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Article History

Received: 23 August 2024

Accepted: 18 October 2024

First Online: 21 November 2024

Declarations

:

: Yang Mao-Draayer: consulting fees from Biogen, Celgene, EMD Serono, Genzyme, Novartis, and Roche-Genentech; contracted research for Biogen, Chugai, NIAID Autoimmune Center of Excellence UM1-AI110557, NIH NINDS R01-NS080821, Novartis, and Sanofi-Genzyme; speaker bureaus for Biogen and Teva. Amit Bar-Or: speaker/consulting fees and/or grant support from Atara Biotherapeutics, Biogen, Celgene/Receptos, Genentech/Roche, GlaxoSmithKline, Medimmune, Merck/EMD Serono, Novartis, and Sanofi-Genzyme. Konstantin Balashov: grant/research support from Biogen; consultant for Genentech/Roche. John Foley: nothing to disclose. Kyle Smoot: received research support from AbbVie, Biogen, EMD Serono, Genentech, IMS Health, MedDay, and Novartis; and consulting fees from Biogen, Celgene, EMD Serono, Genzyme, Genentech, and Janssen. Erin E. Longbrake: consulting fees from Bristol Myers Squibb, EMD Serono, Genentech, Genzyme, Janssen, NGM Bio, and TG Therapeutics; research support from CTSA Grant Number KL2 TR001862, Nancy Davis Center Without Walls, and NIH NINDS K23-NS10762. Derrick Robertson: received grant support from Anokion, Atara Biotherapeutics, Biogen, CorEvitas, EMD Serono, Genentech, GW Pharmaceuticals, Janssen, Novartis, PCORI, PRIME CME, Sanofi, and TG Therapeutics; has received consulting fees from Alexion, Biogen, Bristol Myers Squibb, EMD Serono, Genentech, Greenwich Biosciences, Horizon, Janssen, Mallinckrodt, Novartis, Sanofi, and TG Therapeutics; has received honoraria or speaker fees from Alexion, Biogen, Bristol Myers Squibb, EMD Serono, Genentech, Horizon, Janssen, PRIME CME, Sanofi and TG Therapeutics. Fabrizio Giuliani: speaker/consulting fees and/or grant support from Biogen, Genentech/Roche, Merck/EMD Serono, Novartis, and Sanofi-Genzyme. Jason P. Mendoza, James B. Lewin, Nicholas Everage, Ivan Božin, Jennifer Lyons, Oksana Mokliatchouk, Eris Bame: employees of and may hold stock in Biogen.

: The ESTEEM and PROCLAIM studies were conducted in accordance with the International Conference on Harmonization Guidelines on Good Clinical Practice, the ethical principles outlined in the Declaration of Helsinki, and all applicable local laws and regulations. ESTEEM was approved by local ethics committees at each of the 393 sites, which were overseen by the ESTEEM Study Contract Research Organization ethics committee. PROCLAIM investigators were required to obtain approval of the protocol, informed consent form, and other required study documents from the local ethics committee, overseen by the PROCLAIM Study Contract Research Organization. In both studies, written assent and consent forms were obtained from each patient or their parent or legal guardian.