From Columbia University Medical Center, New York; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, Maryland, USA.
R. Wang, MD, MHS, Division of Rheumatology, Columbia University Medical Center; A. Dasgupta, PhD, Intramural Research Program, NIAMS, NIH; M.M. Ward, MD, MPH, Intramural Research Program, NIAMS.
J Rheumatol. 2018 Apr;45(4):481-490. doi: 10.3899/jrheum.170224. Epub 2018 Jan 15.
To compare the efficacy of 6 tumor necrosis factor-α inhibitors (TNFi) in treatment of ankylosing spondylitis (AS) at 12 weeks and 24 weeks.
We performed a systematic literature review of randomized controlled trials of TNFi in patients with active AS. We included trials that reported efficacy at 10 to 14 weeks (12-week analysis) and at 24 to 30 weeks (24-week analysis). We used Bayesian network metaanalysis (NMA) to compare their relative efficacy to improve the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and C-reactive protein (CRP) level.
We included 20 trials of 6 TNFi, with 43 treatment arms and 3220 participants. All TNFi were significantly better than placebo in reducing BASDAI and BASFI at 12 weeks and 24 weeks; all but certolizumab pegol (CZP) were statistically better than placebo in reducing CRP at 12 weeks; all but CZP and infliximab-dyyb (IFX biosimilar) were significantly better than placebo in reducing CRP at 24 weeks. IFX was superior to the other TNFi in decreasing BASDAI at 12 weeks, but not at 24 weeks. Excluding 1 open-label trial, there were no differences among TNFi.
Based on this NMA of clinical trials, IFX was superior to other TNFi in reducing BASDAI at 12 weeks, but sensitive to inclusion of an open-label trial, and its efficacy was diminished at 24 weeks. The analysis was limited by few direct comparison trials. Further study of relative safety and longterm effectiveness will help inform the choice of TNFi in treating active AS.
比较 6 种肿瘤坏死因子-α 抑制剂（TNFi）在治疗强直性脊柱炎（AS）的 12 周和 24 周时的疗效。
我们对 TNFi 治疗活动期 AS 的随机对照试验进行了系统文献回顾。我们纳入了报告 10 至 14 周（12 周分析）和 24 至 30 周（24 周分析）疗效的试验。我们使用贝叶斯网络荟萃分析（NMA）来比较它们改善巴斯强直性脊柱炎疾病活动指数（BASDAI）、巴斯强直性脊柱炎功能指数（BASFI）和 C 反应蛋白（CRP）水平的相对疗效。
我们纳入了 20 项 6 种 TNFi 的试验，共 43 个治疗组和 3220 名参与者。所有 TNFi 在降低 12 周和 24 周时的 BASDAI 和 BASFI 方面均显著优于安慰剂；除了 certolizumab pegol（CZP）外，所有 TNFi 在降低 12 周时的 CRP 方面均具有统计学意义；除了 CZP 和 infliximab-dyyb（IFX 生物类似物）外，所有 TNFi 在降低 24 周时的 CRP 方面均显著优于安慰剂。IFX 在降低 12 周时的 BASDAI 方面优于其他 TNFi，但在 24 周时则不然。排除 1 项开放标签试验，TNFi 之间无差异。
基于这项临床试验的 NMA，IFX 在降低 12 周时的 BASDAI 方面优于其他 TNFi，但对纳入开放标签试验敏感，其疗效在 24 周时减弱。该分析受到较少直接比较试验的限制。进一步研究相对安全性和长期有效性将有助于指导选择 TNFi 治疗活动期 AS。
