RT Journal Article
SR Electronic
T1 Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP 1464
OP 1472
DO 10.1212/WNL.0000000000003169
VO 87
IS 14
A1 Arnold, Douglas L.
A1 Fisher, Elizabeth
A1 Brinar, Vesna V.
A1 Cohen, Jeffrey A.
A1 Coles, Alasdair J.
A1 Giovannoni, Gavin
A1 Hartung, Hans-Peter
A1 Havrdova, Eva
A1 Selmaj, Krzysztof W.
A1 Stojanovic, Miroslav
A1 Weiner, Howard L.
A1 Lake, Stephen L.
A1 Margolin, David H.
A1 Thomas, David R.
A1 Panzara, Michael A.
A1 Compston, D. Alastair S.
YR 2016
UL http://n.neurology.org/content/87/14/1464.abstract
AB Objective: To describe detailed MRI results from 2 head-to-head phase III trials, Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis Study I (CARE-MS I; NCT00530348) and Study II (CARE-MS II; NCT00548405), of alemtuzumab vs subcutaneous interferon β-1a (SC IFN-β-1a) in patients with active relapsing-remitting multiple sclerosis (RRMS).Methods: The impact of alemtuzumab 12 mg vs SC IFN-β-1a 44 μg on MRI measures was evaluated in patients with RRMS who were treatment-naive (CARE-MS I) or who had an inadequate response, defined as at least one relapse, to prior therapy (CARE-MS II).Results: Both treatments prevented T2-hyperintense lesion volume increases from baseline. Alemtuzumab was more effective than SC IFN-β-1a on most lesion-based endpoints in both studies (p < 0.05), including decreased risk of new/enlarging T2 lesions over 2 years and gadolinium-enhancing lesions at year 2. Reduced risk of new T1 lesions (p < 0.0001) and gadolinium-enhancing lesion conversion to T1-hypointense black holes (p = 0.0078) were observed with alemtuzumab vs SC IFN-β-1a in CARE-MS II. Alemtuzumab slowed brain volume loss over 2 years in CARE-MS I (p < 0.0001) and II (p = 0.012) vs SC IFN-β-1a.Conclusions: Alemtuzumab demonstrated greater efficacy than SC IFN-β-1a on MRI endpoints in active RRMS. The superiority of alemtuzumab was more prominent during the second year of both studies. These findings complement the superior clinical efficacy of alemtuzumab over SC IFN-β-1a in RRMS.ClinicalTrials.gov identifier: NCT00530348 and NCT00548405.Classification of evidence: The results reported here provide Class I evidence that, for patients with active RRMS, alemtuzumab is superior to SC IFN-β-1a on multiple MRI endpoints.BPF=brain parenchymal fraction; CARE-MS=Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis; CI=confidence interval; IFN-β-1a=interferon β-1a; MS=multiple sclerosis; RRMS=relapsing-remitting multiple sclerosis