A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab (SIMA PASS)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ANIFROLUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA51) anifrolumab

  anifrolumab
• Medical condition to be studied:
  Systemic lupus erythematosus

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:
  4941

Study design details

• Main study objective:
  Primary objectives are to estimate the incidence and compare hazard rates of new malignancies and the first occurrence of a serious infection (as a composite outcome) in moderate/severe SLE patients initiating anifrolumab and in comparable moderate/severe SLE patients who do not initiate anifrolumab (exposed to SLE SOC).
• Outcomes:
  Malignancies will be defined as the first coded diagnosis for haematological malignancies and solid tumours available in the data sources. Serious infection will be defined as an infection leading to hospitalisation, use of intravenous antimicrobials or an infection-related death. Specific types of malignancies: haematologic, solid and skin malignancies. Serious infection components: infection leading to hospitalisation, infection requiring treatment with IV antimicrobials and infection-related death. Serious infection types grouped as opportunistic serious infections, other serious infections, pneumonia (overall), fatal and non-fatal pneumonia (separately).
• Data analysis plan:
  A full description of the analytical approach will be developed and described in the SAP. Details on data derivations, category definitions, analyses, handling of missing data, and presentation of the study results will be provided in SAP. SAP will be finalised prior to the conduct of the study analyses. All study results will be presented separately for each country in the study reports, as appropriate when data become available. The final study report will include all descriptive, comparative, exploratory and sensitivity analyses as well as the meta-analysis for all the data sources.