INTRAMUSCULAR INTERFERON BETA-1-ALPHA FOR DISEASE PROGRESSION IN RELAPSING MULTIPLE-SCLEROSIS

Authors
JACOBS LD COOKFAIR DL RUDICK RA HERNDON RM RICHERT JR SALAZAR AM FISCHER JS GOODKIN DE GRANGER CV SIMON JH ALAM JJ BARTOSZAK DM BOURDETTE DN BRAIMAN J BROWNSCHEIDLE CM COATS ME COHAN SL DOUGHERTY DS KINKEL RP MASS MK MUNSCHAUER FE PRIORE RL PULLICINO PM SCHEROKMAN BJ WEINSTOCKGUTTMAN B WHITMAN RH BAIRD WC FILLMORE M BONA LM COLONRUIZ ME NADINE BS DONOVAN A BENNETT S KIEFFER YM UMHAUER MA MILLER CE KILIC AK SARGENT EL SCHACHTER M SHUCARD DW WEIDER V CATALANO BA CERVI JM CZEKAY C FARRELL JL FILIPPINI JS MATYAS RC MICHIENZI KE ITO M OMALLEY JA ZIELEZNY MA BRUN JM DAVIDSON AL GREEN LA OREILLY KM SHELTON JA WENDE KE BARILLA DY BOYLE SL PERKINS KK PERRYMAN JE STIEBELING BG KONECSNI JF ROSS JS CHOI KS GUSTAFSON CJ QUANDT BJ SCHERZINGER AL GRIFFITH DA HARRIS JM LEZAK MD MIMICA I SAUNDERS JA COIT WE FORCE CR GILMORE FJ HARRIS LB JONES MM KAUFFMAN JA MARBERGER KE MCBRIDE JW MILLER LL WRIGHT GK BROOKS JA BROWN HR GRAVES ME SCHMIDT JA MOTHENA JW GRAFMAN JH KENWORTHY MK MORTON MM BROWN DM BROWN DC LEVY LM BORDEN EC RANSOHOFF RM VILCEK JT MCCARTHYKIRBY K CAMPION M
Citation
Ld. Jacobs et al., INTRAMUSCULAR INTERFERON BETA-1-ALPHA FOR DISEASE PROGRESSION IN RELAPSING MULTIPLE-SCLEROSIS, Annals of neurology, 39(3), 1996, pp. 285-294
Citations number
34
Categorie Soggetti
Clinical Neurology",Neurosciences
Journal title
Annals of neurology → ACNP
ISSN journal
03645134
Volume
39
Issue
3
Year of publication
1996
Pages
285 - 294
Database
ISI
SICI code
0364-5134(1996)39:3<285:IIBFDP>2.0.ZU;2-J
Abstract
The accepted standard treatment of relapsing multiple sclerosis consis ts 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 p urpose of this study was to determine whether interferon beta-la could slow the progressive, irreversible, neurological disability of relaps ing multiple sclerosis. Three hundred one patients with relapsing mult iple sclerosis were randomized into a double-blinded, placebo-controll ed, multicenter phase III trial of interferon beta-la. Interferon beta -la, 6.0 million units (30 mu g), was administered by intramuscular in jection weekly. The primary outcome variable was time to sustained dis ability progression of at least 1.0 point on the Kurtzke Expanded Disa bility Status Scale (EDSS). Interferon beta-la treatment produced a si gnificant 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 inte rferon beta-la-treated group. Patients treated with interferon beta-la also had significantly fewer exacerbations (p = 0.03) and a significa ntly lower number and volume of gadolinium-enhanced brain lesions on m agnetic resonance images (p-values ranging between 0.02 and 0.05). Ove r 2 years, the annual exacerbation rate was 0.90 in placebo-treated pa tients 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 patient s by reducing the accumulation of permanent physical disability, exace rbation frequency, and disease activity measured by gadolinium-enhance d lesions on brain magnetic resonance images. This treatment may alter the fundamental course of relapsing multiple sclerosis.