Kesimpta (ofatumumab) pregnancy and infant safety study using real world data

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational, secondary use of data

Study drug and medical condition

• Name of medicine:
  KESIMPTA
• Study drug International non-proprietary name (INN) or common name:
  OFATUMUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA52) ofatumumab

  ofatumumab
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  To compare the risk of Major Congenital Malformations among live births (pregnancies ending in at least one live birth) between the three cohorts, as follows: Primary comparison: Kesimpta-exposed versus MSDMD-exposed, Secondary comparison: Kesimpta-exposed versus MSDMD-unexposed.
• Outcomes:
  Major Congenital Malformations, Spontaneus abortion, elective termination, stillbirth, pre-term birth, preeclampsia, eclampsia, SGA.
• Data analysis plan:
  All analyses are conducted within the individual data sources. Both unadjusted and adjusted outcomes analyses are conducted. The adjustment is performed by means of propensity score weighting using overlap weights (PSOW). The results at the data source level are then combined, using meta-analysis. - Characteristics summary: descriptive statistics of the population baseline characteristics are provided by exposure cohort and for the overall population in each individual database - Outcome analysis: The analytical approaches are outcome specific. Appropriate analyses, including but not limited to the methods below, are conducted to compare the Kesimptaexposed cohort to the MSDMD-exposed cohort and to the MSDMD-unexposed cohort. - Meta-analysis: a meta-analysis of results across the data sources is conducted using aggregated data from each source.