P441 Long-term CD treatment failure and dose modification rates with vedolizumab and other biologics: Results from a large prospective observational study

Siegmund, B.(1)*;Siegel, C.A.(2);Sebastian, S.(3);Zhou, J.(4);Jones, S.(5);Adsul, S.(4);Louis, E.(6);

(1)Charité – Universitätsmedizin Berlin- Campus Benjamin Franklin, Medical Department- Division of Gastroenterology- Infectiology and Rheumatology-, Berlin, Germany;(2)Dartmouth Hitchcock Medical Center, Gastroenterology and Hepatology, Lebanon- NH, United States;(3)Hull University Teaching Hospital, IBD Unit, Hull, United Kingdom;(4)Takeda, Gastroenterology, Cambridge- MA, United States;(5)Takeda, Gastroenterology, Zurich, Switzerland;(6)University Hospital CHU of Liège, Department of Gastroenterology, Liège, Belgium;


Durable treatment effectiveness is an important consideration in the long-term management of patients with Crohn’s disease (CD) receiving biologic therapy. The aim of this analysis was to evaluate rates of failure and dose modification for biologic treatment over time in patients with CD using data from a large long-term observational study evaluating secondary outcomes in patients initiating treatment on vedolizumab (VDZ) and other biologics.


We analysed data from a multicentre, prospective, observational, post-authorisation safety study (PASS; NCT02674308, EUPAS6469) following VDZ or other biologic treatment cohorts under routine standard of care. Longitudinal data on treatment failure (including biologic discontinuation, IBD non-surgical hospitalization, primary IBD surgery and corticosteroid initiation) up to 36 months and dose modification at any time during the study were analysed in biologic-naïve and biologic-experienced patients with CD in the treatment cohorts.


The cohort comprised 1338 biologic-naïve patients (pts) (VDZ, n=312; other biologics, n=1026) and 1543 biologic-experienced pts (VDZ, n=829; other biologics, n=714). Baseline pt characteristics (Table 1) were broadly similar across different treatment cohorts, although there were some notable differences with respect to fistulising disease and age at CD diagnosis. 

Treatment failure rates for biologic-naïve and biologic-experienced pts cumulatively over time at specific time points are shown in Table 2. The proportion of pts continuing biologic treatment with dose modification at any time during the study period for biologic-naïve pts was 13/312 (4.2%) in VDZ-treated pts vs 502/1026 (48.9%) in the group treated with other biologics and 34/829 (4.1%) vs 433/714 (60.6%), respectively for biologic-experienced pts.


This large observational study reported rates of treatment failure, hospitalization, and IBD-related surgeries during long-term follow-up of biologic-naïve and biologic-experienced pts with CD. Dose modification occurred less frequently in biologic-naïve and biologic-experienced pts treated with VDZ compared with pts receiving other biologic treatments during the study.