Prospective, multicentric, national,observational cohort of patients receiving a systemic treatment for psoriasis

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  STELARA

Population studied

• Short description of the study population:
  Patients receiving a systemic treatment for psoriasis.
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  280

Study design details

• Main study objective:
  Document the real life benefit of biologic treatments in psoriasis in French adult patients in France: clinical efficacy, quality of life efficacy, safety profile, drug use
• Outcomes:
  1.Determine patient Initiating Treatment with guselkumab: Socio-demographic Data, comorbidities, disease history. 2.Prescribing information. 3.Therapeutic strategy. 4. Effectiveness: clinical outcomes, duration of maintenance of the therapeutic benefit5. Safety data: incidence of adverse events (AE) and serious adverse events (SAE)
• Data analysis plan:
  Statistical analysis will start with a descriptive analysis. Patient characteristics are described in a descriptive manner and compared to RCT data to show comparability between patients Efficacy analysis is performed on the total population Persistency analysis is performed in a survival analysis on the overall period of evaluation.