Experiences of using vedolizumab in the East Midlands, United Kingdom: A retrospective observational study

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:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective observational study

Study drug and medical condition

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

  Colitis ulcerative

  Crohn's disease

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with inflammatory bowel disease (IBD) receiving vedolizumab between 1st November 2014 and 30th November 2016 in the East Midlands.; Inclusion criteria: ; • Patients aged ≥18 years at initiation of vedolizumab.; • Patients with clinically confirmed diagnosis of Crohn’s disease (CD), ulcerative colitis (UC), or IBD of unclassified type (IBDU), as recorded in medical records.; • Patients who received their first dose of vedolizumab between 1st November 2014 and 30th November 2016 in one of the participating study centres.; ; Exclusion criteria:; • Patients whose hospital medical records were unavailable for review.; • Patients enrolled in an interventional clinical trial of an investigational medicinal product during the observation period.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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 inflammatory bowel disease, colitis ulcerative, crohn's disease
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The main objective of the study is to describe corticosteroid-free and clinical remission in patients with IBD after initiation on vedolizumab.
• Outcomes:
  The primary outcome in this study is time to corticosteroid-free remission after initiation on vedolizumab. Time to clinical remission, change in disease activity from baseline, concomitant drug use, mucosal damage and healing, time to follow up endoscopy, rate of surgery, rate of admissions and adverse events.
• Data analysis plan:
  Both distributions and descriptive statistics of central tendency (medians and arithmetic means) and dispersion (interquartile range and standard deviation) will be presented for quantitative variables wherever possible. Nominal variables will be described with frequencies and percentages. Confidence intervals will be provided for means of numeric variables.