Ozanimod Real-World Safety - A Post-Authorisation Multi-National Long-term Non-Interventional Study (ORION)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ZEPOSIA
• Study drug International non-proprietary name (INN) or common name:
  OZANIMOD HYDROCHLORIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA38) ozanimod

  ozanimod
• 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:
  9000

Study design details

• Main study objective:
  To assess the rate of adverse events in those taking Zeposia compared to two comparator groups.
• Outcomes:
  The primary endpoints of interest are major acute cardiovascular events (MACE) (composite and the individual components of MACE), serious opportunistic infections, serious acute liver injury, macular edema, and malignancy. The secondary outcomes are PRES, PML and symptomatic bradycardia.
• Data analysis plan:
  Incidence rates of MACE, SOI, SALI, macular edema, and malignancy for eligible new users of ozanimod and comparator agents will be estimated and compared at the treatment episode level. Incidence rates will be reported as point estimates (in cases per 1,000 person-years) and 95% CI. Incidence rates and hazard ratios of the “other DMT” cohort will also be reported stratified by route of administration (i.e.: oral, intravenous infusion and self-injectables).