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 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

背景：视神经脊髓炎谱系疾病（NMOSD）是一种自身免疫性脱髓鞘疾病，会反复复发并导致严重残疾。疾病预防的可用选择很少或难以耐受。先前的研究表明，泰它西普可能为涉及B细胞的自身免疫性疾病提供一种有前景的治疗策略。因此，本研究旨在评估泰它西普治疗复发性NMOSD的有效性和安全性。 方法：我们将进行一项单臂、单中心、开放标签的专项研究，共招募8名参与者。治疗方案包括3次血浆置换以及皮下注射泰它西普46个周期，总时长为48周。主要终点是入组后首次复发的时间。次要终点是扩展残疾状态量表（EDSS）评分、视脊髓损伤量表（OSIS）评分、豪泽步行指数、磁共振成像（MRI）上的病灶数量以及视觉诱发电位（VEP）、光学相干断层扫描（OCT）和免疫状态的变化。用药后的所有不良事件都将被记录和调查。 讨论：本研究将首次探讨在视神经脊髓炎谱系疾病（NMOSD）中，血浆置换后使用泰它西普在复发时间方面的安全性和有效性。 临床试验注册：中国临床试验注册中心，注册号ChiCTR1800019427