Telitacicept following plasma exchange seems to be safe and effective for the treatment of patients with recurrent neuromyelitis optica spectrum disorder (NMOSD), according to results of a new clinical trial that were published in CNS Neuroscience & Therapeutics.
The results showed that telitacicept increased the interval of disease recurrence and lowered the total number of recurrences in a year.
The aim of the small single-center, single-arm, open-label study was to assess the safety and potential effectiveness of telitacicept following plasma exchange to treat recurrent NMOSD. It enrolled 8 participants with the disease in China who received plasma exchange 3 times, followed by 240 mg of telitacicept once a week for 46 weeks.
The primary outcome measure was the time to first disease recurrence. Secondary outcome measures were changes in the Expanded Disability Status Scale (EDSS) score, Optic Spinal Impairment Scale (OSIS) score, Hauser Ambulation Index, number of lesions on magnetic resonance imaging, thickness of the retinal nerve fiber layer, latency and amplitude of the visual evoked potential, aquaporin 4 antibody titer, and immune parameters in the blood.
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The disease relapsed in 2 of the 8 patients. One patient withdrew from the study because of a low neutrophil count, and 5 remained relapse-free throughout the study. The treatment was generally well tolerated.
Telitacicept following plasma exchange may be “a novel therapeutic strategy in recurrent NMOSD,” the researchers concluded. However, they said the study “may not have sufficient power to evaluate clinical efficacy” and recommended that another large-scale, multicenter, randomized, and controlled study be conducted to validate these findings.
Telitacicept is a novel recombinant fusion protein that consists of a transmembrane activator and calcium modulator and cyclophilin ligand interaction (TACI), and the Fc portion of human immunoglobulin G specifically targets B cells and T cells, which are involved in NMSOD.
Ding J, Jiang X, Cai Y, et al. Telitacicept following plasma exchange in the treatment of subjects with recurrent neuromyelitis optica spectrum disorders: a single-center, single-arm, open-label study. CNS Neurosci Ther. Published online July 18, 2022. doi:10.1111/cns.13904