Harrold Leslie R, Bingham Clifton O, Pope Janet E, O'Brien Jacqueline, Moore Page C, Roberts-Toler Carla, Yu Miao, Sweet Lindsay L, Shelbaya Ahmed, Masri Karim R
CorEvitas, LLC, Waltham, MA, USA.
Department of Medicine, Division of Rheumatology, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Clin Rheumatol. 2025 Feb;44(2):635-648. doi: 10.1007/s10067-024-07245-3. Epub 2024 Dec 20.
To compare effectiveness of tofacitinib versus tumor necrosis factor inhibitors (TNFi), and across tofacitinib lines of therapy, in patients with rheumatoid arthritis (RA), using US CorEvitas RA Registry data.
Analysis included patients with RA initiating tofacitinib or TNFi with a 12-month follow-up visit between November 2012-February 2021. Primary (Clinical Disease Activity Index-defined low disease activity [CDAI-LDA: CDAI ≤ 10]) and secondary (clinical/disease activity/patient-reported) effectiveness outcomes were assessed at month 12. Outcomes were stratified by treatment regimen (overall tofacitinib vs overall TNFi/tofacitinib monotherapy vs tofacitinib combination therapy/TNFi monotherapy vs TNFi combination therapy/tofacitinib monotherapy vs TNFi combination therapy/tofacitinib combination therapy vs TNFi combination therapy), or tofacitinib line of therapy (2nd/3rd/ ≥ 4th line).
3,481 eligible patients initiated tofacitinib (n = 805) or TNFi (n = 2,676). Improvements in effectiveness at month 12 were generally similar across treatment regimens; 25.1% and 30.1% of overall tofacitinib and TNFi initiators achieved CDAI-LDA, respectively (odds ratio 1.29 [95% confidence interval (CI) 0.94, 1.76]). Odds ratios (95% CIs) for achieving CDAI-LDA at 12 months were 0.70 (0.36, 1.37) for 3rd- versus 2nd-line, and 1.09 (0.63, 1.88) for 3rd- versus ≥ 4th-line tofacitinib initiators. At month 12, mean change from baseline in CDAI was greater among 3rd- versus ≥ 4th-line tofacitinib initiators, and mean Health Assessment Questionnaire and patient-reported pain were greater in 3rd- versus 2nd-line and ≥ 4th- versus 3rd-line tofacitinib initiators.
Generally, there were no differences in effectiveness between tofacitinib versus TNFi regimens. Few differences were observed between tofacitinib lines of therapy; sample sizes were small for 2nd/3rd-line initiators.
NCT01402661 (ClinicalTrials.gov; July 25, 2011). Key Points • Using data from the US CorEvitas rheumatoid arthritis (RA) Registry, this study compared the effectiveness of tofacitinib versus tumor necrosis factor inhibitors (TNFi) and across tofacitinib lines of therapy. • Effectiveness of tofacitinib was similar to TNFi regimens up to month 12, while differences in some effectiveness outcomes at month 12 were observed with tofacitinib across different lines of therapy. • The findings of this study may inform future treatment decision-making in patients with RA.
利用美国CorEvitas类风湿关节炎（RA）注册研究数据，比较托法替布与肿瘤坏死因子抑制剂（TNFi）以及不同治疗线数的托法替布在类风湿关节炎（RA）患者中的疗效。
分析纳入2012年11月至2021年2月间开始使用托法替布或TNFi且有12个月随访的RA患者。在第12个月评估主要疗效指标（临床疾病活动指数定义的低疾病活动度[CDAI-LDA：CDAI≤10]）和次要疗效指标（临床/疾病活动度/患者报告）。疗效结果按治疗方案（总体托法替布与总体TNFi/托法替布单药治疗与托法替布联合治疗/TNFi单药治疗与TNFi联合治疗/托法替布单药治疗与TNFi联合治疗/托法替布联合治疗与TNFi联合治疗）或托法替布治疗线数（第2/3/≥4线）进行分层。
3481例符合条件的患者开始使用托法替布（n = 805）或TNFi（n = 2676）。各治疗方案在第12个月的疗效改善总体相似；总体托法替布和TNFi起始治疗者分别有25.1%和30.1%达到CDAI-LDA（优势比1.29[95%置信区间（CI）0.94，1.76]）。第3线与第2线托法替布起始治疗者在12个月时达到CDAI-LDA的优势比（95%CI）为0.70（0.36，1.37），第3线与≥第4线托法替布起始治疗者为1.09（0.63，1.88）。在第12个月，第3线与≥第4线托法替布起始治疗者的CDAI自基线的平均变化更大，第3线与第2线以及≥第4线与第3线托法替布起始治疗者的健康评估问卷评分和患者报告的疼痛评分更高。
总体而言，托法替布与TNFi治疗方案在疗效上无差异。托法替布不同治疗线数之间观察到的差异较少；第2/3线起始治疗者的样本量较小。
NCT01402661（ClinicalTrials.gov；2011年7月25日）。要点• 本研究利用美国CorEvitas类风湿关节炎（RA）注册研究数据，比较了托法替布与肿瘤坏死因子抑制剂（TNFi）以及不同治疗线数的托法替布的疗效。• 至第12个月，托法替布的疗效与TNFi治疗方案相似，而在第12个月，不同治疗线数的托法替布在一些疗效指标上存在差异。• 本研究结果可为RA患者未来的治疗决策提供参考。
