Document is current

Article History

Received: 8 July 2025

Accepted: 9 December 2025

First Online: 7 January 2026

Declarations

:

: SC is an employee of Sanofi and is a shareholder of this company. JL has received consultancy fees from Sanofi in the context of this work. XL is an employee of Sanofi and is a shareholder of this company. SK is an employee of Teva Pharmaceutical Industries Ltd. DB is an employee of Sanofi. MAB reports funding for her research institute (BPE) in the context of this study from the consortium who funded the study. MR reports funding for her research institute (BPE) in the context of this study from the consortium who funded the study. JC is an employee of Sanofi and is a shareholder of this company. PB : reports funding for his research institute (BPE) in the context of this study from the consortium who funded the study. EB reports funding for her research institute (BPE) in the context of this study from the consortium who funded the study. BS reports funding from Sanofi in the context of this work, consulting fees from Angelini and UCB, honoraria for lectures, presentations or educational events from Angelini, UCB and Desitin Pharma GmbH, and is chair of the board of trustees for the Michael Foundation. LCB reports funding for her research institute (BPE) in the context of this study from the consortium who funded the study.

: We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines. The study received approval from the French ethical and scientific committee for research, studies and assessments in healthcare (CESREES) on 08/OCT/2020 and authorization by the French data protection authority (CNIL) on 1/DEC/2020 (reference: 920412). Since the SDNS is a pseudonymised database, individual patient consent was not required. An agreement was signed between Sanofi and CPRD to access the CPRD GOLD Raw Data and HES linkage under the ISAC protocol 20_000053.

: Not applicable, as data used are pseudonimysed data and dont allow identification of the patients

: Not applicable, as data used are pseudonimysed data and dont allow identification of the patients

: The code is not made available for this study

: The data can’t be made available per ethics authorization restrictions.

: SC contributed to Conceptualization, Investigation, Methodology, Validation, Visualization, Writing—review & editing. JL, XL, SK, DB, JG contributed to Writing—review & editing. MAB contributed to Conceptualization, Software, Methodology, Formal analysis, Data curation, Investigation, Validation, Visualization, Writing—review and editing. MR contributed to Conceptualization, Investigation, Methodology, Validation, Project administration, Visualization, Writing—review & editing. PB contributed to Conceptualization, Investigation, Methodology, Validation, Visualization, Supervision, Funding acquisition, Writing - original draft, Writing - review and editing. EB contributed to Investigation, Validation, Project administration, Visualization, Writing - review and editing. BS contributed to Conceptualization, Investigation, Validation, Writing - review and editing. LCB contributed to Conceptualization, Investigation, Methodology, Validation, Visualization, Writing - original draft, Writing - review & editing. All authors agreed on the journal for submission, all versions, and accepted responsibility and accountability for the manuscript.