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

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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.