Long-term real-world safety of ozanimod – A post-authorisation safety study (PASS) in patients diagnosed with ulcerative colitis

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Evaluate real world safety
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Zeposia
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA38) ozanimod
• Additional medical condition(s):
  Ulcerative colitis

Population studied

• Age groups:
  Adults (18 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  7500

Study design details

• Main study objective:
  To evaluate the risk of developing adverse events of interest in a real-world European population of adults with moderately to severely active ulcerative colitis (UC) in ozanimod-exposed participants versus those treated with advanced therapy.
• Outcomes:
  - To evaluate the risk of developing malignancies, serious opportunistic infections (SOIs), major adverse cardiovascular events (MACE), venous thromboembolism, including pulmonary embolism (VTE) and severe liver injury in ozanimod-exposed participants versus those treated with advanced therapy; ; - To evaluate the risk of developing outcomes of interest by subgroups (age, disease history, previous outcome history) in ozanimod-exposed participants versus those treated with advanced therapy; ; - Frequency, baseline and clinical characteristics of participants experiencing [Macular oedema, Posterior reversible encephalopathy syndrome (PRES), Progressive multifocal leukoencephalopathy (PML)] in ozanimod-exposed participants and those treated with advanced therapy; ; - To evaluate the risk of macular oedema, PRES and PML in ozanimod-exposed participants versus those treated with advanced therapy; ; - To evaluate the risk of cancer, by subtypeSolid tumors excluding non-melanoma skin cancer (NMSC), NMSC, Colorectal cancer, Advanced colonic neoplasia, ie, composite endpoint including colorectal cancer and high-grade dysplasia, Lymphoma] in ozanimod-exposed participants versus those treated with advanced therapy; ; - To evaluate the risk of Major Adverse Cardiovascular Events (MACE) [Acute nonfatal myocardial infarction, Acute nonfatal stroke, Cardiovascular (CV) mortality] in ozanimod-exposed participants versus those treated with advanced therapy
• Data analysis plan:
  Data management will be conducted by each data source independently. Analyses will be executed independently by each data source provider. The unit of observation will be the treatment episode. Clinical and demographic variables will be reported by treatment cohorts before and after the application of Inverse probability of treatment weighting (IPTW). Crude incidence rates (IRs) and 95% CIs will be calculated for each outcome by treatment cohort, before and after IPTW. Hazard ratios and associated 95% CIs will be estimated using the Cox proportional hazards model. For secondary analyses incidence rates, time-to-event and HRs will be computed before and after IPTW with their corresponding 95% CI. Aggregated results including summary estimates resulting from the main analysis of the primary objective of each data source will be pooled for meta-analysis.