Intestinal Research

Original Articles

Week 2 remission with vedolizumab as a predictor of long-term remission in patients with ulcerative colitis: a multicenter, retrospective, observational 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, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi; Received April 9, 2024 Accepted April 6, 2025 Published online July 14, 2025; DOI: https://doi.org/10.5217/ir.2025.00047 [Epub ahead of print]

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Background/Aims
Vedolizumab (VDZ), a gut-selective monoclonal antibody for ulcerative colitis (UC) treatment, has no established biomarkers or clinical features that predict long-term remission. Week 2 remission, a potential predictor of long-term remission, could inform maintenance treatment strategy.
Methods
This retrospective, observational chart review included patients with UC in Japan who initiated VDZ between December 2018 and February 2020. Outcome measures included 14- and 54-week remission rates in patients with week 2 and non-week 2 remission (remission by week 14), 54-week remission rates in patients with week 14 remission and primary nonresponse, and predictive factors of week 2 and week 54 remission (logistic regression).
Results
Overall, 332 patients with UC (176 biologic-naïve and 156 biologic-non-naïve) were included. Significantly more biologic-naïve than biologic-non-naïve patients achieved week 2 remission (36.9% vs. 28.2%; odds ratio [OR], 1.43; 95% confidence interval [CI], 1.05–1.94; P= 0.0224). Week 54 remission rates were significantly different between week 14 remission and primary nonresponse (both groups: P< 0.0001), and between week 2 and non-week 2 remission (all patients: OR, 2.41; 95% CI, 1.30–4.48; P= 0.0052; biologic-naïve patients: OR, 2.40; 95% CI, 1.10–5.24; P= 0.0280). Week 2 remission predictors were male sex, no anti-tumor necrosis factor alpha exposure, and normal/mild endoscopic findings. Week 54 remission was significantly associated with week 2 remission and no tacrolimus use.
Conclusions
Week 2 remission with VDZ is a predictor of week 54 remission in patients with UC. Week 2 may be used as an evaluation point for UC treatment decisions. (Japanese Registry of Clinical Trials: jRCT-1080225363)

Citations

Citations to this article as recorded by

Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
Jung Min Moon
Intestinal Research.2026; 24(1): 3. CrossRef

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592 Download
1 Crossref

The duration of prior anti-tumor necrosis factor agents is associated with the effectiveness of vedolizumab in patients with ulcerative colitis: a real-world multicenter retrospective study: Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Minoru Matsuura, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi; Received August 9, 2024 Accepted March 20, 2025 Published online June 4, 2025; DOI: https://doi.org/10.5217/ir.2024.00126 [Epub ahead of print]

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Background/Aims
Previous literature suggests that the response of patients with ulcerative colitis to vedolizumab may be affected by previous biologic therapy exposure. This real-world study evaluated vedolizumab treatment effectiveness in biologicnon-naïve patients.
Methods
This was a multicenter, retrospective, observational chart review of records from 16 hospitals in Japan (December 1, 2018, to February 29, 2020). Included patients who had ulcerative colitis, were aged ≥ 20 years, and received at least 1 dose of vedolizumab. Outcomes included clinical remission rates from weeks 2 to 54 according to prior biologic exposure status and factors associated with clinical remission up to week 54.
Results
A total of 370 eligible patients were included. Clinical remission rates were significantly higher in biologic-naïve (n=197) than in biologic-non-naïve (n=173) patients for weeks 2 to 54 of vedolizumab treatment. Higher clinical remission rates up to week 54 were significantly associated with lower disease severity (partial Mayo score ≤ 4, P= 0.001; albumin ≥ 3.0, P= 0.019) and the duration of prior anti-tumor necrosis factor α (anti-TNFα) therapy (P= 0.026). Patients with anti-TNFα therapy durations of < 3 months, 3 to < 12 months, and ≥ 12 months had clinical remission rates of 28.1%, 32.7%, and 60.0%, respectively (P= 0.001 across groups).
Conclusions
The effectiveness of vedolizumab in biologic-non-naïve patients was significantly influenced by duration of prior anti-TNFα therapy. (Japanese Registry of Clinical Trials: jRCT-1080225363)

Citations

Citations to this article as recorded by

Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
Jung Min Moon
Intestinal Research.2026; 24(1): 3. CrossRef
Long-Term Outcomes and Prognostic Factors for Vedolizumab-Treated Japanese Patients with Ulcerative Colitis
Shinya Fukushima, Takehiko Katsurada, Takahiro Ito, Atsuo Maemoto, Fumika Orii, Toshifumi Ashida, Masanao Nasuno, Hiroki Tanaka, Katsuyoshi Ando, Mikihiro Fujiya, Yoshihiro Yokoyama, Satoshi Motoya, Hiroshi Nakase
Inflammatory Intestinal Diseases.2025; 11(1): 1. CrossRef

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2 Crossref

IBD

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; Intest Res 2026;24(1):64-75. Published online January 16, 2025; DOI: https://doi.org/10.5217/ir.2024.00063

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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.

