Net Remission Rates with Biologic and Small Molecule Treatment in Ulcerative Colitis: A Reappraisal of the Clinical Trial Data

医学 溃疡性结肠炎 临床试验 内科学 疾病
作者
Maia Kayal,Hannah Posner,Elizabeth A. Spencer,Jean‐Frédéric Colombel,Carlos Stalgis,Ryan C. Ungaro
出处
期刊:Clinical Gastroenterology and Hepatology [Elsevier BV]
卷期号:21 (13): 3433-3436.e1 被引量:15
标识
DOI:10.1016/j.cgh.2023.01.005
摘要

There has been a significant increase in the number of therapies approved for ulcerative colitis (UC) in the last 5 years, specifically with the introduction of the small molecules. Despite this, there is still a treatment gap in UC with substantial rates of primary and secondary nonresponse. 1 Lasa J.S. et al. Lancet Gastroenterol Hepatol. 2022; 7: 161-170 Abstract Full Text Full Text PDF PubMed Scopus (99) Google Scholar One way to investigate this treatment gap is to look at the "net" remission rates in clinical trials defined as the actual percentage of patients enrolled during induction who are in remission at the end of maintenance. We previously reported the "net" remission rates in Crohn's disease clinical trials by using this methodology. 2 Kayal M. et al. Net Remission Rates with Biologic Treatment in Crohn's Disease: A Reappraisal of the Clinical Trial Data. Clin Gastroenterol Hepatol. 2023; 21: 1348-1350 Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar Herein, we apply the same per-protocol analysis to the phase 3 randomized clinical trials for biologics and small molecules approved for UC and calculate 1-year net remission rates.
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