A Real-world Comparative Study on the Efficacy and Safety of Inebilizumab versus Rituximab in the Treatment of Neuromyelitis Optica Spectrum Disorder
Objective:
To study and compare the efficacy and safety of inebilizumab and rituximab in the treatment of neuromyelitis optica spectrum disorder (NMOSD).
Background:
The introduction of Monoclonal antibody is a major advance in NMOSD therapy; however, a critical gap remains in the comparative evidence regarding their efficacy and safety.
Design/Methods:
This study was a multi-center retrospective observational study. Patients diagnosed with AQP4-IgG positive NMOSD were included, regularly treated with inebilizumab or rituximab.The main clinical outcomes included recurrence rate, ARR, EDSS, the number and range of lesions in the MRI T2FLAIR sequence, AQP4-IgG titers, B lymphocyte count and percentage.
Results:
A total of 163 NMOSD patients were included, including inebilizumab(n=107) and rituximab(n=56) groups. The recurrence rates of patients after using inebilizumab and rituximab were 8.41% and 19.64% , and the difference was statistically significant (P<0.05). The ARR and EDSS scores of both groups decreased (P<0.05).In the Inebilizumab and rituximab groups, the number of lesions in the MRI T2FLAIR sequence decreased in 23.33% and 29.63% of the patients, and The lesion range in the MRI decreased in 93.33% and 92.59%. The percentages of B lymphocytes in the inebilizumab group at half a year and one year were 0.64±2.65(%) and 0.25±0.57(%)(P < 0.05),and in the rituximab group are 3.84±4.70(%) and 3.18±3.63(%)(P < 0.05).The difference between the two groups was statistically significant (P < 0.05). To date, there have been 5 and 7 adverse events of inelizumab and rituximab, most of which were pulmonary infections. There were no serious adverse events.
Conclusions:
We found that both inebilizumab and rituximab could effectively reduce the ARR and EDSS of patients with NMOSD and significantly decrease the range of imaging lesions. Inebilizumab is more effective and stable in reducing the percentage and count of B cells. Compared with rituximab, patients using inebilizumab have a lower recurrence rate and cause fewer adverse events.
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