Objective

The study aims to compare the efficacy and safety of biosimilar etanercept (SB4) to original etanercept (ETN) in a real-life national cohort of rheumatoid arthritis (RA).

Methods

Data from RA patients were retrieved electronically from the Romanian Registry of Rheumatic Diseases (RRBR), which contains all patients receiving biologics in the country.

Results

The study included 242 patients with efficacy and safety data after 6 months of treatment: 123 (50.8%) with ETN, 119 (49.2%) with SB4. There were no significant differences after 6 months regarding composite scores of RA activity between patients on ETN and SB4 (e.g. DAS28 remission: 18.7% in ETN group and 17.6% in SB4 group, p = 0.823; Boolean remission: 11.4% in ETN group and 11.8% in SB4 group, p = 0.926). There were 11 adverse events (AE) in the ETN subgroup (including 3 severe AE: lower respiratory tract infection, enterocolitis and anaphylaxis) and 12 AE in SB4 subgroup (including 4 severe AE: lower respiratory tract infection, vasculitis, anaphylaxis and rash).

Conclusion

Biosimilar and original etanercept showed similar efficacy and safety after the first 6 months of treatment in RA patients from a national registry, which brings further evidence for biosimilarity in unselected patients in real-world setting.

中文翻译：

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原始和生物仿制药依那西普（SB4）在活动性类风湿关节炎中的疗效和安全性-在现实世界中的国家队列比较。

目的

这项研究旨在比较现实生活中的类风湿关节炎国家（RA）人群中生物仿制药依那西普（SB4）与原始依那西普（ETN）的疗效和安全性。

方法

罗马尼亚风湿性疾病登记处（RRBR）以电子方式检索了RA患者的数据，其中包含该国所有接受生物制剂治疗的患者。

结果

该研究纳入了242名在治疗6个月后具有疗效和安全性数据的患者：123名（50.8％）的ETN，119名（49.2％）的SB4。6个月后，ETN和SB4患者的RA活动综合评分无显着差异（例如DAS28缓解：ETN组为18.7％，SB4组为17.6％，p = 0.823；布尔缓解：ETN组为11.4％， SB4组为11.8％，p = 0.926）。ETN亚组有11个不良事件（AE）（包括3个严重AE：下呼吸道感染，小肠结肠炎和过敏反应），SB4亚组有12个AE（包括4个严重AE：下呼吸道感染，血管炎，过敏和皮疹） 。

结论

国家注册机构对RA患者治疗的头6个月后，生物仿制药和原始依那西普显示出相似的疗效和安全性，这为现实世界中未选定患者的生物仿制药提供了进一步的证据。