Abstract Details

Title Safety and Efficacy of Inebilizumab as Treatment for Newly Presenting Neuromyelitis Optica Spectrum Disorder

Topic Autoimmune Neurology

Presentation(s) P15 - Poster Session 15 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-004

Background Inebilizumab is an anti-CD19, B-cell depleting monoclonal antibody for adults with aquaporin-4 antibody-seropositive (AQP4+) NMOSD.

Objective To evaluate the safety and efficacy of inebilizumab as treatment for neuromyelitis optica spectrum disorder (NMOSD).

Design/Methods

N-MOmentum (NCT02200770) was a phase 2/3, double-blind trial with a 28-week randomized, placebo-controlled period and an open-label extension of ≥2 years. Post-hoc analyses were conducted for participants with AQP4+ NMOSD enrolled after their first attack. Participants received intravenous inebilizumab 300 mg or placebo on day 1, day 15 and every 26 weeks thereafter. Except for oral corticosteroids during the first 2 weeks with a 1-week taper, no immunosuppressants were used. Primary endpoint was time to first adjudicated attack. Disability was assessed as secondary endpoint via the Expanded Disability Status Scale (EDSS).

Results Of the 37 participants enrolled after their first attack, 1/24 inebilizumab-treated (4.2%) and 3/13 placebo-treated participants (23.1%) had an adjudicated attack (hazard ratio [HR]: 0.160; 95% confidence interval [CI]: 0.017–1.542). By comparison, of the 176 participants with ≥2 pre-study attacks, 17/137 inebilizumab-treated (12.4%) and 19/39 placebo-treated participants (48.7%) had an adjudicated attack (HR: 0.212, 95% CI: 0.110–0.408). Among those with 1 pre-study attack, EDSS worsening from baseline was observed in 3/24 inebilizumab-treated (12.5%) and 3/13 placebo-treated participants (23.1%; odds ratio [OR]: 0.503 [95% CI: 0.082–3.080]), compared with 21/137 inebilizumab-treated (15.3%) and 15/39 placebo-treated (38.5%) participants with ≥2 pre-study attacks (OR: 0.309 [95% CI: 0.138–0.691]). No significant differences in attacks or EDSS worsening were found between participants with 1 pre-study attack and those with ≥2 pre-study attacks. Treatment-emergent adverse events were reported for 19/24 inebilizumab-treated (79.2%) and 10/13 placebo-treated participants (76.9%) with 1 pre-study attack.

Conclusions The safety and efficacy of inebilizumab in AQP4+ adults with newly presenting NMOSD were similar to those in participants previously treated with other immunotherapies.

Authors/Disclosures
Bruce A. Cree, MD, PhD, MCR, FAAN (UCSF, Multiple Sclerosis Center) PRESENTER	The institution of Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Autobahn. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avotres. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuron23. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Pharma. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal/Sandoz. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyverna. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Pharma. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic AG. The institution of Dr. Cree has received research support from Genentech. The institution of Dr. Cree has received research support from Kyverna. Dr. Cree has received publishing royalties from a publication relating to health care.
John W. Lindsey, MD (University of Texas Health Science Center At Houston)	Dr. Lindsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lindsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Banner Life Sciences. Dr. Lindsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Lindsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mapi. Dr. Lindsey has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Teva. The institution of Dr. Lindsey has received research support from Genentech.
Evanthia Bernitsas, MD, FAAN (Wayne State School of Medicine)	Dr. Bernitsas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen@Janssen. Dr. Bernitsas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Bernitsas has received research support from Roche/Genentech.
Dewei She	No disclosure on file
Eliezer Katz, MD (Vielabio)	Dr. Katz has received personal compensation for serving as an employee of Horizon Therapeutics. Dr. Katz has received stock or an ownership interest from Viela Bio/Horizon Therapeutics.