Inflammatory Bowel Disease Unit, AOOR 'Villa Sofia-Cervello', Palermo, Italy.
Inflammatory Bowel Disease Unit, AOU Policlinico 'G. Martino', Messina, Italy.
United European Gastroenterol J. 2020 Nov;8(9):1045-1055. doi: 10.1177/2050640620948802. Epub 2020 Aug 9.
Biologically naïve patients with inflammatory bowel disease treated with vedolizumab (VDZ) are largely underrepresented in real-world cohorts. A multi-centre, observational cohort study was performed on the effectiveness and safety of VDZ in biologically naïve subjects with Crohn's disease (CD) and ulcerative colitis (UC).
Data of consecutive biologically naïve patients with CD and UC treated with VDZ from July 2016 to December 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease.
A total of 172 consecutive patients (CD: = 88; UC: = 84; median age 66.0 years) were included, with a median follow-up of 58.8 weeks. After 14 weeks, a clinical response was reported in 68.2% of patients with CD and 67.9% of patients with UC treated with VDZ, including 45.5% patients in the CD group and 46.4% patients in the UC group who achieved steroid-free remission. After 52 weeks, a clinical response was reported in 77.4% of CD and in 73.8% of UC patients treated with VDZ, including 59.7% patients in the CD group and 60.7% patients in the UC group who achieved steroid-free remission.
This study demonstrates the effectiveness and safety of VDZ as a first-line biological, particularly among elderly patients.
接受 vedolizumab（VDZ）治疗的炎症性肠病初治患者在真实世界队列中代表性不足。对 VDZ 在克罗恩病（CD）和溃疡性结肠炎（UC）初治患者中的有效性和安全性进行了一项多中心、观察性队列研究。
从西西里炎症性肠病网络队列中提取了 2016 年 7 月至 2019 年 12 月接受 VDZ 治疗的连续初治 CD 和 UC 患者的数据。
共纳入 172 例连续初治患者（CD：88 例；UC：84 例；中位年龄 66.0 岁），中位随访 58.8 周。14 周后，VDZ 治疗的 CD 患者中有 68.2%和 UC 患者中有 67.9%出现临床缓解，其中 CD 组有 45.5%的患者和 UC 组有 46.4%的患者达到无激素缓解。52 周后，VDZ 治疗的 CD 患者中有 77.4%和 UC 患者中有 73.8%出现临床缓解，其中 CD 组有 59.7%的患者和 UC 组有 60.7%的患者达到无激素缓解。
这项研究表明 VDZ 作为一线生物制剂的有效性和安全性，特别是在老年患者中。
