Vedolizumab-4030: Understand the Outcomes of Inflammatory Bowel Disease (IBD) Patients Treated with Biologics in Taiwan – A Decentralized Vedolizumab and Biologic Agents Core Assessments in IBD Collaboration

Study type

• Study topic:
  Human medicinal product

  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

  Other
• Non-interventional study design, other:
  Retrospective 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

  Crohn's disease

  Colitis ulcerative

Population studied

• Short description of the study population:
  Newly diagnosed inflammatory bowel disease (IBD) patients aged 20 years or older treated with biologics including vedolizumab, adalimumab, infliximab, or golimumab during February 2008 to March 2020.; Inclusion Criteria: ; 1. Patient aged ≥ 20 years old when IBD (CD or UC) was first diagnosed during February 2008 to March 2020 (or per local IRB permitted date).; - CD (ICD-9-CM: 555.X or ICD-10-CM: K50.XX, K50.XXX); - UC (ICD-9-CM: 556.X or ICD-10-CM: K51.XX, K51.XXX); 2. Had received any dose of biologics for IBD treatment, including vedolizumab adalimumab, infliximab or golimumab, from February 2008 to March 2020 (or per local IRB permitted date); ; Exclusion Criteria: ; Patients with any suspected diagnosis of CD or UC within one year before the initial date of confirmed IBD diagnosis will be excluded.
• 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:
  Inflammatory bowel disease patients
• Estimated number of subjects:
  724

Study design details

• Main study objective:
  The main objective of this study is to quantify the relapse rate after biologic discontinuation, and identify predictors of relapse. Additionally, treatment safety and effectiveness of biologics including anti-TNF-α and vedolizumab in IBD patients will be quantified, along with predictors of response to treatment.
• Outcomes:
  % of relapse and time-to-relapse and correlation b/t clinical variables and the relapse post biologics discontinuation. Incidence rates and potential correlation b/t clinical variables of patients achieving treatment effectiveness and incidence rates of opportunistic, hepatic, GI, respiratory infection/failure or sepsis/septic shock among patients receiving vedolizumab vs those receiving anti-TNF.
• Data analysis plan:
  All demographic covariates will be summarized by the types of disease (CD or UC) and by the types of biologics (anti-TNF-α or anti-α4β7 integrin) descriptively. Categorical variables will be presented as counts and percentage and will be analyzed by Chi-square test. Continuous variables will be presented as number of observation (n), mean and median, standard deviation, minimum and maximum and will be analyzed by Student’s t-test. The predictors will be analyzed using time dependent Cox regression model. All statistical significance will be set at p <0.05 unless otherwise specified.