COHORT STUDY ON THE SAFETY OF BIMEKIZUMAB IN PATIENTS WITH PLAQUE PSORIASIS, PSORIATIC ARTHRITIS, AXIAL SPONDYLOARTHRITIS, OR HIDRADENITIS SUPPURATIVA: A NON-INTERVENTIONAL POST AUTHORIZATION STUDY

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  bimekizumab
• Study drug International non-proprietary name (INN) or common name:
  BIMEKIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC21) bimekizumab

  bimekizumab
• Medical condition to be studied:
  Psoriasis

  Axial spondyloarthritis

  Hidradenitis

  Psoriatic arthropathy

Study design details

• Study design:
  The study is a sequential new-user active-comparator cohort design using secondary healthcare data.
• Main study objective:
  The primary purpose of this post-authorization safety study (PASS) within an active surveillance system will be to provide timely information on any potential increase in the risk of outcomes of interest in PSO, PsA, and axSpA patients using bimekizumab compared to other biologics indicated for moderate to severe plaque PSO, PsA, or axSpA, except for other anti-IL-17 biologics.
• Setting:
  This non-interventional study will analyze secondary data from the US and EU healthcare system (Huybrechts and Schneeweiss, 2021). It is anticipated that all study patients in the EU and US databases will be identified in the respective databases starting Q1 2023 for the [REDACTED] and potentially Q3 2023 for the commercial US claims databases.
• Outcomes:
  Outcomes of interest will include, but are not limited to, the following: MACE, malignancy, IBD, serious infection, and serious hypersensitivity. If additional outcomes of interest are identified, they will be considered for inclusion in the analysis to the extent that the data sources used in this study will contain sufficiently detailed information.