Retrospective Post-Marketing Safety Surveillance Study of Tofacitinib in Psoriatic Arthritis (PsA) and Rheumatoid Arthritis (RA)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  XELJANZ
• Medical condition to be studied:
  Psoriatic arthropathy

  Rheumatoid arthritis

Population studied

• 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)
• Estimated number of subjects:
  73525

Study design details

• Main study objective:
  To characterize the type and reporting rate of adverse events in patients receiving tofacitinib for Psoriatic Arthritis or Rheumatoid Arthritis
• Outcomes:
  Types and reporting rates of treatment emergent adverse events reported for patients treated with Tofacitinib for the indication of Psoriatic Arthritis or Rheumatoid Arthritis. This will include: Adverse Events and Serious Adverse Events
• Data analysis plan:
  All analyses for this study will be descriptive. Data output per indication will be in the form of Case Level Summaries (Demographics and clinical characteristics), Drug level summaries (AEs/SAEs/discontinuations due to AEs) and Adverse Event Reporting Proportion (Reported as SOC and Preferred Term PT, most frequent AEs, AESIs) and Case Listings (SAEs/death) from reports generated from the Pfizer safety database. AESI category data will be generated using pre-defined PTs used in PBRER. Cumulative exposure rates will be generated using IQVIA Health’s MIDAS database as described in Section 9.2. RRs will be calculated using the number of AE/SAEs/most frequent AEs/AESIs reported within the study timeframe (November 6th, 2012 to November 6th, 2021).

Documents

Study results

A3921421 Non-Interventional Study Report Abstract 13 November 2023_Redacted

Study, other information

A3921421 Non Interventional Study Abstract (clean)_v2.0_07Dec2022_Redacted

A3921421 Non Interventional Study Abstract 30 August 2022_Redacted

A3921421 Non-Interventional Study Report 13 November 2023_Redacted