
was designed by the authors according to DAS28 as follows: every
3-5 weeks (DAS28 > 5.1), every 7-9 weeks (DAS28
≥ 3.1 and ≤ 5.1), and every 11-13 weeks (DAS28 < 3.1).
Therapy had to be adjusted with DAS28 > 3.2 unless
patient´s conditions
don’t permit it; we
considered this follow-up type as implementation of a T2T strategy.
We divided patients in two groups: remission-low disease activity
(Rem/LDA) patients and moderate-severe disease activity (MDA/SDA)
patients and the aim of the study was to look at what percentage of
patients who were MDA/SDA disease activity reached a low disease
activity or remission. 158 patients with RA and using Adalimumab,
Infliximab and Etanercept biosimilar (Etanar CP Guojian
Pharmaceutical Co Ltd, China) were involved. The Etanercept
biosimilar was approved for using in Colombia since 2007.
Descriptive epidemiology was done, the medians were analyzed using
t-Student assuming normality for DAS28 distribution and disease
activity was analyzed using Pearson´s statistics.

方法：该研究为横断面研究。研究纳入158例到专科RA治疗中心至少随访6次的患者。随访频率由研究者者根据患者DAS28情况而定：若DAS28＞5.1则每3~5周随访一次，若DSA28≥3.1且≤5.1则每7~9周随访一次，若DAS28＜3.1则每11~13周随访一次。除外患者条件不允许，若DAS28＞3.2则需调整治疗方案，我们将这种随访看作是达标治疗策略的一种体现。患者分为2组，临床缓解-低疾病活动度组（Rem/LDA），和中、高疾病活动度组（MDA/SDA）。本研究旨在探讨MDA/SDA组患者达到Rem/LDA的患者比例。158例RA患者分别使用阿达木单抗、英夫利西单抗和益赛普。2007年益赛普在哥伦比亚获批上市（在当地的商品名为Etanar）。本研究总结了描述性流行病学数据，当DAS28符合正态分布则采用t检验，应用Pearson检验分析疾病活动度。

Results: 158 patients were included in this study, 125 (79.1%) women
and 33 (20.9%) men. Average age was 59 +/- 10 y/o with disease
duration of 11 years (0.5-47). 158 patients with diagnosis of RA
using Adalimumab, Etanercept and Infliximab were involved:
Adalimumab 61 (38.6%), Etanercept 25 mg 62 (39.2%), and
 Infliximab 35 (22.2%). At 24 months was observed
an increase in percentage of patients in remission and a decrease
in percentage of patients in MDA/SDA disease activity statistically
significant. for Adalimumab at beginning DAS28-3.6 and 24 months
later 2.6; for Etanercept biosimilar at beginning DAS28-3.6 and 24
months later 2.6 and for Infliximab at beginnng DAS28-3.6
 and 24 months later 2.6. There
were not statistically significant differences between analyzed
biologics. On the other hand, there were fewer adverse events with
Etanercept-biosimilar than Adalimumab and Infliximab; it was
statistically significant.

结果：研究纳入158例患者，女性125例(79.1%)，男性33例(20.9%)。平均年龄59±10
岁，病程11年(0.5-47)。158例确诊RA患者分别接受阿达木单抗、英夫利西单抗和益赛普治疗，其中61 人(38.6%)使用阿达木单抗,
62例应用益赛普(25mg，39.2%)，英夫利西单抗 35例 (22.2%)。24个月时，缓解患者比例增加，而MDA/SDA患者比例有所下降，均达到统计学显著意义。三种TNF拮抗剂的初始DAS28均为3.6，24个月时均为为2.6，3种生物制剂之间无明显差异。另一方面，益赛普组的不良事件发生率显著低于阿达木单抗组和英夫利西单抗组。

Conclusions: This study shows that the Etanercept biosimilar is as
effective as 2 other traditional anti-TNF biological for disease
activity control in patients with rheumatoid arthritis in a
real-life setting with fewer adverse events, which could have
implications in treatment decisions and health
economics. On the other hand the study proves
effectiveness of implementation of a T2T strategy in patients with
RA.

结论：本研究显示，在真实世界中，益赛普与其它两种传统TNF拮抗剂治疗RA的疗效无显著差异，且不良事件较少。该结论可能对未来治疗决策和健康经济学有借鉴意义。同时，本研究表明在真实世界中对RA患者执行目标治疗策略是有效的。