Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective analysis of a research database

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DIMETHYL FUMARATE
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Short description of the study population:
  All patients who were users of dimethyl fumarate (DMF) in the post launch study period were retrieved from the database.; ; Patients were included in the study if they satisfied the following eligibility criteria:; 1. Treatment initiation with DMF on or after 1 March 2014 without a previous prescription for DMF in the 6 months prior to the index date
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Multiple sclerosis patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective of this study is to estimate the proportion of DMF use that is prescribed “on-label” versus “off-label”.
• Outcomes:
  Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany. Demographic characteristics of dimethyl fumarate (DMF) users, Prescription drug history of DMF users, duration of therapy in participants newly initiating DMF treatment, number of medical specialists prescribing DMF as identified according to specialty-specific billing codes at outpatient visits, medical history of DMF users, concomitant medication use of DMF users.
• Data analysis plan:
  This study is strictly descriptive (i.e. no hypothesis testing is being conducted). Demographic characteristics, concomitant medication, medication history, time on DMF and specialty of prescribing physician will be analysed separately by “on-label” or “off-label” use. All statistical analyses will be reported in a descriptive manner.Continuous data will be described by their mean, standard deviation, median, minimum, and maximum. Categorical data will be described by absolute and relative frequencies. A detailed description of the statistical analysis will be provided in the statistical analysis plan.

Documents

Study results

109MS409_ EUPASResultsPacket_Redacted