A Retrospective Observational Study to describe the Effectiveness and Safety of Vedolizumab With or Without Budesonide Induction Therapy Among Patients with Moderate to Severe Crohn’s Disease (Vedo-BuDy)

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)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective, multi-national, multi-centre, medical chart review study

Study drug and medical condition

• Medical condition to be studied:
  Crohn's disease

Population studied

• Short description of the study population:
  The study population consisted of adult patients (≥18 years of age) with moderately to severely active CD who were not previously treated with VDZ and had initiated VDZ monotherapy or VDZ in combination with budesonide for at least one week during the defined Eligibility Period between 01 Jan 2015 and 31 Jan 2019. Study patients had active disease at the time of VDZ initiation: reporting at least a moderate AP (AP ≥2) and/or mean daily LSF ≥4 for the previous 7 day
• 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:
  200

Study design details

• Main study objective:
  The primary objective of the study is to assess the effectiveness in terms of the Crohn’s Disease Activity Index (CDAI) symptoms: abdominal pain (AP) and/or loose stool frequency (LSF) throughout the induction therapy (through week 14) using VDZ with budesonide and VDZ alone among patients with moderate to severe CD.
• Outcomes:
  The primary outcomes will assess the mean percentage change in AP and LSF at Week 14 in patients using VDZ with or without budesonide. Mean percentage change in AP and LSF,percentage of patients reaching clinical remission,time to clinical remission at Weeks 2,6,10,and 14, percentage of patients reaching symptomatic improvement,adverse events, change in levels of C-reactive protein,fecal calprotectin, albumin, haemoglobin and persistence rate at Week 14, time to treatment discontinuation, demographic and clinical characteristics.
• Data analysis plan:
  Data analysis will be mainly descriptive. Continuous variables will be described with number of patients with valid/missing observations, mean, standard deviation (SD), median, 25 and 75 percentiles (P25 and P75, respectively), minimum and maximum. Categorical variables will be described with number of patients with valid/missing observations, number and percentage of patients per response option. Presentation of the descriptive statistics will be stratified by VDZ treatment group (VDZ with budesonide and VDZ-only). A logistic regression model will be used to identify the main factors associated with the decision to prescribe VDZ and budesonide versus VDZ. In the event that a high number of variables show correlation, a penalized logistic regression model (glmnet model) may be used to identify the main factors associated with the decision to prescribe VDZ and budesonide versus VDZ alone. Kaplan-Meier curves will be used for descriptive time-to-event analyses.

Documents

Study results

Vedolizumab-5051_Report Summary_1 Jun 2021