Assessing the Safety of Ixekizumab in European Psoriasis Registries (I1F-EW-B008)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

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

Population studied

• Short description of the study population:
  This study includes patients with psoriasis from the BADBIR and PsoBest registries and patients with psoriatic arthritis from the RABBIT-SpA registry; patients with axSpA will be also be included upon European Union approval of ixekizumab for the treatment of axSpA.
• 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)
• Estimated number of subjects:
  2500

Study design details

• Study design:
  Data from three independent European registries will be reviewed to provide information about the safety of ixekizumab. The registries included in this protocol are BADBIR, a UK-based psoriasis registry, and the German psoriasis and psoriatic arthritis registries of PsoBest and RABBIT-SpA.
• Main study objective:
  The objective of this study is to perform safety surveillance by monitoring the incidence of AEs occurring in temporal association with ixekizumab among patients with psoriasis enrolled in European biologic registries.
• Comparators:
  BADBIR is a national registry of patients with psoriasis treated with conventional systemic therapy (Comparator cohort)
• Data analysis plan:
  Analysis of BADBIR and PsoBest data is under the control of each registry.