Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study.
BACKGROUND
Interferon beta reduces activity in multiple sclerosis as measured clinically and by magnetic resonance imaging (MRI). We assessed the effect of interferon beta-1a on the occurrence of relapses in patients after first presentation with neurological events, who are at high risk of conversion to clinically definite multiple sclerosis.


METHODS
Eligible patients had had a first episode of neurological dysfunction suggesting multiple sclerosis within the previous 3 months and had strongly suggestive brain MRI findings. Patients were randomly assigned interferon beta-1a 22 microg or placebo subcutaneously once weekly for 2 years. Neurological and clinical assessments were done every 6 months and brain MRI every 12 months. Analyses excluded one patient assigned placebo who received no study injections.


RESULTS
241 (78%) of 308 randomised patients received study treatment for 2 years; 278 (90%) remained in the study until termination. 57 (85%) of 67 who stopped therapy did so after conversion to clinically definite multiple sclerosis. Fewer patients developed clinically definite multiple sclerosis in the interferon group than in the placebo group (52/154 [34%] vs 69/154 [45%]; p=0.047). The time at which 30% of patients had converted to clinically definite multiple sclerosis was 569 days in the interferon group and 252 in the placebo group (p=0.034). The annual relapse rates were 0.33 and 0.43 (p=0.045). The number of new T2-weighted MRI lesions and the increase in lesion burden were significantly lower with active treatment.


CONCLUSIONS
Interferon beta-1a treatment at an early stage of multiple sclerosis had significant positive effects on clinical and MRI outcomes.
Comi
G
G
Multiple Sclerosis Centre, Department of Neuroscience, IRCCS Ospedale S Raffaele, via Olgettina 60, 20132, Milan, Italy. g.comi@hsr.it
Filippi
M
M
Barkhof
F
F
Durelli
L
L
Edan
G
G
Fernández
O
O
Hartung
H
H
Seeldrayers
P
P
Sørensen
P S
PS
Rovaris
M
M
Martinelli
V
V
Hommes
O R
OR
D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D016899:Interferon-beta / Q000008:administration & dosage*; D016015:Logistic Models; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D009103:Multiple Sclerosis / Q000175:diagnosis* / Q000188:drug therapy*; D015999:Multivariate Analysis; D010808:Physical Examination; D012008:Recurrence; D012016:Reference Values; D012720:Severity of Illness Index; D016896:Treatment Outcome
D016899:Interferon-beta