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P511 Baseline characteristics of ulcerative colitis patients in the vedolizumab PASS study: a cohort study assessing the safety and effectiveness of vedolizumab compared to other biologic agents (01)

Wolf D.*1, Lewis J.D.2, Siegmund B.3, Lichtenstein G.2, Sebastian S.4, Siegel C.A.5, Louis E.6, Haas T.7, Nedd K.8, Subramanian S.9, Aguilar H.10, Egan L.11, Gasche C.12, Doherty G.13, Lobo A.14, Spearman D.15, Patel A.16, Moparty R.17, Brookes M.18, Hebuterne X.19, Moum B.20, Dolin P.21

1Atlanta Gastroenterology Associates, Atlanta, United States 2University of Pennsylvania Perelman School of Medicine, Division of Gastroenterology, Philadelphia, United States 3Charité - University Hospital Berlin, Campus Benjamin Franklin, Department of Gastroenterology, Berlin, Germany 4Hull Royal Infirmary, Hull & East Yorkshire Hospitals NHS Trust, Department of Gastroenterology and Hepatology, Hull, United Kingdom 5Dartmouth-Hitchcock Medical Center, Departmnet of Gastroenterology, Lebanon, United States 6CHU Liège, Liège, Belgium 7Darm Praxis Salzburg, Salzburg, Austria 8Infusion Associates, Grand Rapids, United States 9Royal Liverpool University Teaching Hospital, Department of Gastroenterology, Liverpool, United Kingdom 10Shreveport Endoscopy Center, Shreveport, LA, United States 11NUI Galway, Department of Gastroenterology, Galway, Ireland 12Medical University of Vienna, Wien, Austria 13St Vincent's University Hospital, Center for Colorectal Disease, Dublin, Ireland 14Sheffield Teaching Hospitals NHS Foundation Trust, Department of Gastroenterology, Sheffield, United Kingdom 15San Antonio Military Medical Center, San Antonio, TX, United States 16Medical College of Wisconsin, Milwaukee, United States 17Spring Gastroenterology, Humble, TX, United States 18The Royal Wolverhampton Hospital NHS, New Cross Hospital, Department of Gastroenterology, Wolverhampton, United Kingdom 19CHU Archet 2, Department of Gastroenterology, Nice, France 20Oslo University, Department of Gastroenterology, Oslo, Norway 21Takeda Development Centre Europe, Pharmacoepidemiology, London, United Kingdom

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).

Conclusion

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.