Trifirò, Gianluca http://orcid.org/0000-0003-1147-7296
Isgrò, Valentina
Ingrasciotta, Ylenia
Ientile, Valentina
L’Abbate, Luca
Foti, Saveria S.
Belleudi, Valeria
Poggi, Francesca
Fontana, Andrea
Moretti, Ugo
Lora, Riccardo
Sabaini, Alberto
Senesi, Ilenia
Sorrentino, Carla
Puzo, Maria R.
Padula, Angela
Fusco, Mariano
Giordana, Roberta
Solfrini, Valentina
Puccini, Aurora
Rossi, Paola
Del Zotto, Stefania
Leoni, Olivia
Zanforlini, Martina
Ancona, Domenica
Bavaro, Vito
Garau, Donatella
Ledda, Stefano
Scondotto, Salvatore
Allotta, Alessandra
Tuccori, Marco
Gini, Rosa
Bucaneve, Giampaolo
Franchini, David
Cavazzana, Anna
Biasi, Valeria
Spila Alegiani, Stefania
Massari, Marco
Trifirò, Gianluca http://orcid.org/0000-0003-1147-7296
Moretti, Ugo
Lora, Riccardo
Sabaini, Alberto
Isgrò, Valentina
Ingrasciotta, Ylenia
Ientile, Valentina
L’Abbate, Luca
Foti, Saveria Serena
Spila Alegiani, Stefania
Belleudi, Valeria
Poggi, Francesca
Fontana, Andrea
Massari, Marco
Andretta, Ilaria
Tanaglia, Matilde
Senesi, Ilenia
Sorrentino, Carla
Puzo, Maria Rosalia
Padula, Angela
Carriero, Antonio
Sassano, Sergio
De Sarro, Giovambattista
Mirarchi, Simona
Palleria, Caterina
Sarro, Caterina
Fusco, Mariano
Giordana, Roberta
Balestrieri, Marianna
Rostan, Stefania
Capuano, Annalisa
Bernardi, Francesca Futura
Trama, Ugo
Russo, Alessandro
Fumo, Maria Grazia
Belleudi, Valeria
Poggi, Francesca
Addis, Antonio
Musicco, Felice
Solfrini, Valentina
Sapigni, Ester
Puccini, Aurora
Mazzetti, Ilaria
Podetti, Debora
Potenza, Anna Maria
Nikitina, Victoria
Ricciardelli, Rita
Mogheiseh, Nazanin
Croce, Silvia
Rossi, Paola
Pettinelli, Aba
Del Zotto, Stefania
Ejlli, Lucian
Leoni, Olivia
Fortino, Ida
Ercolanoni, Michele
Mazzone, Arianna
Nisic, Andrea
Schiatti, Simone
Ludergnani, Monica
Zanforlini, Martina
Mancini, Mauro
Patregnani, Luigi
Fabbietti, Paolo
Antonicelli, Elisa
Mangano, Antea
Campomori, Annalisa
Urru, Silvana Annamaria
Costa, Giorgio
Guarrera, Giovanni M
Ancona, Domenica
Bavaro, Vito
Stella, Paolo
Garau, Donatella
Serra, Enrico
Ledda, Stefano
Carta, Paolo
Scondotto, Salvatore
Allotta, Alessandra
Gini, Rosa
Tuccori, Marco
Vannacci, Alfredo
Lucenteforte, Ersilia
Parrilli, Maria
Convertino, Irma
Bucaneve, Giampaolo
De Giorgi, Marcello
Franchini, David
Rocchi, Rosalba Elisabetta
Rossi, Mariangela
Scroccaro, Giovanna
Cavazzana, Anna
Biasi, Valeria
Deambrosis, Paola
Grindelli, Giampietro
Ferroni, Eliana
,
Funding for this research was provided by:
agenzia italiana del farmaco, ministero della salute
Università degli Studi di Verona
Article History
Accepted: 25 August 2021
First Online: 12 October 2021
Declarations
:
: This study was funded by the Italian Medicines Agency in the context of the multiregional pharmacovigilance project (AIFA 2012–2014: Postmarketing 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).
