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

Journal article
Authors 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
Gideon Hirschfield
Christoph Schramm
Chung Heng Liu
Christopher L Bowlus
Derek J Estes
Daniel Pratt
Charlotte Hedin
Annika Bergquist
Annemarie C de Vries
C Janneke van der Woude
Lei Yu
David N Assis
James Boyer
Henriette Ytting
Emina Hallibasic
Michael Trauner
Hanns-Ulrich Marschall
Luigi M Daretti
Marco Marzioni
Kidist K Yimam
Nicola Perin
Annarosa Floreani
Benedetta Terziroli Beretta-Piccoli
Jennifer K Rogers
Cynthia Levy
Published in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN 1542-7714
Publication year 2019
Published at Wallenberg Laboratory
Institute of Medicine, Department of Molecular and Clinical Medicine
Language en
Links dx.doi.org/10.1016/j.cgh.2019.05.01...
www.ncbi.nlm.nih.gov/entrez/query.f...
Subject categories Gastroenterology and Hepatology

Abstract

Gut-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.We 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.In 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.In 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.

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