An Active Surveillance, Post-Authorisation Study to Characterize the Safety of Tofacitinib in Patients with Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data from the Swedish Quality Register for Inflammatory Bowel Disease (SWIBREG)

Study type

• 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

• Study drug International non-proprietary name (INN) or common name:
  TOFACITINIB CITRATE
• Medical condition to be studied:
  Colitis ulcerative

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:
  500

Study design details

• Main study objective:
  The primary objective is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer and venous thromboembolism among adult UC patients aged ≥18 years who initiate tofacitinib in the course of routine clinical care, as well as the incidence rates in UC patients treated with other approved systemic agents.
• Outcomes:
  Malignancy, excluding non-melanoma skin cancer, and venous thromboembolism, Non-melanoma skin cancer, serious infections, opportunistic infections, herpes zoster, major adverse cardiac events, progressive multifocal leukoencephalopathy, gastrointestinal perforations, all-cause mortality
• Data analysis plan:
  This study will include descriptive summaries of baseline characteristics of tofacitinib and comparator cohorts. Crude incidence rates (with corresponding 95% confidence intervals) of safety events of interest will be estimated for each cohort. Pending feasibility, incidence rates of all safety events of interest will be compared between tofacitinib and comparator cohorts using propensity score matched multivariable Cox regressions adjusting for potential confounders. Additionally, incidence rates of the primary safety events of interest will be stratified by prior biologic use, patient age, tofacitinib maintenance dose, and patients with ≥1 venous thromboembolism risk factors vs. none. Pending feasibility, comparative measures between tofacitinib and comparator cohorts will be conducted, otherwise crude and age-adjusted rates will be presented along with 95% confidence intervals for all four cohorts.