Real-world evaluation of effectiveness, persistence and usage patterns of tofacitinib in treatment of psoriatic arthritis in Australia.

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective structured data analysis

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Adults patients aged 18 years or older diagnosed with psoriatic arthritis receiving treatment with tofacitinib or a biologic disease-modifying antirheumatic drug (bDMARD) identified from the OPAL database in Australia.; Inclusion criteria: ; • Diagnosed with PsA;; • Aged 18 years but under 95 years of age on the index date (date of commencement of interleukin 17 inhibitor (IL17i), tumor necrosis factor inhibitor (TNFi), or tofacitinib);; • Received at least 1 prescription for IL17i, TNFi, or tofacitinib; and; • Have at least 1 year of follow-up since prescription of IL17i, TNFi, or tofacitinib. ; ; Exclusion criteria: ; • Diagnosis with any autoimmune rheumatic disease except for PsA (eg, rheumatoid arthritis, ankylosing spondylitis).; • Patients who have no visit data recorded within the sample window.; • Patients who have missing start dates for IL17i, TNFi, or tofacitinib during the sample selection window.
• 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:
  Other
• Special population of interest, other:
  Psoriatic arthritis patients
• Estimated number of subjects:
  1540

Study design details

• Main study objective:
  To understand the patterns of treatment (lines of therapy, and use as combination or monotherapy), clinical effectiveness, PROs and treatment persistence among Australian adult patients with PsA treated with tofacitinib. Data will also be collected for patients treated with bDMARDs to provide descriptive information about clinical management of PsA in real world Australian clinical practice.
• Outcomes:
  1. To describe tofacitinib, IL17i, and TNFi treatment patterns among Australian adult patients with PsA, including: • Line of use (eg, first-line, second-line), • Mean dose, • Proportion of patients receiving monotherapy, • Proportion of patients using in combination with NSAIDs, corticosteroids and cDMARDs, • Reasons for discontinuation. Describe treatment persistence to IL17i, TNFi and tofacitinib in patients with PsA. Describe the clinical effectiveness of tofacitinib, IL17i, and TNFi, as defined by disease severity markers (DAS28-ESR, CDAI, SDAI, DAPSA and the percentage of patients reaching targeted treatment goals (remission or low disease activity) To describe patient reported outcomes (HAQ-DI, FACIT-Fatigue, HCRU)
• Data analysis plan:
  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, TNFi or IL17i) will continue to be followed for a period of 1 year.