PDF(Pubmed)
Abstract：
OBJECTIVE: Adults with RA are being switched from etanercept originator to biosimilar in non-medical/cost-saving switching. This analysis aims to investigate outcomes in these patients, including (i) drug survival and (ii) disease activity at 6 months and 12 months, compared with those who remain on the originator.
METHODS: Using BSRBR-RA, those who switched directly from etanercept originator to biosimilar were identified and matched to patients receiving the originator, based on gender, age, disease duration and originator start year. Drug survival was calculated; Cox-proportional hazard models assessed differences in drug persistence between those who switched vs remaining on originator. Change in DAS28 after 6 months and 12 months was compared between cohorts. Multiple imputation was used.
RESULTS: A total of 1024 adults with RA switching from etanercept originator to biosimilar were included, with a matched cohort of patients remaining on the originator. Patients who switched onto a biosimilar product were no more likely to discontinue etanercept treatment vs those who remained on the originator; hazard ratio 1.06 (95%CI 0.89-1.26), with 65% of patients remaining on treatment at three years. Ninety-five (9%) patients switched back to the originator within the first year. After 6 months and 12 months, biosimilar patients were no more likely to have a worsening of DAS28 (>0.6 units) compared with those who remained on the originator.
CONCLUSIONS: This is the largest matched comparative effectiveness analysis showing patients switching from etanercept originator to biosimilar appearing to do just as well with regard to disease activity and drug persistence compared with those who remained on the originator. These data will be reassuring to clinicians and patients regarding non-medical switching.
METHODS: Using BSRBR-RA, those who switched directly from etanercept originator to biosimilar were identified and matched to patients receiving the originator, based on gender, age, disease duration and originator start year. Drug survival was calculated; Cox-proportional hazard models assessed differences in drug persistence between those who switched vs remaining on originator. Change in DAS28 after 6 months and 12 months was compared between cohorts. Multiple imputation was used.
RESULTS: A total of 1024 adults with RA switching from etanercept originator to biosimilar were included, with a matched cohort of patients remaining on the originator. Patients who switched onto a biosimilar product were no more likely to discontinue etanercept treatment vs those who remained on the originator; hazard ratio 1.06 (95%CI 0.89-1.26), with 65% of patients remaining on treatment at three years. Ninety-five (9%) patients switched back to the originator within the first year. After 6 months and 12 months, biosimilar patients were no more likely to have a worsening of DAS28 (>0.6 units) compared with those who remained on the originator.
CONCLUSIONS: This is the largest matched comparative effectiveness analysis showing patients switching from etanercept originator to biosimilar appearing to do just as well with regard to disease activity and drug persistence compared with those who remained on the originator. These data will be reassuring to clinicians and patients regarding non-medical switching.
摘要：
目的：在非医疗/节省成本的转换中，RA患者正在从依那西普的鼻祖转换为生物仿制药。本分析旨在调查这些患者的结局，包括（a）药物存活率和（b）6个月和12个月时的疾病活动，与那些留在鼻祖上的人相比。
方法：使用BSRBR-RA，那些直接从依那西普鼻祖转换为生物仿制药的人被识别并与接受鼻祖的患者相匹配，基于性别，年龄,疾病持续时间,发起人开始年。计算药物存活率；Cox比例风险模型评估了转换者与保留原始者之间药物持久性的差异。比较了6个月和12个月后DAS28的变化。使用了多重归因。
结果：包括1024名RA从依那西普鼻祖转换为生物仿制药的成年人，与匹配的患者队列保留在鼻祖上。转用生物仿制药的患者与继续使用原药的患者相比，不再有可能停止依那西普治疗；风险比1.06（95CI0.89-1.26），65%的患者在三年时仍在接受治疗。在第一年内，有95名（9％）患者转回鼻祖。六个月和十二个月后,生物类似药患者的DAS28恶化(>0.6个单位)的可能性与那些仍留在原药上的患者相比没有增加.
结论：这是最大的匹配比较有效性分析，显示从依那西普鼻祖转换为生物仿制药的患者在疾病活动性和药物持久性方面的表现与保持鼻祖的患者相同。关于非医疗转换，这些数据将使临床医生和患者放心。
方法：使用BSRBR-RA，那些直接从依那西普鼻祖转换为生物仿制药的人被识别并与接受鼻祖的患者相匹配，基于性别，年龄,疾病持续时间,发起人开始年。计算药物存活率；Cox比例风险模型评估了转换者与保留原始者之间药物持久性的差异。比较了6个月和12个月后DAS28的变化。使用了多重归因。
结果：包括1024名RA从依那西普鼻祖转换为生物仿制药的成年人，与匹配的患者队列保留在鼻祖上。转用生物仿制药的患者与继续使用原药的患者相比，不再有可能停止依那西普治疗；风险比1.06（95CI0.89-1.26），65%的患者在三年时仍在接受治疗。在第一年内，有95名（9％）患者转回鼻祖。六个月和十二个月后,生物类似药患者的DAS28恶化(>0.6个单位)的可能性与那些仍留在原药上的患者相比没有增加.
结论：这是最大的匹配比较有效性分析，显示从依那西普鼻祖转换为生物仿制药的患者在疾病活动性和药物持久性方面的表现与保持鼻祖的患者相同。关于非医疗转换，这些数据将使临床医生和患者放心。
