Non-interventional, post-authorization prospective safety study of filgotinib in patients with moderately to severely active ulcerative colitis: a European multi registry-based study

Study type

• Study type:
  Non-interventional study

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:
  (L04AA45) filgotinib

  filgotinib
• Additional medical condition(s):
  Moderately to severely active ulcerative colitis

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:
  1200

Study design details

• Main study objective:
  This study aims to further evaluate the LTS of filgotinib in the treatment of patients with moderately to severely active UC under real-world conditions, specifically with respect to important identified and potential risks listed in the Jyseleca® risk management plan (RMP).
• Outcomes:
  Estimate incidence rates (IRs) following RMP-listed risks: serious and opportunistic infections, herpes zoster, and primary varicella infection, major adverse cardiovascular events (MACE), venous thromboembolism (VTE), pulmonary embolism PE), hyperlipidemia, malignancy, nonmelanoma skin cancer (NMSC), gastrointestinal (GI) perforation, fractures and all-cause mortality. Describe patients’ baseline characteristics. Estimate IRs of the endpoints in comparator cohorts provided by each registry Estimate the hazard ratios (HRs) of the identified and potential risks listed above between patients treated with filgotinib (Cohort 1) and comparator Cohort 2, and Cohort 3 assuming sufficient statistical power.
• Data analysis plan:
  All statistical analyses will be performed by each registry or its local contracted scientific partner. Regular reports adhering to a predefined format will be provided by each registry to the marketing authorization holder (MAH) at 24-month intervals after enrolment is opened to filgotinib-treated patients in the 3 participating countries. The progress reports will be provided as part of the PSUR. The final analysis will be conducted after reaching the end of study period and will summarize descriptive statistics for patients initiating filgotinib as well as for patients in the other cohorts. Depending on adequate statistical power and comparability between the filgotinib cohort and the advanced therapy Cohort 2 and the immunosuppressant/immunomodulator therapy Cohort 3 in relation to their underlying risk of outcome development, comparative analysis between patients exposed to filgotinib and patients in the advanced therapy Cohort 2 and Cohort 3 will be performed in the final analy