Clinical benefits of interferon beta-1a in relapsing-remitting MS: a phase IV study.
OBJECTIVE
To evaluate the efficacy and safety of IFNbeta-1a (Avonex, Biogen, Inc., Cambridge, MA, USA) in patients with relapsing-remitting multiple sclerosis (MS).


METHODS
In this multicenter, open-label, prospective clinical trial, 96 patients with relapsing-remitting MS received IFNbeta-1a 30 mcg intramuscularly once weekly for 2 years. Outcome variables included: change from baseline in mean number of exacerbations, proportion of exacerbation-free patients, and mean Expanded Disability Status Scale (EDSS) scores at Years 1 and 2.


RESULTS
IFNbeta-1a significantly (P < 0.0001) reduced exacerbation rate at Years 1 and 2 of treatment. The percentage of exacerbation-free patients was 53% during Year 1 and 33% during Year 2. Mean EDSS scores were 2.96 +/- 1.26 at baseline, 2.89 +/- 1.42 at Year 1, and 3.00 +/- 1.62 at Year 2 (P = 0.116). EDSS scores improved in 35.4%, remained stable in 28.1%, and worsened in 36.5% of patients. IFNbeta-1a treatment was well tolerated.


CONCLUSIONS
This study confirms and extends the beneficial clinical profile for IFNbeta-1a in relapsing MS.
Fernández
O
O
Department of Neurology, Hospital Regional Universitario Carlos Haya, Málaga, Spain. ofernand@hch.sas.cica.es
Arbizu
T
T
Izquierdo
G
G
Martínez-Yélamos
A
A
Gata
J M
JM
Luque
G
G
de Ramón
E
E
D000293:Adolescent; D000328:Adult; D004185:Disability Evaluation; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007273:Injections, Intramuscular; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy*; D009460:Neurologic Examination / Q000187:drug effects*; D011446:Prospective Studies; D016896:Treatment Outcome
D016899:Interferon-beta; D000068556:Interferon beta-1a