KEM Hospital Research Centre, Sardar Moodliar Road, Pune, 411011, India.
BJ Medical College and Sassoon General Hospital, Pune, India.
Clin Rheumatol. 2022 Oct;41(10):2961-2966. doi: 10.1007/s10067-022-06205-z. Epub 2022 May 21.
Generic tofacitinib has been available in India for more than a year and is widely used in rheumatoid arthritis (RA) therapy. There is scarce real-world data on its effectiveness and safety from India, especially given infection endemicity. We retrospectively analysed records (demographic and clinical information, haematology and biochemistry, adverse events) of patients prescribed generic tofacitinib from a single centre in Mumbai, India. Disease activity was calculated using the disease activity score-28 and erythrocyte sedimentation rate (DAS28-ESR) and other tools, and we used paired T-tests for significant response. We defined clinical tofacitinib failure as a composite outcome, including clinician's decision to change to an alternative disease-modifying anti-rheumatic drug (DMARD) or flare after self-withdrawal. We performed logistic regression and survival analysis for determinants of clinical failure. We reviewed records of 102 patients (92 female; median age: 53 years) with mean RA duration of 146 months. Thirteen had prior treatment with innovator tofacitinib. There was significant improvement in disease activity parameters at a mean duration of 186 days. No serious adverse events were reported; 4 patients had tuberculosis and 19 patients had mild COVID-19 while on treatment. Clinical failure was seen in 25 patients, and mean time to failure on survival analysis was 357 days. No baseline characteristic predicted clinical failure. Generic tofacitinib showed good effectiveness and a tolerable adverse effect profile, despite tuberculosis endemicity and COVID-19. Setting up registries would be valuable in gaining more data on generic tofacitinib. Key Points • There is scarce data from India regarding the use of tofacitinib in rheumatoid arthritis, despite widespread use. • In this retrospective analysis of 102 patients at a single centre, we found tofacitinib monotherapy was efficacious and tolerable. • Tuberculosis was detected in four and nineteen patients had mild covid.
通用托法替布在印度已经上市一年多，广泛用于类风湿关节炎（RA）的治疗。尽管感染流行，但来自印度的关于其有效性和安全性的真实世界数据很少。我们回顾性分析了来自印度孟买的一个单一中心的患者记录（人口统计学和临床信息、血液学和生物化学、不良事件）。使用疾病活动评分-28 和红细胞沉降率（DAS28-ESR）和其他工具计算疾病活动度，我们使用配对 T 检验来衡量显著反应。我们将临床托法替布失败定义为复合结局，包括临床医生决定改用另一种疾病修正抗风湿药物（DMARD）或自行停药后出现的病情加重。我们对临床失败的决定因素进行了逻辑回归和生存分析。我们回顾了 102 名患者（92 名女性；中位年龄：53 岁）的记录，他们的 RA 平均病程为 146 个月。其中 13 人曾接受过创新型托法替布治疗。在平均 186 天的时间里，疾病活动参数显著改善。未报告严重不良事件；4 名患者在治疗期间患有肺结核，19 名患者患有轻度 COVID-19。25 名患者出现临床失败，生存分析中位失败时间为 357 天。无基线特征预测临床失败。尽管存在结核病流行和 COVID-19，但通用托法替布显示出良好的疗效和可耐受的不良反应谱。建立登记处将有助于获得更多关于通用托法替布的数据。关键点 • 尽管在印度广泛使用，但关于托法替布在类风湿关节炎中的应用的数据很少。 • 在对单中心 102 名患者的回顾性分析中，我们发现托法替布单药治疗是有效的且耐受良好。 • 4 名患者检测到肺结核，19 名患者出现轻度新冠。
