An evaluation of non-melanoma skin cancer and melanoma skin cancer rates among patients treated for moderately to severely active rheumatoid arthritis with Xeljanz® (tofacitinib citrate): A retrospective non-interventional database study of observational data embedded within Optimising Patient outcome in Australian RheumatoLogy - Quality Use of Medicines Initiative (OPAL-QUMI) (Skin cancer rates in OpaL - SOL study)

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 use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

• Name of medicine:
  XELJANZ
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with rheumatoid arthritis (RA), received treatment with tofacitinib or a bDMARD and have at least 1 year of follow-up, identified from the OPAL registry, extracted for the period of 01 February 2015 until 01 September 2018.; ; Exclusion criteria:; Patients with any autoimmune rheumatic disease or inflammatory bowel conditions except for RA (eg, psoriatic arthritis, ankylosing spondylitis, psoriasis Crohn’s; disease or ulcerative colitis) are excluded.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with rheumatoid arthritis
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To determine rates of NMSC and MSC among Australian patients with moderately to severely active RA treated with tofacitinib or biologic disease modifying anti-rheumatic drugs. Data will be stratified by patient demographics and clinical characteristics.
• Outcomes:
  To determine the rate of Melanoma Skin Cancer and Non-Melanoma Skin Cancer among patients treated for moderately to severely active RA, as measured by DAS28 at baseline, with tofacitinib, To determine the rate of Melanoma Skin Cancer and Non-Melanoma Skin Cancer among patients treated for moderately to severely active RA, as measured by DAS28 at baseline, with biologic disease modifying anti-rheumatic drugs
• Data analysis plan:
  Patients meeting the inclusion and exclusion criteria described above will be categorised into one of two mutually exclusive drug cohorts, based on the type of DMARD received (tofacitinib or bDMARDs). All continuous variables will be summarised using n (non-missing sample size), mean, standard deviation, median, minimum and maximum. The frequency and percentages (based on the non-missing sample size) or observed levels will be reported for all categorical measures. Descriptive summaries will be produced for each data cut, providing there is sufficient data available, and again at the final analysis. All summaries are descriptive and there are no comparative analyses being undertaken, therefore, no adjustments for multiple data cuts and multiple endpoints are required. Patients who discontinue their index treatment (tofacitinib or bDMARD) will continue to be followed for a period of 1 year.