Natalizumab in cerebrospinal fluid and breastmilk of patients with multiple sclerosis.

"Declarations Ethics approval and consent to participate: All procedures were approved by the Ethical Committee of Northwest Switzerland (study protocol 2021-00908) and by the Ethical Committee of the Medical University of Graz, Austria (study protocol 17-046 ex 05/06 and 31-432 ex 18/19). Milk samples from the Dresden cohort were collected under the University Hospital Dresden ethical approval (EK348092014). Written informed consent was obtained from all the study participants.Consent for publication: Informed consent for publication was provided by the patient donating milk samples.Author contributions:Ilaria Callegari: Conceptualization; Data curation; Formal analysis; Investigation; Methodology; Visualization; Writing – original draft.Mika Schneider: Investigation; Writing – original draft.Vera Aebischer: Investigation; Writing – original draft.Margarete M. Voortman: Investigation; Writing – original draft.Undine Proschmann: Investigation; Writing – review & editing.Tjalf Ziemssen: Investigation; Writing – review & editing.Raija Lindberg: Investigation; Writing – review & editing.Bettina Fischer-Barnicol: Investigation; Writing – original draft.Michael Khalil: Investigation; Methodology; Writing – original draft.Ludwig Kappos: Conceptualization; Writing – original draft.Jens Kuhle: Investigation; Writing – original draft.Nicholas S.R. Sanderson: Conceptualization; Formal analysis; Funding acquisition; Investigation; Methodology; Project administration; Supervision; Writing – original draft.Tobias Derfuss: Conceptualization; Funding acquisition; Investigation; Methodology; Supervision; Writing – original draft.Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Funding was provided by the Swiss National Science Foundation grant number 189043 (Tobias Derfuss) and from Swiss Multiple Sclerosis Society (Nicholas Sanderson).Competing interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: U.P. received speaker fee from Merck, Biogen and Bayer and personal compensation from Biogen and Roche for consulting service. B.F.B. received financial compensation for participation in advisory boards for Biogen. M.K. has received funding for attending meetings or travel from Merck and Biogen, honoraria for lectures or presentations from Novartis and Biogen and speaker serves on scientific advisory boards for Biogen, Merck, Roche, Novartis, Bristol-Myers Squibb, and Gilead. He received research grants from Biogen and Novartis. L.K. discloses research support to his institution (University Hospital Basel): steering committee, advisory board, and consultancy fees (Actelion, Bayer HealthCare, Biogen, BMS, Genzyme, Janssen, Merck, Novartis, Roche, Sanofi, Santhera, and TG Therapeutics); speaker fees (Bayer HealthCare, Biogen, Merck, Novartis, Roche, and Sanofi); support of educational activities (Allergan, Bayer HealthCare, Biogen, CSL Behring, Desitin, Genzyme, Merck, Novartis, Pfizer, Roche, Sanofi, Shire, and Teva); license fees for Neurostatus products; and grants (Bayer HealthCare, Biogen, European Union, InnoSwiss, Merck, Novartis, Roche, Swiss MS Society, and Swiss National Research Foundation). J.K. received speaker fees, research support, travel support, and/or served on advisory boards by Swiss MS Society, Swiss National Research Foundation (320030_189140/1), University of Basel, Progressive MS Alliance, Bayer, Biogen, Bristol Myers Squibb, Celgene, Merck, Novartis, Octave Bioscience, Roche, Sanofi. T.D. received financial compensation for participation in advisory boards, steering committees, and data safety monitoring boards, and for consultation for Alexion, Novartis Pharmaceuticals, Merck, Biogen, Celgene, GeNeuro, MedDay, Mitsubishi Tanabe Pharma, Roche, and Sanofi Genzyme. T.D. also received research support from Alexion, Roche, Biogen, National Swiss Science Foundation, European Union, and Swiss MS Society.Availability of data and materials: All data and material used for this manuscript are available upon request. Competing interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: U.P. received speaker fee from Merck, Biogen and Bayer and personal compensation from Biogen and Roche for consulting service. B.F.B. received financial compensation for participation in advisory boards for Biogen. M.K. has received funding for attending meetings or travel from Merck and Biogen, honoraria for lectures or presentations from Novartis and Biogen and speaker serves on scientific advisory boards for Biogen, Merck, Roche, Novartis, Bristol-Myers Squibb, and Gilead. He received research grants from Biogen and Novartis. L.K. discloses research support to his institution (University Hospital Basel): steering committee, advisory board, and consultancy fees (Actelion, Bayer HealthCare, Biogen, BMS, Genzyme, Janssen, Merck, Novartis, Roche, Sanofi, Santhera, and TG Therapeutics); speaker fees (Bayer HealthCare, Biogen, Merck, Novartis, Roche, and Sanofi); support of educational activities (Allergan, Bayer HealthCare, Biogen, CSL Behring, Desitin, Genzyme, Merck, Novartis, Pfizer, Roche, Sanofi, Shire, and Teva); license fees for Neurostatus products; and grants (Bayer HealthCare, Biogen, European Union, InnoSwiss, Merck, Novartis, Roche, Swiss MS Society, and Swiss National Research Foundation). J.K. received speaker fees, research support, travel support, and/or served on advisory boards by Swiss MS Society, Swiss National Research Foundation (320030_189140/1), University of Basel, Progressive MS Alliance, Bayer, Biogen, Bristol Myers Squibb, Celgene, Merck, Novartis, Octave Bioscience, Roche, Sanofi. T.D. received financial compensation for participation in advisory boards, steering committees, and data safety monitoring boards, and for consultation for Alexion, Novartis Pharmaceuticals, Merck, Biogen, Celgene, GeNeuro, MedDay, Mitsubishi Tanabe Pharma, Roche, and Sanofi Genzyme. T.D. also received research support from Alexion, Roche, Biogen, National Swiss Science Foundation, European Union, and Swiss MS Society."

"Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Funding was provided by the Swiss National Science Foundation grant number 189043 (Tobias Derfuss) and from Swiss Multiple Sclerosis Society (Nicholas Sanderson)."