Efficacy of vedolizumab during intravenous induction therapy in ulcerative colitis and Crohn's disease: post hoc analysis of patient-reported outcomes from the VISIBLE 1 and 2 studies

EurJGastroenterolHepatol. 2024Apr1;36(4):404415. doi:10.1097/MEG.0000000000002728.Epub 2024 Feb 21.


Geert D'Haens 1Filip Baert 2Silvio Danese 3Taku Kobayashi 4Edward V Loftus Jr 5William J Sandborn 6Quentin Dornic 7Dirk Lindner 7Krisztina Kisfalvi 8Ed G Marins 8Séverine Vermeire 9


Author information

1Department of Gastroenterology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.

2Department of Gastroenterology, AZ Delta, Roeselare, Belgium.

3Department of Gastroenterology, IRCCS Ospedale and University Vita-Salute, San Raffaele, Milan, Italy.

4Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.

5Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.

6Department of Medicine, University of California San Diego, La Jolla, California, USA.

7Takeda, Zurich, Switzerland.

8Takeda, Cambridge, Massachusetts, USA.

9Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.


Background: Vedolizumab is an anti-α4β7 integrin antibody used to treat moderate to severe ulcerative colitis (UC) and Crohn's disease (CD). This post hoc analysis of patient-reported outcomes (PROs) from the VISIBLE 1 (NCT02611830) and 2 (NCT02611817) phase 3 studies evaluated onset of treatment effect on patient-reported symptoms during 6-week vedolizumab induction.

Methods: Patient-reported stool frequency (SF) and rectal bleeding (RB) (UC Mayo score), and SF and abdominal pain (AP) in CD were collected via electronic diary from VISIBLE patients receiving one or more open-label intravenous (IV) vedolizumab induction doses (weeks 0 and 2). PRO data were analyzed using descriptive statistics.

Results: Data from 994 patients (UC 383, CD 611) showed mean ratings for all PROs declined consistently week-on-week from baseline through week 6, with early onset of improvement. By week 2, 22% of patients with UC reported RB improvement (≥1-point reduction in RB subscore, 7-day mean), rising to 45% by week 6. By week 6, 18% of patients with UC achieved SF improvement (SF subscore 0; 21% antitumor necrosis factor alpha [anti-TNFα] naive, 13% anti-TNFα experienced). SF improvement in patients with CD (reduction of ≥3 stools, 7-day mean) was achieved by 32% at week 6 (34% anti-TNFα naive, 30% anti-TNFα experienced). Fewer patients with CD reported severe/moderate AP at week 6 (5.1%/28.5%) than baseline (14.6%/61.5%). SF decline appeared greater and faster for anti-TNFα-naive vs. anti-TNFα-experienced patients (UC and CD).

Conclusion: Results indicate early onset of patient-reported UC and CD symptom improvement during vedolizumab IV induction in VISIBLE 1 and 2.

© Copyright 2013-2024 GI Health Foundation. All rights reserved.
This site is maintained as an educational resource for US healthcare providers only. Use of this website is governed by the GIHF terms of use and privacy statement.