Seattle Rheumatology Associates, Seattle, WA 98104, USA.
Rheumatology (Oxford). 2011 Feb;50(2):261-70. doi: 10.1093/rheumatology/keq285. Epub 2010 Sep 25.
Biological agents, including TNF inhibitors, have revolutionized the treatment of RA in recent years. Certolizumab pegol (CZP) is a novel pegylated anti-TNF approved for the treatment of adult patients with moderately to severely active RA. This article provides an overview of three published clinical trials of CZP in RA in patients with active disease who have shown an inadequate response to DMARDs, including MTX: RA prevention of structural damage (RAPID) 1 and 2, which evaluated the efficacy and safety of CZP added to MTX when dosed every 2 weeks, and efficacy and safety of CZP - 4 weekly dosage in rheumatoid arthritis (FAST4WARD), which evaluated CZP monotherapy when dosed every 4 weeks. In the trials, CZP plus MTX or as monotherapy significantly improved the signs and symptoms of RA and RA disease activity, and CZP plus MTX significantly inhibited the progression of radiographic joint damage as early as Week 16 of the treatment. In addition, CZP treatment significantly improved patient-reported outcome measures, providing significant reductions in pain and fatigue and improvements in physical function as early as Week 1 of treatment; improvements in health-related quality of life were evident at the first assessment at Week 12. CZP treatment improved productivity at work, significantly reducing the number of days of missed work as well as the number of days with reduced productivity, and also increased productivity within the home and improved participation in family, social and leisure activities. CZP was generally well tolerated when used either as monotherapy or added to MTX; most adverse events were mild or moderate. Taken together, the results of these trials suggest that CZP is an effective new option for the treatment of RA.
生物制剂，包括 TNF 抑制剂，近年来极大地改变了 RA 的治疗方式。Certolizumab pegol（CZP）是一种新型聚乙二醇化抗 TNF 药物，已被批准用于治疗中重度活动期 RA 的成年患者。本文概述了 CZP 在 RA 中的三项已发表的临床试验，这些试验纳入了对 DMARDs（包括 MTX）反应不足的活动期疾病患者，分别为：RA 结构损伤预防（RAPID）1 和 2 研究，评估了 CZP 联合 MTX（每 2 周给药）的疗效和安全性；以及评估 CZP 每 4 周给药单药治疗疗效和安全性的快速 4 周治疗（FAST4WARD）研究。在这些试验中，CZP 联合 MTX 或单药治疗可显著改善 RA 及 RA 疾病活动的体征和症状，且 CZP 联合 MTX 治疗早在第 16 周即可显著抑制影像学关节损伤的进展。此外，CZP 治疗还显著改善了患者报告的结局指标，治疗第 1 周即可显著减轻疼痛和疲劳，改善躯体功能；治疗第 12 周时健康相关生活质量即有改善。CZP 治疗可提高工作生产力，显著减少旷工天数和生产力下降天数，并且还能提高家庭生产力并增加参与家庭、社会和休闲活动的机会。CZP 无论是单药治疗还是联合 MTX 治疗，总体耐受性良好；大多数不良反应为轻度或中度。综上所述，这些试验的结果表明，CZP 是一种治疗 RA 的有效新选择。
