Premium
Intramuscular interferon beta‐1a for disease progression in relapsing multiple sclerosis
Author(s) -
Jacobs Lawrence D.,
Cookfair Diane L.,
Rudick Richard A.,
Herndon Robert M.,
Richert John R.,
Salazar Andres M.,
Fischer Jill S.,
Goodkin Donald E.,
Granger Carl V.,
Simon Jack H.,
Alam John J.,
Bartoszak David M.,
Bourdette Dennis N.,
Braiman Jonathan,
Brownscheidle Carol M.,
Coats Michael E.,
Cohan Stanley L.,
Dougherty David S.,
Kinkel Revere P.,
Mass Michele K.,
Munschauer Frederick E.,
Priore Roger L.,
Pullicino Patrick M.,
Scherokman Barbara J.,
WeinstockGuttman Bianca,
Whitham Ruth H.
Publication year - 1996
Publication title -
annals of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.764
H-Index - 296
eISSN - 1531-8249
pISSN - 0364-5134
DOI - 10.1002/ana.410390304
Subject(s) - medicine , multiple sclerosis , expanded disability status scale , interferon beta 1a , placebo , interferon beta 1b , exacerbation , adverse effect , gastroenterology , central nervous system disease , immunology , interferon beta , pathology , alternative medicine
The accepted standard treatment of relapsing multiple sclerosis consists of medications for disease symptoms, including treatment for acute exacerbations. However, currently there is no therapy that alters the progression of physical disability associated with this disease. The purpose of this study was to determine whether interferon beta‐1a could slow the progressive, irreversible, neurological disability of relapsing multiple sclerosis. Three hundred one patients with relapsing multiple sclerosis were randomized into a double‐blinded, placebo‐controlled, multicenter phase I11 trial of interferon beta‐la. Interferon beta‐la, 6.0 million units (30 μg), was administered by intramuscular injection weekly. The primary outcome variable was time to sustained disability progression of at least 1.0 point on the Kurtzke Expanded Disability Status Scale (EDSS). Interferon beta‐la treatment produced a significant delay in time to sustained EDSS progression ( p equals; 0.02). The Kaplan‐Meier estimate of the proportion of patients progressing by the end of 104 weeks was 34.9% in the placebo group and 21.9% in the interferon beta‐la‐treated group. Patients treated with interferon beta‐la also had significantly fewer exacerbations ( p = 0.03) and a significantly lower number and volume of gadolinium‐enhanced brain lesions on magnetic resonance images (pvalues ranging between 0.02 and 0.05). Over 2 years, the annual exacerbation rate was 0.90 in placebo‐treated patients versus 0.61 in interferon beta‐la‐treated patients. There were no major adverse events related to treatment. Interferon beta‐ la had a significant beneficial impact in relapsing multiple sclerosis patients by reducing the accumulation of permanent physical disability, exacerbation frequency, and disease activity measured by gadolinium‐enhanced lesions on brain magnetic resonance images. This treatment may alter the hndamen‐ tal course of relapsing multiple sclerosis.