Retrospective non-interventional chart review study of the clinical outcomes of guselkumab in the treatment of Finnish patients with plaque psoriasis (FINGUS)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, non-interventional retrospective patient chart review study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  GUSELKUMAB
• Medical condition to be studied:
  Psoriasis

Population studied

• Short description of the study population:
  Finnish adult patients with confirmed diagnosis of plaque psoriasis (PSO) who have been initiated with guselkumab treatment between 1st December 2017 and 1st december 2019.
• 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:
  200

Study design details

• Main study objective:
  The primary objective of the study is to investigate the real-life outcomes, and drug survival of guselkumab among patients with plaque psoriasis in Finland
• Outcomes:
  The primary outcomes of the study regarding treatment outcomes are absolute psoriasis area and severity index (PASI) score, Body surface area (BSA) affected by plaque psoriasis, and Physician's global assessment. Regarding drug survival, primary outcome is treatment persistence. Secondary outcomes include guselkumab treatment patterns, guselkumab patient characteristics.
• Data analysis plan:
  Descriptive methods will be used to summarize the outcomes. Differences in clinical outcomes will be tested with suitable statistical methods (e.g. student's t-test, Wilcoxon matched-pairs signed-rank test, test of proportions). Missing data points will be omitted from each corresponding analysis, data imputation techniques will not be considered in the base case analysis. However, this should not hinder the use of multivariate input methods, if needed and feasible given the sample size. The alpha level in the analyses is going to be set at 5%. In the statistical procedures used hereby, results having a lower p-value than 0.050 will be considered statistically significant. In case of multiple comparisons, the familywise error will be set at 5%, thus lower than 0.050 significance level will apply to the single hypothesis testing.

Documents

Study, other information

FINGUS List of participating centres