Real-world inflammatory bowel disease-modification outcomes: A narrative review

doi:10.3748/wjg.117240

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Gastroenterol. Sep 14, 2026; 32(34): 117240
Published online Sep 14, 2026. doi: 10.3748/wjg.117240

Real-world inflammatory bowel disease-modification outcomes: A narrative review

Neeraj Narula, Shashi Adsul, Walter Reinisch

Neeraj Narula, Department of Medicine, Division of Gastroenterology, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton L8N 3ZN, Ontario, Canada

Shashi Adsul, Department of Gastroenterology, Takeda Pharmaceutical International AG, Zurich 8152, Switzerland

Walter Reinisch, Department of Medicine III, Division for Gastroenterology and Hepatology, Medical University of Vienna, Vienna A-1090, Austria

Author contributions: Narula N, Adsul S, and Reinisch W contributed to the study conceptualization, data interpretation, draft preparation, and review; all authors have read and approved the final version of the manuscript for submission.

AI contribution statement: No AI tools were used in the development of this manuscript.

Conflict-of-interest statement: Neeraj Narula holds a McMaster University AFP Clinician Researcher Award and has received consulting fees from AbbVie, Bristol Myers Squibb, Celltrion, Eli Lilly, Fresenius Kabi, Innomar Strategies, Iterative Health, Iterative Scopes, Janssen, Organon, Pfizer, and Takeda, and lecture fees from AbbVie, BIOJAMP, Celltrion, Janssen, Pfizer, and Takeda; Shashi Adsul is an employee of and holds stock/options in Takeda; Walter Reinisch has received research grants from AbbVie, Janssen, Pfizer, and Takeda; consulting fees from AbbVie, AOP Orphan, Bioclinica, Bristol Myers Squibb, Calyx, Eli Lilly, Galapagos, Gilead, Index Pharma, Janssen, Landos Biopharma, Microbiotica, MSD, Pfizer, Protagonist, Seres Therapeutics, Takeda, and Teva Pharmaceuticals; and speaker bureau fees from AbbVie, Celltrion, Galapagos, MSD, Janssen, and Takeda.

Corresponding author: Walter Reinisch, MD, PhD, Professor, Department of Medicine III, Division for Gastroenterology and Hepatology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna A-1090, Austria. walter.reinisch@meduniwien.ac.at

Received: December 2, 2025
Revised: March 5, 2026
Accepted: July 27, 2026
Published online: September 14, 2026
Processing time: 260 Days and 9.2 Hours

Abstract

Inflammatory bowel diseases (IBDs) culminate in disease progression in many patients. Characterized by chronic inflammation and gastrointestinal damage, IBD negatively impacts quality of life, often requires surgery, and can result in disability. Disease modification has been a target for treatment for other chronic inflammatory diseases, and disease-modification trials will help determine if this approach can prevent disease progression in IBD. The standard protocol items: Recommendations for interventional trials (SPIRIT) consensus has recommended disease-modification endpoints for use in clinical trials, but before such studies are conducted, real-world data can be informative. This review of real-world studies in patients with ulcerative colitis or Crohn’s disease treated with advanced treatments that employed the SPIRIT endpoints identified considerable gaps in the use of recommended disease-modification endpoints. Specifically, no studies used the recommended outcomes for midterm complications of fecal incontinence or bowel damage, or assessed macroscopic proximal disease extension, permanent stoma, or short-bowel symptoms. Long-term complications of cancer or mortality were not assessed over the recommended 5-year period. Additionally, studies have not assessed quality of life using the recommended composite of the 36-Item IBD Questionnaire and 36-Item Short-Form Health Survey. In conclusion, there remains a need to incorporate SPIRIT-recommended disease-modification endpoints in prospective real-world studies in patients with IBD receiving advanced treatments.

Keywords: Crohn’s disease; Disease modification; Inflammatory bowel disease; Real-world evidence; Standard protocol items: Recommendations for interventional trials consensus; Ulcerative colitis

Core Tip: The standard protocol items: Recommendations for interventional trials (SPIRIT) consensus has recommended disease-modification endpoints for use in clinical trials in patients with inflammatory bowel disease (IBD) to help determine if this approach can prevent disease progression. Before such studies are conducted, real-world evidence can be informative. This review of real-world studies utilizing the SPIRIT consensus endpoints identified considerable gaps in the use of these recommended disease-modification endpoints. Therefore, there remains a need to incorporate SPIRIT recommended disease-modification endpoints in prospective real-world studies in patients with IBD receiving advanced treatments.