Document is current

Article History

Received: 19 December 2023

Accepted: 11 March 2024

First Online: 15 April 2024

Declarations

:

: Melania Dovizio, Valentina Perrone, Chiara Veronesi and Luca Degli Esposti report no conflict of interest in this work. CliCon S.r.l. Società Benefit is an independent company. The agreement signed by CliCon S.r.l. Società Benefit and Eli Lilly and Company did not create any entityship, joint venture or any similar relationship between parties. Neither CliCon S.r.l. Società Benefit nor any of their representatives are employees of Eli Lilly and Company for any purpose. Susanne Hartz, Carlotta Buzzoni, Isabel Redondo and Marijana Nedeljkovic Protic are full-time employees and stock-holders of Eli Lilly and Company. Alessandro Armuzzi has received consulting fees from: AbbVie, Allergan, Amgen, Arena, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, LionHealth, MSD, Mylan, Nestlè, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda; speaker’s fees from: AbbVie, Amgen, Arena, Biogen, Bristol-Myers Squibb, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Tigenix; and research support from: MSD, Takeda, Pfizer, Biogen. Carlotta Buzzoni and Domenico Birra have changed affiliation during the completion of the manus their new affiliations are as follows: Carlotta Buzzoni, Epidemiology Unit, Agency for Health Protection (ATS) of Milan, C.so Italia 52, Milano 20122, Italy. Domenico Birra, Internal Medicine Unit – Asl Napoli 1 Centro – ODM Hospital, Naples, Italy.

: The retrospective analysis of administrative databases involved secondary data extraction, and local ethics committees of each of the participating LHUs approved the study as per Agenzia Italiana del Farmaco (AIFA) guidelines and Italian law. Details of the local ethics committee, including name, protocol code and date of protocol approval are as follows: “Comitato etico interprovinciale Area I”, Protocol 68/CE/20, approval date 3/12/2020; “Comitato Indipendente di Etica Medica”, Protocol 48148, approval date 28/05/2021; “Comitato etico interprovinciale Area I”, Protocol 10/CE/22, approval date 31/01/2022; “Comitato Etico Lazio 2”, Protocol 0031401/2022, approval date 09/02/2022; “Comitato Indipendente di Etica Medica”, Protocol 48144, approval date 28/05/2021; “Comitato Etico per la Sperimentazione Clinica della provincia di Venezia e IRCCS S. Camillo”, Protocol 1405/AULSS 3 Mestre, approval date 26/10/2021; “Comitato Etico Regionale dell’Umbria”, Protocol 19414/20/ON, approval date 27/10/2021; “Comitato Etico Interaziendale A.O. SS. Antonio e Biagio e Cesare Arrigo – Alessandria”, Protocol AslVC.FarmT.21.02, approval date 16/12/2021. The study was conducted in compliance with ethical principles based on the Declaration of Helsinki and consistent with Good Pharmacoepidemiology Practices and applicable laws and regulations of Italy. All patient data collected were anonymised to ensure confidentiality and privacy. The anonymous univocal numeric code ensured total compliance with the European General Data Protection Regulation (GDPR) (2016/679). The results are exclusively in aggregated form and not attributable to a single institution, department, doctor, individual or individual prescribing behaviours. On the basis of the Data Privacy Guarantor Authority (General Authorisation for personal data treatment for scientific research purposes – n.9/2014), informed consent was not required, as its collection would be impossible for organisational reasons.