Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
First Department of Internal Medicine, "Papageorgiou" Hospital, Thessaloniki, Greece.
Aliment Pharmacol Ther. 2018 Dec;48(11-12):1174-1185. doi: 10.1111/apt.15005. Epub 2018 Oct 30.
Patient-reported outcomes are important in the assessment of efficacy of intervention for ulcerative colitis (UC).
To compare the impact of interventions for moderate-to-severe UC on health-related quality of life (HRQL).
We searched Medline, Embase, CENTRAL and grey literature sources through October 2017. We included randomised controlled trials (RCTs) that compared infliximab, adalimumab, golimumab, vedolizumab or tofacitinib to each other or placebo. Outcomes included the change in quality of life scores and the proportion of patients with improvement in quality of life. We performed random-effect pairwise and network meta-analysis. We assessed confidence in estimates using the CINeMA (Confidence in Network Meta-Analysis) framework.
Fourteen RCTs assessed HRQL using the Inflammatory Bowel Disease Questionnaire (IBDQ) (14 trials), the Short Form questionnaire-36 (SF-36) (seven trials) or the European Quality of Life-5 Dimensions questionnaire (EQ-5D) (three trials). At induction (13 trials), low to very low confidence evidence suggested that all agents significantly improved both generic and disease-specific HRQL scores compared to placebo. However, only infliximab (MD 18.58; 95% CI 13.19-23.97) and vedolizumab (MD 18.00; 95% CI 11.08-24.92) showed clinically meaningful improvement in IBDQ score. Differences among individual interventions were imprecise. For maintenance (four trials), very low confidence evidence suggested that vedolizumab, tofacitinib and adalimumab maintained improvement in HRQL.
Induction treatment with infliximab, adalimumab, golimumab, vedolizumab or tofacitinib improves quality of life compared to placebo. Evidence on maintenance therapy is sparse and uncertain. Head-to-head comparisons could enhance confidence in conclusions about differences between drugs in terms of HRQL.
患者报告的结果对于评估溃疡性结肠炎(UC)干预措施的疗效非常重要。
比较中重度 UC 的干预措施对健康相关生活质量(HRQL)的影响。
我们检索了 Medline、Embase、CENTRAL 和灰色文献来源,截至 2017 年 10 月。我们纳入了比较英夫利昔单抗、阿达木单抗、古利昔单抗、维得利珠单抗或托法替布与其他药物或安慰剂的随机对照试验(RCTs)。结局包括生活质量评分的变化和生活质量改善的患者比例。我们进行了随机效应成对和网络荟萃分析。我们使用 CINeMA(网络荟萃分析置信度)框架评估估计值的置信度。
14 项 RCT 使用炎症性肠病问卷(IBDQ)(14 项试验)、36 项简短问卷(SF-36)(7 项试验)或欧洲生活质量-5 维度问卷(EQ-5D)(3 项试验)评估了 HRQL。在诱导期(13 项试验),低至极低可信度证据表明,与安慰剂相比,所有药物均显著改善了通用和疾病特异性 HRQL 评分。然而,只有英夫利昔单抗(MD 18.58;95%CI 13.19-23.97)和维得利珠单抗(MD 18.00;95%CI 11.08-24.92)在 IBDQ 评分上显示出有临床意义的改善。各干预措施之间的差异不精确。在维持期(4 项试验),极低可信度证据表明,维得利珠单抗、托法替布和阿达木单抗维持了 HRQL 的改善。
英夫利昔单抗、阿达木单抗、古利昔单抗、维得利珠单抗或托法替布诱导治疗可改善生活质量,优于安慰剂。维持治疗的证据稀少且不确定。头对头比较可以提高对药物在 HRQL 方面差异的结论的置信度。