Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: The VALORE Project.
Gianluca TrifiròValentina IsgròYlenia IngrasciottaValentina IentileLuca L'AbbateSaveria S FotiValeria BelleudiFrancesca PoggiAndrea FontanaUgo MorettiRiccardo LoraAlberto SabainiIlenia SenesiCarla SorrentinoMaria R PuzoAngela PadulaMariano FuscoRoberta GiordanaValentina SolfriniAurora PucciniPaola RossiStefania Del ZottoOlivia LeoniMartina ZanforliniDomenica AnconaVito BavaroDonatella GarauStefano LeddaSalvatore ScondottoAlessandra AllottaMarco TuccoriRosa GiniGiampaolo BucaneveDavid FranchiniAnna CavazzanaValeria BiasiStefania Spila AlegianiMarco Massarinull nullPublished in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (2021)
The VALORE project multi-database network has access to data on more than 140,000 biological drug users (and > 0.5 million PYs) from 13 Italian regions during the years 2010-2019, which will be further expanded with the inclusion of data from other regions and more recent calendar years. Overall, the cumulated amount of person-time of exposure to biological drugs approved for IMIDs provides enough statistical power to investigate weak/moderate associations of almost all individual compounds and the most relevant safety outcomes. Moreover, this network may offer the opportunity to investigate the interchangeability of originator and biosimilars of several TNFα inhibitors in different therapeutic areas in real-world settings.