Rheumatologist and Dermatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant (baricitinib), a JAK1/2 inhibitor (I4V-MC-B025)

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:
  Cross-sectional

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

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  400

Study design details

• Study design:
  This study uses a multi-national, observational cross-sectional design.
• Main study objective:
  1) assess effectiveness of updated HCP Educational Materials and PAC among dermatologists and rheumatologists. Key risk messages within these materials include those pertaining to pregnancy, infections, lipids, VTE, MACE, malignancy and dosing. 2) The effectiveness of a DHPC distributed to dermatologists and rheumatologists.
• Outcomes:
  The proportion of HCPs who demonstrate understanding of the important safety information in HCP Educational Materials and in the DHPC. We will also report proportion who report communication of important safety information to their patients prescribed baricitinib for the first time and the proportion who distribute the PAC to patients prescribed baricitinib for the first time.
• Data analysis plan:
  Data collected from the survey will be reported as descriptive statistics. Frequency distributions with 95% CIs will be calculated for responses to questions that address the survey objectives (i.e. excluding demographic questions). Survey data will be analysed overall, and stratified by country, prescriber status (has previously prescribed baricitinib or has not previously prescribed baricitinib), and by number of patients treated.