Dewilde, Sarah https://orcid.org/0000-0002-7315-3230
Tollenaar, Nafthali H. https://orcid.org/0000-0001-9271-5959
Boulanger, Pierre
Archer, Annie
Pardo, Raquel
Cortés-Vicente, Elena https://orcid.org/0000-0002-1428-1072
Mantegazza, Renato https://orcid.org/0000-0002-9810-5737
Vanoli, Fiammetta https://orcid.org/0000-0002-9081-6462
Lehnerer, Sophie https://orcid.org/0000-0001-9007-027X
Pawlitzki, Marc https://orcid.org/0000-0003-3080-2277
Heinrich, Malgorzata https://orcid.org/0000-0001-6308-3286
De Ruyck, Femke
Phillips, Glenn https://orcid.org/0000-0002-9676-1909
Paci, Sandra
Funding for this research was provided by:
Argenx
Article History
Received: 28 February 2024
Accepted: 29 May 2025
First Online: 19 June 2025
Declarations
:
: Initial ethical approval for this study (protocol nr. 4244–04-2021) was obtained on 04 May 2021 by Vitaccess Ltd. from IRB Salus for all study countries. Extended approval was granted on 29 April 2022, encompassing the transfer of study data to SHE, change of PI from Mark Larkin (Vitaccess Ltd.) to Sarah Dewilde (SHE), and a change in mode of administration for France. Informed consent was obtained from all participants included in the study.
: All authors have provided consent for the publication of this manuscript.
: SD, the principal investigator of the study, and NT, were commissioned by argenx. EC has received public speaking honoraria and compensation for advisory boards and/or consultations fees from argenx, UCB, Alexion and Janssen. RM has received speaking honoraria from Biomarin, Alexion and UCB, served on advisory boards for Alexion, argenx and UCB and received support for congress participation from Merck, Teva and Biogen. FV received compensation for consulting by Alexion Pharmaceuticals and argenx. SL has received speakers´ honoraria from Alexion, argenx BV, Hormosan and UCB and honoraria for attendance at advisory boards from Alexion, argenx BV, Biogen, UCB and Roche. MP received honoraria for lecturing and travel expenses for attending meetings from Alexion, argenx, Bayer Health Care, Biogen, Hexal, Merck Serono, Novartis, Roche, Sanofi-Aventis, and Teva. His research is funded by Biogen, Hexal, Merck Serono, Novartis, and Teva. MH was an employee of Vitaccess, commissioned by argenx. SP, FDR, and GP are employees of argenx, the sponsor of the study. PB, AA and RP declare that they have no competing interests.