Background: The aim of this study is to quantify and compare the safety and effectiveness of vedolizumab (VDZ) to other biologic agents (OBAs) in IBD. The study is currently recruiting 5,000 IBD patients across 23 countries in North America and Europe, and will follow patients for up to 7 years. This interim analysis presents the baseline data of ulcerative colitis (UC) patients.
Methods: The study is a multi-centre prospective observational cohort study recruiting patients with IBD, aged 18+, initiating or switching to a new biologic agent, and no prior VDZ exposure. Those initiating VDZ enter the VDZ exposure cohort, while those initiating OBAs enter the OBAs exposure cohort, with each cohort enrolling 2,500 patients.
Results: 249 UC patients had enrolled as of 30 September 2016, 135 initiated or switched to VDZ and 114 initiated or switched to an OBA. The VDZ and OBA cohorts were similar with regards to age (range 18–86 years, mean 44 years), gender (46% female), and BMI (range 13–40, mean 26). There was no baseline difference between groups for UC disease location, stool frequency, presence of rectal bleeding, physician rating of disease activity, partial Mayo score, proportion having had a surgical or non-surgical hospital admission in the previous 12 months or previous IBD medications. There was also no difference at baseline in concomitant use of corticosteroids or immunomodulators.
Patients initiating VDZ vs. initiating OBA had UC for longer (9.8 years vs. 7.6 years, p=0.029), were more likely to have had previous biologic therapy (74% vs. 19%, p<0.001), and less likely to have had extra-intestinal manifestations (15% vs. 27%, p=0.016).
Patient-reported quality of life was assessed using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Patients initiating VDZ gave a more positive (i.e. less severe) response at baseline for all questions on physical wellbeing (systemic and bowel), social and emotional functioning as compared to OBA cohort. The overall SIBDQ score suggests that, at baseline, patients who initiated VDZ reported a better quality of life than those starting OBAs (median 4.3 vs. 3.5, p=0.020).
Conclusions: UC patients starting VDZ are more likely, at baseline, to have longer duration of disease, previously used a biologic agent, and are less likely to have extra intestinal manifestations than patients initiating/switching OBAs. The data presented are preliminary as they represent the initial 10% of UC subject enrolment. It will be important to observe if these findings persist and if others emerge with continued and full study enrolment.