Evidence map›Paper›PMID 36626567›Full record

ArticleInflammatory bowel diseases2023

Real-World Evidence of Effectiveness and Safety of Vedolizumab for Inflammatory Bowel Disease in Taiwan: A Prospective Nationwide Registry (VIOLET) Study.

Wei-Chen Lin, Wei-Chen Tai, Chung-Hsin Chang, Chia-Hung Tu, I-Che Feng, Ming-Jium Shieh, Chen-Shuan Chung, Hsu-Heng Yen, Jen-Wei Chou, Jau-Min Wong and 29 more

Open access · greenAbstract read
In one paragraph

Article in Inflammatory bowel diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors at 19 institutions in 1 country.

Wei-Chen LinDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.ORCID 0000-0002-8142-538X
Wei-Chen TaiDivision of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.
Chung-Hsin ChangDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
Chia-Hung TuDepartment of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
I-Che FengDivision of Gastroenterology and Hepatology, Chi Mei Medical Center, Tainan, Taiwan.
Ming-Jium ShiehDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Chen-Shuan ChungDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.
Hsu-Heng YenDivision of Gastroenterology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan.
Jen-Wei ChouDivision of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Jau-Min WongDepartment of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Yu-Hwa LiuDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
Tien-Yu HuangDivision of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
Chiao-Hsiung ChuangDepartment of Internal Medicine, Medical College and Hospital, National Cheng Kung University, Tainan, Taiwan.
Tzung-Jiun TsaiDivision of Gastroenterology and Hepatology, Department of Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
Feng-Fan ChiangDivision of Colon and Rectal Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung, Taiwan.
Chien-Yu LuDivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Wen-Hung HsuDivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Fang-Jung YuDivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Te-Hsin ChaoDivision of Colon and Rectal Surgery, Department of Surgery, Chiayi and Wangiao Branch, Taichung Veterans General Hospital, Taichung, Taiwan.
Deng-Chyang WuDivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Ai-Sheng HoDivision of Gastroenterology, Department of Internal Medicine, Cheng Hsin General Hospital, Taipei, Taiwan.
Hung-Hsin LinDivision of Colon and Rectal Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.
Chun-Lung FengDivision of Gastroenterology and Hepatology, China Medical University Hsinchu Hospital, Hsinchu, Taiwan.
Keng-Liang WuDivision of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.
Ming-Wun WongDepartment of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.
Chien-Chih TungDepartment of Integrated Diagnostics and Therapeutics, National Taiwan University Hospital, Taipei, Taiwan.
Chun-Chi LinDivision of Colon and Rectal Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.
Chia-Chang ChenDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
Huang-Ming HuDivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Lung-Sheng LuDivision of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Huann-Sheng WangDivision of Colorectal Surgery, Department of Surgery, Taipei Veterans General Hospital, National Yang Ming Chiao Tung University, Taipei, Taiwan.
I-Chen WuDivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Hsin-Yu KuoDepartment of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Jia-Feng WuDepartment of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.
Hsiang Yao ShihDivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Yen-Hsuan NiDepartment of Pediatrics, College of Medicine, National Taiwan University, Taipei, Taiwan.
Shu-Lun TangTakeda Pharmaceuticals Taiwan, Ltd., Taipei, Taiwan.
Peng-Hsu ChenTakeda Pharmaceuticals Taiwan, Ltd., Taipei, Taiwan.
Shu-Chen WeiDepartment of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.ORCID 0000-0002-5017-5840
Kaohsiung Medical University · TWNational Taiwan University Hospital · TWTaichung Veterans General Hospital · TWChina Medical University · TWKaohsiung Chang Gung Memorial Hospital · TWTaipei Veterans General Hospital · TWChang Gung University · TWChanghua Christian Hospital · TWCheng Hsin General Hospital · TWChi Mei Medical Center · TWFar Eastern Memorial Hospital · TWKaohsiung Veterans General Hospital · TWMackay Memorial Hospital · TWNational Cheng Kung University · TWNational Cheng Kung University Hospital · TWNational Taiwan University · TWNational Yang Ming Chiao Tung University · TWTri-Service General Hospital · TWTzu Chi University · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis nationwide prospective registry study investigated the real-world effectiveness, safety, and persistence of vedolizumab (VDZ) in inflammatory bowel disease (IBD) patients in Taiwan. Disease relapse rates after VDZ discontinuation due to reimbursement restriction were assessed.

methodsData were collected prospectively (January 2018 to May 2020) from the Taiwan Society of IBD registry.

resultsOverall, 274 patients (147 ulcerative colitis [UC] patients, 127 Crohn's disease [CD] patients) were included. Among them, 70.7% with UC and 50.4% with CD were biologic-naïve. At 1 year, 76.0%, 58.0%, 35.0%, and 62.2% of UC patients and 57.1%, 71.4%, 33.3%, and 30.0% of CD patients achieved clinical response, clinical remission, steroid-free remission, and mucosal healing, respectively. All patients underwent hepatitis B and tuberculosis screening before initiating biologics, and prophylaxis was recommended when necessary. One hepatitis B carrier, without antiviral prophylaxis due to economic barriers, had hepatitis B reactivation during steroid tapering and increasing azathioprine dosage, which was controlled with an antiviral agent. No tuberculosis reactivation was noted. At 12 months, non-reimbursement-related treatment persistence rates were 94.0% and 82.5% in UC and CD patients, respectively. Moreover, 75.3% of IBD patients discontinued VDZ due to mandatory drug holiday. Relapse rates after VDZ discontinuation at 6 and 12 months were 36.7% and 64.3% in CD patients and 42.9% and 52.4% in UC patients, respectively.

conclusionsThe findings demonstrated VDZ effectiveness in IBD patients in Taiwan, with high treatment persistence rates and favorable safety profiles. A substantial IBD relapse rate was observed in patients who had mandatory drug holiday.

Indexed as

Colitis, UlcerativeCrohn DiseaseHepatitis BInflammatory Bowel DiseasesAntibodies, Monoclonal, HumanizedGastrointestinal AgentsHumansRecurrenceRemission InductionRetrospective StudiesTaiwanTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal AgentsvedolizumabCrohn’s diseasereimbursementulcerative colitisvedolizumab

Identifiers

PMID36626567
PMCPMC10918762
OpenAlexW4315436599

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.