: In the last 3 years, Gianluca Trifirò has served on advisory boards/seminars funded by several pharmaceutical companies marketing biologics originators and biosimilars on topics unrelated to this paper; he was the scientific director of a Master program on pharmacovigilance, pharmacoepidemiology, and real-world evidence at University of Messina, which received non-conditional grants from various pharmaceutical companies; he coordinated a pharmacoepidemiology team at the University of Messina until October 2020, which received funding for conducting observational studies from various pharmaceutical companies; he is also scientific coordinator of the academic spin-off “INSPIRE srl,” which received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.), based on funding from pharmaceutical companies. None of these listed activities are related to the topic of the manuscript. Ylenia Ingrasciotta is the CEO of the academic spin-off “INSPIRE srl” of the University of Messina, which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.). Rosa Gini is the head of the Pharmacepidemiology Unit of ARS Toscana. The budget of her unit is partially supported by contracts with pharmaceutical companies whose products are studied in the VALORE project. Such studies are compliant with the ENCePP Code of Conduct. Valentina Isgrò, Valentina Ientile, Luca L’Abbate, Saveria Serena Foti, Valeria Belleudi, Francesca Poggi, Andrea Fontana, Ugo Moretti, Riccardo Lora, Alberto Sabaini, Ilenia Senesi, Carla Sorrentino, Maria Rosalia Puzo, Angela Padula, Mariano Fusco, Roberta Giordana, Valentina Solfrini, Aurora Puccini, Paola Rossi, Stefania Del Zotto, Olivia Leoni, Martina Zanforlini, Domenica Ancona, Vito Bavaro, Donatella Garau, Stefano Ledda, Salvatore Scondotto, Alessandra Allotta, Marco Tuccori, Giampaolo Bucaneve, David Franchini, Anna Cavazzana, Valeria Biasi, Stefania Spila Alegiani, and Marco Massari have no conflicts of interest that are directly relevant to the content of this article.
: This study was conducted in the context of the multiregional active pharmacovigilance VALORE project, funded by the Italian Medicines Agency. This retrospective study protocol was notified to the Ethical Committee of the Academic Hospital of Messina, which was the project’s coordinating center at the time of protocol submission, according to the current national law. The manuscript does not contain clinical studies or patient data. Formal consent is not required for this type of study.
: Not applicable
: The datasets generated and/or analyzed during the current study are not publicly available because of privacy reasons.
: Not applicable
: Gianluca Trifirò and Marco Massari conceived the study. Acquisition of data: Ilenia Senesi, Carla Sorrentino (Abruzzo), Maria Rosalia Puzo, Angela Padula (Basilicata), Mariano Fusco, Roberta Giordana (Campania), Valentina Solfrini, Aurora Puccini (Emilia-Romagna), Paola Rossi, Stefania Del Zotto (Friuli Venezia Giulia), Valeria Belleudi, Francesca Poggi (Lazio), Olivia Leoni, Martina Zanforlini (Lombardia), Domenica Ancona, Vito Bavaro (Puglia), Donatella Garau, Stefano Ledda (Sardegna), Salvatore Scondotto, Alessandra Allotta (Sicilia), Marco Tuccori, Rosa Gini (Toscana), Giampaolo Bucaneve, David Franchini (Umbria), Anna Cavazzana, Valeria Biasi (Veneto). Data management: Valentina Ientile, Luca L’Abbate, Saveria Serena Foti, Stefania Spila Alegiani, Valeria Belleudi, Francesca Poggi, Andrea Fontana, Marco Massari. Analysis and interpretation of data: Gianluca Trifirò, Ugo Moretti, Riccardo Lora, Alberto Sabaini, Valentina Isgrò, Ylenia Ingrasciotta, Valentina Ientile, Luca L’Abbate, Saveria Serena Foti, Stefania Spila Alegiani, Valeria Belleudi, Francesca Poggi, Andrea Fontana, Marco Massari. Preparation of manuscript: Valentina Isgrò, Ylenia Ingrasciotta. Gianluca Trifirò critically revised the paper.