Psoriasis Study of Health Outcomes – an International Observational Study of 3 Year Health Outcomes in the Biologic Treatment of Moderate to Severe Plaque Psoriasis (PSoHO)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness 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

  SECUKINUMAB

  BRODALUMAB

  USTEKINUMAB

  ADALIMUMAB

  ETANERCEPT

  INFLIXIMAB

  GUSELKUMAB

  TILDRAKIZUMAB
• Medical condition to be studied:
  Psoriasis

Population studied

• 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:
  2000

Study design details

• Main study objective:
  To compare the proportion of patients with moderate to severe plaque psoriasis treated in clinical practice with ixekizumab or secukinumab (the anti IL 17A cohort) relative to other biologic treatments who achieve clear or almost clear skin (equivalent to PASI 90 or higher and/or sPGA 0/1) at 12±4 weeks following initiation of or switching to a new biologic
• Outcomes:
  PASI, sPGA, BSA, DLQI
• Data analysis plan:
  Logistic regression will be used to analyze the proportions of the primary endpoint for assigned anti IL 17A and other biologic treatments. In addition to the treatment groups, the propensity scores derived during baseline interim analyses will be included as covariates into the model.