Analyze the real-world adverse event (AE) profile of the FDA approved medications for Neuromyelitis Optica Spectrum Disorder (NMOSD) on Food and Drug Administration Adverse Event Reporting System (FAERS) database.

There are four FDA-approved medications for NMOSD: inebilizumab, eculizumab, satralizumab, and ravulizumab. Limited data exists on the AE profiles and its comparison for these drugs.

The FAERS database was filtered from 2019 to 2023 for each inebilizumab, eculizumab, satralizumab, and ravulizumab. AE outcomes based on system categories as well as seriousness were assessed. Statistical analysis was performed using SAS 9.4 software. Non-serious outcomes and mortality were analysed using logistic regression.

Total 43972 AE were identified, of which AE reported with eculizumab were the highest with 34038 (77.4%) events. Frequency of infections was highest with satralizumab (33.5%), followed by inebilizumab (21.9%), eculizumab (19.2%) and ravulizumab (16.7%). Among satralizumab-associated infections, urinary tract infection was the most frequent infection (26%), followed by COVID-19 infection (13.9%). Fatigue was the most common AE reported with ravulizumab (12.9%) and eculizumab (8.2%), while headache with inebilizumab (15.4%). Death was reported in 7.6% of the AEs associated with eculizumab. Mortality odds were lower for patients receiving ravulizumab (OR 0.525, p< 0.0001) and satralizumab (OR 0.599, p= 0.0034) when compared to eculizumab. Outcomes needing hospitalisations were highest with satralizumab (27.8%), followed by inebilizumab (23.7%), eculizumab (18.2%), and ravulizumab (14.4%).

This study shows differences in the adverse events reported with NMOSD medications. Infections and hospitalizations were most common with satralizumab. Eculizumab and inebulizumab were associated with a greater number of deaths reported as adverse events. Drug target differences could potentially explain these findings. Further studies are needed to refine adverse event profiles and guide clinical use.