Citations

Citations to this article as recorded by

Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
Jung Min Moon
Intestinal Research.2026; 24(1): 3. CrossRef
Real‐World Effectiveness and Safety of Vedolizumab in Patients ≥ 70 Versus < 70 Years With Ulcerative Colitis: Multicenter Retrospective Study
Tadakazu Hisamatsu, Taku Kobayashi, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Sakiko Hiraoka, Ken Takeuchi, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Ma
Journal of Gastroenterology and Hepatology.2025; 40(6): 1435. CrossRef
Increasing age at diagnosis raises malignancy risk and aminosalicylate intolerance influences therapeutic strategies in ulcerative colitis: a multicenter I‑BRITE cohort study
Shintaro Akiyama, Yuka Ito, Mamiko Shiroyama, Satoshi Suzuki, Masanori Ochi, Toshiro Kamoshida, Hiroshi Kashimura, Junichi Iwamoto, Rie Saito, Tsuyoshi Kaneko, Kazuto Ikezawa, Yoshinori Hiroshima, Junji Hattori, Takashi Mamiya, Satoshi Fukuda, Kazuho Iked
Journal of Gastroenterology.2025; 60(10): 1259. CrossRef
Mayo Endoscopic Subscore at Week 24 Is a Predictor of Future Loss of Response to Vedolizumab in Patients with Ulcerative Colitis in Clinical Remission
Daisuke Saito, Minoru Matsuura, Hiromu Morikubo, Noritaka Hibi, Haruka Komatsu, Noriaki Oguri, Takeshi Fujima, Haruka Wada, Ryota Ogihara, Tatsuya Mitsui, Mari Hayashida, Jun Miyoshi, Teppei Omori, Tadakazu Hisamatsu
Inflammatory Intestinal Diseases.2025; 10(1): 387. CrossRef

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IBD

Malnutrition and inflammation status in nonobese patients with inflammatory bowel disease are associated with nonalcoholic fatty liver disease: a retrospective study: Takahiro Nagata, Sadahiro Funakoshi, Daisuke Morihara, Satoshi Shakado, Keiji Yokoyama, Kazuhide Takata, Takashi Tanaka, Atsushi Fukunaga, Ryo Yamauchi, Hiromi Fukuda, Hiroki Matsuoka, So Imakiire, Hideto Sakisaka, Satoshi Matsuoka, Nobuaki Kuno, Koichi Abe, Hideki Ishibashi, Shinya Ashizuka, Fumihito Hirai; Intest Res 2023;21(4):471-480. Published online August 11, 2023; DOI: https://doi.org/10.5217/ir.2023.00035

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Background/Aims
The frequency and details of nonalcoholic fatty liver disease (NAFLD) complications in patients with inflammatory bowel disease (IBD) remain unclear. This study aimed to clarify characteristics of NAFLD in patients with IBD.
Methods
We retrospectively identified and enrolled patients with IBD diagnosed with or without NAFLD by undergoing abdominal computed tomography (CT) at our institution between 2005 and 2020. The primary endpoint was the complication rate of NAFLD in patients with IBD. Secondary endpoints were the clinical characteristics of nonobese patients with IBD and comorbid NAFLD and their association with nutritional and inflammatory parameters.
Results
Twenty-one (21.9%) of 96 eligible patients with IBD also had NAFLD. In nonobese patients (defined as patients with a body mass index <25 kg/m²), C-reactive protein (CRP; P<0.001) and alanine aminotransferase (P=0.018) levels were higher and the albumin level (P=0.005) and prognostic nutritional index (PNI; P=0.002) values were lower in patients with NAFLD than in those without NAFLD. The PNI value was positively correlated (P<0.001) and the CRP level was negatively correlated (P=0.001) with the hepatosplenic ratio. However, in the NAFLD combined group, PNI (P<0.05) and CRP values (P<0.001) were improved over time after CT imaging by continuing IBD treatment.
Conclusions
Worsening nutritional and inflammatory status in IBD patients is associated with complications of NAFLD. Diagnosis of NAFLD in IBD patients using CT imaging might be useful not only for early detection of NAFLD but also in assessing the need for therapeutic intervention for IBD.

Citations

Citations to this article as recorded by

Prevalence and Associated Factors of Nonalcoholic Fatty Liver Disease in Patients with Inflammatory Bowel Disease: An Updated Global Systematic Review and Meta-Analysis of over 1.5 Million Individuals
Narsimha Keetha Rao, Shahriar Ghodous, Anoop Gurram, Mehrdad Khorasani, Madhusudhan Ponnala, Arman Habibi, Kwame Agyeman, Parsa Saberian, Pubali Biswas, Negin Letafatkar, Simran Joshi, Yasmin Sahli, Reza Amani-Beni, Bahar Darouei, Yussif Issaka, Kiran San
Inflammatory Bowel Diseases.2026; 32(2): 350. CrossRef
Elucidating the association between nonalcoholic fatty liver disease and incidence of inflammatory bowel disease: a focus on systemic inflammation
Sihyun Kim, Jong Pil Im
Intestinal Research.2025; 23(1): 3. CrossRef
Metabolic Disorders and Inflammatory Bowel Diseases
Hye Kyung Hyun, Jae Hee Cheon
Gut and Liver.2025; 19(3): 307. CrossRef
Impact of body mass index on clinical outcomes in intestinal Behçet’s disease
Daye Park, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Hee Cheon
The Korean Journal of Internal Medicine.2025; 40(4): 606. CrossRef

5,620 View
262 Download
4 Web of Science
4 Crossref

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