炎症性肠病中先进治疗的安全性、疗效和持久性：ORIGINS 的结果。一项回顾性观察研究。
Safety, Efficacy and Persistence of Advanced Therapies in Inflammatory Bowel Disease: Results from ORIGINS. A Retrospective Observational Study.
机构信息
Gastroenterology Department, Colentina Clinical Hospital, Bucharest, Romania. .
Gastroenterology and Hepatology Center, Fundeni Clinical Institute,Bucharest, Romania.
出版信息
J Gastrointestin Liver Dis. 2023 Dec 22;32(4):444-451. doi: 10.15403/jgld-5128.
BACKGROUND AND AIMS
Real-world assessments of efficacy and safety of advanced therapies used for inflammatory bowel disease (IBD) patients are limited. We aimed to report safety, efficacy and treatment persistence of new molecules (infliximab, adalimumab, vedolizumab, tofacitinib, ustekinumab) in a retrospective multicentric national Romanian analysis.
METHODS
We conducted a nationwide, retrospective observational multicentric study. Data were collected retrospectively from electronic and paper files. Patients who started on one of the five investigated molecules during December 2019-December 2021 were included. The main outcome measures were clinical remission, endoscopic healing, persistence on treatment and safety data.
RESULTS
A total of 678 adult patients from 24 Romanian IBD centers with a diagnosis of ulcerative colitis or Crohn's disease were included. Participants had previously failure to one (268, 39.5%), two (108, 15%) or more treatment lines and only 38% (259) were biologic naïve. In the 24 months study period, most patients were started on vedolizumab (192, 28%), followed by adalimumab, infliximab, ustekinumab and tofacitinib. In biologic-naïve patients, most physicians (72%) preferred anti-TNF treatment as first line biologic (93 patients started on infliximab, 92 on adalimumab), followed by vedolizumab, ustekinumab and tofacitinib. During follow-up, 71% (470, p=0.05) of patients achieved clinical remission and 36% (134, p=0.03) achieved mucosal healing. The 6 months milestone for persistence was reached in 78% (530) of cases. Almost half of patients (47%, 316 patients) persisted on their current treatment for over 12 months. Overall, an adverse reaction was reported for 67 (10.4%) patients, with no lethal events.
CONCLUSIONS
Population of biologic-experienced IBD patients in Romania is increasing and is becoming more difficult to achieve long-term disease control. Discontinuation rates for advanced therapies are high.
背景与目的
用于炎症性肠病（IBD）患者的先进疗法的真实世界疗效和安全性评估有限。我们旨在报告新型分子（英夫利昔单抗、阿达木单抗、维得利珠单抗、托法替布、乌司奴单抗）在罗马尼亚全国回顾性多中心分析中的安全性、疗效和治疗持久性。
方法
我们进行了一项全国性、回顾性多中心研究。数据从电子和纸质文件中回顾性收集。纳入在 2019 年 12 月至 2021 年 12 月期间开始使用五种研究分子之一的成年患者。主要结局指标为临床缓解、内镜愈合、治疗持续时间和安全性数据。
结果
共有来自罗马尼亚 24 个 IBD 中心的 678 名成年患者，其中溃疡性结肠炎或克罗恩病的诊断。参与者之前曾使用过一种（268 例，39.5%）、两种（108 例，15%）或更多治疗方案，只有 38%（259 例）为生物初治患者。在 24 个月的研究期间，大多数患者开始使用维得利珠单抗（192 例，28%），其次是阿达木单抗、英夫利昔单抗、乌司奴单抗和托法替布。在生物初治患者中，大多数医生（72%）首选抗 TNF 治疗作为一线生物治疗（93 例开始使用英夫利昔单抗，92 例开始使用阿达木单抗），其次是维得利珠单抗、乌司奴单抗和托法替布。在随访期间，71%（470 例，p=0.05）的患者达到临床缓解，36%（134 例，p=0.03）达到黏膜愈合。78%（530 例）的病例达到了 6 个月的治疗持续时间里程碑。几乎一半的患者（47%，316 例）持续使用当前治疗方案超过 12 个月。总体而言，67 例（10.4%）患者报告了不良反应，无致死事件。
结论
罗马尼亚生物经验丰富的 IBD 患者人数不断增加，实现长期疾病控制变得更加困难。高级治疗的停药率很高。
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