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

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

Abstract

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.