Efficacy and Safety of Inebilizumab Among Non-White Demographic Groups with Neuromyelitis Optica Spectrum Disorder: N-MOmentum Study Subgroup Analysis
Friedemann Paul1, Kazuo Fujihara2, Marila Avila3, Yanping Wu4, Kristina R. Patterson4, Daniel Cimbora4, Bruce Cree5
1Experimental and Clinical Research Center, Charite Universitatsmedizin in Berlin, 2Department of Multiple Sclerosis Therapeutics, Tohoku University, School of Medicine, 3Texas Tech University Health Sciences Center Lubbock, 4Amgen, Inc., 5Department of Neurology, UCSF Weill Institute for Neurosciences, University of California San Francisco
Objective:

To evaluate the efficacy and safety of inebilizumab(INEB) in AQP4+ NMOSD participants who self-identified as Asian, Hispanic/Latino(H/L), and Black/African American(B/AA) in the N-MOmentum study.

Background:
There is a need for efficacy and safety information of disease modifying therapies on Neuromyelitis Optica Spectrum Disorder(NMOSD) in non-White demographic groups. INEB, an anti-CD19 B cell depleting antibody, is approved for the treatment of NMOSD in adults seropositive for aquaporin-4 antibody(AQP4+). 
Design/Methods:

N-MOmentum(NCT02200770) was a double-blind, phase 2/3 trial that assessed the efficacy and safety of INEB in adults with NMOSD, with a 28-week randomized controlled period(RCP) (intravenous INEB 300mg or placebo[PBO] on days 1 and 15) and an open-label period(OLP) of ≥2 years.  Post hoc analyses were conducted for AQP4+ participants who self-identified as Asian, H/L, B/AA.

Results:

Of 230 participants in N-MOmentum, race/ethnic self-identification included Asian(n=47), H/L(n=43), B/AA(n=20), and White(n=120). Participants receiving INEB in the RCP were less likely to have an attack compared to PBO(Hazard Ratio[95%CI],p-value): Asian 0.20[0.06, 0.66],p=0.01; H/L 0.25[0.06, 1.01],p=0.05; B/AA 0.33[0.02, 5.31],p=0.44; White 0.27[0.11, 0.66],p=0.004. Expanded Disability Status Scale(EDSS) score worsening from baseline to last RCP visit for participants receiving INEB vs PBO (Odds Ratio[95%CI],p-value): Asian 0.58[0.09, 3.63],p=0.56; H/L 0.50[0.09, 2.70],p=0.4; White 0.37[0.14, 0.95], p=0.04; and B/AA participants receiving INEB (0/15) did not experience EDSS worsening compared to 20% of PBO (1/5) participants. In the 225 participants who received any INEB during the study (combined RCP and OLP), the annualized attack rate [95% CI] was: Asian (n=46) 0.10[0.05, 0.18]; H/L (n=40) 0.07[0.04, 0.15]; B/AA (n=19) 0.05[0.01, 0.33]; White (n=120) 0.08[0.05, 0.13]. Among any INEB participants, ≥1 investigational product-related treatment-emergent adverse event (IP-TEAE) was reported: Asian 34.8%(16/46); H/L 30.0%(12/40); B/AA 63.2%(12/19); White 40.0%(48/120).

Conclusions:

Non-White NMOSD participants receiving inebilizumab had improved outcomes when compared to placebo and were similar to White participants although evaluation of larger populations is needed to confirm these results.

10.1212/WNL.0000000000210761
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