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Original Article
Volume 343:898-904 September 28, 2000 Number 13
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Intramuscular Interferon Beta-1A Therapy Initiated during a First Demyelinating Event in Multiple Sclerosis
Lawrence D. Jacobs, M.D., Roy W. Beck, M.D., Ph.D., Jack H. Simon, M.D., Ph.D., R. Phillip Kinkel, M.D., Carol M. Brownscheidle, Ph.D., Thomas J. Murray, M.D., Nancy A. Simonian, M.D., Peter J. Slasor, Sc.D., Alfred W. Sandrock, M.D., Ph.D., for The CHAMPS Study Group

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ABSTRACT

Background Treatment with interferon beta has been shown to help patients with established multiple sclerosis, but it is not known whether initiating treatment at the time of a first clinical demyelinating event is of value.

Methods We conducted a randomized, double-blind trial of 383 patients who had a first acute clinical demyelinating event (optic neuritis, incomplete transverse myelitis, or a brain-stem or cerebellar syndrome) and evidence of prior subclinical demyelination on magnetic resonance imaging (MRI) of the brain. After initial treatment with corticosteroids, 193 patients were randomly assigned to receive weekly intramuscular injections of 30 µg of interferon beta-1a and 190 were assigned to receive weekly injections of placebo. The study end points were the development of clinically definite multiple sclerosis and changes in findings on MRI of the brain. The trial was stopped after a preplanned interim efficacy analysis.

Results During three years of follow-up, the cumulative probability of the development of clinically definite multiple sclerosis was significantly lower in the interferon beta-1a group than in the placebo group (rate ratio, 0.56; 95 percent confidence interval, 0.38 to 0.81; P=0.002). As compared with the patients in the placebo group, patients in the interferon beta-1a group had a relative reduction in the volume of brain lesions (P<0.001), fewer new or enlarging lesions (P<0.001), and fewer gadolinium-enhancing lesions (P<0.001) at 18 months.

Conclusions Initiating treatment with interferon beta-1a at the time of a first demyelinating event is beneficial for patients with brain lesions on MRI that indicate a high risk of clinically definite multiple sclerosis.


Source Information

From the Department of Neurology, State University of New York School of Medicine at Buffalo and Buffalo General Hospital, Buffalo (L.D.J., C.M.B.); the Jaeb Center for Health Research, Tampa, Fla. (R.W.B.); the Department of Radiology–MRI, University of Colorado Health Sciences Center, Denver (J.H.S.); the Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, Cleveland (R.P.K.); the Multiple Sclerosis Research Unit, Centre for Clinical Research, Victoria General Hospital, Queen Elizabeth II Health Sciences Centre, Halifax, N.S., Canada (T.J.M.); and Biogen, Cambridge, Mass. (N.A.S., P.J.S., A.W.S.).

Address reprint requests to Dr. Jacobs at the Department of Neurology, Buffalo General Hospital, 100 High St., Buffalo, NY 14203, or at ljacobs{at}kaleidahealth.org.

Full Text of this Article


Related Letters:

Interferon Beta-1a during a First Demyelinating Event
Poser C. M., Esmonde T. F.G., Jacobs L. D., Beck R. W., Kinkel R. P.
Extract | Full Text | PDF  
N Engl J Med 2001; 344:229-230, Jan 18, 2001. Correspondence

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