An Observational Post-authorization Safety Study to Describe the Safety of Ustekinumab and Other Crohn’s Disease Treatments in a Cohort of Patients With Crohn’s Disease

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

  Other
• Non-interventional study design, other:
  Secondary data analysis from prospective cohort study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  USTEKINUMAB
• Medical condition to be studied:
  Crohn's disease

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:
  5115

Study design details

• Main study objective:
  Evaluate long-term safety of ustekinumab, as measured by the occurrence of malignancies, serious infections & VTEs associated with hospitalization, in adult patients with CD treated with ustekinumab, Evaluate risk factors for VTEs, infections and malignancies, Estimate long-term safety of adult patients with CD between users of ustekinumab and users of other CD therapies.
• Outcomes:
  Malignancies, Serious infections (including opportunistic infections and tuberculosis TB), Events of VTE recorded with/during hospitalization.
• Data analysis plan:
  This study will use data collected from a cohort of patients enrolled into I-CARE and who are treated with ustekinumab or other treatments for CD. The event rate of safety outcomes will be estimated for each cohort. Adverse events and serious adverse events will also be summarized. Where possible, the cumulative event rate outcomes will be estimated using time-to-event analyses, overall by cohorts and then in stratified analyses. Stratification factors (as measured at study entry) will be evaluated one at a time. For each safety outcome, risk will be compared between ustekinumab and comparators using survival analysis. Users of ustekinumab will be compared with users of anti-TNF agents and with users of immunomodulators. Study exposures will be treated as time-dependent variables. Hazard ratios will be used to estimate relative risk. A propensity score (PS) analysis will be performed to assess in an explorative manner the ‘treatment effect’ when adjusting for the potential confounders