Baricitinib Drug Utilisation Study: Assessment of Effectiveness of New Recommendations for Use Based on Secondary Data Sources in France, Germany, The Netherlands, and Sweden (I4V-MC-B038)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other

Study drug and medical condition

• Name of medicine:
  OLUMIANT
• Study drug International non-proprietary name (INN) or common name:
  BARICITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA37) baricitinib

  baricitinib
• 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:
  1200

Study design details

• Main study objective:
  This study aims to describe changes in the utilisation of baricitinib in patients with RA, AA, or AD following the updated recommendations and limitations for use in the new aRMMs as a measure of prescribers’ compliance. The study purpose will be met through primary objectives that will be assessed in the 12 months before and after dissemination of the DHPC.
• Outcomes:
  1. To describe characteristics of patients treated with baricitinib for RA, AA, or AD, in terms of demographics, comorbidities, and prior and current medication use. ; 2. To evaluate prescribers’ adherence to the baricitinib aRMMs, specifically compliance to: recommended posology and duration of use recommendations for patient screening and lab monitoring recommendations for limitations of use
• Data analysis plan:
  All analyses will be descriptive, and results presented by indication and country, and study period, that is, before (Study Period 1) and after (Study Period 2) DHPC distribution. Changes between study periods will be summarised descriptively. No comparisons will be made across countries due to heterogeneity in coding schemes, healthcare systems, and potential differences in prescribing behaviour. Continuous variables will be summarised using the median and interquartile range while categorical variables summarised as count and proportion (%), with 95% CIs where relevant. Missing values will be reported as missing, and no imputation attempted. Patients will be described with regards to demographics, comorbidities, disease characteristics, prior and current treatments, ADD, duration of baricitinib use and patient screening and lab monitoring. Subgroup analyses will be conducted for patients ≥65 years old, and those with ≥1 risk factor for VTE, MACE, malignancy, or serious infection.