A Long-Term, Observational Study within the Corrona Inflammatory Bowel Disease (IBD) Registry to Characterize the Safety of Tofacitinib in Patients with Ulcerative Colitis in the Post-Approval Setting

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:
  • 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:
  6858

Study design details

• Main study objective:
  The primary objective is to assess the incidence of malignancy, excluding non-melanoma skin cancer (NMSC), in adult UC patients exposed to tofacitinib (all approved formulations) in the course of routine clinical care compared to other medications approved to treat UC.
• Outcomes:
  Malignancy, excluding non-melanoma skin cancer (NMSC) in adult UC patients exposed to tofacitinib (all approved formulations) in the course of routine clinical care compared to other medications approved to treat UC, NMSC, opportunistic infections, major adverse cardiac events, thromboembolic events (deep venous thrombosis and pulmonary embolism), hepatic events (serious or requiring liver biopsy), serious infections, herpes zoster, progressive multifocal leukoencephalopathy, gastrointestinal perforations, surgery for UC and all-cause mortality
• Data analysis plan:
  Counts and proportions, unadjusted cumulative incidence proportions, unadjusted incidence rates (number of events/person-years) and associated two-sided 95% confidence intervals will be calculated as appropriate and compared between groups for all safety outcomes. Pending data availability, subgroup analyses (disease severity, tofacitinib dose, prior treatment group and/or comorbidity status) may be performed. The primary summary of reporting rates of events will be based on survival analysis of time to first event based on an index date defined for each population with appropriate censoring rules applied for those who do not experience an event by end of follow-up period. Rates will be expressed as events/100 person-years of follow-up. A Cox regression model will be estimated to analyze time to first event for each safety outcome and compare rates of events between the tofacitinib study population and two defined comparator groups (biologics and immunosuppressant groups).