Intestinal Research

Original Article

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; Received May 1, 2024 Accepted October 5, 2024 Published online January 16, 2025; DOI: https://doi.org/10.5217/ir.2024.00063 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: 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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Case Report

IBD

Combined eosinophilic gastroenteritis and ulcerative colitis successfully treated by vedolizumab: a case report: Hironobu Takedomi, Kayoko Fukuda, Suma Inoue, Nanae Tsuruoka, Yasuhisa Sakata, Shigehisa Aoki, Motohiro Esaki; Intest Res 2025;23(1):107-111. Published online August 29, 2024; DOI: https://doi.org/10.5217/ir.2024.00013

Abstract PDF PubReader ePub: A 47-year-old man with over 10 years’ duration of ulcerative colitis treated by 5-aminosalicylic acid and intermittent topical steroids complained of acute epigastric pain. Esophagogastroduodenoscopy revealed diffuse mucosal edema with patchy redness, multiple erosions and nodularity of the stomach. Bioptic examination revealed marked eosinophilic infiltration, confirming the diagnosis of eosinophilic gastroenteritis. Systemic steroid therapy was initiated, whereas his ulcerative colitis and eosinophilia recurred when tapering the steroid. Addition of azathioprine was ineffective, and we subsequently started vedolizumab for eosinophilic gastroenteritis and ulcerative colitis. The medication effectively improved his abdominal symptoms and esophagogastroduodenoscopy and ileocolonoscopy 1 year later revealed endoscopic improvement of both diseases with histologically decreased level of eosinophilic infiltration. Considering that eosinophils also express α4β7 integrins, vedolizumab can be a possible therapeutic candidate for eosinophilic gastroenteritis as well as ulcerative colitis.

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Original Articles

IBD

Live-attenuated vaccination in patients with inflammatory bowel disease while continuing or after elective switch to vedolizumab: Hisashi Shiga, Hiroshi Nagai, Yusuke Shimoyama, Takeo Naito, Rintaro Moroi, Yoichi Kakuta, Yoshitaka Kinouchi, Atsushi Masamune; Intest Res 2024;22(3):378-386. Published online March 26, 2024; DOI: https://doi.org/10.5217/ir.2023.00203

Abstract PDF PubReader ePub

Background/Aims
Vedolizumab (VDZ) is a gut-selective agent with a favorable safety profile. We aimed to assess the feasibility of elective switch from other advanced therapies to VDZ and subsequent live-attenuated vaccination while continuing VDZ in patients with inflammatory bowel diseases (IBD).
Methods
We measured antibody titers specific for measles, rubella, mumps, and varicella viruses in IBD patients under immunosuppressive therapy. Those with negative titers and without vaccination history were judged unimmunized. Patients were administered vaccines while continuing VDZ or switched to VDZ if receiving other advanced therapies and then administered vaccines. Co-primary outcomes were the rate of maintaining disease severity after vaccination and the rate without vaccine-induced infection.
Results
Among 107 unimmunized patients, 37 agreed to receive live-attenuated vaccines while continuing VDZ (17 patients) or after switching to VDZ (20 patients). In the 20 patients who electively switched to VDZ, disease severity was maintained except for 1 patient who developed intestinal infection. After 54 weeks, 18 patients (90%) continued to receive VDZ, excluding 2 patients who reverted to their originally administered biologics. In all 37 patients administered live-attenuated vaccines under VDZ treatment, disease severity was maintained after vaccination. Antibody titers became positive or equivocal in 34 patients (91.9%). There were no cases of vaccine-induced infection during a median observation period of 121 weeks.
Conclusions
While live-attenuated vaccines are contraindicated under immunosuppressive therapy, they may be safely administered while receiving VDZ immunotherapy. Switching from other advanced therapies to VDZ and subsequently receiving live-attenuated vaccines may be a safe alternative in unimmunized patients.

