Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis
Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis
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DOI：
10.1136/rmdopen-2016-000262
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发表时间：
2016-12-01
期刊：
影响因子：
6.2
通讯作者：
van Vollenhoven, Ronald F.
中科院分区：
文献类型：
--
作者：
Fleischmann, Roy M.;Huizinga, Tom W. J.;van Vollenhoven, Ronald F.
托法替尼是一种用于治疗类风湿性关节炎（RA）的口服Janus激酶抑制剂。在甲氨蝶呤（MTX）初始成人RA患者中，托法替尼单药治疗先前显示可抑制结构损伤，减少RA的临床体征和症状，并在24个月内改善身体功能。在这项事后分析中，我们比较了托法替尼在早期（病程= 1年）RA患者中的疗效和安全性。方法：在一项为期24个月的3期临床试验中，未接受MTX治疗的>= 18岁的活动性RA患者接受托法替尼单药治疗（5或10mg，每天2次，或MTX单药治疗）。结果：在956例患者中（托法替尼5 mg每日2次，n=373；托法替尼10 mg每日2次，n=397； MTX, n=186）， 54%有早期RA。两组的基线疾病活动度和功能失能相似；已确诊RA的患者影像学损害更大。在第24个月，早期RA患者的临床反应率明显高于托法替尼5 mg /天2次组。与MTX相比，两种剂量的托法替尼在1年和2年的临床、功能和影像学改善方面都有更大的效果，与疾病持续时间无关。没有观察到新的安全信号。结论：早期和确诊类风湿性关节炎的治疗效果大体相似；在第24个月，与已建立的RA相比，使用托法替尼5mg，每天2次，可显著改善早期RA。托法替尼5和10mg，每日两次，与MTX相比，无论疾病持续时间如何，都显示出更大的疗效。早期RA患者和已确诊RA患者在安全性方面没有差异。
Introduction: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib monotherapy was previously shown to inhibit structural damage, reduce clinical signs and symptoms of RA, and improve physical functioning over 24 months in methotrexate (MTX)-naive adult patients with RA. In this post hoc analysis, we compared efficacy and safety of tofacitinib in patients with early (disease duration = 1 year) RA.Methods: MTX-naive patients >= 18 years with active RA received tofacitinib monotherapy (5 or 10 mg two times a day, or MTX monotherapy, in a 24-month Phase 3 trial.Results: Of 956 patients (tofacitinib 5 mg two times a day, n=373; tofacitinib 10 mg two times a day, n=397; MTX, n=186), 54% had early RA. Baseline disease activity and functional disability were similar in both groups; radiographic damage was greater in patients with established RA. At month 24, clinical response rates were significantly greater in patients with early versus established RA in the tofacitinib 5 mg two times a day group. Both tofacitinib doses had greater effects on clinical, functional and radiographic improvements at 1 and 2 years compared with MTX, independent of disease duration. No new safety signals were observed.Conclusions: Treatment response was generally similar in early and established RA; significantly greater improvements were observed at month 24 with tofacitinib 5 mg two times a day in early versus established RA. Tofacitinib 5 and 10 mg two times a day demonstrated greater efficacy versus MTX irrespective of disease duration. No difference in safety profiles was observed between patients with early or established RA.