Intramuscular interferon beta‐1a for disease progression in relapsing multiple sclerosis

Lawrence D. Jacobs(Buffalo General Medical Center), Diane L. Cookfair(Women & Children's Hospital of Buffalo), Richard A. Rudick(Cleveland Clinic), Robert M. Herndon(Good Samaritan Hospital), John R. Richert(Georgetown University), Andres Μ. Salazar(Walter Reed Army Institute of Research), Jill S. Fischer(Cleveland Clinic), Donald E. Goodkin(University of California, San Francisco), Carl V. Granger(Buffalo State University), Jack H. Simon(University of Colorado Health), John Alam(Biogen (United States)), David M. Bartoszak(Walter Reed Army Institute of Research), Dennis Bourdette(Oregon Health & Science University), Jonathan Braiman(Walter Reed Army Institute of Research), Carol M. Brownscheidle, Michael E. Coats(Walter Reed Army Institute of Research), Stanley Cohan(Georgetown University), David S. Dougherty(Walter Reed Army Institute of Research), Revere P. Kinkel(Cleveland Clinic), Michele Mass(Good Samaritan Hospital), Frederick Munschauer, Roger L. Priore(Women & Children's Hospital of Buffalo), Patrick M. Pullicino, Barbara Scherokman(Kaiser Permanente), Bianca Weinstock‐Guttman(Cleveland Clinic), Ruth H. Whitham(Oregon Health & Science University)
Annals of Neurology
March 1, 1996
10.1002/ana.410390304
Cited by 2,447

Abstract

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 III trial of interferon beta-1a. Interferon beta-1a, 6.0 million units (30 micrograms¿, 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-1a treatment produced a significant delay in time to sustained EDSS progression (p = 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-1a-treated group. Patients treated with interferon beta-1a also had significantly fewer exacerbations (p = 0.03) and a significantly lower number and volume of gadolinium-enhanced brain lesions on magnetic resonance images (p-values 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-1a-treated patients. There were no major adverse events related to treatment. Interferon beta-1a 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 fundamental course of relapsing multiple sclerosis.

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