Declarations
Acknowledgments
The authors would like to thank Janet Addsion (Biogen IDEC, Maidenhead, UK) for her contribution to the content of the manuscript and critical review, and Maximilian Utzinger (Biogen GmbH, Munich, Germany) for the critical review of the manuscript.
Author contributions
BOP: Data curation, Writing—original draft, Conceptualization, Methodology, Supervision, Writing—review & editing, Validation. FPR: Writing—original draft, Conceptualization, Supervision, Writing—review & editing, Validation. ECC: Writing—original draft, Conceptualization, Supervision, Writing—review & editing, Validation. All authors read and approved the submitted version.
Conflicts of interest
FPR: speaker and advisor for Biogen, advisor for Fresenius-Kabi; member of the Corporative Pharmacy Commission, Basque Health Service-Osakidetza; member of the OSI-EEC Pharmacy Commission; President, OSI EEC/BS Commission for Adequate Clinical Practice and Assistance Implementation; Editor-in-Chief of Exploration of Musculoskeletal Diseases, but had no involvement in the journal review process of this manuscript. BOP is an employee of and may hold stock in Biogen. ECC declares that there are no conflicts of interest.
Ethical approval
The study was approved by the ethics committee from Hospital La Princesa and then registered in the Spanish Agency for Medicines and Health Products (AEMPS. Agencia Española de Medicamentos y Productos Sanitarios) EPA-SP BIO-IMR-2019-01.
Consent to participate
Written and oral information about the study was provided to patients and written, informed consent was obtained from each patient prior to participation in the study.
Consent to publication
Not applicable.
Availability of data and materials
Due to internal regulations from the sponsor, the data pertaining to this research will not be shared. Further details on the sponsor’s clinical trial transparency and data-sharing policy can be found at https://clinicalresearch.biogen.com/. In addition, the authors are willing to answer reasonable questions.
Funding
This study was funded by Biogen International GmbH (Baar, Switzerland). Medical writing assistance was provided by Chloe Schon and Iain Bartlett of Springer Healthcare Ltd, UK, and was funded by Biogen International GmbH in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). The funder developed the methodology of the PROPER study and conducted the formal investigation and data analysis.
Copyright
© The Author(s) 2025.