A Non-Interventional Multi-Database Post-Authorisation Study to Assess PregnancyRelated Safety Data from Women with SLE Exposed to Anifrolumab (ROSE PASS)

Study type

• Study topic:
  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

• Name of medicine, other:
  anifrolumab
• Study drug International non-proprietary name (INN) or common name:
  ANIFROLUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG11) anifrolumab

  anifrolumab
• Medical condition to be studied:
  Systemic lupus erythematosus

Population studied

• Short description of the study population:
  For MCM analysis, a total number of 732 live and non-live births (183 anifrolumab and 549 comparator) using a matching ratio of 1:3. For the select adverse pregnancy loss outcomes analysis, a total number of 244 pregnancies (61 anifrolumab and 183 comparator) using a matching ratio of 1:3 would be necessary.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  976

Study design details

• Study design:
  The study will utilise a non-interventional longitudinal population-based retrospective cohort ; design. It will be conducted using secondary data derived from multiple databases which record; longitudinal medical data.
• Main study objective:
  The aim of this study is to describe major congenital malformations (MCM), adverse pregnancy, and birth outcomes in pregnancies/offspring from women with moderate/severe SLE exposed to anifrolumab and compare the occurrence of these outcomes to outcomes observed in women with moderate/severe SLE whose pregnancies were not exposed to anifrolumab
• Outcomes:
  The primary outcomes of interest are MCM (defined as a composite of all major MCMs) occurring in live or non-live offspring and select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth), Minor congenital malformations (mCM), Adverse pregnancy outcomes, Adverse birth outcomes
• Data analysis plan:
  A full description of the analytical approach will be developed and described in the SAP. Also details on data derivations, category definitions, analyses, and presentation of the study results will be provided in SAP. ; The SAP will be finalised prior to the conduct of the study analyses. All study results will be presented separately for each data source in the study reports, as appropriate when data become available. ; The full study reports for all data sources, including all descriptive, comparative, exploratory, and sensitivity analyses, as well as the meta-analysis results will be provided in the final report.