Comparing clinical trial population representativeness to real-world users of 17 biologics approved for immune-mediated inflammatory diseases: An external validity analysis of 66,639 biologic users from the Italian VALORE project

• Main Authors: Ylenia Ingrasciotta (Author), Andrea Spini (Author), Luca L'Abbate (Author), Elena Sofia Fiore (Author), Massimo Carollo (Author), Valentina Ientile (Author), Valentina Isgrò (Author), Anna Cavazzana (Author), Valeria Biasi (Author), Paola Rossi (Author), Lucian Ejlli (Author), Valeria Belleudi (Author), Francesca Poggi (Author), Ester Sapigni (Author), Aurora Puccini (Author), Domenica Ancona (Author), Paolo Stella (Author), Sebastiano Pollina Addario (Author), Alessandra Allotta (Author), Olivia Leoni (Author), Martina Zanforlini (Author), Marco Tuccori (Author), Rosa Gini (Author), Gianluca Trifirò (Author)
• Format: Book
• Published: Elsevier, 2024-02-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

To date, no population-based studies have specifically explored the external validity of pivotal randomized clinical trials (RCTs) of biologics simultaneously for a broad spectrum of immuno-mediated inflammatory diseases (IMIDs). The aims of this study were, firstly, to compare the patients' ch...