Selmaj, Krzysztof
Roth, Karsten
Höfler, Josef
Vitzithum, Klaus
Derlacz, Rafał
von Richter, Oliver
Hornuss, Cyrill
Poetzl, Johann
Singer, Barry
Jacobs, Laura
Funding for this research was provided by:
Hexal AG
Article History
Accepted: 2 July 2024
First Online: 30 September 2024
Declarations
:
: The investigations and studies included herein were funded/sponsored by Polpharma Biologics S.A. The open access fee for this paper was sponsored by Hexal AG (a Sandoz company). The sponsor (Polpharma Biologics S.A.) had a role in the design and conduct of the studies presented herein. The sponsor and authors had a role in the interpretation of the data and statistical analysis, preparation, review, approval of the manuscript, and decision to submit the manuscript for publication.
: Krzysztof Selmaj, Karsten Roth, Josef Höfler, Klaus Vitzithum, Rafał Derlacz, Oliver von Richter, Cyrill Hornuss, Johann Poetzl, Barry Singer, and Laura Jacobs. Krzysztof Selmaj has received honoraria for speaking, consulting, and serving on advisory boards for Merck, Novartis, Roche, Biogen, Celgene, and TG Therapeutics. Karsten Roth has received personal compensation for serving as an employee of Polpharma Biologics S.A. Klaus Vitzithum has received personal compensation for serving as an employee of Polpharma Biologics S.A. Josef Höfler has received personal compensation for serving as an employee of Staburo GmbH. Rafał Derlacz has received personal compensation for serving as an employee of Polpharma Biologics S.A. Oliver von Richter has received personal compensation for serving as an employee of Hexal AG (a Sandoz company). Cyrill Hornuss has received personal compensation for serving as an employee of Hexal AG (a Sandoz company). Johann Poetzl has received personal compensation for serving as an employee of Hexal AG (a Sandoz company). Laura Jacobs has received personal compensation for serving as an employee of Hexal AG (a Sandoz company). Barry Singer has received research grant support from AbbVie, Biogen, Bristol Myers Squibb, Greenwich Biosciences, Novartis, Sanofi, and TG Therapeutics, and consulting and/or speaking fees from Alexion, Biogen, Bristol Myers Squibb, Cigna, Cycle, EMD Serono, Genentech, Horizon, Janssen, Novartis, Octave Bioscience, Roche, Sanofi, Sandoz, and TG Therapeutics.
: All procedures performed in studies involving human participants were in accordance with the International Council for Harmonization Good Clinical Practice, the Declaration of Helsinki, and relevant ethics committee or regulatory agency procedures.
: Patients or their legally authorized representatives signed statements of informed consent before enrollment and reconsented during the trials.
: Not applicable.
: The data sets generated and/or analyzed during the analytical and functional characterization study are available from the corresponding author upon reasonable request. Data sharing for the PK/PD and Antelope studies is not applicable to this article as no data sets were generated or analyzed during the current review.
: Not applicable.
: All authors were in compliance with the ICMJE criteria. All authors contributed to the concept and design of the studies and the acquisition, analysis, or interpretation of the data. JH performed the statistical analysis of the data. All authors critically reviewed and approved the final version of the manuscript.