Table 2.

Efficacy results of BG-12 in DEFINE⁸⁴,⁸⁵ and CONFIRM⁸⁶ Phase III studies

BG-12 phase III trials
At 2 years	BG-12 240 mg twice daily vs placebo		BG-12 240 mg three times daily vs placebo
Clinical outcome measure	Change	Significance	Change	Significance
DEFINE study
Relapse risk	−49%	P < 0.0001	−50%	P < 0.0001
ARR	−53%	P < 0.001	−48%	P < 0.001
Risk of confirmed disability progression	−38%	P < 0.05	−34%	P < 0.05
MRI outcome measure
Risk of new or newly enlarging T2 lesion	−85%	P < 0.0001	−74%	P < 0.0001
Patients free of new or newly enlarging T2 lesions (placebo 25%)	45%	ns	41%	ns
Odds of increased Gd-enhancing lesion activity	−90%	P < 0.0001	−73%	P < 0.0001
Patients free of Gd-enhancing lesion (placebo 62%)	93%		86%
New T1-hypointense lesions	−73%	P < 0.0001	−63%	P < 0.0001
QoL outcome measure
SF-36		P < 0.001		P < 0.0001
VAS		P = 0.003		P < 0.0001
CONFIRM study
ARR	−44%	P < 0.0001	−51%	P < 0.0001
Proportion of patients experiencing MS relapses	−34%	P < 0.003	−45%	P < 0.0001
Confirmed disability progression*	−21%	ns	−24%	ns
MRI outcome measure
Risk of new or newly enlarging T2 lesion	−71%	P < 0.0001	−73%	P < 0.0001
New T1-hypointense lesions	−57%	P < 0.0001	−65%	P < 0.0001

Note:

^*At 24 weeks.