A Swedish Observational Study on Vedolizumab Assessing Effectiveness And Healthcare Resource Utilization in Patients with Inflammatory Bowel Disease (IBD) (SVEAH)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VEDOLIZUMAB
• Medical condition to be studied:
  Crohn's disease

  Colitis ulcerative

  Inflammatory bowel disease

Population studied

• Short description of the study population:
  Eligible patients were ⩾18years old and had active IBD at the onset of vedolizumab. Active Crohn’s disease was defined as presence of symptoms based on patient reported outcome measures in combination with ulcers at colonoscopy, signs of active disease at magnetic resonance imaging (i.e. contrast enhancement, bowel thickening or combs sign), C-reactive protein (CRP) higher than the lower limit of detection, high-sensitivity CRP >2.87mg/l or faecal calprotectin >200µg/g not more than 4weeks before onset of treatment. The lower limit of detection defines normal CRP concentration in clinical practice. According to the manufacturers, the threshold was 4.0mg/l for most CRP assays. Correspondingly, active ulcerative colitis was defined as the presence of symptoms accompanied by a Mayo endoscopic subscore of ⩾2 not more than 4weeks before initiation of vedolizumab.; Exclusion criteria were concurrent participation in a clinical trial in which IBD treatment was dictated by an (interventional) study protocol, contraindications to vedolizumab (i.e. patients with known hypersensitivity to vedolizumab or any of its excipients), prior exposure to vedolizumab or planned cessation of treatment within 12months from initiation (e.g. planned pregnancy). Written informed consent was obtained from all individual participants included in the study. Vedolizumab therapy was initiated according to its summary of product characteristics, that is, at a dose of 300mg at weeks 0, 2 and 6, followed by 300mg every 8weeks. Patients with Crohn’s disease who had not responded by week 10 were allowed to receive an additional dose at week 10. However, as this was an observational study, the treating physician was permitted to adjust the dose or dosing interval at any time.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with Crohn's disease, Colitis ulcerative, Inflammatory bowel disease
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The primary objective of Phase 1 is to assess the effectiveness of vedolizumab for achieving clinical response at Week 12 and remission at Week 52, and of Phase 2 is to assess long-term effectiveness among 3 months responders/remitters of vedolizumab treatment in clinical practice.
• Outcomes:
  Primary outcome for Phase 1 is clinical response at Week 12 and clinical remission at Week 52 in participants with UC or CD. Primary outcome for Phase 2 is long term remission among 3 months responders/remitters in participants with UC based on partial mayo score (PMS) and in participants with CD based on Harvey Bradshaw Index (HBI) at Week 104 and 156, Clinical remission(Week 12),clinical response(Week 52),corticosteroid free remission,time off corticosteroids rate,Long term effectiveness,sustained long-term remission in 3 months,drug continuation rates, B-Hemoglobin,P-CRP and f-calprotectin,long-term corticosteroid free remission,quality of life,change in presence of extraintestinal manifestations,healthcare resources, adverse-drug reactions.
• Data analysis plan:
  The primary analysis will be performed following the intention to treat principle, where missing data are assumed to represent treatment failure. Where up to two items are missing for the short health scale (SHS) and EQ-5D-5L, these measures will be imputed to the mean value. The potential influence of including imputed data will be assessed by sensitivity analyses where those with any missing data for these measures are excluded.