Incidence of Interstitial Lung Disease (ILD) in Users of ACTEMRA® (Tocilizumab), Rituxan® (Rituximab), Abatacept and Anti-Tumor Necrosis Factor Alpha Agents

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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

  RITUXIMAB

  ABATACEPT

  CERTOLIZUMAB PEGOL

  ETANERCEPT

  ADALIMUMAB

  INFLIXIMAB

  GOLIMUMAB
• Medical condition to be studied:
  Interstitial lung disease

Population studied

• Short description of the study population:
  The study population involved patients with rheumatoid arthritis aged 18 years or older treated with abatacept, rituximab, tocilizumab, or anti-TNF after having discontinued a different biologic agent identified from MarketScan databases between 1 January 2010 and 30 June 2012.
• 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 primary and main objective of this study is to compare the incidence of ILD amongst new users of Actemra®, abatacept, Rituxan® and individual anti-TNF alpha agents in RA patients previously exposed to at least one previous biologic agent.
• Outcomes:
  The primary and main objective of this study is to compare the incidence of ILD amongst new users of Actemra®, abatacept, Rituxan® and individual anti-TNF alpha agents in RA patients previously exposed to at least one previous biologic agent. Secondary objectives include comparing the frequency of ILD complications in the same patient population and the identification of risk factors associated with either incident ILD or ILD complications.
• 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.