Rheumatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant® (baricitinib) a JAK1/2 inhibitor (I4V-MC-B010)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  Olumiant

Population studied

• Short description of the study population:
  Eligible rheumatologists who responded to the survey invitation made up the study population. Rheumatologists were expected to be the prescribing HCP in the EU Member State countries participating in this survey.; ; Inclusion criteria; Rheumatologists were required to meet the following criterion for inclusion in the survey:; • Must identify themselves as currently treating patients with RA and must be previous or potential prescribers of baricitinib.; To ensure that survey results adequately reflect the knowledge of the main target of the survey, at least 50% of the total completed surveys were required from those who had already prescribed baricitinib at the time of survey participation.; ; Exclusion criteria; Rheumatologists meeting the following criterion were not permitted to take the survey:; • Current or past employment with Eli Lilly and Company (Lilly) or any of its affiliates, United BioSource LLC (UBC), the EMA or any NCA.
• 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:
  200

Study design details

• Main study objective:
  a) Rheumatologists’ understanding of impt. safety information from the HCP Educational Material, i.e. information relating to pregnancy/breastfeeding, infections, & changes in lipid parameters,b) Communication of impt. safety information & mitigating actions to patients prescribed baricitinib for the 1st time,c) Distribution of the PAC to patients prescribed baricitinib for the 1st time.
• Outcomes:
  The proportion of rheumatologists who demonstrate understanding of the important safety information.Among prescribers, the proportion who communicate this information and mitigating actions to patients prescribed baricitinib for the first time, and who distribute the PAC to patients prescribed baricitinib for the first time.
• Data analysis plan:
  Rheumatologists’ understanding of the important safety messages detailed in the Healthcare Professional Educational Material, communication of the important safety information and mitigating actions to patients prescribed baricitinib for the first time, and distribution of the PAC to patients prescribed baricitinib for the first time will be analysed by geography, prescribing status/number of patients treated with baricitinib, and experience with treating patients with RA.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). Stratification of results will depend on the distribution of responses to ensure that sufficient numbers are available for each stratum. Each question will be assessed individually.

Documents

Study results

Lilly EU baricitinib HCP PASS v1.0 (1)_Redacted