Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Inflammatory bowel disease
Population studied

Short description of the study population

Patients who were diagnosed with ulcerative colitis (UC) or Crohn’s disease (CD) and who initiated first-line biologic treatment with Vedolizumab (VDZ).
Only patients who initiated VDZ and were biologic-naïve at the point of VDZ initiation (index event) were included in the study. Local site staff identified the sampling frame of patients UC or CD who initiated first-line biologic therapy with VDZ during the eligibility period.
Inclusion criteria: Medical chart documentation of UC or CD diagnosis; at least one dose of VDZ during the eligibility period (1 September 2015 to date of site initiation [first site initiated: 8 May 2018; last site initiated: 6 August 2018]); aged ≥18 years at the time of VDZ treatment initiation (index event); biologic-naïve (no prior biologic use for any pathology including IBD) at time of index event; minimum of six months duration between date of index event and date of chart abstraction initiation.
Exclusion criteria: Received VDZ as part of an interventional clinical trial (includes index treatment); initiated index treatment as combination therapy with two biologic agents; empty or missing medical record; part or all of patient’s index treatment was received at a different site, and the patient’s medical record pertaining to this care was not accessible.

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

Immunocompromised

Estimated number of subjects

100
Study design details

Main study objective

1. Describe treatment patterns associated with first-line VDZ use (i.e. biologic-naïve patients)2. Describe the real-world clinical effectiveness of first-line VDZ at least six months post-treatment initiation

Outcomes

Changes in patients’ biologic treatment (6 mths) following initiation of the index treatment will be described (e.g. treatment persistence, dose modifications, concomitant treatments, discontinuation). Clinical effectiveness will be defined by changes in disease measures and outcomes from the diagnostic procedures conducted closest to the date of index event, and all assessments during post-index, - Disease characteristics- Clinical effectiveness at least 12 months post-treatment initiation- Safety- Healthcare resource utilisation

Data analysis plan

A statistical analysis plan (SAP) will be developed prior to any data analyses being performed that defines all analytic populations and sub-populations, time since diagnosis to index event, including definition of derived variables such as treatment response and clinical effectiveness. The SAP will further provide a detailed description of analyses to be performed, and describe methods to deal with unknown data and censoring.Results will be reported in a descriptive manner, as follows:• Continuous data will be described by their mean, median, standard deviation (SD), minimum, and maximum. • Categorical variables will be described by frequency and percentages (n, %).• Kaplan-Meier curves will be presented to describe time-to-event analyses (e.g. time to first dose escalation, time to discontinuation).• Univariate/multivariate logistic regression will be used to analyse potential predictors of and/or variables associated with response to first-line VDZ Tx