A Non-interventional Observational Longitudinal Post-Authorization Safety Study (PASS) of SIMPONI® in Treatment of Ulcerative Colitis using Nordic National Health Registries (MK-8259-013)

Study type

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

  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  SIMPONI
• Study drug International non-proprietary name (INN) or common name:
  GOLIMUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB06) golimumab

  golimumab
• Medical condition to be studied:
  Colitis ulcerative

  Colorectal cancer

  Hepatosplenic T-cell lymphoma

  Colectomy

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:
  3000

Study design details

• Main study objective:
  To characterize the clinical and demographic profile of first-time users of golimumab (GLM) vs first time users of alternate therapies in the treatment of UC, to describe the risk of incident CRC and the risk of all-cause total colectomy exposed to GLM and alternative therapies.
• Outcomes:
  Incidence of CRC, incidence of all-cause total colectomy
• Data analysis plan:
  Patients in each cohort will be followed for the outcomes of CRC, HSTCL, and colectomy through 18- Mar-2021. The risk of primary outcomes (incident CRC, all-cause total colectomy) will be estimated as cumulative incidence within each inception cohort in unadjusted and adjusted analyses. Censoring events will include death, emigration, and first occurrence of study outcomes. The cohort analyses will be conducted based on automated data only using survival analysis techniques (including Kaplan-Meier) to estimate cumulative risks. Sensitivity analyses have been specified that examine the robustness of results to alternate specifications of the study population, risk window, outcome definitions, and additional adjustment using quantitative bias analysis (QBA).