Post-marketing evaluation of the benefit-risk profile of originator biological drugs and biosimilars in the dermatological, rheumatological, gastroenterological and onco-hematological areas through the establishment of a single multiregional network for the integrated analysis of data from health databases, active surveillance and clinical registers - VALORE project

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB) Tumor necrosis factor alpha (TNF-alpha) inhibitors

  (L04AC) Interleukin inhibitors

  (L04AA33) vedolizumab

  (L04AA24) abatacept

  (L01XC02) rituximab

  (L01XC03) trastuzumab

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  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)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  160000

Study design details

• Main study objective:
  To establish a single multi-regional network aiming at set up a data infrastructure integrating claims data plus clinical registries from 16 Regions with the final aim of conducting post-marketing surveillance of biologics, including biosimilar, in patients with immune-mediated inflammatory diseases.
• Data analysis plan:
  Data will be described using frequencies, percentage, mean with standard deviations (or median with interquartile range, where appropriate). Prevalence of use (adjusted for age categories: < 18, 18–44, 45–64, ≥ 65 years) using a standardized direct method based on the calendar year-specific Italian population), proportion of biosimilar users, pattern of use of biological drugs (i.e. adherence, persistence, switch and swap) will be calculated. Subgroup analysis will be performed in children and adolescents (<18 years old), elderly patients (≥65 years old), pregnant women. Moreover, the main indication of use of biological drugs approved for immune-mediated inflammatory diseases will be identified using coding algorithms.

Documents

Study publications

Trifirò G, Isgrò V, Ingrasciotta Y, Ientile V, L’Abbate L, Foti SS, Belleudi V,…