Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Institut de Rhumatologie de Montréal, Montreal, Quebec, Canada.
Clin Ther. 2022 Jul;44(7):982-997.e2. doi: 10.1016/j.clinthera.2022.05.002. Epub 2022 Jun 4.
Using data from real-world practice, this analysis compared outcomes in patients with rheumatoid arthritis (RA) initiating treatment with an oral Janus kinase inhibitor, tofacitinib, in combination with persistent, discontinued, or interrupted treatment with oral methotrexate (MTX).
This retrospective claims analysis (MarketScan® databases) included data from US patients with RA and at least one prescription claim for tofacitinib, dated between January 1, 2013, and April 30, 2017. Eligible patients were continuously enrolled for ≥12 months before and after treatment initiation, and initiated tofacitinib in combination with oral MTX, with at least two prescription claims for each. Patients were grouped according to treatment pattern (MTX-Persistent, MTX-Discontinued, or MTX-Interrupted). Tofacitinib treatment persistence, adherence, and effectiveness, as well as all-cause and RA-related health care costs, were assessed.
A total of 671 patients were eligible for inclusion; 504 (75.1%) were MTX-Persistent; 131 (19.5%), MTX-Discontinued; and 36 (5.4%), MTX-Interrupted. Rates of tofacitinib treatment persistence, adherence, and effectiveness at 12 months were similar between the MTX-Persistent and MTX-Discontinued cohorts. The percentage of patients switched from tofacitinib to another advanced disease-modifying antirheumatic drug within 12 months of tofacitinib initiation was greater in the MTX-Persistent cohort compared with that in the MTX-Discontinued cohort. RA-related health care costs at 12 months post-initiation were significantly greater in the MTX-Persistent cohort compared with those in the MTX-Discontinued cohort.
The findings from this analysis of real-world data indicate that patients who initiate tofacitinib in combination with oral MTX may discontinue MTX and still experience outcomes similar to those in patients who persist with MTX, with lesser RA-related health care costs. These results support those from a previous clinical study on methotrexate withdrawal in patients with RA (NCT02831855).
利用真实世界数据进行分析，本研究比较了接受口服 JAK 抑制剂托法替布（tofacitinib）联合持续、中断或终止口服甲氨蝶呤（MTX）治疗的类风湿关节炎（RA）患者的结局。
本回顾性理赔分析（MarketScan®数据库）纳入了 2013 年 1 月 1 日至 2017 年 4 月 30 日期间至少有一次托法替布处方的美国 RA 患者数据。符合条件的患者在治疗开始前和开始后至少连续 12 个月有数据，并联合口服 MTX 起始托法替布治疗，且每个药物至少有两次处方。根据治疗模式（MTX-持续、MTX-中断或 MTX-终止）将患者进行分组。评估了托法替布治疗的持续性、依从性和有效性，以及全因和 RA 相关医疗费用。
共纳入 671 例患者；504 例（75.1%）为 MTX-持续组，131 例（19.5%）为 MTX-中断组，36 例（5.4%）为 MTX-终止组。MTX-持续组和 MTX-中断组患者在 12 个月时托法替布治疗的持续性、依从性和有效性相当。在托法替布治疗起始后 12 个月内，从托法替布转为其他高级疾病修饰抗风湿药物的患者百分比在 MTX-持续组高于 MTX-中断组。与 MTX-中断组相比，MTX-持续组患者在托法替布治疗起始后 12 个月的 RA 相关医疗费用显著更高。
真实世界数据的分析结果表明，接受托法替布联合口服 MTX 治疗的患者可能会停用 MTX，但其结局仍与继续使用 MTX 的患者相似，且 RA 相关医疗费用较低。这些结果与 RA 患者中 MTX 停药的一项既往临床研究结果一致（NCT02831855）。
