Yu, Huixin
Graham, Gordon
David, Olivier J.
Kahn, Joseph M.
Savelieva, Marina
Pigeolet, Etienne
Das Gupta, Ayan
Pingili, Ratnakar
Willi, Roman
Ramanathan, Krishnan
Kieseier, Bernd C.
Häring, Dieter A.
Bagger, Morten
Soelberg Sørensen, Per
Funding for this research was provided by:
novartis pharma
Article History
Accepted: 21 December 2021
First Online: 1 March 2022
Declarations
:
: The development of this publication was organized and funded by Novartis Pharma AG, who also paid the open access fee.
: Per Soelberg Sørensen has served on scientific advisory boards for Genmab (a co-developer of ofatumumab) and GlaxoSmithKline; has served on steering committees or independent data monitoring boards in clinical trials sponsored by Genmab, GlaxoSmithKline, Merck, Novartis, and TEVA; has also served on scientific advisory boards or has received speaker honoraria for Biogen, and Celgene/BMS; has received funding of travel for these activities; and has served as editor-in-chief of the <i>European Journal of Neurology</i>. Go to Neurology.org/N for full disclosures. Huixin Yu, Gordon Graham, Olivier J. David, Joseph M. Kahn, Marina Savelieva, Etienne Pigeolet, Ayan Das Gupta, Ratnakar Pingili, Roman Willi, Krishnan Ramanathan, Bernd C. Kieseier, Dieter A. Häring, and Morten Bagger are all employees of Novartis.
: All five studies were conducted in compliance with the tenets of the Declaration of Helsinki. Approvals were obtained from the designated independent Ethics Committee or Institutional Review boards and all patients provided written informed consent before enrollment into the trials. The present analysis did not require additional ethical approval beyond the approvals given in the clinical study protocols, as these allowed for the use of anonymized data for secondary analyses.
: All patients provided written informed consent before enrollment into the trials.
: Not applicable.
: The reader is able to request the raw data (anonymized) and related documents (e.g., protocol, reporting and analysis plan, clinical study report) of the five studies that underlie the modeling results reported in this article by connecting to ExternalRef removed and signing a Data Sharing Agreement with Novartis. These will be made available to qualified external researchers, with requests reviewed and approved by an independent review panel on the basis of scientific merit.
: All analyses and graphics were produced in Monolix (version 2019R2) and R (version 3.6.1).
: HY, GG and OJD generated the PK–B cell model, and MS and JMK generated the B cell–MRI model; RP, KR, DAH, MB, JMK, and MS were involved in the study design. All the authors previously mentioned, as well as EP, ADG, RW, BCK, and PSS, were involved in data interpretation, critically reviewed and provided their final approval to the manuscript, and agree to be accountable for the work.