Post Authorization Safety Study (PASS) to Investigate Relevant Safety Outcomes among Patients Treated with Benepali for Psoriasis within the British Association of Dermatologists Biologic Interventions Register (BADBIR)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  BENEPALI
• Study drug International non-proprietary name (INN) or common name:
  ETANERCEPT
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB01) etanercept

  etanercept
• Medical condition to be studied:
  Psoriasis

Population studied

• Short description of the study population:
  Psoriasis patients treated with Benepali (etanercept)
• 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)
• Estimated number of subjects:
  451

Study design details

• Study design:
  This is a prospective, non-interventional observational cohort study utilizing data from the BADBIR registry. It compares the long-term safety of Benepali (etanercept) to conventional systemic therapies in patients with psoriasis across the UK and Republic of Ireland.
• Main study objective:
  The main objective of this study is to assess the long-term safety and the risk of serious adverse events in psoriasis patients treated with Benepali (etanercept) compared to those receiving conventional systemic therapies with comparable disease severity. Specifically, the study aims to evaluate the incidence rates of serious infections, malignancies, demyelinating diseases, tuberculosis, and other safety events of interest. This assessment is conducted by utilizing real-world data prospectively collected within the British Association of Dermatologists Biologic Interventions Register (BADBIR).
• Setting:
  Patients were recruited from 85 dermatology centres across the UK and ROI. Data were collected via online Case Report Forms every six months for the first 3 years and annually thereafter. The data were linked to national healthcare providers (e.g., NHS Digital) to capture additional information on mortality, malignancy, and overnight hospital admissions.
• Comparators:
  Those receiving conventional systemic therapies with comparable disease severity
• Outcomes:
  The following pre-selected events, which were agreed at a European Meeting (Manchester 2002) involving three rheumatology Biologics Registers (UK, Sweden and Germany) alongside the pharmaceutical companies that market biologic therapy and form the basis for the “Manchester Template”, and death were analyzed: ; • Aplastic anaemia, pancytopaenia, serious neutropenia ; • Cerebrovascular accident (CVA) ; • Hepatitis B reactivation ; • Lymphoproliferative disease ; • Malignancy (not including skin) ; • Melanoma or skin cancer including Bowen’s disease ; • Myocardial infarction / acute coronary disease ; • Pregnancy ; • Pulmonary embolism ; • Serious demyelination / optic neuritis ; • Serious congestive heart failure ; • Serious hepatic dysfunction/failure ; • Serious hypersensitivity reaction ; • Serious infection (excluding tuberculosis) ; • Serious lupus / lupus-like illness ; • Serious psoriasis flare ; • Serious skin reaction (e.g. Stevens Johnson syndrome, erythema multiforme toxic epidermal necrolysis) ; • Surgery (overnight hospitalisation) ; • Tuberculosis (not latent)
• Summary results:
  Benepali was well-tolerated with no new safety signals identified. Total Serious Infection incidence was 26.3/1,000 person-years in the Benepali group versus 34.4/1,000 person-years in the conventional group (adjusted HR 0.74, 95% CI: 0.50-1.09). Skin (non-cancer) events were significantly lower in the Benepali group (adjusted HR 0.15). No tuberculosis or haematologic events were reported in the Benepali cohort. The benefit-risk profile remains positive.