Evidence map›Paper›PMID 31100458›Full record

ArticleClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2020

Effects of Vedolizumab in Patients With Primary Sclerosing Cholangitis and Inflammatory Bowel Diseases.

Kate D Lynch, Roger W Chapman, Satish Keshav, Aldo J Montano-Loza, Andrew L Mason, Andreas E Kremer, Marcel Vetter, Manon de Krijger, Cyriel Y Ponsioen, Palak Trivedi and 26 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 4 pooled it
5.9field-weighted citation impact, top 3% 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

43 citing papers in PubMed, 4 syntheses or guidelines pooled it, 97 citations in OpenAlex.

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  15. Liver Involvement in Celiac Disease and Immune-Mediated Diseases of the Small Bowel.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Review
  16. Review
  17. Primary sclerosing cholangitis.Nature reviews. Disease primers · 2025
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

36 authors at 20 institutions in 10 countries.

Kate D LynchTranslational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Roger W ChapmanTranslational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Satish KeshavTranslational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Aldo J Montano-LozaDivision of Gastroenterology, University of Alberta, Edmonton, Canada.
Andrew L MasonDivision of Gastroenterology, University of Alberta, Edmonton, Canada.
Andreas E KremerDepartment of Medicine 1, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.
Marcel VetterDepartment of Medicine 1, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.
Manon de KrijgerDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Centres, Location AMC, Amsterdam, The Netherlands.
Cyriel Y PonsioenDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Centres, Location AMC, Amsterdam, The Netherlands.
Palak TrivediCentre for Liver and Gastroenterology Research, National Institute for Health Research, Birmingham Biomedical Research Centre, Birmingham, United Kingdom; University Hospitals Birmingham, Birmingham, United Kingdom; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, United Kingdom.
Gideon HirschfieldCentre for Liver and Gastroenterology Research, National Institute for Health Research, Birmingham Biomedical Research Centre, Birmingham, United Kingdom; University Hospitals Birmingham, Birmingham, United Kingdom; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, United Kingdom; Toronto Centre for Liver Disease, University Health Network and University of Toronto, Toronto, Canada.
Christoph SchrammFirst Department of Medicine and Martin Zeitz Centre for Rare Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Chung Heng LiuDivision of Gastroenterology and Hepatology, University of California Davis, Sacramento, California.
Christopher L BowlusDivision of Gastroenterology and Hepatology, University of California Davis, Sacramento, California.
Derek J EstesDivision of Hepatology, University of Miami, Miami, Florida.
Daniel PrattAutoimmune and Cholestatic Liver Center, Massachusetts General Hospital, Boston, Massachusetts.
Charlotte HedinPatient Flow Gastrointestinal Diseases, Patient Area Gastroenterology, Dermatovenerology and Rheumatology, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
Annika BergquistCentre for Digestive Diseases, Division of Hepatology, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
Annemarie C de VriesDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.
C Janneke van der WoudeDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.
Lei YuLiver Care & Transplantation Services, University of Washington Medical Center, Seattle, Washington.
David N AssisYale Autoimmune and Cholestatic Liver Disease Program, Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut.
James BoyerYale Autoimmune and Cholestatic Liver Disease Program, Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut.
Henriette YttingDepartment of Hepatology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Emina HallibasicDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University if Vienna, Vienna, Austria.
Michael TraunerDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University if Vienna, Vienna, Austria.
Hanns-Ulrich MarschallDepartment of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Luigi M DarettiClinic of Gastroenterology and Hepatology, Ospedali Riuniti University Hospital, Ancona, Italy.
Marco MarzioniClinic of Gastroenterology and Hepatology, Ospedali Riuniti University Hospital, Ancona, Italy.
Kidist K YimamDivision of Hepatology and Liver Transplantation, California Pacific Medical Center, San Francisco, California.
Nicola PerinDepartment of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Annarosa FloreaniDepartment of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Benedetta Terziroli Beretta-PiccoliEpatocentro Ticino, Lugano, Switzerland.
Jennifer K RogersDepartment of Statistics, University of Oxford, Oxford, United Kingdom.
International Primary Sclerosing Cholangitis Study Group (IPSCSG)Department of Gastroenterology and Hepatology, Amsterdam University Medical Centres, Location AMC, Amsterdam, The Netherlands.
Cynthia LevyDivision of Hepatology, University of Miami, Miami, Florida. Electronic address: clevy@med.miami.edu.
University of Oxford · GBAmsterdam University Medical Centers · NLAzienda Ospedaliero Universitaria Ospedali Riuniti · ITErasmus MC · NLFriedrich-Alexander-Universität Erlangen-Nürnberg · DEKarolinska University Hospital · SEMedical University of Vienna · ATUniversity of Alberta · CAUniversity of California, Davis · USUniversity of Miami · USUniversity of Padua · ITYale University · USCalifornia Pacific Medical Center · USEpatocentro Ticino · CHMassachusetts General Hospital · USNational Institute for Health Research · GBUniversität Hamburg · DEUniversity Health Network · CAUniversity of Copenhagen · DKUniversity of Gothenburg · SE

