Characteristics and Risk Profile of Adult Patients Treated with Apremilast Included in the British Association of Dermatologists Biologic Interventions Register (BADBIR) : A Retrospective Database Analysis (20210230)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

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

Study drug and medical condition

• Medicinal product name:
  OTEZLA
• Medical condition to be studied:
  Psoriasis

Population studied

• Short description of the study population:
  Patients aged ≥18 years diagnosed with psoriasis treated with apremilast identified from the British Association of Dermatologists Biologic Interventions Register (BADBIR) between October 2015 to March 2021.
• 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:
  Other
• Special population of interest, other:
  Psoriasis patients
• Estimated number of subjects:
  286

Study design details

• Main study objective:
  The main objective of this study is to describe the profile of patients diagnosed with psoriasis receiving apremilast in routine clinical practice.
• Outcomes:
  Distribution of patients across different severity risk categorization at the time of apremilast initiation. Time from diagnosis of psoriasis to apremilast initiation, time from discontinuation of the most recent prior therapy for psoriasis to apremilast initiation.
• Data analysis plan:
  Continuous variables will be presented with the mean and standard deviation, median and inter-quartile range (IQR), and range. Categorical variables will be presented as the number and proportion in each category. No formal statistical comparisons or significance testing are planned.