Department of Rheumatology - Hôpital Cochin. Assistance Publique - Hôpitaux de Paris, EULAR center of excellence, Paris Descartes University, Paris University, 27 rue du Faubourg Saint-Jacques, 75014, Paris, France.
Department of Pharmacy, Cochin Hospital, AP-HP, Paris, France.
Eur J Clin Pharmacol. 2021 Jan;77(1):25-33. doi: 10.1007/s00228-020-02957-2. Epub 2020 Sep 5.
To describe the switch to biosimilar etanercept (bETN), evaluate factors associated with this switch, and evaluate the efficacy of this switch in a real-life setting METHODS: We included patients, from October 2016 to April 2017, with rheumatoid arthritis (RA) and spondyloarthritis (SpA) who received innovator ETN (iETN) for at least 6 months. After receiving information on biosimilars, all physicians were invited to propose a switch from iETN to bETN. Factors associated with bETN discontinuation were explored by univariate and multivariate analyses. We estimated the proportion of patients still on bETN over time by Kaplan-Meier survival analysis. We assessed serum trough concentrations of iETN and bETN and anti-drug antibodies to ETN.
Overall, 183 outpatients were eligible for a potential switch; 94 (51.6%) switched from iETN to bETN. The probability of a switch was greater with an older than younger aged physician (mean [SD] age 50.4 [14.3] with a switch vs 44.8 [11.3] with no switch, p = 0.005) and the physician having a full-time academic position than other position (56.4% with a switch vs 13.5% with no switch, p < 0.001). After a 6-month follow-up, bETN retention rate was 83% (95% CI: 0.76-0.92). The first cause of bETN discontinuation was inefficacy (50%). On multivariate analysis, no factor was independently associated with a bETN switch or discontinuation. Drug trough levels did not significantly differ by discontinuation or continuation of bETN. No patient showed anti-drug antibodies.
The probability of switching from iETN to bETN was likely related to physician characteristics.
描述依那西普(etanercept)生物类似药(bETN)的转换情况,评估与转换相关的因素,并评估该转换在真实环境下的疗效。
我们纳入了 2016 年 10 月至 2017 年 4 月期间患有类风湿关节炎(RA)和脊柱关节炎(SpA)且至少接受过 6 个月依那西普(iETN)治疗的患者。在接受了关于生物类似药的信息后,所有医生均被邀请提出从 iETN 转换为 bETN 的方案。采用单变量和多变量分析来探索与 bETN 停药相关的因素。我们采用 Kaplan-Meier 生存分析估计随时间推移仍使用 bETN 的患者比例。我们评估了 iETN 和 bETN 的血清谷浓度和抗 ETN 药物抗体。
总体而言,183 名门诊患者有资格进行潜在转换;其中 94 名(51.6%)从 iETN 转换为 bETN。与年轻医生相比,年龄较大(平均[标准差]年龄 50.4[14.3]岁与转换相比,44.8[11.3]岁与不转换相比,p=0.005)和全职学术职位的医生更有可能进行转换(转换率为 56.4%,不转换率为 13.5%,p<0.001)。在 6 个月的随访后,bETN 的保留率为 83%(95%CI:0.76-0.92)。bETN 停药的首要原因是无效(50%)。多变量分析显示,没有任何因素与 bETN 转换或停药独立相关。bETN 停药或继续用药的药物谷浓度无显著差异。没有患者出现抗药物抗体。
从 iETN 转换为 bETN 的可能性可能与医生的特征有关。