Abstract Details

Title Inebilizumab Improves Pain Outcomes and Quality of Life in Neuromyelitis Optica Spectrum Disorder

Topic Autoimmune Neurology

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

Poster/Presentation
Number 9-001

Objective To assess the impact of long-term inebilizumab, an anti-CD19, B-cell depleting antibody, on pain and quality of life (QoL) in patients with neuromyelitis optica spectrum disorder (NMOSD).

Background Pain is a common, debilitating symptom of NMOSD that has a detrimental impact on the QoL of patients. Correlations were previously reported between 11-point Pain Numeric Rating Scale (NRS-11) scores and 36-Item Short-Form Survey Body Pain Subscores (SF36-BPS) in the N-MOmentum study (NCT02200770), in which inebilizumab significantly improved SF36-BPS after first dose in participants with moderate-to-severe pain (SF36-BPS <40) at baseline.

Design/Methods

N-MOmentum was a double-blind trial in 230 participants, randomized 3:1 to inebilizumab 300mg:placebo with an open-label extension period of ≥2 years. Pain, QoL and disability were measured using the SF36-BPS, SF36-Physical Component Score (PCS) and Expanded Disability Status Scale (EDSS), respectively.

Results

In participants who received inebilizumab with baseline SF36-BPS <40, there was a year-on-year improvement from baseline in mean (95% confidence interval) SF36-BPS of 6.57 (4.75–8.38) points after 1 year, 7.08 (5.34–8.82) after 2 years and 7.96 (6.29–9.64) after 3 years. Data for long-term effects of inebilizumab on NRS-11, SF36-PCS and other SF36 subdomain scores will also be reported.

At baseline, NRS-11 scores correlated with EDSS scores (Spearman R: 0.39) and SF36-PCS controlled for baseline EDSS score (Spearman R: −0.67). The proportion of participants reporting SF36-BPS <40 was lower after 3 years of inebilizumab treatment than at baseline for those with baseline EDSS score <5 (16/91 [17.6%] versus 47/156 [30.1%]) and those with baseline EDSS score ≥5 (17/31 [54.8%] versus 36/57 [63.2%]), respectively.

Conclusions Long-term inebilizumab treatment over 3 years was associated with improved pain outcomes in patients with NMOSD. Correlations between measures of pain, QoL and disability suggest all may be valid metrics of disease status and treatment effects in NMOSD.

Authors/Disclosures
Friedemann Paul (Charite Universitatsmedizin in Berlin) PRESENTER	Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hoffmann-La Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol-Myers Squibb GmbH & Co. KGaA (BMS. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon Therapeutics GmbH. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Paul has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Paul has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Paul has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for sanofi. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche . Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for F&U Confirm. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb GesmbH. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for MICE Service. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for VINDICO medical education. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Beijing Novartis. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sandoz Internation GmbH. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche Thailand. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche . Dr. Paul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Paul has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology, Neuroimmunology&Neuroinflammation.
Ho Jin Kim, MD (National Cancer Center)	Dr. Kim has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Altos Biologics, AstraZeneca, Biogen, Daewoong Pharmaceutical, Kaigene, Kolon Life Science, MDimune, Roche, and Sanofi. Dr. Kim has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion, AstraZeneca, Eisai, GC Pharma, Merck, Mitsubishi Tanabe Pharma, and Roche. Dr. Kim has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Multiple Sclerosis Journal, Journal of Clinical Neurology.
	No disclosure on file
William Rees	William Rees has received personal compensation for serving as an employee of Horizon Therapeutics. William Rees has received personal compensation for serving as an employee of Viela Bio. William Rees has received stock or an ownership interest from Horizon Therapeutics. William Rees has received stock or an ownership interest from Viela Bio. William Rees has received intellectual property interests from a discovery or technology relating to health care. William Rees has received intellectual property interests from a discovery or technology relating to health care.
	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.

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