Drug utilization of biological drugs in patients over 65 years with Immune- mediated inflammatory diseases through the Italian VALORE network

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:
  ABATACEPT

  ADALIMUMAB

  ANAKINRA

  BRODALUMAB

  CERTOLIZUMAB PEGOL

  ETANERCEPT

  GOLIMUMAB

  GUSELKUMAB

  INFLIXIMAB

  IXEKIZUMAB

  RISANKIZUMAB

  SARILUMAB

  SECUKINUMAB

  TILDRAKIZUMAB

  TOCILIZUMAB

  USTEKINUMAB

  VEDOLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA24) abatacept

  abatacept

  (L04AG05) vedolizumab

  vedolizumab

  (L04AB01) etanercept

  etanercept

  (L04AB02) infliximab

  infliximab

  (L04AB04) adalimumab

  adalimumab

  (L04AB05) certolizumab pegol

  certolizumab pegol

  (L04AB06) golimumab

  golimumab

  (L04AC03) anakinra

  anakinra

  (L04AC05) ustekinumab

  ustekinumab

  (L04AC07) tocilizumab

  tocilizumab

  (L04AC10) secukinumab

  secukinumab

  (L04AC12) brodalumab

  brodalumab

  (L04AC13) ixekizumab

  ixekizumab

  (L04AC14) sarilumab

  sarilumab

  (L04AC16) guselkumab

  guselkumab

  (L04AC17) tildrakizumab

  tildrakizumab

  (L04AC18) risankizumab

  risankizumab

Population studied

• Short description of the study population:
  Elderly patients using biological drugs in the Italian Valore distributed database (2010-2022)
• Age groups:
  • Adult and elderly population (≥18 years)

    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients over 65 years
• Estimated number of subjects:
  25000

Study design details

• Study design:
  retrospective, cohort study will be performed
• Main study objective:
  This study aims to assess the utilization of TNF-alpha inhibitors, anti-interleukin, selective immunosuppressants and anti-integrins in IMIDs patients over 65 years of age to shed a light of their use in clinical practice using data from the VALORE project, specifically observing persistence to biological therapies.
• Setting:
  Italian setting
• Comparators:
  None
• Outcomes:
  Adherence, persistence of biological treatment