P714 Mucosal healing in CD with vedolizumab versus other biologics: endoscopic outcomes during long-term routine care in a multinational observational study
Siegel, C.(1)*;Sebastian, S.(2);Siegmund, B.(3);Zhou, J.(4);Jones, S.(5);Adsul, S.(4);Louis, E.(6);
(1)Dartmouth Hitchcock Medical Center, Gastroenterology and Hepatology, Lebanon- NH, United States;(2)Hull University Teaching Hospital, IBD Unit, Hull, United Kingdom;(3)Charité – Universitätsmedizin Berlin- Campus Benjamin Franklin, Medical Department- Division of Gastroenterology- Infectiology and Rheumatology-, Berlin, Germany;(4)Takeda, Gastroenterology, Cambridge- MA, United States;(5)Takeda, Gastroenterology, Zurich, Switzerland;(6)University Hospital CHU of Liège, Department of Gastroenterology, Liège, Belgium;
Background
Mucosal healing (MH) is considered an important treatment target for patients (pts) with moderate to severe Crohn’s disease (CD). The aim of this analysis was to evaluate rates of MH achieved during treatment with vedolizumab (VDZ) or other biologics in pts with CD who underwent endoscopic assessments during routine clinical practice in a long-term observational study across a number of multinational study centres.
Methods
Data were analysed from a long-term prospective, multicentre, post-authorization safety study (PASS; NCT02674308, EUPAS6469) cohort of pts with CD. This secondary outcome was evaluated in pts initiating treatment with VDZ or other biologics, including infliximab, adalimumab and ustekinumab. Pts received treatment under routine standard of care with clinical decisions at the discretion of treating physicians, treatment could be modified or changed without the need to withdraw from the study. For pts with available endoscopy data, rates of MH (simple endoscopy score [SES-CD] ≤ 2) at baseline and 12-months were compared in biologic-naïve or biologic-experienced pts treated with VDZ versus other biologics.
Results
MH was analysed in pts with CD who had endoscopic assessment. In those pts who were biologic-naïve and had baseline endoscopy (VDZ n=76, other biologics n=239), MH rates at baseline were 11.8% (9/76) versus 12.1% (29/239), respectively. After 12-months’ treatment, MH rates in biologic-naïve pts who had endoscopy data at month 12 (VDZ n=48, other biologics n=108) were 70.8% (34/48) in VDZ-treated pts versus 60.2% (65/108) in pts treated with other biologics (Table 1). In pts who received biologic treatment prior to study entry (biologic-experienced) and had baseline endoscopy (VDZ n=151, other biologic n=146), MH rates at baseline were 11.9% (18/151) versus 16.4% (24/146), and 51.1% (45/88) versus 31.4% (27/86) after 12 months of treatment in the VDZ and other biologic cohorts, respectively.
Conclusion
These real-world data from a multinational observational study show that VDZ was effective at achieving MH, particularly as a first-line biologic treatment, and also in biologic-experienced pts.