Good efficacy and safety of vedolizumab in Crohn's disease and ulcerative colitis in a real-world scenario

Fabiana Zingone; Brigida Barberio; Federico Compostella; Giulia Girardin; Renata D'Incà; Carla Marinelli; Ilaria Marsilio; Greta Lorenzon; Edoardo Vincenzo Savarino

doi:10.1177/1756284820936536

Good efficacy and safety of vedolizumab in Crohn's disease and ulcerative colitis in a real-world scenario

Therap Adv Gastroenterol. 2020 Jul 9:13:1756284820936536. doi: 10.1177/1756284820936536. eCollection 2020.

Authors

Fabiana Zingone¹, Brigida Barberio², Federico Compostella², Giulia Girardin², Renata D'Incà², Carla Marinelli², Ilaria Marsilio², Greta Lorenzon², Edoardo Vincenzo Savarino²

Affiliations

¹ Department of Surgery, Division of Gastroenterology, Oncology and Gastroenterology, University of Padua, Via Giustiniani 2, Padua 35121, Italy.
² Department of Surgery, Division of Gastroenterology, Oncology and Gastroenterology, University of Padua, Padua, Italy.

Abstract

Background: Data on vedolizumab (VDZ) use in inflammatory bowel disease (IBD) patients are still limited. We aimed to assess the effectiveness and tolerability of VDZ in a real-life clinical scenario.

Methods: We retrospectively collected data of all consecutive IBD patients who started VDZ from September 2016 to December 2018 at our IBD Unit of the University Hospital of Padua and strictly followed them for 1 year. Clinical benefit (rate of clinical steroid-free remission plus clinical response), endoscopic and histological responses were evaluated over 1 year.

Results: A total of 117 patients who started VDZ for Crohn's disease (CD) and ulcerative colitis (UC) were included in the main analysis (69 CD patients, 48 UC patients). We obtained a clinical benefit in 68.1%, 68.1% and 59.4% of CD patients and in 68.7%, 54.2% and 54.1% of UC patients after induction, and at 30 weeks and 52 weeks, respectively. After 1 year, endoscopy response was observed in 47% of CD and 38.2% of UC patients, while the histological response was 19.6% and 23.5%, respectively. Finally, we found that 20.5% of patients needed treatment optimization, with 33.3% of them failing to respond despite this action. No deaths or serious adverse events requiring hospitalization were observed. The main cause of VDZ interruption was drug inefficacy. During the study, two patients developed new spondylarthritis, and two had a worsening of pre-existing arthralgia.

Conclusion: Vedolizumab resulted in being effective and safe in CD as well as in UC patients.

Keywords: Crohn’s disease; IBD; effectiveness; ulcerative colitis; vedolizumab.