Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing–remitting MS

Background: Alemtuzumab efficacy and safety was demonstrated in CARE-MS I and extension studies (CAMMS03409; TOPAZ). Objective: Evaluate serum neurofilament light chain (sNfL) in CARE-MS I patients and highly active disease (HAD) subgroup, over 7 and 2 years for alemtuzumab and subcutaneous interfer...

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Published in:Multiple sclerosis 2022-04, Vol.28 (4), p.573-582
Main Authors: Kuhle, Jens, Daizadeh, Nadia, Benkert, Pascal, Maceski, Aleksandra, Barro, Christian, Michalak, Zuzanna, Sormani, Maria Pia, Godin, Jean, Shankara, Srinivas, Samad, Tarek A, Jacobs, Alan, Chung, Luke, Rӧsch, Nora, Kaiser, Carina, Mitchell, Colin P, Leppert, David, Havari, Evis, Kappos, Ludwig
Format: Article
Language:English
Subjects:
Alemtuzumab - adverse effects
Gadolinium
Humans
Interferon
Interferon beta-1a - therapeutic use
Intermediate Filaments
Monoclonal antibodies
Multiple Sclerosis, Relapsing-Remitting - drug therapy
Neurofilament Proteins
Original Research Papers
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Summary:Background: Alemtuzumab efficacy and safety was demonstrated in CARE-MS I and extension studies (CAMMS03409; TOPAZ). Objective: Evaluate serum neurofilament light chain (sNfL) in CARE-MS I patients and highly active disease (HAD) subgroup, over 7 and 2 years for alemtuzumab and subcutaneous interferon beta-1a (SC IFNB-1a), respectively. Methods: Patients received SC IFNB-1a 44 µg 3×/week or alemtuzumab 12 mg/day at baseline and month 12, with further as-needed 3-day courses. sNfL was measured using single-molecule array (Simoa™). HAD definition was ⩾2 relapses in year before randomization and ⩾1 baseline gadolinium-enhancing lesion. Results: Baseline median sNfL levels were similar in alemtuzumab (n = 354) and SC IFNB-1a–treated (n = 159) patients (31.7 vs 31.4 pg/mL), but decreased with alemtuzumab versus SC IFNB-1a until year 2 (Y2; 13.2 vs 18.7 pg/mL; p < 0.0001); 12.7 pg/mL for alemtuzumab at Y7. Alemtuzumab-treated patients had sNfL at/below healthy control median at Y2 (72% vs 47%; p < 0.0001); 73% for alemtuzumab at Y7. HAD patients (n = 102) had higher baseline sNfL (49.4 pg/mL) versus overall population; alemtuzumab HAD patients attained similar levels (Y2, 12.8 pg/mL; Y7, 12.7 pg/mL; 75% were at/below control median at Y7). Conclusion: Alemtuzumab was superior to SC IFNB-1a in reducing sNfL, with levels in alemtuzumab patients remaining stable through Y7. ClinicalTrials.gov identifier: NCT00530348, NCT00930553, NCT02255656
ISSN:1352-4585
1477-0970
DOI:10.1177/13524585211032348