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
betamethasone
(H02AB02) dexamethasone
dexamethasone
(H02AB03) fluocortolone
fluocortolone
(H02AB04) methylprednisolone
methylprednisolone
(H02AB05) paramethasone
paramethasone
(H02AB06) prednisolone
prednisolone
(H02AB07) prednisone
prednisone
(H02AB08) triamcinolone
triamcinolone
(H02AB09) hydrocortisone
hydrocortisone
(H02AB10) cortisone
cortisone
(H02AB11) prednylidene
prednylidene
(H02AB12) rimexolone
rimexolone
(H02AB13) deflazacort
deflazacort
(H02AB14) cloprednol
cloprednol
(H02AB15) meprednisone
meprednisone
(H02AB17) cortivazol
cortivazol
(L01AA01) cyclophosphamide
cyclophosphamide
(L01BA01) methotrexate
methotrexate
(L01FA01) rituximab
rituximab
(L04AA06) mycophenolic acid
mycophenolic acid
(L04AA26) belimumab
belimumab
(L04AD01) ciclosporin
ciclosporin
(L04AD02) tacrolimus
tacrolimus
(L04AD03) voclosporin
voclosporin
(L04AX01) azathioprine
azathioprine
(L04AX03) methotrexate
methotrexate
(P01BA02) hydroxychloroquine
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

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