Rapid benefits of a new formulation of subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis

被引:30
作者
De Stefano, Nicola [1 ]
Curtin, Francois [2 ,7 ]
Stubinski, Bettina [2 ,7 ]
Blevins, Gregg [3 ]
Drulovic, Jelena [4 ]
Issard, Delphine [2 ,7 ]
Shotekov, Penko [5 ]
Gasperini, Claudio [6 ]
机构
[1] Univ Siena, Dept Neurol & Behav Sci, I-53100 Siena, Italy
[2] Merck Serono SA, Geneva, Switzerland
[3] Univ Alberta, Div Neurol, Edmonton, AB, Canada
[4] Univ Belgrade, Inst Neurol, Clin Ctr Serbia, Belgrade, Serbia
[5] UMBAL Alexandovska, Neurol Clin, Sofia, Bulgaria
[6] San Camillo Forlanini Hosp, Rome, Italy
[7] Merck KGaA, Darmstadt, Germany
关键词
efficacy; interferon beta-1a; magnetic resonance imaging; randomized controlled trial; relapsing-remitting multiple sclerosis;
D O I
10.1177/1352458510362442
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
w This study evaluated the efficacy of a new formulation of subcutaneous (sc) interferon (IFN)-beta 1a in relapsing-remitting multiple sclerosis (RRMS). Patients (n=180) were randomized (2:1) to IFN-beta 1a or placebo for 16 weeks; all patients then received IFN-beta 1a for 24 weeks. Monthly brain MRI was performed. At week 16, the mean number of combined unique active (CUA) lesions was lower with IFN-beta 1a than with placebo (p < 0.001; 69% fewer lesions). The mean cumulative number of CUA lesions was already lower with IFN-beta 1a by week 4 ( post hoc analysis; p=0.015). The new formulation of sc IFN-beta 1a has rapid beneficial effects on MRI outcomes in RRMS.
引用
收藏
页码:888 / 892
页数:5
相关论文
共 8 条
[1]   Safety and immunogenicity of a new formulation of interferon β-1a (Rebif® New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week results [J].
Giovannoni, G. ;
Barbarash, O. ;
Casset-Semanaz, F. ;
King, J. ;
Metz, L. ;
Pardo, G. ;
Simsarian, J. ;
Sorensen, P. S. ;
Stubinski, B. .
MULTIPLE SCLEROSIS JOURNAL, 2009, 15 (02) :219-228
[2]  
KURTZKE JF, 1983, NEUROLOGY, V33, P1444, DOI 10.1212/WNL.33.11.1444
[3]  
Li DKB, 1999, ANN NEUROL, V46, P197, DOI 10.1002/1531-8249(199908)46:2<197::AID-ANA9>3.0.CO
[4]  
2-P
[5]   Recommended diagnostic criteria for multiple sclerosis: Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis [J].
McDonald, WI ;
Compston, A ;
Edan, G ;
Goodkin, D ;
Hartung, HP ;
Lublin, FD ;
McFarland, HF ;
Paty, DW ;
Polman, CH ;
Reingold, SC ;
Sandberg-Wollheim, M ;
Sibley, W ;
Thompson, AJ ;
van den Noort, S ;
Weinshenker, BY ;
Wolinsky, JS .
ANNALS OF NEUROLOGY, 2001, 50 (01) :121-127
[6]   Sensitivity and reproducibility of volume change measurements of different brain portions on magnetic resonance imaging in patients with multiple sclerosis [J].
Rovaris, M ;
Inglese, M ;
van Schijndel, RA ;
Sormani, MP ;
Rodegher, M ;
Comi, G ;
Filippi, M .
JOURNAL OF NEUROLOGY, 2000, 247 (12) :960-965
[7]   Modelling MRI enhancing lesion counts in multiple sclerosis using a negative binomial model: implications for clinical trials [J].
Sormani, MP ;
Bruzzi, P ;
Miller, DH ;
Gasperini, C ;
Barkhof, F ;
Filippi, L .
JOURNAL OF THE NEUROLOGICAL SCIENCES, 1999, 163 (01) :74-80
[8]   Regression of new gadolinium enhancing lesion activity in relapsing-remitting multiple sclerosis [J].
Zhao, Yinshan ;
Traboulsee, Anthony ;
Petkau, A. John ;
Li, David .
NEUROLOGY, 2008, 70 (13) :1092-1097