Literature DB >> 32419909

Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response.

Mark A Samaan1, Siddharth Birdi1, Maria Sierra Morales1,2, Sailish Honap1, Aravind Gokul Tamilarasan1, Georgina Cunningham1, Ioannis Koumoutsos1, Shuvra Ray1, Joel Mawdsley1, Simon H C Anderson1, Jeremy Sanderson1, Peter M Irving1.   

Abstract

BACKGROUND: Despite the proven efficacy of vedolizumab (VDZ) for ulcerative colitis (UC) and Crohn's disease (CD), suboptimal response is commonly encountered. However, data regarding the effectiveness of dose intensification (by interval shortening) to achieve response are limited.
OBJECTIVES: We evaluated the effectiveness of dose intensification at achieving response in patients with a previously suboptimal response to VDZ. Additionally, we aimed to identify predictors of response to this strategy.
METHODS: We performed a retrospective cohort study of patients who underwent VDZ dose intensification for suboptimal response. Clinical disease activity was evaluated at the point of dose intensification (baseline) and at weeks 12 and 24. Response was defined as Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) reduction of ≥3, and remission as HBI <5 or SCCAI <3.
RESULTS: A total of 36 patients received dose intensification to 4-weekly infusions: 18 CD, 14 UC and 4 inflammatory bowel disease-unclassified (analysed in the UC group). Median SCCAI scores fell from 6 (range 0-11) at baseline to 4 (0-6, p=0.008) at week 24, while HBI scores did not change significantly (4 (0-27) and 3 (0-8), p=0.092). Overall median C reactive protein (CRP) fell from 6 mg/L (1-23) to 2 mg/L (1-17, p=0.011). Of 20 patients with clinically active disease at baseline, 10 (50%) responded, of whom 4 (20%) achieved remission at week 24. Univariate analysis demonstrated low baseline CRP (p=0.045) and response at week 12 (0.020) were associated with week 24 response.
CONCLUSIONS: Our findings demonstrate VDZ dose intensification to be effective at achieving clinical response in half of patients. Low baseline CRP and response at week 12 are potential predictors of week 24 response. © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

Entities:  

Keywords:  crohn’s disease; dose intensification; entyvio; inflammatory bowel disease; ulcerative colitis; vedolizumab

Year:  2019        PMID: 32419909      PMCID: PMC7223295          DOI: 10.1136/flgastro-2019-101259

Source DB:  PubMed          Journal:  Frontline Gastroenterol        ISSN: 2041-4137


  25 in total

1.  Correlation between the Crohn's disease activity and Harvey-Bradshaw indices in assessing Crohn's disease severity.

Authors:  Severine Vermeire; Stefan Schreiber; William J Sandborn; Cécile Dubois; Paul Rutgeerts
Journal:  Clin Gastroenterol Hepatol       Date:  2010-01-21       Impact factor: 11.382

2.  Association Between Low Trough Levels of Vedolizumab During Induction Therapy for Inflammatory Bowel Diseases and Need for Additional Doses Within 6 Months.

Authors:  Nicolas Williet; Gilles Boschetti; Marion Fovet; Thomas Di Bernado; Pierre Claudez; Emilie Del Tedesco; Camille Jarlot; Leslie Rinaldi; Anne Berger; Jean-Marc Phelip; Bernard Flourie; Stéphane Nancey; Stéphane Paul; Xavier Roblin
Journal:  Clin Gastroenterol Hepatol       Date:  2016-11-24       Impact factor: 11.382

Review 3.  Clinical Parameters Correlate With Endoscopic Activity of Ulcerative Colitis: A Systematic Review.

Authors:  Sophie Restellini; Che-Yung Chao; Myriam Martel; Alan Barkun; Omar Kherad; Ernest Seidman; Gary Wild; Alain Bitton; Waqqas Afif; Talat Bessissow; Peter L Lakatos
Journal:  Clin Gastroenterol Hepatol       Date:  2018-12-21       Impact factor: 11.382

4.  Predictors and Management of Loss of Response to Vedolizumab in Inflammatory Bowel Disease.

Authors:  Eugenia Shmidt; Gursimran Kochhar; Justin Hartke; Prianka Chilukuri; Joseph Meserve; Khadija Chaudrey; Jenna L Koliani-Pace; Robert Hirten; David Faleck; Morris Barocas; Michelle Luo; Karen Lasch; Brigid S Boland; Siddharth Singh; Niels Vande Casteele; Sashidhar Varma Sagi; Monika Fischer; Shannon Chang; Matthew Bohm; Dana Lukin; Keith Sultan; Arun Swaminath; David Hudesman; Nitin Gupta; Sunanda Kane; Edward V Loftus; William J Sandborn; Corey A Siegel; Bruce E Sands; Jean-Frederic Colombel; Bo Shen; Parambir S Dulai
Journal:  Inflamm Bowel Dis       Date:  2018-10-12       Impact factor: 5.325

5.  The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications.

Authors:  J Satsangi; M S Silverberg; S Vermeire; J-F Colombel
Journal:  Gut       Date:  2006-06       Impact factor: 23.059

6.  A simple clinical colitis activity index.

Authors:  R S Walmsley; R C Ayres; R E Pounder; R N Allan
Journal:  Gut       Date:  1998-07       Impact factor: 23.059

Review 7.  Clinical pharmacokinetics and use of infliximab.

Authors:  Ulrich Klotz; Alexander Teml; Matthias Schwab
Journal:  Clin Pharmacokinet       Date:  2007       Impact factor: 6.447

8.  Early vedolizumab trough levels predict mucosal healing in inflammatory bowel disease: a multicentre prospective observational study.

Authors:  W Yacoub; N Williet; L Pouillon; T Di-Bernado; M De Carvalho Bittencourt; S Nancey; A Lopez; S Paul; C Zallot; X Roblin; L Peyrin-Biroulet
Journal:  Aliment Pharmacol Ther       Date:  2018-01-31       Impact factor: 8.171

Review 9.  Loss of Response to Vedolizumab and Ability of Dose Intensification to Restore Response in Patients With Crohn's Disease or Ulcerative Colitis: A Systematic Review and Meta-analysis.

Authors:  Laurent Peyrin-Biroulet; Silvio Danese; Marjorie Argollo; Lieven Pouillon; Spyros Peppas; Marien Gonzalez-Lorenzo; Theodore Lytras; Stefanos Bonovas
Journal:  Clin Gastroenterol Hepatol       Date:  2018-06-20       Impact factor: 11.382

Review 10.  A Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Vedolizumab.

Authors:  Maria Rosario; Nathanael L Dirks; Catherine Milch; Asit Parikh; Michael Bargfrede; Tim Wyant; Eric Fedyk; Irving Fox
Journal:  Clin Pharmacokinet       Date:  2017-11       Impact factor: 6.447

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