Association of tofacitinib with psychiatric disorders

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 data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TOFACITINIB CITRATE

  TOCILIZUMAB

  BARICITINIB
• Additional medical condition(s):
  Mania/bipolar or severe depression, Other depression, Other mood disorder, Schizophrenia-related disorder, Suicidal and self-harm events

Population studied

• Short description of the study population:
  The study population will include adult patients aged ≥18 years registered in the IMS® Disease Analyzer Germany database with a history of rheumatoid arthritis who are initiating treatment with baricitinib, tofacitinib or tocilizumab on or after 1 January 2017 and have at least 365 days of observation prior to the first prescription.
• 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:
  1891

Study design details

• Main study objective:
  To describe incidence rates of recorded psychiatric disorders occurring in association with tofacitinib, baricitinib or tocilizumab in adult patients with a diagnosis of rheumatoid arthritis (ICD 10 codes M05 and M06), To describe characteristics of adult patients with rheumatoid arthritis experiencing psychiatric events with tofacitinib, baricitinib or tocilizumab
• Data analysis plan:
  See section 6.7 of the report

Documents

Study results

RDA-tofacitinib_report on results