Abstract Details

Title Effect of Alemtuzumab on Serum Neurofilament Light Chain Levels: Comparison to SC IFNB-1a and Assessment Over 7 Years (CARE-MS I)

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-045

Objective To assess the effect of alemtuzumab on serum neurofilament light (sNfL) levels in RRMS patients versus SC IFNB-1a over 2 years, and of alemtuzumab over 7 years.

Background sNfL is a promising biomarker of neuroaxonal damage. In CARE-MS I (NCT00530348), alemtuzumab significantly improved clinical/MRI outcomes vs SC IFNB-1a over 2 years in treatment-naive RRMS patients. Alemtuzumab efficacy was maintained over 7 years in 2 extension studies (NCT00930553; NCT02255656).

Design/Methods CARE-MS I patients received SC IFNB-1a 44 µg 3×/week or alemtuzumab 12 mg/day (baseline: 5 days; 1 year later: 3 days; further 3-day courses ≥12 months apart in the extensions as needed). A single-molecule array (SIMOA) assay was used to determine sNfL levels. P values comparing sNfL levels between treatment groups were derived using ranked ANCOVA adjusted for age and baseline sNfL.

Results Median sNfL levels were similar in alemtuzumab-treated (n=354) and SC IFNB-1a-treated (n=159) patients at baseline (31.7 pg/mL vs 31.3 pg/mL). Median sNfL levels were significantly lower with alemtuzumab at 6 months post-treatment versus SC IFNB-1a (17.2 pg/mL vs 21.4 pg/mL; P<0.0001), with significant differences persisting at Month 24 (13.2 pg/mL vs 18.7 pg/mL; P<0.0001). At Month 24, more alemtuzumab-treated patients had reduction in sNfL levels (81% vs 72%), more had a reduction of ≥50% (69% vs 57%), and fewer patients had a sNfL level above the age-adjusted 80^th percentile of non-MS healthy controls (12% vs 30%; P=0.0003). sNfL levels remained stable and low in alemtuzumab-treated patients at Month 84 (median, 12.7 pg/mL), despite 57% receiving no additional treatment after the initial 2 courses.

Conclusions Alemtuzumab was more effective than SC IFNB-1a in reducing sNfL levels in treatment-naive patients with RRMS. Post-alemtuzumab levels comparable with healthy controls persisted at Month 84. These findings are consistent with the effect of alemtuzumab on clinical and MRI outcomes.

Authors/Disclosures
Jens Kuhle, MD PRESENTER	Dr. Kuhle has nothing to disclose.
	No disclosure on file
Christian Barro, MD, PhD (Brigham and Women's Hospital)	Dr. Barro has nothing to disclose.
	No disclosure on file
David Leppert, MD (University Hospital Basel)	Dr. Leppert has received personal compensation for serving as an employee of GeNeuro. Dr. Leppert has received personal compensation for serving as an employee of GeNeuro. Dr. Leppert has received personal compensation for serving as an employee of Geneuro. Dr. Leppert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Leppert has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Leppert has received personal compensation in the range of $0-$499 for serving as a Consultant for Orion. Dr. Leppert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Leppert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Quanterix. Dr. Leppert has stock in Novartis.
Jean Godin, MD, MBA (Novartis Pharmaceuticals Canada Inc.)	No disclosure on file
Srinivas Shankara, PhD (Sanofi)	Dr. Shankara has received personal compensation for serving as an employee of Sanofi.
Tarek Samad, PhD (Sanofi)	No disclosure on file
Alan K. Jacobs, MD, FAAN (Satellos Biosciences)	Dr. Jacobs has received personal compensation for serving as an employee of Immunovant, Inc. Dr. Jacobs has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Galler Consulting.
Luke Chung (Sanofi Genzyme)	Luke Chung has received personal compensation for serving as an employee of Sanofi Genzyme. Luke Chung has received stock or an ownership interest from Sanofi Genzyme.
Nora Roesch	No disclosure on file
Carina Kaiser	No disclosure on file
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.
Evis Havari, Msc (Sanofi)	Ms. Havari has received personal compensation for serving as an employee of sanofi.

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