An Observational Post-Authorisation Safety Study of Skilarence in European Psoriasis Registers

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety 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

• Medicinal product name:
  SKILARENCE
• Study drug International non-proprietary name (INN) or common name:
  DIMETHYL FUMARATE
• Medical condition to be studied:
  Psoriasis

Population studied

• Short description of the study population:
  Patients with psoriasis who initiate treatment with a systemic therapy in regular clinical practice in selected European countries
• 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:
  1.600

Study design details

• Study design:
  Long-term, non-interventional, observational PASS that will use a prospective cohort design
• Main study objective:
  The primary objectives are to evaluate the risk of serious infections, malignancies, and renal impairment in new users of Skilarence compared with new users of conventional systemic therapies and to describe the characteristics of users of Skilarence and users of conventitional systemic therapies.
• Comparators:
  Conventional (non-biologic) systemic therapies (hereafter, “conventional systemic ; therapies”)
• Outcomes:
  - All serious infections- Serious opportunistic infections (including progressive multifocal leukoencephalopathy)- All malignancies- All renal impairments, including Fanconi syndrome, - All “other” SAEs by MedDRA System Organ Class- All AEs by MedDRA System Organ Class
• Data analysis plan:
  Annual analyses based on standard periodic analyses conducted by each register, describing:-Cohorts at baseline using mean values and standard deviations for continuous variables and percentages for categorical variables-Treatment course, including number of patients and cumulative person-time in each cohort, proportion of treatment discontinuations and reasons for discontinuation -Safety endpoints-All “other” SAEs and AEsFinal analyses, at end of study period:-Incidence rates for patients initiating Skilarence and for patients initiating other conventional systemic therapies will be estimated overall and stratified by relevant baseline factors -Crude, stratified, and adjusted incidence rates ratio estimates comparing Skilarence and other conventional systemic therapies -Point estimates from pooled analysis of estimates from the three registers: incidence rates, overall and stratified by selected factors, and IRRs adjusted for relevant factors