期刊
NEUROLOGY
卷 76, 期 14, 页码 1222-1228出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e3182143577
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资金
- Bayer HealthCare Pharmaceuticals, Monvtille, NJ
- Bayer HealthCare Pharmaceuticals
- Bayer Schering Pharma
- Biogen-Dompe AG
- Genmab A/S
- Merck Serono
- Teva Pharmaceutical Industries Ltd.
- Fondazione Italiana Sclerosi Multipla
- Fondazione Mariani
- Biogen Idec
- Novartis
- BioMS Medical
- Sanofi-Aventis
- CIS Pharma
- Roche
- MS Society of Canada
- Questcor Pharmaceuticals, Inc.
- University Hospital Basel from Acorda Therapeutics Inc.
- Actelion Pharmaceuticals Ltd
- Advancell
- Allozyne
- Barofold
- Bayhill
- BioMarin
- Boehringer Ingelheim
- CSL Behring
- Geneuro
- Genmab
- GlaxoSmithKline
- Glenmark
- MediciNova
- Santhera Pharmaceuticals
- Shire Plc
- Teva
- UCB
- Wyeth
- Swiss MS Society
- Swiss National Research Foundation
- European Union
- Gianni Rubato
- Novartis Foundations
- Pfizer Inc.
- NIH
- Clayton Foundation for Research
- National Multiple Sclerosis Society
- University of Texas Health Science Center at Houston to Millipore (Chemicon International) Corporation.
- Canadian Institutes of Health Research
- Multiple Sclerosis Society of Canada
- Millenium Pharmaceuticals, Inc.
- Klein Buendel, Inc.
- Alexion Pharmaceuticals, Inc.
- Androclus Therapeutics, Inc.
- University of Illinois
- Amgen
- New York University
- Somnus Therapeutics, Inc.
- NIH (NINDS/NIAID/NHLBI/NIDR/NIDDK)
- Consortium of Multiple Sclerosis Centers
Objective: To compare interferon beta-1b (IFN beta-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)-a marker of irreversible tissue damage-in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: BEYOND was a large, phase III, clinical trial comparing IFN beta-1b 250 mu g, IFN beta-1b 500 mu g, and GA (2: 2: 1). Patient scans were reexamined post hoc for PBH in a rater-blinded manner. Two predefined coprimary endpoints compared IFN beta-1b 250 mu g with GA: first, number of PBH per patient at year 2 evolving from year 1 NL, then proportion of year 1 NL evolving into PBH at year 2. IFN beta-1b 500 mu g and GA were compared in an exploratory fashion. Results: Approximately 90% (1,957/2,244) of patients had NL at year 1 with follow-up at year 2. Mean numbers of PBH per patient at year 2 evolving from year 1 NL were lower for IFN beta-1b 250 mu g than GA (0.30 vs 0.43; p = 0.0451). The proportion of NL evolving into PBH was similar (IFN beta-1b 250 mu g vs GA: 21.6% vs 23.5%; p > 0.20). For IFN beta-1b 500 mu g, both the mean PBH number per patient at year 2 evolving from year 1 NL (0.26 vs 0.43; p = 0.0037) and proportion of NL evolving into PBH (16.3% vs 23.5%; p = 0.0409) were lower relative to GA. Conclusion: IFN beta-1b affected PBH development to a similar or better extent than GA. IFN beta-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFN beta-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment. Neurology (R) 2011;76:1222-1228
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