A Prospective, Observational Study to Assess the Long-Term Safety of Ixekizumab Compared with Other Therapies Used in the Treatment of Adults with Moderate-to-Severe Psoriasis in the Course of Routine Clinical Care (I1F-MC-RHBT)

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:
  The study population includes all patients in the Corrona Psoriasis Registry, with some exclusions employed for specific analyses.
• Age groups:
  • 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:
  4000

Study design details

• Study design:
  This study uses prospectively collected data from the Corrona Psoriasis Registry, an existing prospective, multicentre, observational psoriasis registry, and will use a cohort study design.
• Main study objective:
  To assess the long-term safety of ixekizumab compared with other therapies used in the treatment of adults with moderate-to-severe psoriasis (may include psoriatic arthritis) in the course of routine clinical care
• Comparators:
  A minimum of 4000 non-IL-17 comparator patients
• Outcomes:
  Malignancy, excluding non-melanoma skin cancer, Non-melanoma skin cancer, serious infections, opportunistic infections (including tuberculosis), inflammatory bowel disease, major adverse cardiac events, serious hypersensitivity reactions, demyelinating disease, and gastrointestinal perforation
• Data analysis plan:
  A number of descriptive statistics and crude rates will be generated to understand the registry data before comparative analyses begin. Propensity score models will be used to account for channeling bias. The models will include variables that are known risk factors for safety outcomes and associated with systemic treatments for psoriasis. Before initiating the outcome analysis, the ability of the propensity score stratification to balance the distribution of baseline confounders and reduce channeling bias will be evaluated. Cox proportional hazards models will be used to evaluate the rate of study outcomes among ixekizumab treated patients relative to the comparator populations. Several sensitivity analyses will be performed to examine the impact of assumptions on study conclusions.