Background: The aim of this study is to quantify and compare the safety and effectiveness of vedolizumab (VDZ) with other biologic agents (OBAs) in ulcerative colitis and Crohn's disease (CD). 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 CD patients.
Methods: The study is a multi-centre prospective observational cohort study. Inclusion criteria are that a patient has IBD, aged 18+, initiating or switching biologic agents, 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. Recruitment includes patients who are starting their first biologic and patients who are biologic experienced and changing to a new biologic agent.
Results: 237 of the 576 patients enrolled into the study as of 30 September 2016 had CD. 156 had CD and initiated VDZ, and 171 had CD and initiated an OBA. CD Patient age ranged from 18 to 75 years (mean=40y), 56% were female, and BMI ranged from 14 to 42 (mean=25). There was no difference between VDZ and Oba patients in disease location, history of fistula or proportion with active fistula and occurrence of all extra-intestinal manifestations and concurrent use of immunomodulators. There were also no baseline differences between cohorts in patient-reported quality of life as assessed using the Short IBD Questionnaire (SIBDQ).
CD patients who initiated VDZ were more likely than OBA patients to be female (63% vs. 50%, p=0.017), have a longer disease duration (15 vs. 10 years, p<0.001), to have had previously biologic therapy (87% vs. 28%, p<0.001), moderate or severe disease (43% vs. 25%; p=0.013) as measured by Harvey Bradshaw Index (mean HBI score 7.3 vs. 5.6, p=0.004), very poor general wellbeing (9% vs. 3%, p=0.048), more liquid stools per day (4.2 vs. 2.8, p=0.002) and to have had prior IBD surgery (55% vs. 37%, p<0.001). In addition, among biologic experienced CD patients, concurrent steroid use was more frequent in those initiating VZD than OBA (43% vs. 23%, p=0.015).
Conclusions: At baseline, CD patients initiating or switching to VDZ compared to those initiating or switching to OBAs were more likely to be female, have longer disease duration, more severe disease, poorer general wellbeing, more liquid stools per day and most had previously used a biologic therapy. These results demonstrate that at baseline, patients treated with VDZ are different to those treated with OBAs. The vedolizumab PASS Study will account for these patient differences at baseline when evaluating long-term safety and efficacy of VDZ.