A Retrospective Cohort Study to Assess the Long-Term Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Adults with Moderate to Severe Rheumatoid Arthritis in the Course of Routine Clinical Care (I4V-MC-B004)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  OLUMIANT
• Medical condition to be studied:
  Rheumatoid arthritis

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:
  12000

Study design details

• Main study objective:
  The goal of this study is to monitor the incidence and nature of key serious infections, MACE, VTE, and malignancies amongst patients exposed long-term to baricitinib compared to patients treated long-term with bDMARDs or cDMARDs.
• Outcomes:
  1. Primary outcomes to be evaluated in comparative analyses: serious infections and opportunistic infections, major adverse cardiovascular events (MACE), malignancies, and venous thromboembolism. 2. Primary outcomes for descriptive analyses: lymphoma, herpes zoster, opportunistic infections, rhabdomyolysis, myelosuppression (agranulocytosis), hyperlipidemia, GI perforations, and liver injury.
• Data analysis plan:
  Risk of each aggregate primary outcome will be compared between patients with rheumatoid arthritis (RA) treated with baricitinib and similar patients treated with (a) bDMARDs and (b)cDMARDs. Hazard ratios will be calculated based on Cox proportional hazard regression as a measure of the association between baricitinib and each comparative outcome. Propensity scores will be used to address imbalance of potential confounding factors across groups that might otherwise lead to confounding bias. Sensitivity analyses of malignancy will examine the effect of duration of baricitinib exposure and use of different latency windows. For MACE, sensitivity analyses will investigate an intent-to-treat approach. Recurrent events, such as for infections, will also be explored. Overall incidence rates and rates over time will be calculated separately for comparative, aggregate outcomes (primary outcomes #1 above) and less common outcomes (primary outcomes #2).

Documents

Study results

LY300914 B004 Non-interventional PASS Final Study Report