Background: Clinical trials may not reflect real world clinical practice. We aim to assess long-term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD), in a variety of care context, by implementing a national study integrated with the national Swedish quality registry for IBD (SWIBREG).
Methods: Patients with active IBD disease (defined by endoscopy, MRI and biochemical activity) initiating vedolizumab from 1/6/2015 have consented to participate in a prospective, observational, multi-centre cohort study in Sweden. Exclusion criteria were concurrent participation in a clinical trial in which IBD treatment is dictated by a study protocol, contraindications to vedolizumab and planned discontinuation of vedolizumab treatment within <12 months from baseline. Information on clinical characteristics, treatment (previous and ongoing), clinical-, biochemical-, endoscopic activity, quality of life measures, health-care resource use is recorded at baseline and prospectively, using an electronic Case Record Form, integrated with SWIBREG. Data from other national registries that is the Patient Registry, the Cancer Registry, Statistics Sweden's LISA registry on occupational details, the Social Insurance register on long-term sick leave and the Prescription registry are linked to the dataset. Outcomes, including clinical effectiveness, defined by Harvey Bradshaw index and Mayo score, are assessed at 12 and 52 weeks.
Results: 120 Crohn's disease (CD) and 80 ulcerative colitis (UC) patients were included, by 1/11/2016 (Table 1) At this time, 24 CD and 19 UC patients had completed the 12 month study period, of whom 21 (88%) and 14 (73%), respectively, were still on treatment with vedolizumab. Interim analyses are ongoing and further results will be reported.
Conclusions: Our national implementation of a prospective observational study, where data are electronically integrated with the national Swedish quality registry for IBD and additional data retrieved from other national registries, illustrates next generation of prospective real world cohort studies, aiming to generate robust long-term data on effectiveness, safety, and used health care resources in vedolizumab treated IBD patients.
The study was financially supported by Takeda.