Kesimpta long-term retrospective safety study utilizing real- world data from existing multiple sclerosis registries and databases from multiple countries

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational, comparative, retrospective, new user cohort study using longitudinal secondary data from national and multi-national real-world databases

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  OFATUMUMAB
• Medical condition to be studied:
  Multiple sclerosis

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:
  5000

Study design details

• Main study objective:
  In patients diagnosed with MS, to compare the risk of ; 1) malignancy (except non melanoma skin cancers NMSC overall and for pre-defined type) and ; 2) late-onset infections between Kesimpta-initiators and other DMT-initiators irrespective of therapy discontinuation or switch and ; 3) acute-onset and opportunistic infections between Kesimpta-initiators and other DMT-initiators while on therapy.
• Outcomes:
  malignancies (excluding NMSC), pre-defined malignancies, late and acute-onset infections (overall, by type and seriousness) including opportunistic infections. serious adverse events (SAE) (overall, by type, if feasible), suicidal ideation, intestinal or bowel obstruction and sarcoidosis (if feasible)
• Data analysis plan:
  Analyses will be performed in two stages. ; First, data will be analyzed locally for each data source following a common statistical methodology. ; Second, the aggregated data or stratified summaries, as appropriate, from each data source will be provided to CRO to conduct integrated analyses using meta-analytical methods. ; Annual update reports will be descriptive. ; Final and interim reports will include both descriptive and comparative analyses. ; In each data source, the Kesimpta-initiator and other DMT-initiator cohorts will be extracted and described in terms of patient demographics, potential confounders for malignancy and infections, drug use and duration of follow-up. ; In addition, for each study outcome of interest, the total number of incident and recurrent events, cumulative person time and unadjusted incidence and event rates with 95% confidence intervals (CIs) will be presented.