Telitacicept Following Plasma Exchange in the Treatment of Subjects With Recurrent NMOSD: Study Protocol for a Single-Center, Single-Arm, Open-Label Study

Background: Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune demyelinating disease that recurrently relapses and leads to severe disability. The available choices for disease prevention are few or intolerable. Previous studies suggested that telitacicept may provide a promising therap...

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Published inFrontiers in neurology Vol. 12; p. 596791
Main Authors Ding, Jie, Cai, Yu, Deng, Ye, Jiang, Xianguo, Gao, Meichun, Lin, Yan, Zhao, Nan, Wang, Ze, Yu, Haojun, Lv, Wenwen, Zhang, Ying, Hao, Yong, Guan, Yangtai
Format Journal Article
LanguageEnglish
Published Switzerland Frontiers Media S.A 18.03.2021
Subjects
clinical study
effectiveness
Neurology
neuromyelitis optica spectrum disorders
plasma exchange
safety
telitacicept
clinical study
effectiveness
safety
telitacicept
study protocol
plasma exchange
neuromyelitis optica spectrum disorders
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Summary:Background: Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune demyelinating disease that recurrently relapses and leads to severe disability. The available choices for disease prevention are few or intolerable. Previous studies suggested that telitacicept may provide a promising therapeutic strategy for autoimmune diseases involving B cells. Therefore, this study aims to assess the effectiveness and safety of telitacicept for recurrent NMOSD. Methods: We will perform a single-arm, single-center, open-label, specialist study with a total enrollment of eight participants. The treatment regimen includes plasma exchange three times and subcutaneous injection of telitacicept for 46 cycles, with a total period of 48 weeks. The primary endpoint is the time to first recurrence after enrollment. Secondary endpoints are Expanded Disability Status Scale (EDSS) score, Opticospinal Impairment Scale (OSIS) score, Hauser Ambulation Index, number of lesions on MRI, and changes in visual evoked potential (VEP), optical coherence tomography (OCT) and immunologic status. All adverse events after medication will be documented and investigated. Discussion: This study will explore the safety and effectiveness of telitacicept following plasma exchange regarding the time to recurrence in neuromyelitis optica spectrum disorder (NMOSD) for the first time. Clinical Trial Registration: Chictr.org.cn , identifier ChiCTR1800019427
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Edited by: Scott S. Zamvil, University of California, San Francisco, United States
This article was submitted to Multiple Sclerosis and Neuroimmunology, a section of the journal Frontiers in Neurology
Reviewed by: Eleonora Allocati, Istituto di Ricerche Farmacologiche Mario Negri (IRCCS), Italy; Li Yang, Tianjin Medical University General Hospital, China
These authors have contributed equally to this work
ISSN:1664-2295
1664-2295
DOI:10.3389/fneur.2021.596791