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
Background Treatment with interferon beta has been shown tohelp patients with established multiple sclerosis, but it isnot known whether initiating treatment at the time of a firstclinical demyelinating event is of value.
Methods We conducted a randomized, double-blind trial of 383patients who had a first acute clinical demyelinating event(optic neuritis, incomplete transverse myelitis, or a brain-stemor cerebellar syndrome) and evidence of prior subclinical demyelinationon magnetic resonance imaging (MRI) of the brain. After initialtreatment with corticosteroids, 193 patients were randomly assignedto receive weekly intramuscular injections of 30 µg ofinterferon beta-1a and 190 were assigned to receive weekly injectionsof placebo. The study end points were the development of clinicallydefinite multiple sclerosis and changes in findings on MRI ofthe brain. The trial was stopped after a preplanned interimefficacy analysis.
Results During three years of follow-up, the cumulative probabilityof the development of clinically definite multiple sclerosiswas significantly lower in the interferon beta-1a group thanin the placebo group (rate ratio, 0.56; 95 percent confidenceinterval, 0.38 to 0.81; P=0.002). As compared with the patientsin the placebo group, patients in the interferon beta-1a grouphad a relative reduction in the volume of brain lesions (P<0.001),fewer new or enlarging lesions (P<0.001), and fewer gadolinium-enhancinglesions (P<0.001) at 18 months.
Conclusions Initiating treatment with interferon beta-1a atthe time of a first demyelinating event is beneficial for patientswith brain lesions on MRI that indicate a high risk of clinicallydefinite 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 RadiologyMRI, 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.
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