A Retrospective Cohort Study to Assess the Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Rheumatoid Arthritis in Nordic Countries (I4V-MC-B011)

Study type

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

  Drug utilisation

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)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  12000

Study design details

• Main study objective:
  1. To compare risk of serious infections overall, opportunistic infections, MACE, malignancies overall and VTE among RA patients treated with baricitinib vs. with other medications, 2. To describe the incidence rates of the following individual outcomes: lymphoma, herpes zoster, specific opportunistic infections, rhabdomyolysis, agranulocytosis, hyperlipidemia, GI perforations, and liver injury.
• Outcomes:
  Primary outcomes: 1. serious infections overall, opportunistic infections, MACE, malignancies overall, and VTE 2. lymphoma, herpes zoster, opportunistic infections such as tuberculosis, Candida, and PML, rhabdomyolysis, agranulocytosis, hyperlipidaemia (hypercholesterolaemia, hypertriglyceridaemia), gastrointestinal perforations, and liver injury, Secondary outcomes include the occurrence of pregnancy, active tuberculosis or active viral hepatitis and the outcomes described in primary outcomes #1 (above), but among very elderly patients (≥75 years of age) treated with baricitinib.
• Data analysis plan:
  Risk of each aggregate primary outcomes 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 match patients between cohorts. Sensitivity analyses will examine the effect of duration of baricitinib exposure and different latency periods on risk of malignancy. Sensitivity analyses will also investigate recurrent events such as infections. 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 report

LY3009104 B011 Non-interventional PASS Final Study Report Objective 4 (5)