1.Factors affecting 1-year persistence with vedolizumab for ulcerative colitis: a multicenter, retrospective real-world study
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
Intestinal Research 2026;24(1):64-75
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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