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Abstract Details

Exploratory Post Hoc Analysis of Neutrophil-to-lymphocyte Ratio as a Novel Response Biomarker for Edaravone Oral Suspension-treated Patients with Amyotrophic Lateral Sclerosis vs Untreated Propensity Score-matched PRO-ACT Historical Placebo Controls
General Neurology
S32 - General Neurology 1 (4:54 PM-5:06 PM)
008
Assess Neutrophil-to-Lymphocyte Ratio (NLR) response to edaravone oral suspension treatment in patients with amyotrophic lateral sclerosis (ALS) and whether baseline NLR may predict NLR response vs propensity score-matched Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) placebo controls.
The US Food and Drug Administration (FDA) approved an on/off dosing regimen of Radicava ORS® (edaravone) oral suspension for patients with ALS. Edaravone oral suspension-treated patients with ALS from Studies MT-1186-A01/A02/A03/A04 showed a 7.3-month significantly prolonged mean survival vs matched PRO-ACT controls (P<0.001) over 34 months. Elevated NLR is a potential prognostic biomarker for ALS, correlating with clinical deterioration. In some non-ALS oxidative stress disease models, edaravone treatment was associated with NLR decline, paralleling clinical improvement.
MT-1186-A01 (NCT04165824) was a phase 3, open-label, 48-week study conducted to evaluate the long-term safety and tolerability of FDA-approved on/off edaravone oral suspension; MT-1186-A03 (NCT04577404) was its 96-week extension. MT-1186-A02 (NCT04569084) was a phase 3b, double-blind study in patients randomized to an investigational drug once daily or FDA-approved on/off edaravone oral suspension regimen; MT-1186-A04 (NCT05151471) was its 48-week extension. MT-1186-A01/A02/A03/A04 patients were propensity score-matched 1:1 on 11 baseline variables with historical, PRO-ACT controls (patients given placebo may have received riluzole).
Patients from Studies MT-1186-A01/02/03/04 (n=221) showed a numeric trend towards decreasing NLR at 48 weeks (least squares mean difference= −0.2851) vs matched PRO-ACT controls (n=221) (P=0.065). Patients were grouped by baseline NLR<3 or NLR≥3. Edaravone-treated patients with NLR<3 showed significantly lower NLR at 48 weeks (P=0.038) vs PRO-ACT controls.

Edaravone oral suspension treatment in MT-1186 studies vs PRO-ACT controls supports the possible role of NLR as a novel ALS prognostic biomarker. These analyses were non-randomized comparisons, and there was a potential time bias between matched groups. Further studies are needed to validate NLR as a prognostic biomarker across ALS populations.
Authors/Disclosures
Benjamin R. Brooks, MD, FAAN (Clinical Trials Planning LLC)
PRESENTER 		Dr. Brooks has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Mitsubishi Tanabe Pharma America. Dr. Brooks has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medicinova. Dr. Brooks has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Brooks has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AB Science. Dr. Brooks has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ionis. Dr. Brooks has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Mitsubishi Tanabe Pharma America. The institution of Dr. Brooks has received research support from Mitsubishi TanabePharma America. Dr. Brooks has received personal compensation in the range of $0-$499 for serving as a Member Annual Surveillance Committee CDC National ALS Registry with Center for Disease Control Agency Toxic Substances Disease Registry. Dr. Brooks has a non-compensated relationship as a Member ALS Quality Measures Subcommittee with 好色先生 that is relevant to AAN interests or activities.
Angela L. Genge, MD (Mcgill University) Dr. Genge has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AL-S Pharma. Dr. Genge has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amylyx. Dr. Genge has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Quralis. Dr. Genge has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MTPA. Dr. Genge has received personal compensation in the range of $0-$499 for serving as a Consultant for WAVE. Dr. Genge has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for eikonizo. Dr. Genge has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for rapa.
Fumiaki Tanaka, MD, PhD Prof. Tanaka has nothing to disclose.
Yuichiro Kato Mr. Kato has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma Corporation.
Ushirogawa Yoshiteru, MPH Mr. Yoshiteru has nothing to disclose.
Fumihiro Takahashi, PhD Dr. Takahashi has nothing to disclose.
Manabu Hirai Mr. Hirai has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America.
Stephen Apple Stephen Apple has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America, Inc.