Table 2.

Summary of efficacy outcomes of the Japanese patients enrolled in APEX.

Part I	Placebo(n = 58)	DMF(n = 56)	Reduction rate, % (95% CI)
Mean number of new Gd+ lesionsa
Weeks 12–24	2.7	0.4	85.3 (69.5, 92.9)
Weeks 0–24	4.3	0.9	78.4 (63.1, 87.4)
Adjusted mean number of new or newly enlarging T2 hyperintense lesions at Week 24b	3.7	1.4	63.2 (40.2, 77.4)c
Adjusted mean number of new T1 hypointense lesions
Weeks 0–24	1.6b	1.3b	19.0 (–47.9, 55.6)c
Adjusted ARRd	1.17	0.60	48.4 (7.4, 71.2)c
Proportion of patients with relapse at Week 24, %	45.1	26.2	55.7 (13.1, 77.4)c
	Placebo/DMF (n = 53)		DMF/DMF (n = 53)
Part II	Weeks 24	Week 48	Week 24	Week 48
Mean (SD) number of Gd+ lesionse	0.7 (1.2)	0.1 (0.3)	0.2 (0.6)	0.3 (1.1)
Mean (SD) number of new or newly enlarging T2 hyperintense lesionse	3.9 (4.5)	1.3 (2.6)	1.7 (3.0)	0.9 (2.5)
Mean (SD) number of new T1 hypointense lesionse	2.0 (3.3)	1.0 (1.8)	1.3 (2.2)	0.3 (0.8)
	Week 0–24	Week 24–72	Week 0–24	Week 24–72
ARR	1.2	0.41	0.60	0.35
Proportion of patients relapsed through Week 72, %	52.7		43.5

^aAdjusted for baseline number of Gd+ lesions.

^bAdjusted for baseline volume of T2 lesions.

^cThe value at Week 24 was adapted from Part I population.

^dAdjusted for baseline EDSS (≤2.0 vs >2.0), baseline age (<40 vs ≥40), and number of relapses in the 1 year prior to study entry.

^en=44 in placebo/DMF and n=49 in DMF/DMF.

ARR, annualized relapse rate; CI, confidence interval; EDSS, Expanded Disability Status Scale; Gd+, gadolinium-enhancing.