A SECONDARY DATA USE STUDY OF LONG TERM SAFETY OF TOCILIZUMAB BASED ON ANTI RHEUMATIC THERAPY IN SWEDEN (ARTIS) PATIENT REGISTRY

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Rheumatoid arthritis patients treated with tocilizumab in Sweden.
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To provide long term safety evaluation of Tocilizumab (TCZ) and descriptive 6-monthly reports of incidence rates of safety events of interest in TCZ patients.To conduct an adjusted multivariate analysis of data comparing risk of seriousadverse events in TCZ treated patients as compared with multiple RA biologic and non-biologic treated patients and a general population comparison cohorts
• Outcomes:
  Events in 1) TCZ recipients will be compared with those in patients with 2) anti-TNF therapy and 3) standard DMARD.For the above groups, incidence rates of the following primary endpoints will be determined:• Serious infection requiring hospitalization • Malignancy • Myocardial infarction • Stroke leading to hospitalization • Death • GI perforations • Serious hepatic events • Tuberculosis, Other outcomes, occurrence of the following events will be assessed from the adverse events reporting, no comparator data are, however, available for these events:• occurrence of serious hypersensitivity reactions (depending on data availability)• Demyelinating disorders• Lower gastrointestinal ulcer/bleeding/perforation• Aplastic anaemia/pancytopenia• Lymphoproliferative tumour
• Data analysis plan:
  Descriptive data will be provided on incidence rates of safety events of interestand a final adjusted analysis that compares risk of safety eventsin tocilizumab treated group with multiple RA and generalpopulation cohorts. Discrete or continuous variables will be summarized in terms of mean, standard deviation, median, and first and third quartile. Categorical variables will be summarized in terms of frequencies of categories. Treatment groups will be compared using Kruskal–Wallis tests for discrete or continuous variables and Fisher’s exact tests for categorical variables.