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April 1, 1993

Interferon beta‐1b is effective in relapsing‐remitting multiple sclerosis
I. Clinical results of a multicenter, randomized, double‐blind, placebo-controlled trial

April 1993 issue
43 (4) 655


We report a multicenter, randomized, double-blind, placebo-controlled trial of interferon beta-lb (IFNB) in 372 ambulatory patients with relapsing-remitting multiple sclerosis (MS). Entry criteria included an Expanded Disability Status Scale (EDSS) score of 0 to 5.5 and at least two exacerbations in the previous 2 years. One-third of the patients received placebo, one-third 1.6 million international units (MIU) of IFNB, and one-third 8 MIU of IFNB, self-administered by subcutaneous injections every other day. The primary end points were differences in exacerbation rates and proportion of patients remaining exacerbation-free. The annual exacerbation rate for patients receiving placebo was 1.27; for 1.6 MIU IFNB, 1.17; and for 8 MIU IFNB, 0.84 after 2 years. Exacerbation rates were significantly lower in both treatment groups compared with the placebo group (8 MIU versus placebo, p = 0.0001; 1.6 MIU versus placebo, p = 0.0101; and 8 MIU versus 1.6 MIU, p = 0.0086), suggesting a dosage effect. The reduction in exacerbation severity in the 8 MIU group was attributable to a twofold reduction in the frequency of moderate and severe attacks. More patients in the 8 MIU group (n = 36) were exacerbation-free at 2 years compared with the placebo group (n = 18; p = 0.007). EDSS scores changed little from baseline in both the placebo and treatment arms. Accordingly, a significant change in disability could not be discerned in this trial. Finally, in serial MRIs, MS activity was significantly less in the high-dose IFNB group. IFNB treatment was well tolerated: the significant reductions in exacerbation rates, severity of exacerbations, and accumulation of MRI abnormalities occurred in the absence of serious side effects. IFNB is the only treatment that has substantially altered the natural history of MS in a properly controlled clinical trial.

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Published In

Volume 43Number 4April 1993
Pages: 655

Publication History

Published online: April 1, 1993
Published in print: April 1993


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The IFNB Multiple Sclerosis Study Group

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