dc.contributor.author | Coles, AJ | en_US |
dc.contributor.author | Cohen, JA | en_US |
dc.contributor.author | Fox, EJ | en_US |
dc.contributor.author | Giovannoni, G | en_US |
dc.contributor.author | Hartung, H-P | en_US |
dc.contributor.author | Havrdova, E | en_US |
dc.contributor.author | Schippling, S | en_US |
dc.contributor.author | Selmaj, KW | en_US |
dc.contributor.author | Traboulsee, A | en_US |
dc.contributor.author | Compston, DAS | en_US |
dc.contributor.author | Margolin, DH | en_US |
dc.contributor.author | Thangavelu, K | en_US |
dc.contributor.author | Chirieac, MC | en_US |
dc.contributor.author | Jody, D | en_US |
dc.contributor.author | Xenopoulos, P | en_US |
dc.contributor.author | Hogan, RJ | en_US |
dc.contributor.author | Panzara, MA | en_US |
dc.contributor.author | Arnold, DL | en_US |
dc.contributor.author | CARE-MS II and CAMMS03409 Investigators | en_US |
dc.date.accessioned | 2018-03-08T11:45:55Z | |
dc.date.available | 2017-06-22 | en_US |
dc.date.issued | 2017-09-12 | en_US |
dc.date.submitted | 2018-03-08T10:49:56.999Z | |
dc.identifier.other | 10.1212/WNL.0000000000004354 | |
dc.identifier.uri | http://n.neurology.org/content/89/11/1117.long | |
dc.identifier.uri | http://qmro.qmul.ac.uk/xmlui/handle/123456789/34451 | |
dc.description.abstract | OBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy. METHODS: In the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II study (NCT00548405), alemtuzumab-treated patients received 2 courses (baseline and 12 months later). Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or MRI activity. Annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; ≥1-point Expanded Disability Status Scale [EDSS] score increase [≥1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline score ≥2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs) were assessed. RESULTS: Most alemtuzumab-treated patients (92.9%) who completed CARE-MS II entered the extension; 59.8% received no alemtuzumab retreatment. ARR was low in each extension year (years 3-5: 0.22, 0.23, 0.18). Through 5 years, 75.1% of patients were free of 6-month CDW; 42.9% achieved 6-month CDI. In years 3, 4, and 5, proportions with NEDA were 52.9%, 54.2%, and 58.2%, respectively. Median yearly BVL remained low in the extension (years 1-5: -0.48%, -0.22%, -0.10%, -0.19%, -0.07%). AE exposure-adjusted incidence rates in the extension were lower than in the core study. Thyroid disorders peaked at year 3, declining thereafter. CONCLUSIONS: Alemtuzumab provides durable efficacy through 5 years in patients with an inadequate response to prior therapy in the absence of continuous treatment. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that alemtuzumab provides efficacy and slowing of brain atrophy through 5 years. | en_US |
dc.description.sponsorship | Supported by Sanofi and Bayer HealthCare Pharmaceuticals.
A.J. Coles reports institutional grant support from Sanofi Genzyme
E. Havrdova reports grant support from Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi Genzyme, and Teva, and is supported by Ministry of Education of Czech Republic, project PROGRES Q27/LF1.
S. Schippling reports research grants from Novartis and Sanofi Genzyme
D.A.S. Compston reports grant support from Genzyme | en_US |
dc.format.extent | 1117 - 1126 | en_US |
dc.language | eng | en_US |
dc.language.iso | en | en_US |
dc.relation.ispartof | Neurology | en_US |
dc.rights | CC-BY-NC | |
dc.subject | Alemtuzumab | en_US |
dc.subject | Antibodies, Monoclonal, Humanized | en_US |
dc.subject | Atrophy | en_US |
dc.subject | Brain | en_US |
dc.subject | Disability Evaluation | en_US |
dc.subject | Follow-Up Studies | en_US |
dc.subject | Humans | en_US |
dc.subject | Immunologic Factors | en_US |
dc.subject | Kaplan-Meier Estimate | en_US |
dc.subject | Multiple Sclerosis, Relapsing-Remitting | en_US |
dc.subject | Organ Size | en_US |
dc.subject | Time Factors | en_US |
dc.subject | Treatment Outcome | en_US |
dc.title | Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings. | en_US |
dc.type | Article | |
dc.rights.holder | 2017 The Authors. | |
dc.identifier.doi | 10.1212/WNL.0000000000004354 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/28835403 | en_US |
pubs.issue | 11 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published | en_US |
pubs.volume | 89 | en_US |
dcterms.dateAccepted | 2017-06-22 | en_US |