Incidence of Gastrointestinal Perforation in Users of ACTEMRA® (Tocilizumab), Abatacept and Anti-Tumor Necrosis Factor Alpha Agents

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• 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:
  TOCILIZUMAB
• Medical condition to be studied:
  Gastrointestinal perforation

Population studied

• Short description of the study population:
  New users of tocilizumab, abatacept, and individual and aggregate anti-TNF alpha agents in rheumatoid arthritis patients previously exposed to at least one anti-TNF alpha agent.
• 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:
  0

Study design details

• Main study objective:
  The primary objective of this study is to compare the incidence of GI perforation amongst new users of tocilizumab, abatacept, and individual and aggregate anti-TNF alpha agents in RA patients previously exposed to at least one anti-TNF alpha agent.
• Outcomes:
  The primary objective of this study is to compare the incidence of GI perforation amongst new users of tocilizumab, abatacept, and individual and aggregate anti-TNF alpha agents in RA patients previously exposed to at least one anti-TNF alpha agent. To describe demographic, clinical and treatment characteristics of the study cohort and factors associated with increased risk of GI perforation.
• Data analysis plan:
  Basic analyses will include descriptive profiles of all independent and dependent variables. Categorical variables will be summarized in frequency tables. Continuous and other numeric variables will be summarized by presenting the number of observations, mean, standard deviation, and median. Statistical tests of significance for differences in these distributions will be carried out. Chi-square tests will be used to assess the statistical significance of categorical variables, t-tests and ANOVA will be used for continuous variables.