Adherence to disease modifying drugs of patients with multiple sclerosis (ADAPIMS)

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

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L03AB07) interferon beta-1a

  interferon beta-1a

  (L03AB08) interferon beta-1b

  interferon beta-1b

  (L03AX13) glatiramer acetate

  glatiramer acetate

Population studied

• Short description of the study population:
  Patients using disease modifying drugs (DMD) for multiple sclerosis who had their first prescription of any DMD between January 01, 2002, and December 31, 2006.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  80000

Study design details

• Main study objective:
  To quantify persistence and compliance with disease modifying drugs for multiple sclerosis from a representative pharmacy dispensing database in Germany.
• Outcomes:
  persistence with disease modifying drugs for multiple sclerosis (estimated from a pharmacy dispensing database with method of allowable gaps between refills), compliance with disease modifying drugs for multiple sclerosis (estimated from a pharmacy dispensing database with method of medication possession ratio)
• Data analysis plan:
  Persistence will be quantified as the proportion of patients not exceeding the allowable gap between refills during follow-up (730 days from index prescription) as well as median duration of persistence. Compliance will be quantified as the proportion of patients with medication possession ratio exceeding 0.8.Differences in persistence and compliance will be analysed for the different types of disease modifying drugs (3 interferon products and glatiramer acetate) as well as by index year in order to estimate trends in persistence and compliance during recent years.