Pfizer, Bogota, Colombia.
Pfizer, Santiago, Chile.
Reumatol Clin (Engl Ed). 2023 Jun-Jul;19(6):319-327. doi: 10.1016/j.reumae.2023.02.006.
To describe efficacy, safety, and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) treated with tofacitinib or biological DMARDs (bDMARDs) in real-life conditions.
A noninterventional study was performed between March 2017 and September 2019 at 13 sites in Colombia and Peru. Outcomes measured at baseline and at the 6-month follow-up were disease activity (RAPID3 [Routine Assessment of Patients Index Data] score), functional status (HAQ-DI [Health Assessment Questionnaire] score), and quality of life (EQ-5D-3L [EuroQol Questionnaire]). The Disease Activity Score-28 (DAS28-ESR) and frequency of adverse events (AEs) were also reported. Unadjusted and adjusted differences from baseline were estimated and expressed as the least squares mean difference (LSMD).
Data from 100 patients treated with tofacitinib and 70 patients with bDMARDs were collected. At baseline, the patients' mean age was 53.53 years (SD 13.77), the mean disease duration was 6.31 years (SD 7.01). The change from baseline at month 6 was not statistically significant different in the adjusted LSMD [SD] for tofacitinib vs. bDMARDs for RAPID3 score (-2.55[.30] vs. -2.52[.26]), HAQ-DI score (-.56[.07] vs. -.50[.08]), EQ-5D-3L score (.39[.04] vs. .37[.04]) and DAS28-ESR (-2.37[.22] vs. -2.77[.20]). Patients from both groups presented similar proportions of nonserious and serious AEs. No deaths were reported.
Changes from baseline were not statistically significantly different between tofacitinib and bDMARDs in terms of RAPID3 scores and secondary outcomes. Patients from both groups presented similar proportions of nonserious and serious AEs.
NCT03073109.
描述在常规合成疾病修饰抗风湿药物（csDMARDs）治疗反应不足的类风湿关节炎（RA）患者中，使用托法替尼或生物 DMARDs（bDMARDs）进行治疗的疗效、安全性和患者报告的结局（PROs）。
这是一项在哥伦比亚和秘鲁的 13 个地点于 2017 年 3 月至 2019 年 9 月期间开展的非干预性研究。在基线和 6 个月随访时测量的结局包括疾病活动度（RAPID3 [常规评估患者指数数据]评分）、功能状态（HAQ-DI [健康评估问卷]评分）和生活质量（EQ-5D-3L [EuroQol 问卷]）。还报告了疾病活动评分-28（DAS28-ESR）和不良事件（AE）的发生频率。从基线的未调整和调整差异进行了估计，并表示为最小二乘均数差值（LSMD）。
共收集了 100 例接受托法替尼治疗和 70 例接受 bDMARDs 治疗患者的数据。基线时，患者的平均年龄为 53.53 岁（SD 13.77），平均疾病病程为 6.31 年（SD 7.01）。托法替尼与 bDMARDs 治疗 6 个月后，RAPID3 评分（调整后的 LSMD [SD]：-2.55[.30]比-2.52[.26]）、HAQ-DI 评分（-0.56[.07]比-0.50[.08]）、EQ-5D-3L 评分（.39[.04]比.37[.04]）和 DAS28-ESR（-2.37[.22]比-2.77[.20]）的变化无统计学意义。两组患者的非严重和严重 AE 比例相似。没有报告死亡。
在 RAPID3 评分和次要结局方面，托法替尼与 bDMARDs 之间的变化无统计学意义。两组患者的非严重和严重 AE 比例相似。
NCT03073109。
