IBD Unit, 'Villa Sofia-Cervello' Hospital, Palermo, Italy.
Directorate General of Medical Device and Pharmaceutical Service, Italian Ministry of Health, Rome, Italy.
J Crohns Colitis. 2023 Aug 21;17(8):1217-1227. doi: 10.1093/ecco-jcc/jjad043.
Many observational studies on the use of vedolizumab [VDZ] in patients with Crohn's disease [CD] and ulcerative colitis [UC] have been published in the past few years. We aimed to comprehensively summarise its effectiveness and safety by pooling data only from observational studies.
PubMed/Medline and Embase were systematically searched for observational studies on patients with CD and UC treated with VDZ through December 2021. The rates of clinical remission and overall adverse events were the primary outcomes. The rates of steroid-free clinical remission, clinical response, mucosal healing, C-reactive protein normalisation, loss of response, VDZ dose escalation, colectomy, serious adverse events, infections, and malignancies were considered as secondary outcomes.
In all, 88 studies comprising 25 678 patients [13 663 with CD and 12 015 with UC] met the inclusion criteria. In patients with CD, the pooled estimate rates of clinical remission were 36% at induction and 39% at maintenance. In patients with UC, the pooled estimate rates of clinical remission were 40% at induction and 45% at maintenance. The pooled estimate of incidence rate of adverse events was 34.6 per 100 person-years. At multivariable meta-regression analysis, studies with increased male proportion were independently associated with higher rates of clinical remission and steroid-free clinical remission at both induction and maintenance, and clinical response at maintenance in patients with CD. Studies with increased disease duration were independently associated with higher mucosal healing rates at maintenance in patients with UC.
Observational studies demonstrated extensively the effectiveness of VDZ, with a reassuring safety profile.
过去几年发表了许多关于维多珠单抗[VDZ]在克罗恩病[CD]和溃疡性结肠炎[UC]患者中应用的观察性研究。我们旨在通过仅汇总观察性研究的数据，全面总结其疗效和安全性。
系统检索了PubMed/Medline 和 Embase 数据库，以获取截至 2021 年 12 月接受 VDZ 治疗的 CD 和 UC 患者的观察性研究。临床缓解率和总体不良事件发生率为主要结局。无类固醇临床缓解率、临床反应率、黏膜愈合率、C 反应蛋白正常化率、应答丧失率、VDZ 剂量升级率、结肠切除术率、严重不良事件发生率、感染发生率和恶性肿瘤发生率被视为次要结局。
共有 88 项研究纳入了 25678 例患者[13663 例 CD 和 12015 例 UC]，符合纳入标准。在 CD 患者中，诱导期和维持期的临床缓解率汇总估计值分别为 36%和 39%。在 UC 患者中，诱导期和维持期的临床缓解率汇总估计值分别为 40%和 45%。不良事件发生率的汇总估计值为每 100 人年 34.6 例。在多变量荟萃回归分析中，男性比例增加的研究与 CD 患者诱导和维持期的临床缓解率和无类固醇临床缓解率以及维持期的临床反应率升高独立相关。疾病持续时间增加的研究与 UC 患者维持期的黏膜愈合率升高独立相关。
观察性研究广泛证实了 VDZ 的疗效，且安全性良好。