Citations

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Live Typhoid and Yellow Fever Vaccines Administered to a Patient With Ulcerative Colitis on Vedolizumab
Yash Hegde, Mary S. Hayney, Freddy Caldera
ACG Case Reports Journal.2024; 11(10): e01507. CrossRef

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IBD

Vedolizumab for perianal fistulizing Crohn’s disease: systematic review and meta-analysis: Fares Ayoub, Matthew Odenwald, Dejan Micic, Sushila R. Dalal, Joel Pekow, Russell D. Cohen, David T. Rubin, Atsushi Sakuraba; Intest Res 2022;20(2):240-250. Published online February 8, 2022; DOI: https://doi.org/10.5217/ir.2021.00091

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Perianal fistulas are a debilitating manifestation of Crohn’s disease (CD). Despite the advent of anti-tumor necrosis factor (anti-TNF) therapy, the medical management of fistulizing CD continues to be challenged by unmet needs. We conducted a systematic review and meta-analysis of the effectiveness of vedolizumab for the management of perianal fistulizing CD.
Methods
A search of PubMed, EMBASE and the Cochrane Library was performed from inception to June 2020 for studies reporting rates of perianal fistula healing in CD patients treated with vedolizumab. The primary outcome of interest was complete healing of perianal fistulas and the secondary outcome was partial healing. The pooled fistula healing rates with 95% confidence intervals (CI) were calculated utilizing a random effects model.
Results
A total of 74 studies were initially identified, 4 of which met the inclusion criteria. A total of 198 patients with active perianal fistulas were included, 87% of whom had failed previous anti-TNF therapy. The pooled complete healing rate was 27.6% (95% CI, 18.9%–37.3%) with moderate heterogeneity (I2=49.4%) and the pooled partial healing rate was 34.9% (95% CI, 23.2%–47.7%) with high heterogeneity (I2=67.1%).
Conclusions
In a meta-analysis of 4 studies that included 198 patients with perianal fistulizing CD, the majority of whom had failed previous anti-TNF therapy, vedolizumab treatment led to healing of perianal fistulas in nearly one-third of the patients. The lack of high-quality data and significant study heterogeneity underscores the need for future prospective studies of fistula healing in patients receiving anti-integrin therapy.

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Kimia Basiji, Nesa Kazemifard, Maryam Farmani, Kasra Jahankhani, Shaghayegh Baradaran Ghavami, Amir Fallahnia, Hesameddin Eghlimi, Adil Mir
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Malcolm Irani, Bincy Abraham
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Antonio Tursi, Giammarco Mocci, Angelo Del Gaudio, Alfredo Papa
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Soo-Young Na, You Sun Kim
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IBD

Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation: Brigida Barberio, Edoardo Vincenzo Savarino, Timothy Card, Cristina Canova, Francesco Baldisser, Alessandro Gubbiotti, Davide Massimi, Matteo Ghisa, Fabiana Zingone; Intest Res 2022;20(1):114-123. Published online August 4, 2021; DOI: https://doi.org/10.5217/ir.2021.00037

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Current literature is lacking in studies comparing the incidence of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. Therefore, our primary aim was to compare the AEs occurring in patients taking ADA to those of patients taking VDZ.
Methods
In this single center study, data on AEs from IBD patients who underwent treatment with ADA and VDZ were retrospectively collected. AE rates per 100 person-years were calculated. A Cox regression model was used to estimate the hazard ratios of the AEs between the 2 drugs.
Results
A total of 16 ADA patients (17.2%) and 11 VDZ patients (7.6%) had AEs causing drug interruption during the study period (P=0.02). Most of the AEs were noninfectious extraintestinal events (50% in ADA and 54.5% in VDZ) while infections accounted for 31.2% of the AEs in patients treated with ADA and 27.3% in those treated with VDZ. The incidence rate of AEs causing withdrawal of therapy was 13.2 per 100 person-years for ADA and 5.3 per 100 person-years for VDZ, corresponding to a 76% lower risk in patients in VDZ. Considering the first year of treatment, we observed 34 subjects treated with ADA (36.5%) having at least 1 AEs and 57 (39.3%) among those taking VDZ (P=0.67).
Conclusions
VDZ has a lower incidence rate of AEs causing withdrawal of treatment compared to ADA but a similar risk of AEs not causing drug interruption. Real-life head-to-head studies are still necessary to further explore the safety profile of these drugs.

