Assessment of off-label use of baricitinib in the paediatric population (Paediatric use of baricitinib)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Olumiant

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  50

Study design details

• Main study objective:
  This study’s primary objective is to evaluate the proportion of baricitinib prescribing that occurs off-label in paediatric patients (defined as less than 18 years of age).
• Data analysis plan:
  A descriptive approach will be used to answer the study research questions. Specifically, the total number of identified baricitinib-prescribed patients and the proportion of these patients who are younger than 18 years at index will be reported. The paediatric subgroups will be further described in terms of age (mean/standard deviation, median/ interquartile range and age categories: 0 to 5 years, 6 to 10 years, 11 to 14 years and 15 to 17 years), sex, and diagnoses (read codes) received during the 1-year pre-index (including theindex day).