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Article History

Received: 28 October 2024

Accepted: 16 June 2025

First Online: 18 July 2025

Declarations

:

: AG is an employee of Janssen Biologics B.V. and owns stock/stock options in Johnson & Johnson, of which Janssen is a subsidiary. SLL and YG are employees of Novartis and own stock. All other co-authors have no competing interests to disclose.

: Finland: Ethical approval is not required for register-based studies. Institutional Review Board at the Finnish Institute for Health and Welfare approved the study and waived the requirement for obtaining informed consent for the secondary use of health administrative data from study participants (THL/543/6.02.00/2021). Data were handled and stored in accordance with the General Data Protection Regulation. France: The EFEMERIS cohort was approved by the French Data Protection Authority on 7 April 2005 (authorization number 05-1140). This study was performed on anonymized patient data. The women included in the EFEMERIS database were informed of their inclusion and of the potential use of their anonymized data for research purposes. They could oppose the use of their data at any time. The women included in the EFEMERIS database know that their collected and anonymized data can be used for medical research purposes and can thus be published. The study was approved by the EFEMERIS steering group. Data were handled and stored in accordance with the General Data Protection Regulation. Italy: The study was approved by the local ethical committee (approval number 593/2023/Oss/UniFe). Data were handled and stored in accordance with the General Data Protection Regulation and in agreement with the Authority for Healthcare and Welfare, Emilia Romagna Regional Health Service, Bologna, Italy. Norway: The study was approved by the Regional Committee for Research Ethics in South-East Norway (approval number 85224) and by the Data Protection Officer at the University of Oslo (approval number 519858). Data were handled and stored in accordance with the General Data Protection Regulation. Spain (Valencian Region): The study (code: IMI-IMN-2019-01) was classified as an Observational Post-authorisation Study “Other designs” (EPA-OD) by Spanish Medicines Agency (AEMPS), available on: ; and approved by the Arnau de Vilanova Hospital’s Clinical Research Ethics Committee on 29th January 2020, according to the Spanish regulations (approval number 1/2020). At regional level following the national Personal Data Protection and guaranteeing digital rights (Law 3/2018), the study was approved by the Commission of the Regional Government (PROSIGA) that has the right of giving RDRU Fisabio authorisation to process the data (references: SD2556; SD2577; SD2578; SD2579; SD2580; SD2581; SD2582). Wales: This study uses anonymised data held in the Secure Anonymised Information Linkage (SAIL) Databank. The SAIL Databank independent Information Governance Review Panel (IGRP) approved the study as part of project 0823, on 16th October 2020.