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Comparative Risk of Serious Infection With Vedolizumab vs Anti-Tumor Necrosis Factor in Inflammatory Bowel Disease: Results From Nationwide Swedish Registers
Sara Karlqvist, Michael C. Sachs, Carl Eriksson, Yang Cao, Scott Montgomery, Jonas F. Ludvigsson, Ola Olén, Jonas Halfvarson
American Journal of Gastroenterology.2024; 119(12): 2480. CrossRef
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Infectious complications in patients with inflammatory bowel disease in Asia: the results of a multinational web-based survey in the 8th Asian Organization for Crohn’s and Colitis meeting
Yu Kyung Jun, Seong-Joon Koh, Dae Seong Myung, Sang Hyoung Park, Choon Jin Ooi, Ajit Sood, Jong Pil Im
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Jihye Park
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IBD

Vedolizumab does not increase perioperative surgical complications in patients with inflammatory bowel disease, cohort study: Vitaliy Y. Poylin, Jose Cataneo Serrato, Jonathan Pastrana Del Valle, Joseph D. Feuerstein; Intest Res 2022;20(1):72-77. Published online February 3, 2021; DOI: https://doi.org/10.5217/ir.2020.00117

Abstract PDF PubReader ePub

Background/Aims
Biologics are increasingly used to manage ulcerative colitis (UC) and Crohn’s disease (CD). However, even with earlier usage of biologic therapy, a significant proportion of patients will require surgery. Vedolizumab is an anti-integrin antibody that is increasingly used given that it is more gut selective and associated with fewer side effects. The aim of this study is to assess the effect of vedolizumab compared to anti-tumor necrosis factor (anti-TNF) therapy on the perioperative complications in patients undergoing surgery for inflammatory bowel disease (IBD).
Methods
Retrospective review of patients treated for IBD at a tertiary care center between 2013 and 2017. Rates of 30- and 90-day complications for patients on vedolizumab were compared to patients on anti-TNF regimens.
Results
One hundred and ninety-nine patients met inclusion criteria with 87 (43%) patients undergoing surgery for CD, 111 (55.8%) for UC and 1 (0.5%) for indeterminate colitis. Thirty-eight patients received preoperative vedolizumab and 94 received anti-TNF. There were more males and lower body mass index in the anti-TNF group. There was no significant difference in overall rate of complications at 30 or 90 days. There was a trend for lower leak rate vedolizumab group (0% for vedolizumab vs. 2.1% for anti-TNF at 30 days, P= 1.00; 0% for vedolizumab vs. 1.1% for anti-TNF at 90 days, P= 1.00). Multivariate analysis showed low albumin ( < 3.6 g/dL) at the time of surgery to be a significant risk factor for overall and infectious complications at 90 days (odds ratio, 3.24; 95% confidence interval, 1.12–8.79; P= 0.021).
Conclusions
Perioperative vedolizumab does not increase rates of perioperative complications in IBD surgery when compared to anti-TNF medications.

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Inflammatory Bowel Diseases

Efficacy and safety of vedolizumab in Crohn’s disease in patients from Asian countries in the GEMINI 2 study: Rupa Banerjee, Sai Wei Chuah, Ida Normiha Hilmi, Deng-Chyang Wu, Suk-Kyun Yang, Dirk Demuth, Dirk Lindner, Shashi Adsul; Intest Res 2021;19(1):83-94. Published online December 31, 2020; DOI: https://doi.org/10.5217/ir.2019.09160

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The efficacy and safety of vedolizumab in moderate-to-severely active Crohn’s disease (CD) were demonstrated in the GEMINI 2 study (NCT00783692). This post-hoc exploratory analysis aimed to assess the efficacy and safety of vedolizumab in the subgroup of patients from Asian countries.
Methods
During the induction phase (doses at day 1, 15), clinical remission, enhanced clinical response, and change in C-reactive protein at 6 weeks; during the maintenance phase, clinical remission, enhanced clinical response, glucocorticoid-free remission and durable clinical remission at 52 weeks, were the efficacy outcomes of interest. Efficacy and safety of vedolizumab compared to placebo were assessed in Asian countries (Hong Kong, India, Malaysia, Singapore, South Korea, and Taiwan) using descriptive analyses.
Results
During the induction phase, in Asian countries (n = 51), 14.7% of the vedolizumab-treated patients achieved clinical remission at week 6 compared to none with placebo (difference, 14.7%; 95% confidence interval, 15.8%–43.5%). In non-Asian countries (n = 317), the remission rate at week 6 with vedolizumab was 14.5%. During maintenance, in Asian countries, clinical remission rates at 52 weeks with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks and placebo were 41.7%, 36.4%, and 0%, respectively; while enhanced clinical response rates were 41.7%, 63.6%, and 42.9%, respectively. During induction, 39.7% of patients with vedolizumab experienced an adverse event compared to 58.8% of patients with placebo, and vedolizumab was generally well-tolerated.
Conclusions
This post-hoc analysis demonstrates the treatment effect and safety of vedolizumab in moderateto-severely active CD in patients from Asian countries.

