The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Case-crossover

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BRODALUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC12) brodalumab

  brodalumab
• Medical condition to be studied:
  Psoriasis

Population studied

• 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)
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  The study aims to evaluate potential excess risks associated with the use of brodalumab in the treatment of psoriasis with regards to: ; 1) Suicidal attempts (fatal or non-fatal), ; 2) Serious infections (incident serious chronic infections or serious infections leading to hospitalization), ; 3) MACE (acute myocardial infarction, stroke or cardiovascular death), ; 4) Malignancies
• Outcomes:
  1) Suicidal attempts (fatal or non-fatal), ; 2) Serious infections (incident serious chronic infections or serious infections leading to hospitalization), ; 3) MACE (acute myocardial infarction, stroke or cardiovascular death), ; 4) Malignancies
• Data analysis plan:
  Two different designs are used:; A case-time-control design is used in the analysis of 1) serious infections 2) suicidal behaviour and 3) MACE. In this design a patient´s risk of experiencing an outcome while being exposed to brodalumab is compared to the same patient´s risk of an outcome while not being exposed. Due to the inherently matched nature of the case-time-control design conditional logistic regression is used to calculate odds ratios. ; An active-comparator cohort design is used in the analysis of 1) serious infections, 2) suicidal behaviour, 3) MACE, and 4) malignancies. In this design, the event rate of outcomes among subjects exposed to brodalumab is compared to the event rate of outcomes among subjects who are exposed to other biological drugs. In the cohort design propensity score matching is used to adjust for confounding, whereas Cox proportional hazard model is used to calculate hazard ratios.

Documents

Study report

NIS-KYNTHEUM-1345 Regulatory Agency - Progress Report_Redacted

NIS-KYNTHEUM-1345 Regulatory Agency - Progress Report_Redacted 2020

Study, other information

NIS-KYNTHEUM-1345 Regulatory Agency - Progress Report_Redacted 2020.pdf