A longitudinal study of 4 cohorts of patients with psoriasis and psoriatic arthritis: one treated with Otezla (apremilast), one with an injectable comparator drug, one with an oral comparator drug and one with an oral and an injectable comparator drug (Otezla-CPRD-001)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  Psoriatic arthropathy

Population studied

• Short description of the study population:
  Patients with psoriasis and/or psoriatic arthritis.
• 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:
  Immunocompromised
• Estimated number of subjects:
  1065

Study design details

• Main study objective:
  To identify all cases of adverse events of special interest (AESIs) among users of the newly marketed drug Otezla (exposed) and to compare the rates of these events with the rates in 2 populations of patients with psoriasis and/or psoriatic arthritis who received non-Otezla treatments (non-exposed): patients who received oral treatments and patients who received injectable treatments.
• Outcomes:
  The outcomes proposed in the study were selected based on adverse events of special interest observed in the clinical trials for apremilast (marketed as Otezla). These events include:malignancy, opportunistic and serious infections, suicide and suicide ideation, depression, major adverse cardiovascular events (MACE), vasculitis, tachyarrhythmia, hypersensitivity, and anxiety/nervousness.
• Data analysis plan:
  For phase 1, the population of Otezla users after the first year of marketing of the drug will be described since there is a gradual uptake of a new drug in a market and there may not be a sufficient number of patients exposed within the first year. Descriptions/counts of all AESIs that occur in this population of users will be provided. Only data that do not allow identification of patients will be reported to comply with UKconfidentiality rulings. For phases 2 and 3, the rates of each AESI will be described separately for the Otezla study cohort and the Otezla non-exposed cohorts using Kaplan Meier curves. Composite events, which will include MACE codes, will also be examined. Incidence rates of each of the AESIs, with 95% confidence intervals, for each cohort will be estimated. Rates between the Otezla-exposed cohort and 2 treatment comparator cohorts will be compared by calculating both crude and adjusted incidence rate ratios.