A Long-Term Observational, Retrospective Cohort Study to Evaluate the Safety, Including Cardiovascular Safety, of Fremanezumab in Patients with Migraine in Routine Clinical Practice in the United States and Europe

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FREMANEZUMAB
• Medical condition to be studied:
  Migraine prophylaxis

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:
  5000

Study design details

• Main study objective:
  The objectives of the study are to evaluate: the long-term safety of fremanezumab in patients with migraine, the safety of fremanezumab in a sub population of CV compromised patients and the incidence of new-onset hypertension and worsening of preexisting hypertension in fremanzumab treated patients. T
• Outcomes:
  incidence of new-onset hypertension and worsening of preexisting hypertension, Hypersensitivity reactions, Alopecia, Anaphylaxis, Angioedema, Constipation, Raynaud’s Phenomenon, MI, Stroke, Unstable angina, • To assess the treatment pattern in the fremanezumab and comparative cohorts (i.e. switches from/to treatment, add-on treatments, treatment duration).
• Data analysis plan:
  All variables will be analyzed descriptively with appropriate statistical methods: categorical variables by frequency tables (absolute and relative frequencies) and continuous variables by sample statistics (i.e. mean, standard deviation, minimum, median, quartiles and maximum). Comparison of the proportion of AEs between fremanezumab and comparative cohorts will be evaluated through a multivariable model for count data (eg, Poisson or Negative Binomial regression model) with propensity scores used as inverse probability of treatment weighting. For all primary objectives, fremanezumab cohort will be compared to all comparative cohorts. In addition to the comparison of all the patients in the cohorts, the analyses will also be conducted using the subgroups of patients with a long-term use of the drug of interest. The long-term use subgroup will be defined as patients with persistent treatment of the drug of interest for at least 3 years with at least 80% adherence.