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Factors affecting 1-year persistence with vedolizumab for ulcerative colitis: a multicenter, retrospective real-world study
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Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Jovelle L. Fernandez, Kaori Ishiguro, Mary Cavaliere, Hisato Deguchi, Toshifumi Hibi
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Received May 1, 2024 Accepted October 5, 2024 Published online January 16, 2025
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DOI: https://doi.org/10.5217/ir.2024.00063
[Epub ahead of print]
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Abstract
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- Background/Aims
The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response.
Methods In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled.
Results Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00–7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13–0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response.
Conclusions Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.
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