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 use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ZEPOSIA
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA38) ozanimod

  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, i.e., 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.