Telitacicept following plasma exchange in the treatment of subjects with recurrent neuromyelitis optica spectrum disorders: A single‐center, single‐arm, open‐label study

• DOI: 10.1111/cns.13904
• Publication Date: 2022-07-19T06:41:05Z
• Authors: Jie Ding; Xianguo Jiang; Yu Cai; Shuting Pan; Ye Deng; Meichun Gao; Yan Lin; Nan Zhao; Ze Wang; Haojun Yu; Huiying Qiu; Yuyan Jin; Jiahui Xue; Quan Guo; Liping Ni; Ying Zhang; Yong Hao; Yangtai Guan
• Keywords: Neuromyelitis Optica; Clinical endpoint; Single Center

Abstract Introduction Neuromyelitis optica spectrum disorders (NMOSD), mainly mediated by B cells and AQP4 antibody, has a high rate of recurrence. Telitacicept is novel drug specifically targeting the upstream signaling for activation cell with its following production autoimmune antibodies. Thus, it may be promising approach. Our study preliminarily explored potential safety effectiveness plasma exchange in treatment recurrent NMOSD. Methods This was single‐center, single‐arm, open‐label enrolling eight patients NMOSD China. All received three times, followed 240 mg every week 46 times. The primary endpoint time first recurrence after enrollment. Secondary end points included: changes Expanded Disability Status Scale score, Optic Spinal Impairment Hauser Ambulation Index, number lesions on MRI, retinal nerve fiber layer thickness measured optical coherence tomography, latency amplitude visual evoked potential, titer immune parameters blood. Safety also assessed. registered Chictr.org.cn (ChiCTR1800019427). Results Eight eligible were enrolled. Relapse occurred two (25%) five (63%) remained relapse free 48 weeks treatment. to prolonged recurrences reduced ( p < 0.001, power test = 1). One patient withdrew from due low neutrophil count. No serious adverse events occurred. Conclusions In this small, uncontrolled study, safe It prolong interval reduces annual count recurrences. A multicenter randomized controlled larger sample thus feasible needed further assess efficacy.