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Alemtuzumab improves neurological functional systems in treatment-naive relapsing-remitting multiple sclerosis patients.

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Fox, Edward J 
Wynn, Daniel 
Coles, Alasdair J 
Palmer, Jeffrey 
Margolin, David H 


BACKGROUND: Individual functional system scores (FSS) of the Expanded Disability Status Scale (EDSS) play a central role in determining the overall EDSS score in patients with early-stage multiple sclerosis (MS). Alemtuzumab treatment improves preexisting disability for many patients; however, it is unknown whether improvement is specific to certain functional systems. OBJECTIVE: We assessed the effect of alemtuzumab on individual FSS of the EDSS. METHODS: CAMMS223 was a 36-month, rater-blinded, phase 2 trial; treatment-naive patients with active relapsing-remitting MS, EDSS ≤3, and symptom onset within 3 years were randomized to annual courses of alemtuzumab or subcutaneous interferon beta-1a (SC IFNB-1a) 44 μg three times weekly. RESULTS: Alemtuzumab-treated patients had improved outcomes versus SC IFNB-1a patients on most FSS at Month 36; the greatest effect occurred for sensory, pyramidal, and cerebellar FSS. Among patients who experienced 6-month sustained accumulation of disability, clinical worsening occurred most frequently in the brainstem and sensory systems. For patients with 6-month sustained reduction in preexisting disability, pyramidal and sensory systems contributed most frequently to clinical improvement. CONCLUSIONS: Alemtuzumab demonstrated a broad treatment effect in improving preexisting disability. These findings may influence treatment decisions in patients with early, active relapsing-remitting MS displaying neurological deficits. Identifier NCT00050778.



Alemtuzumab, Disability, Disease-modifying therapy, Expanded Disability Status Scale, Functional systems, Multiple sclerosis, Adult, Alemtuzumab, Antibodies, Monoclonal, Humanized, Female, Humans, Male, Multiple Sclerosis, Relapsing-Remitting, Nervous System Diseases, Single-Blind Method

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J Neurol Sci

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Elsevier BV
Funding was provided by Sanofi Genzyme and Bayer Healthcare Pharmaceuticals. The authors would like to thank Marco Rizzo and Isabel Firmino for reviewing and providing input on the manuscript; Isabel Firmino is an employee of Sanofi Genzyme; Marco Rizzo was an employee of Sanofi Genzyme at the time the work was conducted. Data analysis was carried out by Linda Kasten, PROMETRIKA, LLC, Cambridge, MA, USA, which was supported by Sanofi Genzyme. Editorial support for this manuscript was provided by Fiona Nitsche, PhD, and Susan M Kaup, PhD, which was funded by Sanofi Genzyme. Fiona Nitsche is an employee of Evidence Scientific Solutions; Susan M Kaup was an employee of Evidence Scientific Solutions at the time the work was conducted.