Characterization and outcomes follow up of patients with rheumatoid arthritis initiating tofacitinib: A retrospective, observational PASS using the British Society of Rheumatology Biologics Register-Rheumatoid Arthritis (BSRBR-RA) A3921448

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  XELJANZ
• Study drug International non-proprietary name (INN) or common name:
  TOFACITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA29) tofacitinib

  tofacitinib
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  The study population will comprise all patients with RA enrolled within BSRBR-RA who receive tofacitinib following EU approval and marketing, with a data cut off of November 2021. For some objectives, one comparator cohort of patients within BSRBR with active RA at cohort entry will be used. This comparator cohort consists of RA patients initiating TNFi.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  2356

Study design details

• Study design:
  Voluntary, exploratory PASS study to understand baseline characteristics, continuation and efficacy outcomes for adult patients with Rheumatoid Arthritis initiating tofacitinib in the UK, using the existing BSRBR-RA dataset supplied to Pfizer as part of the ongoing commitment PASS A3921312.
• Main study objective:
  1. To assess the feasibility, completeness and quality of the datacut from the BSRBR-RA register to address the research question and subsequent objectives; 2. To describe baseline characteristics for patients initiating tofacitinib in the UK and compare to a TNFi cohort; 3. To assess and quantify the proportion of patients who exhibit specific co-morbidities at baseline initiating tofacitinib and compare to a TNFi cohort; 4. To describe the change in disease activity and pain scores from baseline to 36 months post tofacitinib initiation and compare to a TNFi cohort; 5. Assess continuation of tofacitinib from baseline across 36 months and stratify by bio-experienced and bio-naïve populations;