Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  RINVOQ
• Study drug International non-proprietary name (INN) or common name:
  UPADACITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA44) upadacitinib

  upadacitinib
• Medical condition to be studied:
  Crohn's disease

  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:
  7500

Study design details

• Main study objective:
  To describe and compare the incidence of gastrointestinal (GI) perforation, and where possible, the incidence of fractures, drug-induced liver injury (DILI), and where possible, the incidence of the secondary safety outcomes, in adults with UC or CD treated with upadacitinib, relative to those treated with select biologic inflammatory bowel disease (IBD) treatments at a similar line of therapy
• Outcomes:
  GI perforation, fractures and DILI. Malignancy excluding non-melanoma skin cancer (NMSC), stratified by type, NMSC, major adverse cardiovascular events, venous thromboembolic event, serious infections (defined as all infections that require hospitalization, including opportunistic infections), herpes zoster, active tuberculosis, all-cause mortality
• Data analysis plan:
  Comparison of rates of GI perforation between upadacitinib and comparators will be made with a Cox regression model, by each line of treatment cohorts. If assessed as feasible, based on (1) number of upadacitinib users, (2) number of other select biologic IBD treatments users suitable for comparison, and (3) number of safety events, Cox regression analyses will be performed to compare rates of DILI, bone fracture and all the secondary outcomes between upadacitinib and comparator treatments. Cox regression models will be performed separately for each outcome, stratified by line of treatment. Comparative analyses of GI perforation will be performed in the interim report if number of patients is sufficient. Comparative analyses on all other outcomes will be performed in the final report, as applicable