A multi-centre observational study to describe the impact of vedolizumab on concomitant prescribing and quality of life in patients with ulcerative colitis and Crohn’s disease in the UK and Ireland: OCTAVO

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:
  Combined primary data collection and secondary use of data

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:
  Colitis ulcerative

  Crohn's disease

  Inflammatory bowel disease

Population studied

• Short description of the study population:
  Cohort 1; To be included in Cohort 1, patients were required to meet the following criteria:; Inclusion criteria:; - Have a diagnosis of UC.; - Be biologic naïve at the time they were initiated on first-line biologic treatment with VDZ or an anti-TNF as an outpatient.; - Be aged ≥18 years at initiation of first-line biologic treatment with VDZ or anti-TNF.; - Have data available for matching criteria (age, gender, baseline disease extent and corticosteroid use on the day of initiation of first-line biologic treatment with VDZ or an anti-TNF).; - Have at least 12 months of follow-up data after initiation of first-line biologic treatment with VDZ or an anti-TNF.; Exclusion criteria:; - Patients with primary fistulising disease.; - Patients with acute severe disease.; - Patients who were corticosteroid resistant or refractory at the time of initiation of first-line biologic treatment with VDZ or an anti-TNF.; - Patients whose hospital medical records were unavailable for review.; - Patients who declined consent for their primary and secondary care medical records to be accessed for the purposes of this study (except for deceased patients whose data were collected by members of the National Health Service [NHS] direct care team to preserve patient confidentiality).; - Patients enrolled in an interventional clinical trial of an investigational medicinal product during the study period.; Cohort 2; To be included in Cohort 2, patients were required to meet the following criteria:; Inclusion criteria:; - Have a diagnosis of CD or UC.; - Have initiated treatment with VDZ as an outpatient for the first time at the point of enrolment into the study.; - Be aged ≥18 years at initiation of VDZ.; Exclusion criteria:; - Patients with primary fistulising disease.; - Patients with acute severe disease.; - Patients whose hospital medical records were unavailable for review.; - Patients who declined consent for their hospital medical records to be accessed for the purposes of this study.; - Patients enrolled in
• 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:
  Immunocompromised
• Estimated number of subjects:
  230

Study design details

• Main study objective:
  Primary objective in Cohort 1 is to evaluate changes in corticosteroid prescribing in first 12 months of first-line biologic therapy in UC patients started on vedolizumab compared to patients initiated on an anti-TNF and in Cohort 2 is to evaluate HRQoL, work productivity and activity impairment in first 12 months of vedolizumab therapy started at any point in treatment pathway in UC/CD patients.
• Outcomes:
  Primary outcome for Cohort 1 is mean total dose of corticosteroid in maintenance period of Week 14 to Month 12 in patients started on vedolizumab compared with patients started on anti-TNF as first-line biologic therapy, and for Cohort 2 is change from baseline in mean short inflammatory bowel disease questionnaire (SIBDQ) values at Week 14 and Month 6 and Month 12 after initiation on vedolizumab. Cohort 1 will compare patients initiated on vedolizumab with anti-TNF therapy to assess post-initiation change in biologic treatment, prescribing of corticosteroids, immunomodulators and antibiotics, and type of adverse events related to and caused by vedolizumab or anti-TNF. Cohort 2 will assess change from baseline in patient reported outcomes (PROs) at Week 6 and 14, and at Month 12.
• Data analysis plan:
  Analyses will be descriptive and comparative in nature. Distributions and descriptive statistics of central tendency (arithmetic means or medians) and dispersion (standard deviation or interquartile range) will be presented for quantitative variables. Nominal variables will be described with frequencies and percentages. Between-group differences for quantitative variables will be evaluated by unpaired t-tests or Wilcoxon rank-sum test. Between-group differences for categorical variables will be assessed by Chi-square test. Within-group differences for quantitative variables will be assessed by paired sample t-test or Wilcoxon matched-pairs signed-ranks test. Within-group differences for categorical variables will be assessed by McNemar test. 95 percent (%) confidence intervals will be presented for estimates of proportions and means of distributions, as appropriate.