系统评价和荟萃分析：抗 TNF-α 在炎症性肠病中深度缓解的真实世界数据率。
Systematic review and meta-analysis: real-world data rates of deep remission with anti-TNFα in inflammatory bowel disease.
机构信息
Department of Medicine, Division of Gastroenterology, University of Washington, 1959 NE Pacific Street, Box 356424, Seattle, WA, 98195, USA.
Department of Medicine, Division of Gastroenterology and Hepatology, University of California San Francisco - Fresno, 155 N Fresno Street, Fresno, CA, 93721, USA.
出版信息
BMC Gastroenterol. 2021 Aug 3;21(1):312. doi: 10.1186/s12876-021-01883-6.
BACKGROUND
Deep remission (DR) is a treatment target in IBD associated with reduced hospitalization and improved outcome. Randomized control trial (RCT) data demonstrates efficacy of anti-TNFα agents in achieving DR; however, real-world data (RWD) can provide information complementary to RCTs, specifically regarding treatment duration. In this systematic review with meta-analysis, we use real-world data (RWD) to determine rates of DR in IBD treated with anti-TNFα.
METHODS
We completed a systematic search of MEDLINE and EMBASE on July 8, 2019 with review of major gastrointestinal conference abstracts from 2012 to 2019. Studies utilizing RWD (data not from phase I-III RCTs) of adult IBD patients treated with anti-TNFα agents were included. DR was defined by clinical and endoscopic remission at minimum. DR was assessed at 8 weeks, 6 months, 1 year, and 2 years. Risk of bias was assessed with the Newcastle Ottawa Scale.
RESULTS
29,033 publications were identified. Fifteen publications, nine manuscripts and six conference abstracts, were included encompassing 1212 patients (769 Crohn's disease-CD, 443 ulcerative colitis-UC), and analyzed using Comprehensive Meta-Analysis. Rate of DR was 36.4% (95% CI 12.6-69.4%) at 8 weeks, 39.1% (95% CI 10.4-78%) at 6 months, 44.4% (95% CI 34.6-54.6%) at 1 year, and 36% (95% CI 18.7-58%) at 2 years. DR in CD at 1 year was 48.6% (95% CI 32.8-64.7%) and in UC was 43.6% (95% CI 32.8-55.1%).
CONCLUSIONS
The rate of DR was highest after 1 year of therapy, in nearly 45% of IBD patients treated with anti-TNFα. Similar rates were achieved between patients with UC and CD. The findings highlight the efficacy of anti-TNFα in real-world setting. Future studies using RWD can determine efficacy of newer IBD therapeutics in routine clinical practice.
背景
深度缓解（DR）是与减少住院和改善预后相关的 IBD 治疗目标。随机对照试验（RCT）数据表明抗 TNFα 药物在实现 DR 方面的疗效；然而，真实世界数据（RWD）可以提供 RCT 无法提供的补充信息，特别是关于治疗持续时间。在这项系统评价和荟萃分析中，我们使用真实世界数据（RWD）来确定接受抗 TNFα 治疗的 IBD 患者达到 DR 的比率。
方法
我们于 2019 年 7 月 8 日完成了对 MEDLINE 和 EMBASE 的系统检索，并回顾了 2012 年至 2019 年主要胃肠道会议的摘要。纳入了使用 RWD（非来自 I-III 期 RCT 的数据）治疗的成年 IBD 患者的抗 TNFα 药物的研究。最低限度通过临床和内镜缓解来定义 DR。在 8 周、6 个月、1 年和 2 年评估 DR。使用纽卡斯尔-渥太华量表评估偏倚风险。
结果
共确定了 29033 篇出版物。纳入了 15 篇出版物，9 篇手稿和 6 篇会议摘要，共纳入 1212 名患者（769 名克罗恩病-CD，443 名溃疡性结肠炎-UC），并使用 Comprehensive Meta-Analysis 进行了分析。在 8 周时，DR 率为 36.4%（95%CI 12.6-69.4%），在 6 个月时为 39.1%（95%CI 10.4-78%），在 1 年时为 44.4%（95%CI 34.6-54.6%），在 2 年时为 36%（95%CI 18.7-58%）。1 年时 CD 的 DR 率为 48.6%（95%CI 32.8-64.7%），UC 为 43.6%（95%CI 32.8-55.1%）。
结论
在接受抗 TNFα 治疗 1 年后，DR 率最高，在接受抗 TNFα 治疗的 IBD 患者中接近 45%。UC 和 CD 患者的结果相似。这些发现突出了抗 TNFα 在真实世界环境中的疗效。未来使用 RWD 的研究可以确定新型 IBD 治疗药物在常规临床实践中的疗效。
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