DARWIN EU® Treatment patterns of drugs used in adult and paediatric population with systemic lupus erythematosus

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  - Cyclosporine; - Fluocortolone; - Paramethasone ; - Prednisone; - Triamcinolone ; - Cortisone; - Prednylidene; - Rimexolone ; - Deflazacort; - Cloprednol ; - Meprednisone ; - Cortivazol
• Study drug International non-proprietary name (INN) or common name:
  AZATHIOPRINE

  BELIMUMAB

  BETAMETHASONE

  CYCLOPHOSPHAMIDE

  DEXAMETHASONE

  HYDROCORTISONE

  HYDROXYCHLOROQUINE

  METHOTREXATE

  METHYLPREDNISOLONE

  MYCOPHENOLATE MOFETIL

  PREDNISOLONE

  RITUXIMAB

  TACROLIMUS

  VOCLOSPORIN
• Anatomical Therapeutic Chemical (ATC) code:
  (H02AB01) betamethasone

  (H02AB02) dexamethasone

  (H02AB03) fluocortolone

  (H02AB04) methylprednisolone

  (H02AB05) paramethasone

  (H02AB06) prednisolone

  (H02AB07) prednisone

  (H02AB08) triamcinolone

  (H02AB09) hydrocortisone

  (H02AB10) cortisone

  (H02AB11) prednylidene

  (H02AB12) rimexolone

  (H02AB13) deflazacort

  (H02AB14) cloprednol

  (H02AB15) meprednisone

  (H02AB17) cortivazol

  (L01AA01) cyclophosphamide

  (L01BA01) methotrexate

  (L01FA01) rituximab

  (L04AA06) mycophenolic acid

  (L04AA26) belimumab

  (L04AD01) ciclosporin

  (L04AD02) tacrolimus

  (L04AD03) voclosporin

  (L04AX01) azathioprine

  (L04AX03) methotrexate

  (P01BA02) hydroxychloroquine
• Medical condition to be studied:
  Systemic lupus erythematosus

Population studied

• Short description of the study population:
  The study population will include all individuals with a first diagnosis of SLE identified in the database during the patient selection period, which is between 01/01/2013 and 180 days prior to the end of available data in each database.
• Age groups:
  Infants and toddlers (28 days – 23 months)

  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)
• Estimated number of subjects:
  19900000

Study design details

• Study design:
  A retrospective cohort study of all patients newly diagnosed with SLE will be conducted. For the description of each treatment objective, a new drug user cohort will be used to characterise patient-level SLE drug utilisation.
• Main study objective:
  To characterise paediatric and adult patients with SLE.
• Data analysis plan:
  Large scale patient level characterisation will be conducted. Medical condition and medication use history will be reported at any time and 365 days prior to index date, respectively. The number and percentage of patients receiving each of a pre specified list of SLE treatments and treatment combinations will be described per calendar year. Additionally, sunburst plots and Sankey diagrams will be used to describe treatment patterns and sequences over time. For the new user cohort, the index date is the initiation of SLE treatment after SLE diagnosis. Treatment duration, initial dose strength, cumulative dose, number of prescriptions will be estimated for new users of each SLE treatments at the ingredient level. For all continuous variables, mean with standard deviation and median with interquartile range will be reported. For all categorical analyses, number and percentages will be reported. A minimum cell count of 5 will be used when reporting results, smaller counts reported as 5.

Documents

Study report

DARWIN_EU_Study_Report_P2-C1-006_v2.0_final.pdf