Vedolizumab-4081: Infection Outcomes among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025

Study type

• Study topic:
  Other
• 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

• Medicinal product name:
  ENTYVIO
• Study drug International non-proprietary name (INN) or common name:
  VEDOLIZUMAB

  USTEKINUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG05) vedolizumab

  vedolizumab

  (L04AC05) ustekinumab

  ustekinumab

  (L04AB) Tumor necrosis factor alpha (TNF-alpha) inhibitors

  Tumor necrosis factor alpha (TNF-alpha) inhibitors
• Medical condition to be studied:
  Colitis ulcerative

  Crohn's disease

Population studied

• Short description of the study population:
  United States (US) adult participants diagnosed with UC or CD who initiated ENTYVIO or other advanced medical therapies (AMTs) will be included in this study.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Elderly (≥ 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:
  Ulcerative Colitis or Crohn’s Disease
• Estimated number of subjects:
  23900

Study design details

• Study design:
  A retrospective, observational, matched-cohort study design will be employed using 100% sourced Medicare FFS secondary claims data from Parts A and B, standalone Part D PDE data to assess safety outcomes.
• Main study objective:
  The main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (called TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha).
• Outcomes:
  The primary outcomes will assess the percentage of participants hospitalized due to serious infections over a period of up to 4 months.; ; The secondary outcomes will assess the percentage of participants who experience non-serious infections over a period of up to 4 months.
• Data analysis plan:
  The statistical analysis of the data will be primarily descriptive. Continuous variables will be reported using means, medians, standard deviations (SD), and interquartile ranges (IQRs). Categorical variables will be reported as frequencies and percentages.