Comparative safety of abatacept in rheumatoid arthritis with COPD: A real-world population-based observational study

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

  Infective exacerbation of chronic obstructive airways disease

  Pneumococcal infection

  Influenza

  Bronchitis

Population studied

• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  12650

Study design details

• Main study objective:
  To assess whether treatment with abatacept for RA among patients with COPD is associated with an increased risk of COPD exacerbation, bronchitis and pneumonia/influenza compared with other BDMs.
• Outcomes:
  Primary outcomes of interest include COPD exacerbations, bronchitis and pneumonia/influenza, Secondary outcome will be combining COPD exacerbation, bronchitis and pneumonia/influenza
• Data analysis plan:
  Descriptive statistics will be calculated within each database to compare baseline characteristics between patients who are prescribed abatacept and other BDMs. The primary analysis will be based on the cox proportional hazards regression model to estimate the hazard ratio and 95% CI of each outcome event comparing patients using abatacept with users of other BDMs, further adjusted for confounders found to be unbalanced despite matching on propensity scores.