Inebilizumab reduces the risk of a neuromyelitis optica spectrum disorder (NMOSD) attack as well as disability progression, magnetic resonance imaging (MRI) lesion activity, and disease-related hospitalizations in Asian patients with the disease. This is according to a subgroup analysis of the phase 2/3 N-MOmentum study, published in the journal Multiple Sclerosis and Related Disorders.
The authors of the study reported that the efficacy of the treatment continued with no unexpected safety signals or concerns during long-term use.
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The safety and efficacy of inebilizumab treatment specifically in Asian patients have not been fully reported previously.
Here, a team of researchers from Japan, Korea, and the US conducted a post-hoc subgroup analysis of the N-MOmentum study to evaluate the safety and efficacy of the treatment in Asian patients.
Of the 230 patients who took part in the study, 47 were Asian. Of these, 30 received inebilizumab and 8 received a placebo.
The researchers found that inebilizumab reduced the risk of NMOSD attacks compared to placebo in the Asian subgroup. The rate of NMOSD attacks was similar between the Asian and nonAsian subgroups.
The rate of worsening in the Expanded Disability Status Scale score, active MRI lesions, and disease-related hospitalizations were lower in Asian patients treated with inebilizumab compared to those given placebo. Again, these results were similar to the ones in the nonAsian subgroup.
The annualized adjudicated NMOSD attack rate was lower in Asian patients treated with inebilizumab than at baseline. This was consistent with the results obtained in the nonAsian group.
The incidence of treatment-emergent adverse events was comparable between Asian and nonAsian participants. In the Asian subgroup, 15.2% of participants had at least 1 serious and/or Grade 3 or higher treatment-emergent adverse event during long-term treatment. This percentage was 35.2% in the nonAsian subgroup. Three deaths occurred in the nonAsian subgroup, whereas none occurred in the Asian subgroup.
Fujihara K, Kim H,J, Saida T, et al. Efficacy and safety of inebilizumab in Asian participants with neuromyelitis optica spectrum disorder: Subgroup analyses of the N-MOmentum study. Mult Scler Relat Disord. Published online August 20, 2023. doi:10.1016/j.msard.2023.104938
N-MOmentum: A clinical research study of inebilizumab in neuromyelitis optica spectrum disorders. US National Library of Medicine. Updated December 3, 2021. Accessed August 24, 2023