Non-interventional post-authorization prospective cohort study evaluating the effectiveness of the additional risk minimization measures for filgotinib (Jyseleca®) use in patients with ulcerative colitis: a European multi registry-based study

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  JYSELECA
• Study drug International non-proprietary name (INN) or common name:
  FILGOTINIB MALEATE
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AF04) filgotinib

  filgotinib
• Medical condition to be studied:
  Colitis ulcerative

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 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:
  1500

Study design details

• Main study objective:
  This longitudinal DUS aims to evaluate the effectiveness of the additional risk minimization measures (aRMMs) by assessing how HCPs prescribing filgotinib adhere to the updated filgotinib Summary of Product Characteristics (SmPC) and HCP Guide with a specific focus on aRMMs.
• Outcomes:
  The study will include baseline and follow-up information relevant for the specific aRMM as well as information on the distribution of risk factors indicative of a high risk of major adverse cardiovascular event (MACE), venous thromboembolism (VTE), malignancy, or serious and opportunistic infections.
• Data analysis plan:
  The patients’ baseline and follow-up characteristics will be summarized to assess adherence to the aRMMs with a focus on posology, contraindications, special warnings and precautions, monitoring, as well as the proportion of patients at high risk of major adverse cardiovascular event (MACE), venous thromboembolism (VTE), malignancy, or severe and opportunistic infections. Data will be summarized using univariable descriptive statistical methods. Categorical variables will be summarized by number and percentage of patients in each categorical definition including 95% confidence intervals (CIs). Continuous variables will be summarized descriptively (mean, standard deviation, and median, lower quartile, upper quartile, minimum, maximum, 95% CIs). All statistical analyses will be performed by each registry or its local contracted scientific service provider.