Post Authorization Safety Study (PASS) among Patients Treated with Flixabi for Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Other Spondyloarthropathies (SpA), and Psoriatic Arthritis (PsA) within the Swedish, Population based, Anti-Rheumatic Therapies in Sweden (ARTIS) register. (Safety of Flixabi in ARTIS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  FLIXABI
• Study drug International non-proprietary name (INN) or common name:
  INFLIXIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB02) infliximab

  infliximab
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  Patients treated with Flixabi
• 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)

Study design details

• Study design:
  The study design used in this comparative safety report is an active-comparator new-user cohort design
• Main study objective:
  The objective of the analyses presented in this comparative safety report is to provide an assessment of pre-specified safety outcomes for Flixabi as used in the treatment of RA, AS and other spondyloarthropathies (SpA), and PsA in Sweden, using data from the ARTIS system since 2015.
• Setting:
  The data used in the current report was extracted from Swedish registers in which information is prospectively collected (see section 9.5 Data sources and measurement). Patients treated with Flixabi entered the study from January 1st 2019 (i.e. first year of availability of Flixabi for the treatment of RA in Sweden); Patients treated with another TNFi (excluding infliximab), bionaive patients and general population comparators may entered the study from January 1st 2015, i.e. four years earlier (to optimize statistical power).
• Comparators:
  Patients who are treated with the drug of interest are compared to patients who are treated with alternative biological or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs)(i.e., active-comparator)
• Outcomes:
  1) All primary invasive cancers excluding non-melanoma skin cancers ; 2) Lymphoma ; 3) Tuberculosis (TB) ; 4) Demyelinating event/Multiple sclerosis (MS)
• Summary results:
  This nationwide safety monitoring study identified 161 RA, 152 AS-SpA, and 65 PsA patients initiating Flixabi treatment in Sweden between 2019-2024. For all primary invasive cancers excluding non-melanoma skin cancers, standardized incidence rates were 11.3/1000 PYs (RA), 9.6/1000 PYs (AS-SpA), and 6.9/1000 PYs (PsA), which were comparable to originator-product infliximab and other TNFi cohorts . No tuberculosis or demyelinating events were observed in any Flixabi cohort across all indications, while one lymphoma event occurred in the AS-SpA cohort (3.2/1000 PYs) . Cox proportional hazards modeling was not performed due to insufficient events (<5 per cohort), limiting statistical comparisons between treatment groups.