Real-World Comparative Effectiveness of Tofacitinib and Tumor Necrosis Factor Inhibitors as Monotherapy and Combination Therapy for Treatment of Rheumatoid Arthritis
Real-World Comparative Effectiveness of Tofacitinib and Tumor Necrosis Factor Inhibitors as Monotherapy and Combination Therapy for Treatment of Rheumatoid Arthritis
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DOI：
10.1007/s40744-019-00177-4
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发表时间：
2019-11-09
影响因子：
3.8
通讯作者：
Wallenstein, Gene
中科院分区：
文献类型：
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作者：
Reed, George W.;Gerber, Robert A.;Wallenstein, Gene
在现实世界的临床实践中，没有发表的研究比较托法替尼与其他先进疗法治疗类风湿性关节炎（RA）的有效性。在此，我们报告了使用美国Corrona注册数据，与标准治疗、肿瘤坏死因子抑制剂（TNFi）、合并或不合并甲氨蝶呤（MTX）相比，托法替尼的有效性差异。方法这项观察性队列研究包括接受托法替尼（从2012年11月6日; N = 558）或TNFi（从2001年11月1日; N = 8014）伴或不伴MTX的RA患者，直至2016年7月31日。6个月时的疗效结局包括改良的美国流变学学会20%应答、临床疾病活动指数（CDAI）和疼痛。比较了接受TNFi和托法替尼联合或不联合MTX治疗的患者的结局，并按治疗线进行了比较。使用倾向评分匹配比较治疗线内的结局;使用混合效应回归模型估计组间差异。结果与接受TNFi的患者相比，接受托法替尼治疗的患者RA持续时间更长，既往接受过生物制剂治疗的比例更大;其他基线特征相似。在接受二线和三线TNFi治疗的患者中，伴随MTX治疗的CDAI低疾病活动/缓解缓解率显著更好。接受托法替布作为二线治疗的患者太少，无法进行有意义的评估。托法替尼单药治疗与托法替尼合并MTX治疗之间的结局无显著差异。结论在临床实践中，TNFi的疗效与MTX在二线和三线合并使用。在三线/四线治疗中，患者接受托法替尼单药治疗或TNFi或托法替尼与MTX联合治疗可能获得相似的疗效。为辉瑞公司提供资金
Introduction No published studies exist comparing the effectiveness of tofacitinib with other advanced therapies for the treatment of rheumatoid arthritis (RA) in real-world clinical practice. Here, we report differences in effectiveness of tofacitinib compared with standard of care, tumor necrosis factor inhibitors (TNFi), with or without concomitant methotrexate (MTX), using US Corrona registry data. Methods This observational cohort study included RA patients receiving tofacitinib (from 6 November 2012; N = 558) or TNFi (from 1 November 2001; N = 8014) with or without MTX until 31 July 2016. Efficacy outcomes at 6 months included modified American College of Rheumatology 20% responses, Clinical Disease Activity Index (CDAI) and Pain. Outcomes were compared between patients receiving TNFi and tofacitinib with or without MTX and by line of therapy. Outcomes within therapy lines were compared using propensity-score matching; between-group differences were estimated using mixed-effects regression models. Results Patients receiving tofacitinib had longer RA duration and a greater proportion had previously received biologics than those receiving TNFi; other baseline characteristics were comparable. In patients receiving second- and third-line TNFi therapy, CDAI low disease activity/remission response rates were significantly better with concomitant MTX. Too few patients received tofacitinib as second line for meaningful assessment. No significant differences were observed in outcomes between tofacitinib as monotherapy and tofacitinib with concomitant MTX. Conclusions In clinical practice, TNFi efficacy is improved with concomitant MTX in the second and third line. In the third/fourth line, patients are likely to achieve similar efficacy with tofacitinib monotherapy, or TNFi or tofacitinib in combination with MTX. Funding Pfizer Inc