Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Department of Pharmaeconomics and Market Access, Weber, Madrid, Spain.
Inflamm Bowel Dis. 2024 Feb 1;30(2):292-302. doi: 10.1093/ibd/izac275.
This study aimed to evaluate ustekinumab efficacy, effectiveness, and safety as a treatment for ulcerative colitis in adult patients.
A systematic review of the efficacy, effectiveness, and safety of ustekinumab in ulcerative colitis was carried out. The search was conducted via PubMed, Embase, and the Cochrane library. Two reviewers independently assessed the quality of studies and extracted study data.
Of the 892 studies identified, 17 were included: 1 randomized controlled trial (RCT), 3 long-term extensions, and 13 observational studies. In the randomized clinical trial evaluating efficacy at week 8, clinical remission was achieved in 16% of patients, whereas clinical response was achieved in 51% and 62% of patients who received intravenous ustekinumab at a dose of 130 mg and 6 mg/kg, respectively. At 3 years' follow-up, symptomatic remission was achieved in 68% of patients. On the other hand, the effectiveness of ustekinumab was evaluated in 13 observational studies. In these studies, clinical remission at induction was achieved in 24% to 61% of cases, whereas clinical response at induction was achieved in 47% to 77% of cases. Moreover, clinical remission was achieved in 33% to 79% of cases at 52 weeks of follow-up. The adverse events ranged from 2.6% to 77% of all the studies that reported safety data. Adverse events leading to discontinuation ranged from 2.6% to 8.1%, and serious adverse events were uncommon and ranged from 3.7% to 6.0%.
Ustekinumab has demonstrated efficacy (in RCTs), effectiveness (in real clinical practice), and safety for the treatment of ulcerative colitis.
本研究旨在评估乌司奴单抗治疗成人溃疡性结肠炎的疗效、有效性和安全性。
对乌司奴单抗治疗溃疡性结肠炎的疗效、有效性和安全性进行了系统评价。通过 PubMed、Embase 和 Cochrane 图书馆进行了检索。两名评审员独立评估了研究质量并提取了研究数据。
在确定的 892 项研究中，有 17 项被纳入：1 项随机对照试验（RCT）、3 项长期扩展研究和 13 项观察性研究。在评估第 8 周疗效的 RCT 中，分别有 16%、51%和 62%的静脉注射乌司奴单抗 130mg 和 6mg/kg 的患者达到了临床缓解，而临床应答分别为 51%和 62%。在 3 年随访时，68%的患者达到了症状缓解。另一方面，乌司奴单抗的有效性在 13 项观察性研究中得到了评估。在这些研究中，诱导期达到临床缓解的患者比例为 24%至 61%，而诱导期达到临床应答的患者比例为 47%至 77%。此外，在 52 周随访时，33%至 79%的患者达到了临床缓解。报告安全性数据的所有研究中，不良事件的发生率为 2.6%至 77%。导致停药的不良事件发生率为 2.6%至 8.1%，严重不良事件少见，发生率为 3.7%至 6.0%。
乌司奴单抗治疗溃疡性结肠炎具有疗效（在 RCT 中）、有效性（在真实临床实践中）和安全性。
