Vedolizumab-5014: Incidence of adverse events of special interest in patients with Crohn’s disease or ulcerative colitis treated with Entyvio as compared to anti-TNF-alpha agents

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  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

  ADALIMUMAB

  CERTOLIZUMAB

  GOLIMUMAB

  INFLIXIMAB
• Medical condition to be studied:
  Colitis ulcerative

  Crohn's disease

Population studied

• Short description of the study population:
  All participants with UC or CD who initiated Entyvio (Vedolizumab infusion) or an anti-TNF-alpha agent as first line or second line biologic therapy on or after 1 June 2014. Data was collected from Optum health insurance claims database from May 1, 2000.
• 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:
  Patients with Crohn's disease, Colitis ulcerative
• Estimated number of subjects:
  1250

Study design details

• Main study objective:
  To describe clinical characteristics and treatment history of participants initiating Entyvio and to quantify the incidence rates of adverse events in UC or CD participants who initiated Entyvio or an anti-TNF-alpha agent.
• Outcomes:
  Percentage of Participants with Adverse Events of Special Interest
• Data analysis plan:
  Descriptive analysis used to describe clinical characteristics and treatment history of participants. Incidence rates (and 95 percent % confidence interval CIs) of outcomes will be calculated as cumulative incidence and as incidence rate per 100 person years. Rates will be stratified into Entyvio or anti-TNF-alpha agent initiated as 1st or 2nd line biologic therapy. Mean and standard deviations, medians and ranges will be generated for continuous variables. Participant counts, proportions and Chi-square test will be used for categorical variables. For continuous variables, Student's t test will be used to test means between groups (CD vs UC, Entyvio vs anti-TNF-alpha), and Rank sums Wilcoxon two-sample median test will be used to test medians between groups. Two-sample independent tests will be used for group comparisons, participants who had both Entyvio and anti-TNF-alpha observation periods will be considered Entyvio participants only for baseline characteristics.