Observational Study of Inebilizumab as a Salvage Therapy for Acute Optic Neuritis in Neuromyelitis Optica Spectrum Disorder (NMOSD-ON)
Hui Yang1, Yaping Cao1, Ziyan Xu1
1Zhongshan Ophthalmic Center, Sun Yat-Sen University
Objective:
To assess the efficacy and safety of inebilizumab as a salvage therapy for acute NMOSD-ON when corticosteroids fail, and explore its potential as a first-line treatment.
Background:
Acute attacks of NMOSD-ON frequently result in severe, irreversible optic nerve damage and visual loss. Current first-line acute-phase therapies, such as intravenous methylprednisolone (IVMP), often result in suboptimal responses in a significant proportion of patients, thus highlighting the need for more effective acute-phase salvage therapies. While inebilizumab effectively prevents NMOSD relapses, its role in acute NMOSD-ON attacks remains unexplored.
Design/Methods:
This single-center, open-label, retrospective, case-control study included 8 patients with AQP4(+) NMOSD-ON in the acute phase. The inebilizumab group (n=4) received 300 mg of inebilizumab intravenously immediately after ineffective corticosteroid, with a repeat dose on day 15. The control group (n=4) did not receive inebilizumab or other salvage therapies but initiated inebilizumab 3 months post-attack. The primary outcomes were best-corrected visual acuity (BCVA), visual field, and peripapillary retinal nerve fiber layer (pRNFL) thickness. Secondary outcomes included safety and relapse status. The patients were followed up for 6 months.
Results:
The inebilizumab group exhibited superior improvement in visual field mean deviation (VF-MD) compared to the control group (8.72±10.18 vs 6.66±5.463, p<0.05). Thinning of the pRNFL (-3.67±12.896 vs -4.00±13) and ganglion cell layer (GCL) (0.67±1.528 vs 10.00±22.60) was less pronounced in the inebilizumab group. LogMAR visual acuity improved more significantly in the inebilizumab group (-1.03±1.18 vs -0.93±0.67, p<0.05). In the inebilizumab group, two patients experienced transient fatigue and weakness post-treatment, and one developed shingles at the 6-month follow-up, which resolved with antiviral therapy. No other adverse events or relapses were observed.
Conclusions:
Inebilizumab salvage therapy appears to be effective and well-tolerated in acute NMOSD-ON. Large-scale prospective randomized controlled trials are warranted to further validate these findings.
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