A Prospective Observational Study to Assess the Long-Term Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Adults in the United States with Moderate-to-Severe Rheumatoid Arthritis in the Course of Routine Clinical Care (I4V-MC-B003)

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 aggregate serious and opportunistic infections, MACE, malignancies and VTE amongst patients with long-term exposure to baricitinib compared to patients treated long-term with bDMARDs or cDMARDs and to describe the incidence of key individual outcomes.
• Outcomes:
  The primary outcomes are: 1. the following aggregate outcomes to be evaluated in comparative analyses: serious infections and opportunistic infections, MACE, malignancies, and VTE, 2. the following descriptive outcomes: lymphoma, herpes zoster, opportunistic infections, rhabdomyolysis, myelosuppression (agranulocytosis), hyperlipidemia, GI perforations, and evidence of liver injury. To describe the incidence of the above outcomes in very elderly patients (aged ≥75 years).
• 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 match patients between cohorts. Sensitivity analyses will examine the effect of duration of baricitinib exposure and different latency periods on risk of malignancy. The impact of unmeasured confounding will also be evaluated. Sensitivity analyses will also investigate recurrent events such as infections using generalised estimating equation negative binomial regression models with a log link. 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 B003 NI PASS Final Study Report v1