Strand Vibeke, Michalska Margaret, Birchwood Christine, Pei Jinglan, Tuckwell Katie, Finch Rebecca, Gabay Cem, Kavanaugh Arthur, Jones Graeme
Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA.
US Medical Affairs, Immunology, Genentech, Inc., South San Francisco, California, USA.
RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.
Two randomised controlled trials, AMBITION (NCT00109408) and ADACTA (NCT01119859), showed tocilizumab (TCZ) monotherapy superior to methotrexate (MTX) and adalimumab (ADA) monotherapy, respectively, for improving rheumatoid arthritis (RA) disease activity. This study compared the benefit of TCZ versus MTX or ADA monotherapy for improving patient-reported outcomes (PROs) in patients with RA.
PROs included patient global assessment (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue and Short Form-36 (SF-36) physical component summary (PCS) and mental component summary (MCS) and eight domain scores. Outcomes included proportions of patients reporting changes from baseline in PRO scores ≥minimum clinically important differences (MCID) and ≥age-matched and gender-matched normative values at 24 weeks.
In AMBITION, TCZ-treated patients reported significantly greater mean improvements in HAQ (-0.7 vs -0.5), FACIT-Fatigue (8.7 vs 5.7), SF-36 PCS (9.8 vs 7.8) and five SF-36 domains at week 24 than with MTX; 45.0%-84.0% of TCZ-treated patients reported improvements ≥MCID, and 24.3%-52.1% reported scores ≥normative values across all PROs versus 39.4%-81.8% and 14.5%-45.0%, respectively, with MTX. In ADACTA, TCZ-treated patients reported significantly greater improvements in PtGA (-42.3 vs -31.8), pain (-40.1 vs -28.7), SF-36 MCS (7.9 vs 5.0) and three SF-36 domains than with ADA; 57.7%-83.3% of TCZ-treated patients reported improvements ≥MCID, and 22.1%-49.3% reported scores ≥normative values across all PROs versus 13.6%-37.8%, respectively, with ADA.
TCZ monotherapy resulted in more patients reporting clinically meaningful PRO improvements and PRO scores ≥normative values compared with MTX or ADA monotherapy.
NCT00109408 and NCT01119859; Post-results.
两项随机对照试验,即AMBITION(NCT00109408)和ADACTA(NCT01119859),显示托珠单抗(TCZ)单药疗法在改善类风湿性关节炎(RA)疾病活动方面分别优于甲氨蝶呤(MTX)和阿达木单抗(ADA)单药疗法。本研究比较了TCZ与MTX或ADA单药疗法在改善RA患者报告结局(PRO)方面的益处。
PRO包括患者整体评估(PtGA)、疼痛、健康评估问卷残疾指数(HAQ-DI)、慢性病治疗功能评估(FACIT)-疲劳以及简明健康调查问卷36项(SF-36)身体成分汇总(PCS)和精神成分汇总(MCS)以及八个领域得分。结局包括在24周时报告PRO得分较基线变化≥最小临床重要差异(MCID)以及≥年龄和性别匹配的标准值的患者比例。
在AMBITION试验中,与MTX相比,接受TCZ治疗的患者在第24周时HAQ(-0.7对-0.5)、FACIT-疲劳(8.7对5.7)、SF-36 PCS(9.8对7.8)以及五个SF-36领域的平均改善显著更大;45.0%-84.0%接受TCZ治疗的患者报告改善≥MCID,并且在所有PRO中,24.3%-52.1%的患者报告得分≥标准值,而MTX组分别为39.4%-81.8%和14.5%-45.0%。在ADACTA试验中,与ADA相比,接受TCZ治疗的患者在PtGA(-42.3对-31.8)、疼痛(-40.1对-28.7)、SF-36 MCS(7.9对5.0)以及三个SF-36领域的改善显著更大;57.7%-83.3%接受TCZ治疗的患者报告改善≥MCID,并且在所有PRO中,22.1%-49.3%的患者报告得分≥标准值,而ADA组分别为13.6%-37.8%。
与MTX或ADA单药疗法相比,TCZ单药疗法使更多患者报告有临床意义的PRO改善且PRO得分≥标准值。
NCT00109408和NCT01119859;结果公布后。