BG-12 reduces evolution of new enhancing lesions to T1-hypointense lesions in patients with multiple sclerosis.
BG-12, an immunomodulatory agent, reduces frequency of new gadolinium-enhancing (Gd+) lesions in relapsing multiple sclerosis (MS). This study reports the effect of 240 mg BG-12 orally three times daily (tid) for 24 weeks on the evolution of new Gd+ lesions to T1-hypointense lesions. Brain magnetic resonance imaging (MRI) scans from patients in placebo and 240 mg BG-12 tid arms of a phase 2b study were examined retrospectively. Included patients had at least one new Gd+ lesion from weeks 4 to 12. Week 24 scans were analyzed for number and proportion of new Gd+ lesions that evolved to T1-hypointense lesions. Eighteen patients receiving BG-12 and 38 patients receiving placebo were included in the analysis. The analysis tracked 147 new Gd+ lesions in patients from the BG-12 group and 221 Gd+ lesions in patients from the placebo group. The percentage of Gd+ lesions that evolved to T1-hypointense lesions was 34% lower with BG-12 treatment versus placebo (29%, BG-12; 44%, placebo; odds ratio 0.51; 95% confidence interval 0.43, 0.61; p < 0.0001). In addition to reducing frequency of new Gd+ lesions, BG-12 significantly reduced probability of their evolution to T1-hypointense lesions in patients with MS compared with placebo.
MacManus
D G
DG
NMR Research Unit, University College London Institute of Neurology, Queen Square, London WCIN 3BG, UK.
Miller
D H
DH
Kappos
L
L
Gold
R
R
Havrdova
E
E
Limmroth
V
V
Polman
C H
CH
Schmierer
K
K
Yousry
T A
TA
Eraksoy
M
M
Meluzinova
E
E
Dufek
M
M
Yang
M
M
O'Neill
G N
GN
Dawson
K
K
D000293:Adolescent; D000328:Adult; D000069462:Dimethyl Fumarate; D004311:Double-Blind Method; D005260:Female; D005650:Fumarates / Q000627:therapeutic use*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000639:trends; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000473:pathology* / Q000517:prevention & control*; D012189:Retrospective Studies; D055815:Young Adult
D005650:Fumarates; D000069462:Dimethyl Fumarate