Abstract
Purpose
The therapeutic effect of top-down therapy for inflammatory bowel disease (IBD) has not been fully evaluated in real-world clinical settings. We compared the effectiveness of top-down and step-up therapies for IBD.
Methods
We retrospectively evaluated patients who were admitted with IBD (Crohn’s disease [CD] or ulcerative colitis [UC]) between 2012 and 2019 using the nationwide Japan Diagnosis Procedure Combination database. Patients who received immunomodulators or biologic agents at the start of observation were assigned to the top-down group and those who did not were enrolled in the step-up group. Relapse was the primary outcome, a composite outcome defined as surgery, new steroid or immunomodulator use, hospitalization, a new biologic agent, or switching biologic agents.
Results
We analyzed 6715 patients (CD, N = 3643; UC, N = 3072). Relapse occurred in 1982 CD cases (54.4%).
The cumulative CD relapse incidence was 32.9% at 1 year and 61.3% at 5 years in the top-down group and 30.7% at 1 year and 58.6% at 5 years in the step-up group. Relapse occurred in 2032 UC cases (47.8%). The cumulative relapse incidence was 33.5% at 1 year and 50.0% at 5 years in the top-down group and 35.2% at 1 year and 51.6% at 5 years in the step-up group. No clinical factors associated with relapse were identified in patients with CD or UC.
Conclusion
Compared with step-up therapy, top-down therapy was not associated with a decreased relapse risk in a real-world population of patients with CD or UC.
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Acknowledgements
Data for this study was provided by the Database Center of the National University Hospitals, University of Tokyo Hospital. Use of the data was approved by the Database Center Management Committee, National University Hospital Council of Japan (No. 2020-K001: 1/19/2021).
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Ochi M, Niikura R, Otsubo T, Yamada A, Kawai T, and Koike K contributed equally to this work. Ochi M, Niikura R, and Otsubo T collected and analyzed the data. Ochi M drafted the manuscript. Ochi M and Niikura R designed and supervised the study. The statistical methods of this study were reviewed by Otsubo T. Yamada A, Kawai T, and Koike K offered technical or material support. All authors have read and approved the final version to be published.
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The University of Tokyo Hospital Institutional Review Board approved the study (2058–2). The study was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.
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Ochi, M., Niikura, R., Otsubo, T. et al. Comparison of inflammatory bowel disease relapse after top-down or step-up therapy: a population-based cohort study. Int J Colorectal Dis 36, 2227–2235 (2021). https://doi.org/10.1007/s00384-021-04007-4
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DOI: https://doi.org/10.1007/s00384-021-04007-4