Incidence of Gastrointestinal Perforation in Users of ACTEMRA® (Tocilizumab), Rituxan® (Rituximab), 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

  Other
• Non-interventional study design, other:
  Retrospective study

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:
  The study population involved patients treated with tocilizumab for gastrointestinal perforation identified from the US healthcare claims databases (Truven Health MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits).
• 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 rheumatoid arthritis
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The main and primary objective of this study was to compare the incidence of GI perforation amongst new users of Actemra, abatacept, Rituxan and individual anti-TNF alpha agents in RA patients who have previously discontinued at least one biologic agent.
• Outcomes:
  The main and primary objective of this study was to compare the incidence of GI perforation amongst new users of Actemra, abatacept, Rituxan and individual anti-TNF alpha agents in RA patients who have previously discontinued at least one biologic agent. Secondary objectives were twofold: to identify risk factors associated with GI perforation as well as to identify differences in patients treated with Actemra, abatacept, Rituxan or another anti-TNF agent after discontinuation of a previous biologic agent.
• Data analysis plan:
  Descriptive results are presented in tabular format. Basic analyses included descriptive profiles of all independent and dependent variables. Categorical variables are summarized in frequency tables. Continuous and other numeric variables are summarized by presenting the number of observations, mean, standard deviation, and median. Statistical tests of significance for differences in these distributions were carried out. Chi-square tests were used to assess the statistical significance of categorical variables, t-tests and ANOVA were used for continuous variables. Standard errors were adjusted for the lack of independence across cohorts and within the anti-TNF cohort.