An Observational Study to Assess the Utilisation and Safety of Ixekizumab Among Pediatric Patients Treated in the Course of Routine Clinical Care (I1F-MC-B015)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  IXEKIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC13) ixekizumab

  ixekizumab
• Medical condition to be studied:
  Psoriasis

  Infection

  Colitis ulcerative

  Crohn's disease

Population studied

• Short description of the study population:
  children (6 to less than 18 years of age) within a large, US administrative insurance claims database diagnosed with plaque psoriasis and exposed to ixekizumab or comparator medications
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  400

Study design details

• Study design:
  This cohort study uses US administrative health care data from the HealthCore Integrated Research Database (HIRD). It will take place in two phases as described below. Phase 1: Uptake Monitoring. Phase 2: Comparative Safety Analysis.
• Main study objective:
  To monitor the uptake of ixekizumab in a real-world pediatric population To characterize the demographics and clinical characteristics of pediatric patients receiving ixekizumab To provide additional information about the long-term safety pertaining to serious infections and inflammatory bowel disease
• Comparators:
  Comparator medications: biologic medication (etanercept), non-biologic systemic ; medication (acitretin, cyclosporine, and methotrexate), and non-systemic topical treatment ; (corticosteroids, calcipotriene).
• Outcomes:
  Demographic and clinical characteristics of pediatric patients receiving ixekizumab, Long-term safety pertaining to serious infections and inflammatory bowel disease in pediatric patients receiving ixekizumab
• Data analysis plan:
  TBD