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类风湿关节炎患者中托法替布和 TNF 抑制剂的停药情况:来自加拿大两个登记处的汇总数据分析。

Discontinuation of tofacitinib and TNF inhibitors in patients with rheumatoid arthritis: analysis of pooled data from two registries in Canada.

机构信息

Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada

IHMPE, Univeristy of Toronto, Toronto, Ontario, Canada.

出版信息

BMJ Open. 2023 Mar 6;13(3):e063198. doi: 10.1136/bmjopen-2022-063198.

Abstract

OBJECTIVES

The similarity in retention of tumour necrosis factor inhibitors (TNFi) and tofacitinib (TOFA) was previously reported separately by the Ontario Best Practices Research Initiative and the Quebec cohort Rhumadata. However, because of small sample sizes in each registry, we aimed to confirm the findings by repeating the analysis of discontinuation of TNFi compared with TOFA, using pooled data from both these registries.

DESIGN

Retrospective cohort study.

SETTING

Pooled data from two rheumatoid arthritis (RA) registries in Canada.

PARTICIPANTS

Patients with RA starting TOFA or TNFi between June 2014 and December 2019 were included. A total of 1318 patients were included TNFi (n=825) or TOFA (n=493).

OUTCOME MEASURES

Time to discontinuation was assessed using Kaplan-Meier survival and Cox proportional hazards regression analysis. Propensity score (PS) stratification (deciles) and PS weighting were used to estimate treatment effects.

RESULTS

The mean disease duration in the TNFi group was shorter (8.9 years vs 13 years, p<0.001). Prior biological use (33.9% vs 66.9%, p<0.001) and clinical disease activity index (20.0 vs 22.1, p=0.02) were lower in the TNFi group.Discontinuation was reported in 309 (37.5%) and 181 (36.7%) TNFi and TOFA patients, respectively. After covariate adjustment using PS, there was no statistically significant difference between the two groups in discontinuation due to any reason HR=0.96 (95% CI 0.78 to 1.19, p=0.74)) as well as discontinuation due to ineffectiveness only HR=1.08 (95% CI 0.81 to 1.43, p=0.61)).TNFi users were less likely to discontinue due to adverse events (AEs) (adjusted HRs: 0.46, 95% CI 0.29 to 0.74; p=0.001). Results remained consistent for firstline users.

CONCLUSIONS

In this pooled real-world data study, the discontinuation rates overall were similar. However, discontinuation due to AEs was higher in TOFA compared with TNFi users.

摘要

目的

先前安大略最佳实践研究倡议和魁北克 Rhumadata 分别单独报道了肿瘤坏死因子抑制剂 (TNFi) 和托法替尼 (TOFA) 的保留率相似。然而,由于每个登记处的样本量都很小,我们旨在通过使用这两个登记处的汇总数据重复分析 TNFi 与 TOFA 停药的情况来证实这一发现。

设计

回顾性队列研究。

设置

加拿大两个类风湿关节炎 (RA) 登记处的汇总数据。

参与者

纳入 2014 年 6 月至 2019 年 12 月期间开始使用 TOFA 或 TNFi 的 RA 患者。共纳入 1318 例患者,包括 TNFi(n=825)或 TOFA(n=493)。

结局指标

使用 Kaplan-Meier 生存分析和 Cox 比例风险回归分析评估停药时间。采用倾向评分 (PS) 分层(十分位数)和 PS 加权来估计治疗效果。

结果

TNFi 组的平均疾病持续时间较短(8.9 年 vs 13 年,p<0.001)。先前使用生物制剂(33.9% vs 66.9%,p<0.001)和临床疾病活动指数(20.0 vs 22.1,p=0.02)较低。分别有 309 例(37.5%)和 181 例(36.7%)TNFi 和 TOFA 患者报告停药。在使用 PS 进行协变量调整后,两组因任何原因停药的差异无统计学意义(HR=0.96[95%CI 0.78 至 1.19,p=0.74]),因无效而停药的差异也无统计学意义(HR=1.08[95%CI 0.81 至 1.43,p=0.61])。与 TOFA 使用者相比,TNFi 使用者因不良事件(AE)停药的可能性较低(调整后的 HRs:0.46,95%CI 0.29 至 0.74;p=0.001)。对于一线使用者,结果仍然一致。

结论

在这项汇总真实世界数据研究中,总体停药率相似。然而,与 TNFi 使用者相比,TOFA 使用者因 AE 停药的比例更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd42/9990670/a7bc92710605/bmjopen-2022-063198f01.jpg

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