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.
2.Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
Shunji WATANABE ; Naoki MORIMOTO ; Kouichi MIURA ; Toshimitsu MUROHISA ; Toshiyuki TAHARA ; Takashi SATO ; Shigeo TANO ; Yukimura FUKAYA ; Hidekazu KURATA ; Yukishige OKAMURA ; Norikatsu NUMAO ; Keita UEHARA ; Kozue MURAYAMA ; Katsuyuki NAKAZAWA ; Hitoshi SUGAYA ; Hiroaki YOSHIZUMI ; Makoto IIJIMA ; Mamiko TSUKUI ; Takuya HIROSAWA ; Yoshinari TAKAOKA ; Hiroaki NOMOTO ; Hiroshi MAEDA ; Rie GOKA ; Norio ISODA ; Hironori YAMAMOTO
Journal of Rural Medicine 2020;15(4):139-145
Objective: Combination therapy with glecaprevir and pibrentasvir (G/P) has been shown to provide a sustained virologic response (SVR) rate of >97% in patients with chronic hepatitis C virus (HCV) infection in the first published real-world Japanese data. However, a recently published study showed that the treatment was often discontinued in patients ≥75 years old, resulting in low SVR in intention-to-treat (ITT) analysis. Thus, our aim was to evaluate real-world data for G/P therapy in patients ≥75 years of age, the population density of which is high in “rural” regions.Patients and Methods: We conducted a multicenter study to assess the efficacy and safety of G/P therapy for chronic HCV infection, in the North Kanto area in Japan.Results: Of the 308 patients enrolled, 294 (95.5%) completed the treatment according to the protocol. In ITT and per-protocol analyses, the overall SVR12 rate was 97.1% and 99.7%, respectively. The old-aged patients group consisted of 59 participants, 56 of whom (94.9%) completed the scheduled protocol. Although old-aged patients tended to have non-SVR factors such as liver cirrhosis, history of HCC, and prior DAA therapies, the SVR12 rates in old-aged patients were 98.3% and 100% in the ITT and PP analyses, respectively. Of 308 patients enrolled, adverse events were observed in 74 patients (24.0%), with grade ≥3 events in 8 patients (2.6%). There was no significant difference in any grade and grade ≥3 adverse events between the old-aged group and the rest of the study participants. Only one patient discontinued the treatment because of adverse events.Conclusion: G/P therapy is effective and safe for old-aged patients.


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