Non-interventional post-authorization safety study of filgotinib in the treatment of patients with moderate to severe active rheumatoid arthritis within European registries

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FILGOTINIB MALEATE
• Medical condition to be studied:
  Rheumatoid arthritis

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:
  2500

Study design details

• Main study objective:
  To estimate incidence rates of the risks listed in the risk management plan, including: serious and opportunistic infections, Herpes zoster and primary Varicella infection, MACE, VTE, hyperlipidemia, malignancy, non-melanoma skin cancer, gastrointestinal perforation and fractures and all-cause mortality in RA patients in Denmark, Germany, Sweden, Spain, and the UK who initiate filgotinib treatment.
• Outcomes:
  Serious and opportunistic infections, Herpes zoster and primary Varicella infection, major adverse cardiovascular events (MACE), venous thromboembolism -VTE- (including deep venous thromboembolism DVT, pulmonary embolism PE), hyperlipidemia, malignancy, nonmelanoma skin cancer (NMSC), gastrointestinal (GI) perforation and fractures and all-cause mortality.
• Data analysis plan:
  All statistical analyses will be performed by each registry and described in detail in the statistical analysis plan. Regular reports adhering to a predefined format will be provided by each registry to the marketing authorization holder at 6 or 12 month intervals after enrolment is opened to filgotinib-treated patients in participating countries. At the end of the study period the final analysis will summarize descriptive statistics for patients initiating filgotinib (overall and in subgroups) and for patients in the other treatment-defined cohorts. Event counts and crude incidence rates derived from registry linkages will be tabulated for each cohort and safety event. Depending on adequate statistical power and comparability between the filgotinib and other exposure cohorts in relation to their underlying risk of outcome development, comparative analysis will be performed between filgotinib-exposed and comparator-exposed cohorts, adjusted for potential confounders.