A non-interventional post-authorisation safety study to investigate drug utilisation and safety monitoring patterns for Lemtrada (alemtuzumab)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Name of medicine:
  LEMTRADA
• Study drug International non-proprietary name (INN) or common name:
  ALEMTUZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA34) alemtuzumab

  alemtuzumab
• Medical condition to be studied:
  Multiple sclerosis

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:
  120

Study design details

• Main study objective:
  1a) to measure the proportion of patients who meet the newly restricted indication on initiating their first course of LEMTRADA after implementation of the revised EU SmPC January 2020 1b) to measure the proportion of LEMTRADA courses, first or continuing, that are not contraindicated after implementation of revised SmPC January 2020
• Data analysis plan:
  In each individual data source, descriptive proportions will be calculated as: ; • Proportion of new LEMTRADA users prescribed in accordance with the newly revised indication (numerator = # patients with revised indication, denominator = all patients initiating their first course of LEMTRADA after implementation of the revised EU SmPC in 01/2020). ; • Proportion of new or continuing LEMTRADA users without any contraindications at time of course initiation after 01/2020 (numerator = # courses without contraindications, denominator = all LEMTRADA courses post 01/2020) ; • Proportion of LEMTRADA users receiving advised cardiac monitoring (ECG/HR/BP) and blood testing prior to, HR/BP during, and platelet testing during LEMTRADA course (numerator = # courses with each unique test prior to and during infusion, denominator = all LEMTRADA courses post 01/2020) Additionally, percentage adherence to each long-term test will be calculated at patient level for up to 48 months since last infusion.