Assessment of off-label use of baricitinib in the paediatric population in the United Kingdom

Date of Approval
Application Number
18_220
Technical Summary

Baricitinib is approved in the United Kingdom (UK) for the treatment of rheumatoid arthritis (RA) and atopic dermatitis (AD) in adults. Baricitinib has not yet been studied in children and adolescents and hence its use in this population is classified as a safety concern (missing information) in the Risk Management Plan for baricitinib. Lilly has proposed this study in order to provide a more systematic evaluation of use in children and adolescents in the UK. Understanding the proportion of baricitinib prescribing that is off-label to children and adolescent will help quantitate the level of this safety concern.

Using a descriptive cohort design, subjects within the Clinical Practice Research Datalink (CPRD) database that receive at least one prescription for baricitinib from April-2017 to June-2022 will be recruited into the study and indexed on the date of their first CPRD recorded baricitinib prescription during the timeframe. Using this cohort, this study will evaluate the proportion of baricitinib prescribing that occurs off-label to paediatric patients (less than 18 years of age at index). If paediatric prescribing is found, this study will further describe paediatric patients who receive a prescription for baricitinib in terms of demographics (age, gender) and diagnoses received during the 1-year before receipt of baricitinib.

Health Outcomes to be Measured

• Age at baricitinib prescription (primary)
• Gender (secondary)
• Region (secondary)
• Baseline/pre-index diagnoses (secondary)

Collaborators

Krista Schroeder - Chief Investigator - Eli Lilly & Co Ltd - US Headquarters
Krista Schroeder - Corresponding Applicant - Eli Lilly & Co Ltd - US Headquarters
Claudia Salinas - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Jonathan Swain - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Kristin Meyers - Collaborator - Eli Lilly & Co Ltd - US Headquarters