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Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS
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...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5075976/ https://www.ncbi.nlm.nih.gov/pubmed/27590291 http://dx.doi.org/10.1212/WNL.0000000000003169 |
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author | Arnold, Douglas L. Fisher, Elizabeth Brinar, Vesna V. Cohen, Jeffrey A. Coles, Alasdair J. Giovannoni, Gavin Hartung, Hans-Peter Havrdova, Eva Selmaj, Krzysztof W. Stojanovic, Miroslav Weiner, Howard L. Lake, Stephen L. Margolin, David H. Thomas, David R. Panzara, Michael A. Compston, D. Alastair S. |
author_facet | Arnold, Douglas L. Fisher, Elizabeth Brinar, Vesna V. Cohen, Jeffrey A. Coles, Alasdair J. Giovannoni, Gavin Hartung, Hans-Peter Havrdova, Eva Selmaj, Krzysztof W. Stojanovic, Miroslav Weiner, Howard L. Lake, Stephen L. Margolin, David H. Thomas, David R. Panzara, Michael A. Compston, D. Alastair S. |
author_sort | Arnold, Douglas L. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5075976 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-50759762016-10-31 Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS Arnold, Douglas L. Fisher, Elizabeth Brinar, Vesna V. Cohen, Jeffrey A. Coles, Alasdair J. Giovannoni, Gavin Hartung, Hans-Peter Havrdova, Eva Selmaj, Krzysztof W. Stojanovic, Miroslav Weiner, Howard L. Lake, Stephen L. Margolin, David H. Thomas, David R. Panzara, Michael A. Compston, D. Alastair S. Neurology Article 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. Lippincott Williams & Wilkins 2016-10-04 /pmc/articles/PMC5075976/ /pubmed/27590291 http://dx.doi.org/10.1212/WNL.0000000000003169 Text en © 2016 American Academy of Neurology https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially. |
spellingShingle | Article Arnold, Douglas L. Fisher, Elizabeth Brinar, Vesna V. Cohen, Jeffrey A. Coles, Alasdair J. Giovannoni, Gavin Hartung, Hans-Peter Havrdova, Eva Selmaj, Krzysztof W. Stojanovic, Miroslav Weiner, Howard L. Lake, Stephen L. Margolin, David H. Thomas, David R. Panzara, Michael A. Compston, D. Alastair S. Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS |
title | Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS |
title_full | Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS |
title_fullStr | Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS |
title_full_unstemmed | Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS |
title_short | Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS |
title_sort | superior mri outcomes with alemtuzumab compared with subcutaneous interferon β-1a in ms |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5075976/ https://www.ncbi.nlm.nih.gov/pubmed/27590291 http://dx.doi.org/10.1212/WNL.0000000000003169 |
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