DARWIN EU® - Azathioprine - user characteristics

Study type

• Study topic:
  Disease /health condition

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

  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:
  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
• Outcomes:
  Outcomes of interest ; • Characteristics (sex and age) ; • Indication ;  Organ transplantation ;  Severe rheumatoid arthritis or chronic polyarthritis ;  Inflammatory bowel diseases ;  Autoimmune hepatitis ;  Systemic lupus erythematosus ;  Dermatomyositis ;  Polyarteritis nodosa ;  Pemphigus vulgaris and bullous pemphigoid ;  Behcet’s disease ;  Refractory autoimmune haemolytic anaemia ;  Refractory idiopathic thrombocytopenic purpura ;  Polymyositis ;  Pyoderma gangrenosum ;  Multiple sclerosis ;  Myasthenia gravis ;  None of the above/missing ; • Large-scale characterisation: drugs and comorbidities within one year prior to the index date (; 365 to -1 day to the index date) and on the index date ; • Treatment duration, overall and by indication
• Summary results:
  In this study the number of incident azathioprine ranged between 692 to 31,857 patients in the different databases. Azathioprine users were slightly more often female than male, with a median age ranging between 48-53 years. Median treatment duration ranged between 90 to 1,019 days and most patients had a treatment duration of less than 1 year. IBD was most often the indication for azathioprine use, followed by autoimmune hepatitis. In the azathioprine users without an indication prednisone/prednisolone was the most prescribed drug in the year before treatment initiation. Lastly conditions related to abdominal pain and IBD, specifically Crohn’s disease and ulcerative colitis, were also often present in the year before treatment initiation in azathioprine users without an indication.