Strand Vibeke, Lee Eun Bong, Fleischmann Roy, Alten Rieke E, Koncz Tamas, Zwillich Samuel H, Gruben David, Wilkinson Bethanie, Krishnaswami Sriram, Wallenstein Gene
Division of Immunology/Rheumatology , Stanford University School of Medicine , Palo Alto, California , USA.
Department of Internal Medicine , Seoul National University College of Medicine , Seoul , South Korea.
RMD Open. 2016 Sep 28;2(2):e000308. doi: 10.1136/rmdopen-2016-000308. eCollection 2016.
To compare patient-reported outcomes (PROs) in methotrexate (MTX)-naive patients (defined as no prior treatment or ≤3 doses) receiving tofacitinib versus MTX.
In the 24-month, phase III, randomised, controlled, ORAL Start trial (NCT01039688), patients were randomised 2:2:1 to receive tofacitinib 5 mg two times per day (n=373), tofacitinib 10 mg two times per day (n=397) or MTX (n=186). PROs assessed included Patient Global Assessment of disease (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and health-related quality of life (Short Form-36 [SF-36]).
PROs improved following tofacitinib and MTX treatment: benefits were sustained over 24 months. Patients receiving tofacitinib reported earlier responses which were significantly different between each tofacitinib dose and MTX at month 3 through month 24. At month 6 (primary end point), significant improvements versus MTX were observed in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 5/8 domain scores and FACIT-F with tofacitinib 5 mg two times per day; all PROs, except SF-36 Mental Component Summary Score and Medical Outcomes Survey-Sleep, with tofacitinib 10 mg two times per day. At month 6, the proportion of patients reporting improvements ≥minimum clinically important difference were significant versus MTX with tofacitinib 5 mg two times per day in PtGA and 3/8 SF-36 domains; and with tofacitinib 10 mg two times per day in PtGA, pain, HAQ-DI, SF-36 PCS, 4/8 domains and FACIT-F.
Patients with rheumatoid arthritis receiving tofacitinib 5 and 10 mg two times per day monotherapy versus MTX reported statistically significant and clinically meaningful improvements in multiple PROs over 24 months; onset of benefit with tofacitinib treatment occurred earlier.
NCT01039688.
比较初治甲氨蝶呤（MTX）患者（定义为未接受过治疗或接受过≤3剂治疗）接受托法替布与MTX治疗后的患者报告结局（PROs）。
在为期24个月的III期随机对照ORAL Start试验（NCT01039688）中，患者按2:2:1随机分组，分别接受托法替布5mg每日2次（n = 373）、托法替布10mg每日2次（n = 397）或MTX（n = 186）治疗。评估的PROs包括患者对疾病的整体评估（PtGA）、疼痛、健康评估问卷残疾指数（HAQ-DI）、慢性病治疗功能评估-疲劳量表（FACIT-F）以及健康相关生活质量（简明健康调查问卷36项量表[SF-36]）。
托法替布和MTX治疗后PROs均有改善，且在24个月内持续获益。接受托法替布治疗的患者反应出现得更早，在第3个月至第24个月期间，各托法替布剂量组与MTX组之间存在显著差异。在第6个月（主要终点），每日2次服用托法替布5mg组在PtGA、疼痛、HAQ-DI、SF-36身体成分汇总量表（PCS）、5/8个领域评分以及FACIT-F方面与MTX相比有显著改善；每日2次服用托法替布10mg组，除SF-36精神成分汇总评分和医学结局研究睡眠量表外，所有PROs均有改善。在第6个月，报告改善程度≥最小临床重要差异的患者比例，在每日2次服用托法替布5mg组的PtGA和3/8个SF-36领域中与MTX相比有显著差异；在每日2次服用托法替布10mg组的PtGA、疼痛、HAQ-DI、SF-36 PCS、4/8个领域以及FACIT-F方面与MTX相比有显著差异。
类风湿关节炎患者接受每日2次服用托法替布5mg和10mg单药治疗与MTX相比，在24个月内多项PROs有统计学意义且具有临床意义的改善；托法替布治疗的获益起效更早。
NCT01039688。
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