Department of Medicine, Robarts Research Institute, University of Western Ontario, London, Canada.
Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.
Crohn's disease (CD) is associated with impaired health-related quality of life (HRQoL). Certolizumab pegol, administered either every 2 weeks (q2w) or q4w, maintains efficacy in patients previously failing on the anti-TNF agent infliximab (WELCOME study).
To investigate the impact of certolizumab pegol administered q2w and q4w on work productivity and HRQoL in the WELCOME study.
Patients with loss of response to infliximab received open-label certolizumab pegol induction and were randomised to receive double-blind maintenance treatment with certolizumab pegol 400 mg either q4w or q2w through week 24, with a final evaluation at week 26. Work productivity and HRQoL were assessed using the Work Productivity and Activity Impairment:CD questionnaire and Inflammatory Bowel Disease Questionnaire respectively.
Baseline HRQoL burden was representative of moderately to severely active CD. HRQoL, daily activity and work productivity improved in both treatment groups as early as week 6 and were maintained through week 26. Treatment benefits to HRQoL, daily activity and work productivity were similar between the certolizumab pegol q2w vs. q4w groups.
Certolizumab pegol therapy results in meaningful improvements in work productivity, daily activities and HRQoL in patients with active CD who previously responded to but either lost response or could not tolerate infliximab (ClinicalTrials.gov number: NCT00308581).
克罗恩病（CD）与健康相关生活质量（HRQoL）受损有关。培塞利珠单抗每 2 周（q2w）或 q4w 给药，可维持对先前对 TNF 拮抗剂英夫利昔单抗治疗应答失败的患者的疗效（WELCOME 研究）。
在 WELCOME 研究中，调查培塞利珠单抗 q2w 和 q4w 给药对工作生产力和 HRQoL 的影响。
对英夫利昔单抗应答丧失的患者给予培塞利珠单抗开放标签诱导，并随机接受培塞利珠单抗 400mg 双盲维持治疗，q4w 或 q2w 至第 24 周，最后评估在第 26 周。使用工作生产力和活动障碍：CD 问卷和炎症性肠病问卷分别评估工作生产力和 HRQoL。
基线 HRQoL 负担代表中重度活动期 CD。在第 6 周时，两种治疗组的 HRQoL、日常活动和工作生产力均得到改善，并持续到第 26 周。培塞利珠单抗 q2w 与 q4w 组之间，HRQoL、日常活动和工作生产力的治疗获益相似。
培塞利珠单抗治疗可使先前对英夫利昔单抗有应答但失去应答或不能耐受英夫利昔单抗的活动性 CD 患者的工作生产力、日常活动和 HRQoL 得到显著改善（ClinicalTrials.gov 编号：NCT00308581）。
