Abstract

Abstract Background The characteristics and outcomes of patients treated with vedolizumab in routine healthcare settings have not been widely evaluated in the UK. Methods Prospective, multicentre observational study of 364 patients started on vedolizumab in UK practice from January 2017 until February 2019 using the UK IBD Registry clinical web-based tool. For the present analysis, the primary outcome was drug survival (persistence) at 1-year, defined as attendance for infusion ≥48 weeks after the first dose. Secondary outcomes were: Clinical remission (CR, based on partial Mayo score [≤1] or Harvey Bradshaw index [≤4]), physician global assessment (PGA), IBD-Control Questionnaire (IBD-Control-8, IBD-Control-VAS and individual item scores), laboratory parameters and adverse events. Results Age (mean): 44 yrs; Males: 48%; IBD duration (mean): 6 yrs; Prev. resection: 18%; Steroids at baseline: 39%; Outcomes are summarized in Table 1. 37% of CD patients were assessed as being in clinical remission at baseline. Overall, 210 (58%) continued treatment beyond 48 weeks. At 1 year, 67.1% and 52.3% of CD and UC patients were in clinical remission with a clear improvement in QoL as assessed by IBD-Control -8. There were significant improvements across each IBD-Control-8 domain, including fatigue, with few patients considering switching treatment at that point (Figure 1). Conclusion Vedolizumab was effective in clinical practice with 58% of patients remaining on treatment at one-year. Baseline status differed significantly from those recruited into RCTs. Patient reported outcomes demonstrated significant and meaningful improvements across physical, psychological, social and treatment domains.

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