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- Original Article Clinical characteristics of patients with difficult-to-treat ulcerative colitis: a nested case-control study using a Japanese claims database
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Katsuyoshi Matsuoka1
, Ataru Igarashi2,3
, Noriko Sato4
, Naomi Mizuno4
, Manabu Ishii5
, Masato Iizuka5
, Katsuhiko Iwasaki6
, Ayako Shoji6
, Tadakazu Hisamatsu7
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DOI: https://doi.org/10.5217/ir.2024.00119 [Epub ahead of print]
Published online: April 25, 2025
1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan
2Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan
3Department of Health Data Science, Yokohama City University School of Medicine, Yokohama, Japan
4Medical Affairs Department, Development and Medical Affairs Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
5Data Science Department, Development and Medical Affairs Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
6Healthcare Consulting, Inc., Tokyo, Japan
7Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan
2Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan
3Department of Health Data Science, Yokohama City University School of Medicine, Yokohama, Japan
4Medical Affairs Department, Development and Medical Affairs Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
5Data Science Department, Development and Medical Affairs Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
6Healthcare Consulting, Inc., Tokyo, Japan
7Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan
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Corresponding author:
Tadakazu Hisamatsu,
Email: thisamatsu@ks.kyorin-u.ac.jp
Received: 22 July 2024 • Revised: 24 January 2025 • Accepted: 11 February 2025
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Abstract
Background/Aims
Despite the advent of advanced therapies, cases of so-called “difficult-to-treat” (D2T) ulcerative colitis (UC) persist. This study aims to clarify the epidemiological and clinical characteristics of patients with D2T UC.
Methods
We conducted a nested case-control study using the Medical Data Vision Claims Database in patients with UC who began an advanced therapy (biologics, advanced small molecules, calcineurin inhibitors) from January 2018 through April 2023. D2T UC patients were defined as having 2 or more switches of advanced therapies, or as undergoing surgery for UC, within 2 years after the first advanced therapy.
Results
Four hundred and one (16.7%) and 1,996 patients (83.3%) met the definitions of patients with D2T UC and non-D2T UC, respectively. After 1:1 matching by index year, 355 patients per group were included in the analysis. Multivariate logistic regression analyses, including sensitivity analyses based on follow-up period after the first advanced therapy, showed that a prescribed corticosteroid dose of ≥ 30 mg/day during the 6-month baseline period was associated with D2T UC. In D2T UC patients, median duration of the first advanced therapy was 99 days, and median number of advanced therapies per year was 1.7. The first advanced therapy was continued for 2 years in 78% of patients with non-D2T UC.
Conclusions
The proportion of D2T UC patients among UC patients starting advanced therapy was 16.7%. The factor most associated with D2T UC was the need for a corticosteroid dose ≥ 30 mg/day during the 6 months before initiation of advanced therapy.
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