DARWIN EU® - Azathioprine - user characteristics

Study type

• Study topic:
  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

• Study drug International non-proprietary name (INN) or common name:
  AZATHIOPRINE
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AX01) azathioprine

  azathioprine

Population studied

• Short description of the study population:
  For this study we have one cohort, namely:; • Population of individuals newly treated with Azathioprine

Study design details

• Study design:
  New drug/s user cohort
• Main study objective:
  1. Characterise azathioprine initiators by sex and age at first prescription.; 2. Identify potential indications for azathioprine, and the percentage of azathioprine-treated patients for each pre-defined approved indication:; a) Organ transplantation; b) Severe rheumatoid arthritis or chronic polyarthritis; c) Inflammatory bowel disease; d) Systemic lupus erythematosus; e) Dermatomyositis; f) Polyarteritis nodosa; g) Pemphigus vulgaris and bullous pemphigoid; h) Behçet's disease; i) Refractory autoimmune haemolytic anaemia; j) Refractory idiopathic thrombocytopenic purpura; k) Polymyositis; l) Pyoderma gangrenosum; m) Multiple sclerosis; n) Myasthenia gravis.; 3. Large-scale characterisation overall and per indication of drugs and conditions within one year prior to the index date (-365 to -1 day to the index date) and on the index date will be assessed.; 4. Estimate and summarise duration of treatment with azathioprine, overall, and stratified per indication.
• Setting:
  This study will use routinely collected health data from 5 databases in the DARWIN EU® network of data partners from 4 European countries. All databases were previously mapped to the OMOP CDM. ; Data sources ; 1. Clinical Practice Research Datalink (CPRD) GOLD, United Kingdom; 2. Integrated Primary Care Information (IPCI), Netherlands; 3. IQVIA Disease Analyzer Germany (IQVIA DA Germany), Germany; 4. Institut Municipal Assistència Sanitària Information System (IMASIS), Spain; 5. The Information System for Research in Primary Care (SIDIAP), Spain

Documents

Study report

DARWIN EU_Report_P3-C1-014 Azathioprine_V3.pdf