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Prevention of postoperative recurrence in Crohn’s disease: the never-ending story
Jung-Bin Park, Sang Hyoung Park
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Seung Hwan Shin, Sang Hyoung Park
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Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
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Hyo Yeop Song, Geom Seog Seo
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Inflammatory Bowel Diseases

Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study: Choon Jin Ooi, Ida Normiha Hilmi, Hyo-Jong Kim, Umesh Jalihal, Deng-Chyang Wu, Dirk Demuth, Dirk Lindner, Shashi Adsul; Intest Res 2021;19(1):71-82. Published online September 4, 2020; DOI: https://doi.org/10.5217/ir.2019.09159

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The efficacy and safety of vedolizumab in moderate to severely active ulcerative colitis (UC) have been demonstrated in the GEMINI 1 study (NCT00783718). This post-hoc exploratory analysis sought to establish the efficacy and safety of vedolizumab in a subgroup of patients from Asian countries with UC from GEMINI 1.
Methods
Efficacy outcomes of interest were clinical response, clinical remission and mucosal healing at week 6 (induction phase); and clinical remission, durable clinical response, durable clinical remission, mucosal healing and glucocorticoid-free remission at week 52 (maintenance phase). Differences in outcome rates between vedolizumab and placebo in Asian countries (Hong Kong, India, Malaysia, Singapore, South Korea, and Taiwan) were assessed using descriptive analyses, and efficacy and safety compared between Asian and non-Asian countries.
Results
During induction, in Asian countries (n = 58), clinical response rates at week 6 with vedolizumab and placebo were 55.2% and 24.1%, respectively (difference 31.0%; 95% confidence interval: 7.2%–54.9%). In non-Asian countries (n = 316), response rates at week 6 with vedolizumab and placebo were 45.9% and 25.8%, respectively. During maintenance, in Asian countries, clinical remission rates at 52 weeks with vedolizumab administered every 8 weeks, vedolizumab administered every 4 weeks and placebo were 9.1%, 36.8%, and 31.6%, respectively; corresponding rates for mucosal healing were 45.5%, 47.4%, and 47.4%, respectively. Vedolizumab was well-tolerated; adverse event frequency was comparable in Asian and non-Asian countries.
Conclusions
In patients from Asian countries, the efficacy and safety of vedolizumab in treatment of UC were broadly consistent with that in the overall study population.

