RT Journal Article
SR Electronic
T1 ALEMTUZUMAB IMPROVES EDSS FUNCTIONAL SYSTEMS SCORES IN RRMS
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP e1
OP e1
DO 10.1136/jnnp-2016-315106.132
VO 87
IS 12
A1 Giovannoni, Gavin
A1 Berkovich, Regina
A1 Fernandez, Oscar
A1 Wiendl, Heinz
A1 Margolin, David
A1 Thangavelu, Karthinathan
A1 LaGanke, Christopher
A1 on behalf of the CARE-MS I and CARE-MS II Investigators
YR 2016
UL http://jnnp.bmj.com/content/87/12/e1.38.abstract
AB In patients with relapsing-remitting MS (RRMS) and an inadequate response (≥1 relapse) to prior therapy, alemtuzumab improved Expanded Disability Status Scale (EDSS) functional systems scores (FSS) over 2 years versus subcutaneous interferon beta-1a (CARE-MS II; NCT00548405). Here we assess alemtuzumab's effect on FSS over 5 years. Patients received alemtuzumab at baseline and Month 12 in the core study. Patients entering an extension (NCT00930553) could receive as-needed alemtuzumab retreatment, or another disease-modifying therapy (DMT), for disease activity. EDSS was evaluated quarterly by blinded raters. 6-month confirmed FSS disability progression was defined as ≥1.0-point increase in an FSS. 393 (93%) alemtuzumab patients entered the extension; 357 (91%) remained on study through 5 years, 60% received no alemtuzumab after Month 12, and 92% received no other DMT. Over 5 years, mean cerebellar, pyramidal, sensory, and cerebral FSS did not exceed baseline; for each FSS, 71%–80% of patients were free from disability progression. Patients who received only 2 courses of alemtuzumab and no other DMT for 5 years generally had lower FSS than other patients. RRMS patients with inadequate response to prior therapy had persistent improvement/stability across multiple FSS over 5 years with alemtuzumab; most patients received no additional treatment since Month 12.Study supported by Sanofi Genzyme and Bayer Healthcare Pharmaceuticals.