Switch pattern of biological drugs (originator and biosimilars) for the treatment of chronic immune-mediated inflammatory diseases through an Italian network of regional administrative databases: the VALORE Project

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective, multicenter study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB02) infliximab

  (L04AB01) etanercept

  (L04AB04) adalimumab

  (L04AB05) certolizumab pegol

  (L04AB06) golimumab

  (L04AC03) anakinra

  (L04AC10) secukinumab

  (L04AA24) abatacept

  (L04AA33) vedolizumab

  (L04AC05) ustekinumab
• Medical condition to be studied:
  Colitis ulcerative

  Crohn's disease

  Psoriasis

  Rheumatoid arthritis

  Psoriatic arthropathy
• Additional medical condition(s):
  Axial spondylarthritis

Population studied

• Short description of the study population:
  The study population included incident users of biological drugs approved for the immune mediated inflammatory diseases (IMIDs) in dermatology, rheumatology, and gastroenterology identified through the regional claims databases from 2010 to 2020.
• 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:
  30000

Study design details

• Main study objective:
  To describe the pattern of switch and swap among incident users of biological drugs approved for IMIDs in different therapeutic areas (dermatology, rheumatology and gastroenterology).
• Data analysis plan:
  Descriptive analyses will be conducted to assess demographic and clinical characteristics of biological drug users in relation to indication of use. Continuous variables will be described by means and standard deviation or by median and interquartile range (in case of outliers). Categorical variables will be described by patient counts and percentages. Starting from the index drug, we will describe switching to biosimilar or originator, swapping to other classes different from the index drug class or no switching by using proportions. Also the switch back and multiple switch will be described. Time to switch and swap will be described using a Kaplan Meier approach stratifying by indication and class of biological drugs.