瑞桑基祖马布与乌斯特基努马布用于中度至重度克罗恩氏病
Laurent Peyrin-Biroulet1, J Casey Chapman1, Jean-Frederic Colombel1
1From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada; the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.); the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York; the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan; the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium; the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany; the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London; the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.); and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).
瑞桑基祖马布在克罗恩氏病24周临床缓解方面表现出与乌斯特基努马布的非劣势. 这项研究还发现,在中度至重度克罗恩病患者中,在48周内镜缓解后,瑞桑基祖马布在内镜缓解方面优越.
科学领域:
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 克罗恩氏病是一种慢性炎症性肠病.
- 目前的治疗方法,如抗瘤亡因子 (TNF) 治疗,都有局限性.
- 在克罗恩氏病中,瑞桑基祖马布和乌斯特基努马布的比较疗效尚未得到充分证实.
研究的目的:
- 为了比较risankizumab与ustekinumab在中度至重度克罗恩病患者的疗效和安全性.
- 评估24周的临床缓解和48周的内镜缓解.
主要方法:
- 第3b期,多中心,开放标签,随机对照试验.
- 对抗TNF治疗反应不充分或不耐受的患者被随机分组.
- 标准剂量的瑞桑基祖马布或乌斯特基努马布被用在48周内.
主要成果:
- 瑞桑基祖马布在24周的临床缓解方面与乌斯特基努马布无差 (58.6%对39.5%).
- 瑞桑基祖马布在48周内镜缓解方面表现出优越性 (31.8%对16.2%).
- 在两组治疗中,不良事件发生率相似.
结论:
- 瑞桑基祖马布是适度至重度克罗恩病的可行的治疗选择.
- 该研究满足了其主要终点,证明了与risankizumab相比较的临床疗效和优越的内镜结局.
- 进一步的研究可能会探索长期的结果和安全性.
相关概念视频
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