A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the SRQ Register

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  ORENCIA
• Medical condition to be studied:
  Rheumatoid arthritis

  Psoriatic arthropathy

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • 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)
• Estimated number of subjects:
  4000

Study design details

• Main study objective:
  The objective of this study is to estimate the incidence of pre-specified events of malignancies in abatacept-exposed patients and patients receiving select comparators enrolled in the ARTIS Register.
• Data analysis plan:
  Incidence of pre-specified malignancies will exclude events reported in the first 180 days of follow-up. Overall cancer IR (95% CI) per 100 p-y and the IR rate will be calculated for abatacept users, anti-TNF users, non-anti-TNF users, and for biologic naive patients. Adjusted HRs will be calculated. Each cohort will be analyzed overall and stratified by indication.