Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
BACKGROUND
In the Betaseron/Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study, interferon beta-1b delayed conversion to multiple sclerosis in patients with a first clinical event and at least 2 clinically silent brain magnetic resonance imaging (MRI) lesions.


OBJECTIVE
To examine detailed MRI findings from the first 2 years of this trial.


METHODS
Double-blind, placebo-controlled, randomized, parallel-group, multicenter, phase 3 study.


METHODS
Ninety-eight centers worldwide.


METHODS
A total of 404 individuals with a first demyelinating event suggestive of multiple sclerosis.


METHODS
Patients were randomized to receive interferon beta-1b, 250 microg subcutaneously every other day, or placebo. After 24 months of treatment or on conversion to clinically definite multiple sclerosis, open-label interferon beta-1b treatment was offered.


METHODS
Reported MRI data from patients completing 2 years of follow-up.


RESULTS
Data were analyzed from 248 patients taking interferon beta-1b and 156 taking placebo. Across 2 years the cumulative number of newly active lesions was lower in patients receiving interferon beta-1b vs placebo (median, 2.0 vs 5.0 [reduction of 60%]; P < .001). This corresponded to lower cumulative numbers of new T2 lesions (median, 1.0 vs 3.0 [reduction of 66%]; P < .001) and new gadolinium-enhancing lesions (median, 0.0 vs 1.0; P < .001) in patients receiving interferon beta-1b vs placebo. From screening to month 24, T2 lesion volume decreased and was more pronounced in patients receiving interferon beta-1b (P = .02).


CONCLUSIONS
Interferon beta-1b treatment had a robust effect on MRI measures, supporting its value as an early intervention in this patient group. This effect was maintained despite including patients who switched from placebo to interferon beta-1b in the active treatment group. Trial Registration clinicaltrials.gov Identifier: NCT00185211.
Barkhof
Frederik
F
Department of Diagnostic Radiology and Image Analysis Center, Vrije Universiteit Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands. f.barkhof@vumc.nl
Polman
Chris H
CH
Radue
Ernst-Wilhelm
EW
Kappos
Ludwig
L
Freedman
Mark S
MS
Edan
Gilles
G
Hartung
Hans-Peter
HP
Miller
David H
DH
Montalbán
Xavier
X
Poppe
Peter
P
de Vos
Marlieke
M
Lasri
Fatiha
F
Bauer
Lars
L
Dahms
Susanne
S
Wagner
Klaus
K
Pohl
Christoph
C
Sandbrink
Rupert
R
D000293:Adolescent; D000328:Adult; D003287:Contrast Media; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005682:Gadolinium; D006801:Humans; D007279:Injections, Subcutaneous; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*
D003287:Contrast Media; D000068576:Interferon beta-1b; D016899:Interferon-beta; D005682:Gadolinium