托珠单抗单药治疗与肿瘤坏死因子抑制剂联合甲氨蝶呤治疗类风湿关节炎患者的真实世界比较疗效
Real-world Comparative Effectiveness of Tocilizumab Monotherapy vs. Tumor Necrosis Factor Inhibitors with Methotrexate in Patients with Rheumatoid Arthritis.
作者信息
Harrold Leslie R, Reed George W, Best Jennie, Zlotnick Steve, Kremer Joel M
机构信息
University of Massachusetts Medical School, Worcester, MA, USA.
Corrona, LLC, Waltham, MA, USA.
出版信息
Rheumatol Ther. 2018 Dec;5(2):507-523. doi: 10.1007/s40744-018-0127-1. Epub 2018 Oct 6.
INTRODUCTION
Controlled clinical studies have shown that the efficacy of tocilizumab (TCZ) monotherapy is superior to that of tumor necrosis factor inhibitor (TNFi) monotherapy and comparable to that of TCZ plus methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). This study compared the real-world effectiveness of TCZ monotherapy vs. TNFis plus MTX in US patients with RA.
METHODS
TCZ-naïve patients from the Corrona RA registry with prior exposure to ≥ 1 TNFi who initiated TCZ monotherapy or TNFi + MTX were included. Outcomes included mean change in Clinical Disease Activity Index (CDAI), achievement of low disease activity (LDA; CDAI ≤ 10), achievement of modified American College of Rheumatology (mACR) 20/50 responses, and mean change in modified Health Assessment Questionnaire (mHAQ) at 6 months. Patients initiating TNFi + MTX were grouped by MTX dose (≤ 10 mg; > 10 to ≤ 15 mg; > 15 to ≤ 20 mg; > 20 mg); outcomes in each group were compared with TCZ monotherapy using trimmed populations (excluding patients outside the propensity score distribution overlap).
RESULTS
Patients in all groups experienced improvement in CDAI at 6 months (mean change, - 6.9 to - 9.7), with no significant differences between the TCZ monotherapy and TNFi + MTX groups. Achievement of LDA and mACR responses at 6 months were comparable between the TCZ monotherapy and TNFi + MTX groups; overall, 26.8-38.0% of patients achieved LDA, 24.3-37.6% achieved mACR20 response and 13.2-20.8% achieved mACR50 response. The mean change in mHAQ at 6 months was - 0.1 in all groups.
CONCLUSIONS
In this real-world population of US patients with RA who had prior TNFi exposure, there was no evidence of a difference in the effectiveness of TCZ monotherapy compared with that of TNFi + MTX, regardless of MTX dose, at 6 months for improving RA disease activity.
FUNDING
Corrona, LLC. Plain language summary available for this article.
引言
对照临床研究表明，托珠单抗（TCZ）单药治疗类风湿关节炎（RA）的疗效优于肿瘤坏死因子抑制剂（TNFi）单药治疗，且与TCZ联合甲氨蝶呤（MTX）相当。本研究比较了美国RA患者中TCZ单药治疗与TNFi联合MTX的实际疗效。
方法
纳入来自Corrona RA注册中心的初治TCZ患者，这些患者既往曾接受≥1种TNFi治疗，随后开始TCZ单药治疗或TNFi + MTX治疗。观察指标包括临床疾病活动指数（CDAI）的平均变化、达到低疾病活动度（LDA；CDAI≤10）、达到美国风湿病学会改良标准（mACR）20/50反应，以及6个月时改良健康评估问卷（mHAQ）的平均变化。开始TNFi + MTX治疗的患者按MTX剂量分组（≤10 mg；>10至≤15 mg；>15至≤20 mg；>20 mg）；使用修剪后的人群（排除倾向评分分布重叠范围外的患者）将每组的观察指标与TCZ单药治疗组进行比较。
结果
所有组的患者在6个月时CDAI均有改善（平均变化为-6.9至-9.7），TCZ单药治疗组与TNFi + MTX组之间无显著差异。TCZ单药治疗组与TNFi + MTX组在6个月时达到LDA和mACR反应的情况相当；总体而言，26.8%-38.0%的患者达到LDA，24.3%-37.6%的患者达到mACR20反应，13.2%-20.8%的患者达到mACR50反应。所有组在6个月时mHAQ的平均变化均为-0.1。
结论
在这群既往接受过TNFi治疗的美国RA患者中，没有证据表明在6个月时，无论MTX剂量如何，TCZ单药治疗与TNFi + MTX在改善RA疾病活动度方面的疗效存在差异。
资助
Corrona有限责任公司。本文提供通俗易懂的摘要。
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