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Application of clinical decision support tools for predicting outcomes with vedolizumab therapy in patients with inflammatory bowel disease: A KASID multicentre study
Kyuwon Kim, Jae Jun Park, Hyuk Yoon, Jun Lee, Kyeong Ok Kim, Eun Sun Kim, Su Young Kim, Sun‐Jin Boo, Yunho Jung, Jun Hwan Yoo, Sung Wook Hwang, Sang Hyoung Park, Suk‐Kyun Yang, Byong Duk Ye
Alimentary Pharmacology & Therapeutics.2024; 59(12): 1539. CrossRef
Clinical performance of fecal calprotectin, lactoferrin, and hemoglobin for evaluating the disease activity of IBD and detecting colorectal tumors
Tsukasa Yamakawa, Takakazu Miyake, Yoshihiro Yokoyama, Tomoe Kazama, Yuki Hayashi, Daisuke Hirayama, Shinji Yoshii, Hiro‐o Yamano, Satoshi Takahashi, Hiroshi Nakase
JGH Open.2024;[Epub] CrossRef
The role and prospect of tofacitinib in patients with ulcerative colitis
Jun Lee
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The treatment of inflammatory bowel disease with monoclonal antibodies in Asia
Yu Chen, Guolin Zhang, Yuewen Yang, Shuangshuang Zhang, Haozheng Jiang, Kang Tian, Arenbaoligao, Dapeng Chen
Biomedicine & Pharmacotherapy.2023; 157: 114081. CrossRef
Effectiveness and safety of vedolizumab for ulcerative colitis: a single-center retrospective real-world study in China
Kaituo Huang, Jing Liu, Wenhao Xia, Chuwen Tian, Lingya Yao, Qian Cao, Haotian Chen
Frontiers in Pharmacology.2023;[Epub] CrossRef
The effectiveness and safety of vedolizumab induction for moderate to severe ulcerative colitis for Asia patient: A real practice observational study
Chia-Jung Kuo, Puo-Hsien Le, Wei-Chen Tai, Keng-Liang Wu, Hsu-Heng Yen, Chih-Wei Yen, Shui-Yi Tung, Chen-Shuan Chung, Ming-Yao Su, Cheng-Tang Chiu
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Vitaliy Y. Poylin, Jose Cataneo Serrato, Jonathan Pastrana Del Valle, Joseph D. Feuerstein
Intestinal Research.2022; 20(1): 72. CrossRef
Comparative effectiveness of second-line biological therapies for ulcerative colitis and Crohn’s disease in patients with prior failure of anti-tumour necrosis factor treatment
Hye Kyung Hyun, Hyun-Soo Zhang, Jongwook Yu, Eun Ae Kang, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Won Ho Kim, Jae Hee Cheon
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Myeong Geun Choi, Byong Duk Ye, Suk-Kyun Yang, Tae Sun Shim, Kyung-Wook Jo, Sang Hyoung Park
Journal of Korean Medical Science.2022;[Epub] CrossRef
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Su Hyun Park, Sang Hyoung Park
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Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis
Kyuwon Kim, Hee Seung Hong, Kyunghwan Oh, Jae Yong Lee, Seung Wook Hong, Jin Hwa Park, Sung Wook Hwang, Dong-Hoon Yang, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Byong Duk Ye, Sang Hyoung Park
The Korean Journal of Internal Medicine.2022; 37(6): 1140. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
Soo-Young Na, You Sun Kim
The Korean Journal of Internal Medicine.2022; 37(5): 906. CrossRef
Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
Intestinal Research.2022; 20(4): 418. CrossRef
Treatment of inflammatory bowel diseases: focusing on biologic agents and new therapies
Hyo Yeop Song, Geom Seog Seo
Journal of the Korean Medical Association.2021; 64(9): 605. CrossRef
Combination of vedolizumab and immunomodulators in ulcerative colitis
P Pinton
Journal of Gastroenterology and Hepatology.2021; 36(12): 3556. CrossRef
Adalimumab, Infliximab, and Vedolizumab in Treatment of Ulcerative Colitis: A Long-Term Retrospective Study in a Tertiary Referral Center
Ann-Lorie Gagnon, William Beauchesne, Laurence Tessier, Charles David, Djamal Berbiche, Alexandre Lavoie, Alban Michaud-Herbst, Karine Tremblay
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Prasanta Debnath, Pravin M. Rathi
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Inflammatory Bowel Diseases

Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis: Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2021;19(4):448-460. Published online August 18, 2020; DOI: https://doi.org/10.5217/ir.2020.00026

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.
Methods
Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.
Results
Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.
Conclusions
Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)

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Valoración de la transición de vedolizumab intravenoso a subcutáneo en pacientes con enfermedad inflamatoria intestinal
Carmen Amor Costa, Cristina Suárez Ferrer, Laura García Ramírez, Eduardo Martín-Arranz, Joaquín Poza Cordón, José Luis Rueda García, María Sánchez Azofra, Irene González Diaz, Clara Amiama Roig, María Dolores Martín-Arranz
Gastroenterología y Hepatología.2025; 48(3): 502201. CrossRef
Evaluation of the transition from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease
Carmen Amor Costa, Cristina Suárez Ferrer, Laura García Ramírez, Eduardo Martín-Arranz, Joaquín Poza Cordón, José Luis Rueda García, María Sánchez Azofra, Irene González Diaz, Clara Amiama Roig, María Dolores Martín-Arranz
Gastroenterología y Hepatología (English Edition).2025; 48(3): 502201. CrossRef
Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis
Qiong Hu, Xing-zhou Tang, Fang Liu, De-wu Liu, Bo Cao
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef
Network meta-analysis on efficacy and safety of different biologics for ulcerative colitis
Xinqiao Chu, Yaning Biao, Chengjiang Liu, Yixin Zhang, Chenxu Liu, Ji-zheng Ma, Yufeng Guo, Yaru Gu
BMC Gastroenterology.2023;[Epub] CrossRef
Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease – a systematic review with meta-analysis
Mohamed Attauabi, Gorm Roager Madsen, Flemming Bendtsen, Jakob Benedict Seidelin, Johan Burisch
Digestive and Liver Disease.2022; 54(9): 1168. CrossRef
AJM300 (carotegrast methyl), an oral antagonist of α4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study
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Sheridan M. Hoy
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Inflammatory Bowel Diseases

Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn’s disease: Hiroyuki Okamoto, Nathanael L. Dirks, Maria Rosario, Tetsuharu Hori, Toshifumi Hibi; Intest Res 2021;19(1):95-105. Published online July 10, 2020; DOI: https://doi.org/10.5217/ir.2019.09167

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Vedolizumab is indicated for moderately-to-severely active ulcerative colitis (UC) and Crohn’s disease (CD). Because multiple factors may result in different pharmacokinetics and clinical efficacies, understanding determinants of vedolizumab clearance may enhance dose and treatment strategies. The aim was to characterize vedolizumab pharmacokinetics in Asian and non-Asian UC and CD patients.
Methods
Population pharmacokinetic analysis for repeated measures, using data from 5 studies, was conducted using nonlinear mixed-effects modeling. A Bayesian estimation approach in NONMEM 7.3 was utilized to leverage the predominantly sparse data available for this analysis with results from a prior population pharmacokinetic analysis of vedolizumab.
Results
Vedolizumab pharmacokinetics were described by a 2-compartment model with parallel linear and nonlinear elimination. Using reference covariate values, linear elimination half life of vedolizumab was 24.7 days for anti-vedolizumab antibody (AVA)-negative patients and 18.1 days for AVA-positive patients; linear clearance (CL_L) was 0.165 L/day for AVA-negative patients and 0.246 L/day for AVA-positive patients; central (V_c) and peripheral compartment volumes of distribution were 3.16 L and 1.84 L, respectively. Interindividual variabilities (percent coefficient of variation) were 30.8% for CL_L and 19% for V_c; interoccasion variability on CL_L was 20.3%; residual variance was 17.8%. For albumin, body weight and AVA, only extreme values were identified as potentially clinically important predictors of CL_L. The effect of race (Asian/non-Asian) and diagnosis (UC/CD) on CL_L was negligible and likely not of clinical importance.
Conclusions
Pharmacokinetic parameters were similar in Asian and non-Asian patients with moderately-to-severely active UC and CD. This analysis supports use of vedolizumab flat-fixed dosing in these patients. (Clinicaltrials.gov Identifiers: NCT00783718 (GEMINI 1); NCT00783692 (GEMINI 2). CCT 101; NCT02039505 and CCT-001; NCT02038920)

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Review

IBD

Current new challenges in the management of ulcerative colitis: Tomohiro Fukuda, Makoto Naganuma, Takanori Kanai; Intest Res 2019;17(1):36-44. Published online January 25, 2019; DOI: https://doi.org/10.5217/ir.2018.00126

Abstract PDF PubReader ePub

Ulcerative colitis (UC) is a chronic inflammatory condition of the gastrointestinal tract. Although the cause of UC is postulated to be multifactorial in nature, including genetic predisposition, epithelial barrier defects, dysregulation of immune responses, and environmental factors, the specific pathogenesis of UC is still incompletely understood. In the treatment of UC so far, a method of suppressing immunity and treating it has been mainstream. Immunosuppressant drugs, including thiopurines (azathioprine or 6-mercaptopurine), anti-tumor necrosis factor-α (anti-TNF-α) antibody (infliximab and adalimumab), and calcineurin inhibitor, can be used in treat patients with corticosteroid-dependent and/or corticosteroid-refractory moderateto- severe UC. Recently, in addition to such a conventional therapeutic agent, golimumab, which is the first transgenic human monoclonal anti-TNF-α antibody to be fabricated, anti α-4/β-7 integrin antibody, and Janus kinase inhibitor have been reported to novel immunosuppressant therapy. Furthermore, other treatments with unique mechanisms different from immunosuppression, have also been suggested, including fecal microbiota transplantation and Indigo naturalis, which is a Chinese herbal medicine. We compared the features and efficacy of these new treatments. In this issue, the features and treatment options for these new treatments is reviewed.

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