Mortezavi Mahta, Mysler Eduardo F
Pfizer Inc, 66 Hudson Boulevard, New York, NY 10001, USA.
Organización Médica de Investigación, Buenos Aires, Argentina.
Ther Adv Chronic Dis. 2023 Jun 20;14:20406223231178273. doi: 10.1177/20406223231178273. eCollection 2023.
Tofacitinib was the first Janus kinase inhibitor to be approved for the treatment of rheumatoid arthritis (RA), and there is a large body of data to inform the efficacy and safety of this drug for patients at different places in their treatment journeys and with diverse demographics and characteristics. Here, we summarize tofacitinib clinical efficacy and safety data from some clinical trials, analyses, and real-world studies, which provide evidence of the efficacy of tofacitinib in treating patients with RA at various stages of their treatment journeys, and with differentiating baseline characteristics, such as age, gender, race, and body mass index. In addition, we review the safety data available from different patient subpopulations in the tofacitinib clinical development program, real-world data, and findings from the ORAL Surveillance post-marketing safety study that included patients aged ⩾50 years with pre-existing cardiovascular risk factors. The available efficacy and safety data in these subpopulations can enable better discussions between clinicians and patients to guide informed decision-making and individualized patient care.
托法替布是首个被批准用于治疗类风湿关节炎(RA)的 Janus 激酶抑制剂,有大量数据可说明该药物在不同治疗阶段、具有不同人口统计学特征和特点的患者中的疗效和安全性。在此,我们总结了来自一些临床试验、分析和真实世界研究的托法替布临床疗效和安全性数据,这些数据证明了托法替布在治疗处于不同治疗阶段、具有不同基线特征(如年龄、性别、种族和体重指数)的 RA 患者中的疗效。此外,我们回顾了托法替布临床开发项目中不同患者亚组的可用安全性数据、真实世界数据,以及包括年龄≥50 岁且有心血管疾病既往风险因素的患者在内的 ORAL Surveillance 上市后安全性研究的结果。这些亚组中可用的疗效和安全性数据能够使临床医生和患者之间进行更好的讨论,以指导明智的决策制定和个体化患者护理。