Retrospective chart review to assess the effectiveness of the Skilarence® risk minimisation activities in daily practice – a post-authorisation safety study (PASS) (RETROSKIL)

Study type

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

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective Chart Review (RCR)

Study drug and medical condition

• Name of medicine:
  SKILARENCE

Population studied

• Short description of the study population:
  The study population included patients treated with Skilarence® under routine clinical practice.
• 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)
• Estimated number of subjects:
  173

Study design details

• Main study objective:
  To assess the effectiveness of risk minimisation measures for Skilarence® in daily clinical practice. The Summary of Product Characteristics (SmPC) and an educational programme aim to inform HCPs about the risk of serious opportunistic infections such as PML, associated with the use of Skilarence® and to provide guidance on how to minimise and manage this risk through appropriate monitoring of lym
• Outcomes:
  Number of patients who adhere to the appropriate monitoring of lymphocyte and leukocyte counts and who comply with the associated actions to be taken with regard to Skilarence® treatment as described in the SmPC and as detailed in the educational material. Patient characteristics of interest: Demographics (age, sex), BMI, smoking status, alcohol use, Baseline comorbidities, Comedications at baseline Disease characteristics. Average starting dose and average maintenance dose of Skilarence® based on physicians’ prescriptions Number of patients with recorded diagnosis of serious infections Number of patients with ADRs and SADRs
• Data analysis plan:
  All analyses are exploratory and descriptive in nature and will be performed using epidemiological methods as appropriate. Categorical variables will be analysed by frequency tables (absolute and relative frequencies) and continuous variables by summary statistics (mean, standard deviation, median, minimum, maximum, and quartiles). For categorical variables changes from baseline will be presented in shift tables. Due to the nature of the data sources and the non-interventional approach, missing and inconsistent data will occur and will be considered in the analysis and the assessment of the results. All analyses will be performed overall and for each country separately. Depending on scientific interest and the distribution of the data, subsequent exploratory analyses may be performed.