Characterizing Otezla Use and Exposure Among Pregnant Women (20220012)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

• Name of medicine:
  OTEZLA
• Medical condition to be studied:
  Psoriatic arthropathy

  Mouth ulceration

  Psoriasis

Population studied

• Short description of the study population:
  The study population included pregnant women aged 16 to 55 years treated with Otezla identified from the IBM Watson Health MarketScan Commercial Claims and Encounters with Medicare Supplemental Research Database (MarketScan) and the UnitedHealth Group Optum Analytics (Optum) database.
• Age groups:
  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)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  80

Study design details

• Main study objective:
  The main objectives of this study are to describe the use and exposure of Otezla among pregnant women, and to estimate the number of infants born linked to women exposed to Otezla during pregnancy.
• Outcomes:
  • Counts and proportions of Otezla use and exposure in the cohort of pregnant women characterized by: • Age • Diagnosis • Calendar year • Number of claims • Timing of exposure Cumulative probability of descontinuation at 6, 12 and 24 months • Counts of live born infants linked to Otezla-exposed pregnancies
• Data analysis plan:
  We will estimate the frequency of dosing (number of Otezla claims during pregnancy) and timing of exposure. Among those exposed to Otezla, we will further characterize these patients by age, calendar year of exposure(s), psoriasis, psoriatic arthritis, or Behcet's disease diagnoses. This is a descriptive analysis. Only summary statistics will be produced in the form of numbers and proportions for frequency of doses, timing of exposure, as well as the number of infants linked to exposed pregnancies.