Persistence of AMGEVITA® in patients with plaque psoriasis: a retrospective database analysis from the British Association of Dermatology Biologics and Immunomodulators Register (20210149)

Study type

• Study topic:
  Human medicinal product

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

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective database analysis

Study drug and medical condition

• Name of medicine:
  AMGEVITA
• Medical condition to be studied:
  Psoriasis

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with plaque psoriasis received Amgevita for the treatment and registered in the BADBIR registry for the period of October 2018 to July 2021. ; Inclusion criteria: ;  Diagnosed with plaque psoriasis;  Patients ≥18 years of age at Amgevita initiation (index date);  Received at least one dose of Amgevita;  Observed at least 6 months of follow-up data after starting Amgevita ; ; Exclusion criteria: ; None
• 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:
  Other
• Special population of interest, other:
  Patients with plaque psoriasis
• Estimated number of subjects:
  1598

Study design details

• Main study objective:
  The main objective of the study is to describe the persistence of Amgevita in plaque psoriasis patients according to prior adalimumab/biologic experience.
• Outcomes:
  • Median (or mean) time to first Amgevita discontinuation (in months). • Cumulative probability of discontinuation at 6,12, and 24 months. • All outcomes will be described by the following categories of biologic exposure: o Adalimumab/Biologic-naïve o Prior Adalimumab o Other Prior Biologic, Throughout study: Frequency & proportion of each reason given for discontinuing Amgevita Frequencies & proportions of all characteristics at baseline
• Data analysis plan:
  Analyses of primary and secondary endpoints will be performed separately for biologic-naïve and biologic-experienced participants. Continuous variables will be described using the mean with standard deviation, median with interquartile range (IQR) and range, whereas categorical variables will be described using frequencies and proportions. Persistence will be assessed using Kaplan-Meier survival estimates and plots. The median durations and event probabilities at 6, 12, and 24 months after index date will be reported. Changes in PASI or DLQI scores will be derived by subtracting scores at 6, 12, and 24 months from baseline.