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale Liver CenterP30DK034989 · NIDDK · YALE UNIVERSITY · PI YASUKO IWAKIRI · 1986 to 2026
$31.1M
NCATS NIH HHS UL1 TR001863NIDDK NIH HHS P30 DK034989Wellcome TrustWellcome Trust 200154/Z/15/Z
6 · The paper itself

Abstract

BACKGROUND &

aimsGut-homing lymphocytes that express the integrin α4β7 and CCR9 might contribute to development of primary sclerosing cholangitis (PSC). Vedolizumab, which blocks the integrin α4β7, is used to treat patients with inflammatory bowel diseases (IBD), but there are few data on its efficacy in patients with PSC. We investigated the effects of vedolizumab in a large international cohort of patients with PSC and IBD.

methodsWe collected data from European and North American centers participating in the International PSC Study Group from patients with PSC and IBD who received at least 3 doses of vedolizumab (n = 102; median vedolizumab treatment duration, 412 days). Demographic and clinical data were collected from baseline and during the follow-up period (until liver transplantation, death, or 56 days after the final vedolizumab infusion). We analyzed overall changes in biochemical features of liver and proportions of patients with reductions in serum levels of alkaline phosphatase (ALP) of 20% or more, from baseline through last follow-up evaluation. Other endpoints included response of IBD to treatment (improved, unchanged, or worsened, judged by the treating clinician, as well as endoscopic score) and liver-related outcomes.

resultsIn the entire cohort, the median serum level of ALP increased from 1.54-fold the upper limit of normal at baseline to 1.64-fold the upper limit of normal at the last follow-up examination (P = .018); serum levels of transaminases and bilirubin also increased by a small amount between baseline and the last follow-up examination. Serum levels of ALP decreased by 20% or more in 21 patients (20.6%); only the presence of cirrhosis (odds ratio, 4.48; P = .019) was independently associated with this outcome. Of patients with available endoscopic data, 56.8% had a response of IBD to treatment. Liver-related events occurred in 21 patients (20.6%), including bacterial cholangitis, cirrhosis decompensation, or transplantation.

conclusionsIn an analysis of patients with PSC and IBD in an international study group, we found no evidence for a biochemical response to vedolizumab, although serum level of ALP decreased by 20% or more in a subset of patients. Vedolizumab appears to be well tolerated and the overall response of IBD was the same as expected for patients without PSC.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedChildCholangitis, SclerosingGastrointestinal AgentsHumansInflammatory Bowel DiseasesIntegrinsLiver Function TestsMiddle AgedRetrospective StudiesYoung AdultAntibodies, Monoclonal, HumanizedGastrointestinal Agentsintegrin alpha4beta7IntegrinsvedolizumabCholestatic Liver DiseaseCrohn’s DiseaseIntegrin alpha4beta7Ulcerative Colitis

Identifiers

PMID31100458
PMCPMC6941216
OpenAlexW2946175247

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.