An Observational Postauthorization Safety Study To Describe The Safety Of Ustekinumab and Other Biologic Treatments in a Cohort of Patients With Ulcerative Colitis or Crohn’s Disease Using Compulsory Swedish Nationwide Healthcare Registers and the Independent Swedish National Quality Register for Inflammatory Bowel Disease (SWIBREG) (Stelara UC/CD PASS (SWIBREG))

Study type

• Study topic:
  Human medicinal product
• Study type:
  Clinical trial

Study drug and medical condition

• Name of medicine:
  STELARA
• Name of medicine, other:
  ustekinumab
• Study drug International non-proprietary name (INN) or common name:
  USTEKINUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC05) ustekinumab

  ustekinumab
• Medical condition to be studied:
  Colitis ulcerative

  Crohn's disease

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)
• Estimated number of subjects:
  8000

Study design details

• Main study objective:
  To describe the long-term safety of ustekinumab for UC and/or CD, as measured by incidence of malignancies, infections (serious infections, opportunistic infections, and tuberculosis TB), venous thromboembolism (VTE), major adverse cardiac events (MACE), and all-cause mortality.
• Data analysis plan:
  The event rate of safety outcomes will be estimated for each cohort for patients using ustekinumab, TNFi, or anti-integrins. ; The analysis will be performed to compare the following outcomes: ; •incidence rate of malignancies; •incidence rate of infections (incl. serious infections, opportunistic infections, TB); •incidence rate of VTEs. Incidence rates per 1,000 person-years of follow-up. For malignancy outcomes, patients will be assigned to treatment cohorts based on a hierarchical order of exposure: ; •STELARA (ustekinumab); •TNFi biologics; •Integrin Inhibitors. The final report, as well as the interim reports, will include data on the number of patients who have entered the study in each of the treatment cohorts, cumulative follow-up time accrued in each cohort, and counts of each study outcome of interest tabulated by exposure status at cohort entry. The analysis will be performed separately for patients with CD, patients with UC and patients with IBD (UC or CD).