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维多珠单抗与优特克单抗治疗溃疡性结肠炎患者的疗效比较:一项真实世界回顾性研究

Comparison of the Effectiveness of Vedolizumab and Ustekinumab in Patients with Ulcerative Colitis: A Real-World Retrospective Study.

作者信息

Nomura Kei, Shibuya Tomoyoshi, Odakura Rina, Haraikawa Mayuko, Ishino Hirotaka, Orikasa Masayuki, Omori Masashi, Koma Masao, Ito Kentaro, Maruyama Takafumi, Nomura Osamu, Ishikawa Dai, Hojo Mariko, Nagahara Akihito

机构信息

Department of Gastroenterology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.

Department of Pathophysiological Research and Therapeutics for Gastrointestinal Disease, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.

出版信息

Biomedicines. 2024 Sep 2;12(9):1991. doi: 10.3390/biomedicines12091991.

Abstract

Ulcerative colitis (UC) is a chronic inflammatory disorder of the large intestine. Data on the comparative effectiveness of biological therapies such as vedolizumab (VDZ) and ustekinumab (UST) remain limited. This retrospective study compared the effectiveness and safety of VDZ and UST in UC patients. Between November 2018 and November 2023, 106 patients were included: 64 received VDZ and 42 received UST. Bio-failure was significantly higher ( = 0.005) in the UST group versus the VDZ group. The remission rates at 6, 22, and 54 weeks in VDZ group were 51.6%, 61.3%, and 66.7%. The remission rates at 8, 24, and 56 weeks in the UST group were 66.7%, 65.0%, and 66.7%, respectively. Both treatments were comparable in inducing and maintaining clinical remission over 54-56 weeks, with no significant differences observed in the Lichtiger clinical activity index. Subgroup analyses highlighted the potential short-term effectiveness of UST among cases of bio-failure and a white blood cell level ≥ 9000/µL. Safety profiles were generally favorable, with no significant adverse events. Usutekinumab demonstrated effectiveness as a salvage therapy in patients who failed VDZ. Despite the increased disease severity in the UST group compared to the VDZ group, both groups demonstrated similar remission rates, suggesting UST shows significant efficacy even in moderate to severe UC.

摘要

溃疡性结肠炎(UC)是一种大肠的慢性炎症性疾病。关于维多珠单抗(VDZ)和优特克单抗(UST)等生物疗法的比较疗效数据仍然有限。这项回顾性研究比较了VDZ和UST在UC患者中的有效性和安全性。在2018年11月至2023年11月期间,纳入了106例患者:64例接受VDZ治疗,42例接受UST治疗。UST组的生物治疗失败率显著高于VDZ组( = 0.005)。VDZ组在6周、22周和54周时的缓解率分别为51.6%、61.3%和66.7%。UST组在8周、24周和56周时的缓解率分别为66.7%、65.0%和66.7%。在诱导和维持54 - 56周的临床缓解方面,两种治疗方法具有可比性,在利希特格临床活动指数方面未观察到显著差异。亚组分析突出了UST在生物治疗失败且白细胞水平≥9000/µL的病例中的潜在短期有效性。安全性概况总体良好,未出现显著不良事件。优特克单抗在VDZ治疗失败的患者中作为挽救疗法显示出有效性。尽管UST组的疾病严重程度高于VDZ组,但两组的缓解率相似,这表明UST即使在中度至重度UC中也显示出显著疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f73/11428936/e13bc4f0f45a/biomedicines-12-01991-g001.jpg

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