Fautrel, Bruno https://orcid.org/0000-0001-8845-4274
Bouhnik, Yoram https://orcid.org/0000-0002-5787-4943
Salliot, Carine https://orcid.org/0000-0003-1066-4161
Carbonnel, Franck https://orcid.org/0000-0002-4779-5168
Fumery, Mathurin
Bernardeau, Christophe https://orcid.org/0000-0002-2337-2902
Maugars, Yves https://orcid.org/0000-0002-5131-8524
Flamant, Mathurin https://orcid.org/0000-0002-8076-7046
Coury, Fabienne https://orcid.org/0000-0002-9175-8620
Braithwaite, Ben https://orcid.org/0000-0002-7378-1034
Hateb, Salima
Addison, Janet
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study
https://doi.org/10.1007/s40801-024-00459-6
Funding for this research was provided by:
Biogen Int GmbH
Article History
Accepted: 26 September 2024
First Online: 10 October 2024
Change Date: 16 January 2025
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s40801-024-00477-4
Declarations
:
: This study was sponsored by Biogen Int GmbH (Baar, Switzerland). Funding was provided by Biogen. Open access fees were sponsored by Biogen.
: Bruno Fautrel: received speaker/consulting fees from AbbVie, Biogen, Boehringer Ingelheim, BMS, Celgene, Janssen, Lilly, Medac, MSD, NORDIC Pharma, Novartis, Pfizer, Roche, Sobi and UCB, and grant/research support from AbbVie, MSD and Pfizer. Yoram Bouhnik: received consultancy and/or speaker fees from AbbVie, Biogaran, Biogen, Boehringer Ingelheim, CTMA, Ferring, Gilead, Hospira, ICON, Inception IBD, Janssen, Lilly, Mayoly Spindler, Merck, Merck Sharp & Dohme, Norgine, Pfizer, Robarts Clinical Trials, Roche, Sanofi, Shire, Takeda, UCB and Vifor Pharma. Carine Salliot: received consultancy and/or speaker fees from Novartis, Roche-Chugai, Pfizer and Galapagos, and grant/research support from Roche-Chugai and Novartis. Frank Carbonnel: received speaker fees from Abbvie, Astra, Biocodex, Biogen, Ferring, Janssen, MSD, Pfizer, Pileje, Takeda, Tillotts; and is a member of advisory boards for Amgen, Arena, BMS, Celltrion, Enterome, Ferring, Janssen, Medtronic, Pfizer, Pharmacosmos, Roche and Tillotts. Mathurin Fumery: received consultancy and/or speaker fees from AbbVie, Biogen, Boehringer Ingelheim, CTMA, Ferring, Gilead, Hospira, Janssen, Lilly, Merck Sharp & Dohme, Pfizer, Takeda, Tillots and Celgene. Chirstophe Bernardeau: nothing to disclose with respect to their contributions to this work. Yves Maugars: nothing to disclose with respect to their contributions to this work. Mathurin Flamant: received consultancy and/or speaker fees from AbbVie, Amgen, Biogen, Ferring, Janssen, Mayoly Spindler, Merck Sharp & Dohme, Pfizer, Takeda, Tillots and Pharma. Fabienne Coury: received speaker/consulting fees from Abbvie, Amgen, BMS, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, Sanofi and UCB, and grant/research support from Abbvie, Biogen, Celgene, Chugai, Novartis, Pfizer and UCB. Ben Braithwaite: no conflicts of interest to disclose. Salima Hateb: is an employee of and may hold stock in Biogen. Janet Addison: is an employee of and may hold stock in Biogen.
: The datasets generated and analysed during the current study are not publicly available as data for this study contain potentially identifying information.
: All necessary ethical considerations and measures were taken to ensure the protection of all participants: patients were eligible for the study only if they were able to understand and sign a consent form. This study is listed on clinicaltrials.gov under the identifier NCT03662919 and was approved by the appropriate bodies in terms of quality of methodology, data security and scientific merit. The final amendment to the protocol for this study was approved by an independent ethics committee (Comité de Protection des Personnes, CPP) in France on 25 April 2019, in accordance with French regulations (CPP SUD-EST II; study ref. 2018-06; internal ref. 19.03.29.73319). Furthermore, this study conformed to all regulations concerning the use of personal data. All procedures were carried out in accordance with the ethical rules and the principles of the Declaration of Helsinki and its later amendments.
: Informed consent was obtained from all individual participants included in the study in the form of a non-opposition form signed and archived by the physician in accordance with French regulations.
: The code used to perform data management and run the analyses uses proprietary modules owned by eXYSTAT. Thus, the code cannot be made publicly available.
: Bruno Fautrel: as the coordinating investigator for rheumatology, made substantial contributions to the conception and design of the work, the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Yoram Bouhnik: as the coordinating investigator for gastroenterology, made substantial contributions to the conception and design of the work, the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Carine Salliot: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Mathurin Fumery: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Chirstophe Bernardeau: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Mathurin Flamant: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Fabienne Coury: as an investigator, made substantial contributions to the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Ben Braithwaite: as the lead writer and biostatistics coordinator for this work, made substantial contributions to the design of the work, acquisition, analysis and interpretation of data for the work and produced all draft versions of the manuscript. Salima Hateb: as a study coordinator for the sponsor, made substantial contributions to the conception and design of the work, the acquisition and interpretation of data for the work and reviewed all draft versions of the manuscript for important intellectual content. Janet Addison: as the sponsor’s lead scientist for this work, made substantial contributions to the conception and design of the work, the analysis and interpretation of data for the work and critically reviewed, commented upon and edited all draft versions of the manuscript. The first draft of the manuscript was written by Ben Braithwaite and all authors commented on previous versions of the manuscript. All authors read, provided input and approved the final manuscript. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.