A Retrospective Cohort Study for Estimating Incidence Rates of Infusion Site Events for ABBV-951 for the Treatment of Advanced Parkinson's Disease

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  A longitudinal cohort study using secondary data on individuals with advanced PD treated with ABBV-951 as part of their routine clinical care in Finland and Portugal. The overall study period will span from the date of ABBV-951's market availability (01 April 2024 in Finland and 16 April 2024 in Portugal) until 31 March 2027 in both countries, including a patient identification period from the market availability date to 31 March 2026 in both countries, and a 1-year follow-up window thereafter until 31 March 2027. Index date will be defined as the date of initiation of ABBV-951. A censoring event will be defined as the earliest of treatment discontinuation, end of the study period, migration, loss to follow-up, or death.

Study drug and medical condition

• Medicinal product name:
  PRODUODOPA
• Medicinal product name, other:
  Foslevodopa/Foscarbidopa
• Study drug International non-proprietary name (INN) or common name:
  LEVODOPA

  CARBIDOPA

  ENTACAPONE
• Anatomical Therapeutic Chemical (ATC) code:
  (N04BA07) foslevodopa and decarboxylase inhibitor

  foslevodopa and decarboxylase inhibitor
• Medical condition to be studied:
  Parkinson's disease
• Additional medical condition(s):
  NA

Population studied

• Short description of the study population:
  Parkinson's disease patients who initiated ABBV-951 between 01 April 2024 and 31 March 2026 in Finland and between 16 April 2024 and 31 March 2026 in Portugal.
• Age groups:
  • 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

  Other
• Special population of interest, other:
  Diabetes Mellitus
• Estimated number of subjects:
  300

Study design details

• Study design:
  Longitudinal cohort study using secondary data from advanced PD patients treated with ABBV-951 in Finland and Portugal. The study covers market availability through 31 Mar 2027, with patient identification through 31 Mar 2026 and 1-year follow-up thereafter.
• Main study objective:
  Primary objective:; 1. To quantify the incidence rate of first infusion site event (first infusion site infection OR first serious infusion site reaction); ; Secondary objectives: ; 2. To quantify the incidence rate of first infusion site infection; 3. To quantify the incidence rate of first serious infusion site reaction
• Setting:
  Patients with advanced PD treated with ABBV-951 as part of their routine clinical care in Finland from 01 April 2024 to 31 March 2026 and in Portugal from 16 April 2024 to 31 March 2026, utilizing primary care and/or secondary care data sources.
• Comparators:
  Not applicable
• Outcomes:
  • Infusion site event (first occurrence only) defined as infusion site infection OR serious infusion site reaction; • Infusion site infection (first occurrence only); • Serious infusion site reactions (first occurrence only);
• Data analysis plan:
  The incidence rate of the first outcome following initiation of ABBV-951 will be calculated as the total number of first events diagnosed during the time exposed to ABBV-951 divided by the person-time at-risk from index date to the first occurrence of the outcome or censoring (if no outcome occurs) and expressed as 100 person-years. ; If sample size allows, incidence rates will be stratified by the baseline characteristics of i) diabetes status and ii) other immunosuppressed conditions as these underlying conditions will make patients more prone to infections.