Uveitis in chronic inflammatory conditions and ulcerative colitis-related pyoderma gangrenosum and axial spondylarthritis: an observational study of patients receiving advanced therapies in the United States

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

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 CITRATE
• Medical condition to be studied:
  Axial spondyloarthritis

  Colitis ulcerative

  Psoriatic arthropathy

Population studied

• Short description of the study population:
  All individuals meeting study entry criteria will be included in the analysis. Estimated number of patients will be updated after data analysis.
• 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)

Study design details

• Main study objective:
  This non-interventional study aims to provide data on the comparative clinical effectiveness of advanced therapies on incidence of uveitis among several chronic inflammatory conditions, as well as incidence of pyoderma gangrenosum and axial spondylarthritis in patients with ulcerative colitis (UC).
• Outcomes:
  To estimate the distributions of demographic and clinical characteristics among patients with inflammatory conditions on tofacitinib and other advanced treatments. To estimate crude incidence rates and hazard ratios of anterior uveitis among patients with inflammatory conditions, and pyoderma gangrenosum and axial spondylarthritis in UC patients on tofacitinib and other treatments. To examine the stratified incidence rates and adjusted hazard ratios of anterior uveitis and pyoderma gangrenosum by previous history of uveitis and pyoderma gangrenosum, respectively.
• Data analysis plan:
  Number of events, person-years at risk, and crude incidences will be calculated for each outcome. IRs for select safety events will be calculated with person-time at risk starting on the index date and ending on the date of a censoring event: 1) death, 2) end of study period, 3) the event of interest, 4) treatment switch, 5) treatment discontinuation (+ 90 days), or 6) end of enrollment in the database. IRs per 100 person-years will be calculated based on the number of new events divided by the sum of the duration of patient exposures from the index date to censoring date during the risk period. Hazard ratios will be estimated using an inverse probability (IP) weighted Cox proportional hazards model with time since treatment start as timescale. IP weighting will be used to control for potential confounding variables at baseline, and selected based on a priori knowledge and statistical properties of the cohorts under study.