To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry.
转换或不转换: 从发起人到生物仿制药依那西普强制转换的全国性指南的结果。来自 DANBIO 注册中心的 2061年炎症性关节炎患者的一年治疗结果。
DMARDs (biologic) anti-TNF epidemiology outcomes research
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摘要

OBJECTIVES:Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised.
METHODS:Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted).
RESULTS:1621 (79%) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months' preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77% (95% CI: 72% to 82%)/switchers: 83% (79% to 87%)/historic cohort: 90% (88% to 92%). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7% of switchers) back-switched to ETA. Back-switchers' clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective.
CONCLUSION:Seventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects.

译文

目的: 关于转换到 biosimila r 依那西普的有效性的真实世界证据很少。在丹麦,针对类风湿性关节炎 (RA) 、牛皮癣关节炎 (PsA) 患者,发布了一项从 50 毫克原产者 (ETA) 强制转换为生物仿制药 (SB4) 依那西普的全国性指南和 2016年的中轴脊柱关节炎 (AxSpA)。研究了 ETA 治疗的患者的临床特征和治疗结果,这些患者转而使用 SB4 (转换程序) 或维持 ETA (非转换程序)。将保留率与 ETA 治疗患者的历史队列进行比较。恢复 ETA 治疗的转换者 (反向转换者) 是有特征的。
方法: 基于 DANBIO 注册的观察性队列研究。通过 Kaplan-Meier 图和 Cox 回归 (粗略,调整) 探索治疗保留。
结果: 2061年埃塔治疗的患者中有 1621 (79%) 转到了 sb4。疾病活动度 3 个月前/后无变化。非开关通常收到 25 毫克 ETA (ETA 25 毫克笔/注射器和粉末溶液仍然可用)。一年期调整保留率为: 非转换者: 77% (95% CI: 72% 至 82%)/转换者: 83% (79% 至 87%)/历史队列: 90% (88% 至 92%)。没有缓解的患者比缓解的患者有更低的保留率,包括转换者 (粗略 HR 1.7 (1.3 到 2.2)) 和非转换者 (2.4 (1.7 到 3.6))。在随访期间,120 名患者 (7% 的转换者) 返回到 ETA。切换者的临床特征与切换者相似,SB4 退出的原因主要是主观原因。
结论: 的患者从 ETA 转向 sb4。1 年后,与历史 ETA 队列相比,转换者的调整治疗保留率较低,但高于非转换者。停药在未缓解的患者中更常见。结果表明,常规护理中的转换结果受患者相关因素和非特异性药物效应的影响。

Etanercept

骨科 关节炎,脊柱炎 药物
概述  :  

依那西普是由人类肿瘤坏死因子受体的细胞外配体结合部分与人类 IgGl Fc段融合组成的抗体融合蛋白药物。由931个氨基酸组成,,相对分子质量为150000。由美国英姆纳克斯( Immunex)公司应用基因重组技术合成制备合成,,1998年11月被美国食品药品管理局批准用于治疗类风湿关节炎,,是全球首个用于风湿病治疗的全人源化可溶性的肿瘤坏死因子拮抗剂。2000年6月被美国食品药品管理局批准作为治疗中度至重度活动性类风湿关节炎一线药物,,并于同年1

etanercept

释义   依那西普

短语   Etanercept for Injection 注射用依那西普,依那西普注射液
例句   Patients were either given a placebo or etanercept, a compound which blocks the effects of toxic cytokines. 患者分别接受安慰剂或依那西普(一种可以阻断毒性细胞因子作用的复合物)治疗。

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