Histologic assessments in ulcerative colitis: the evidence behind a new endpoint in clinical trials

Rish K. Pai, Geert D’Haens, Taku Kobayashi, Bruce E. Sands, Simon Travis, Vipul Jairath, Gert De Hertogh, Bomina Park, Kim McGinnis, Isabel Redondo, Nicole G. Lipitz, Theresa Hunter Gibble, Fernando Magro

Research output: Contribution to journalReview articlepeer-review

1 Scopus citations

Abstract

Introduction: Treatment goals for ulcerative colitis (UC) are evolving from the achievement of clinical remission to more rigorous goals defined by endoscopic and histologic healing. Achievement of deeper remission targets aims to reduce the risk of colectomy, hospitalizations, and colorectal cancer. Areas covered: This review covers histologic assessments, histologic remission as a clinical trial endpoint, and the association between histologic disease activity and clinical outcomes. Future directions are also discussed, including the use of advanced imaging and artificial intelligence technologies, as well as potential future treatment targets beyond histologic remission. Expert opinion: Histologic assessments are used for their sensitivity in measuring mucosal inflammatory changes in UC. Due to correlation with disease activity, histologic assessments may support clinical decision-making regarding treatment decisions as such assessments can be associated with rates of clinical relapse, hospitalization, colectomy, and neoplasia. While histologic remission is limited by varying definitions and multiple histologic indices, work is ongoing to create a consensus on the use of histologic assessments in clinical trials. As research advances, aspirational targets beyond histologic remission, such as molecular healing and disease clearance, are being explored.

Original languageEnglish
Pages (from-to)73-87
Number of pages15
JournalExpert Review of Gastroenterology and Hepatology
Volume18
Issue number1-3
DOIs
StatePublished - 2024

Keywords

  • Ulcerative colitis
  • clinical trial endpoints
  • endoscopic remission
  • histologic healing
  • histologic remission
  • inflammatory bowel diseases
  • mucosal healing

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