Table 2 MRI and clinical endpoints in the ITT population, East Asian subgroup, Japanese subgroup, and Eastern European subgroup
ITT | East Asian subgroup | Japanese subgroup | Eastern European subgroup | |||||
|---|---|---|---|---|---|---|---|---|
Endpoint, n (%) | Placebo n = 113 | DMFa n = 111 | Placebo n = 72 | DMFa n = 70 | Placebo n = 58 | DMFa n = 56 | Placebo n = 41 | DMFa n = 41 |
Adjusted mean total number of new Gd+ lesions from weeks 12–24 | ||||||||
Mean | 3.3 | 0.5 | 3.2 | 0.6 | 2.7 | 0.4 | 5.1 | 1.8 |
Percentage reduction vs placebo | 84 | 82 | 85 | 87 | ||||
(95% CI) | (73.4–89.9) | (64.7–90.3) | (69.5–92.9) | (71.5–93.7) | ||||
p value | < 0.0001 | < 0.0001 | < 0.0001 | NT | ||||
Adjusted mean total number of new Gd+ lesions from baseline to week 24 | ||||||||
Mean | 4.8 | 1.2 | 4.9 | 1.2 | 4.3 | 0.9 | 7.0 | 4.8 |
Percentage reduction vs placebo | 75 | 76 | 78 | 73 | ||||
(95% CI) | (63.4–83.3) | (60.5–85.6) | (63.1–87.4) | (48.5–85.3) | ||||
p value | < 0.0001 | < 0.0001 | < 0.0001 | NT | ||||
Adjusted mean number of new/newly enlarging T2 hyperintense lesions at week 24 compared vs baseline | ||||||||
Mean | 4.3 | 1.6 | 3.9 | 1.6 | 3.7 | 1.4 | 4.9 | 1.5 |
Percentage reduction vs placebo | 63 | 58 | 63 | 70 | ||||
(95% CI) | (47.5–74.2) | (35.4–73.1) | (40.2–77.4) | (44.1–83.7) | ||||
p value | < 0.0001 | < 0.0001 | < 0.0001 | NT | ||||
ARR at week 24 | ||||||||
Adjusted ARR | 0.65 | 0.45 | 1.01 | 0.53 | 1.17 | 0.60 | 0.20 | 0.39 |
Percentage reduction vs placebo | 31 | 47 | 48 | −100.2 | ||||
(95% CI) | (−10.8, 56.8) | (8.3–69.7) | (7.4–71.2) | (− 525.6–36.0) | ||||
p value | 0.1251 | NT | NT | NT | ||||
Proportion of patients relapsed at week 24 | ||||||||
Estimated proportion relapsed | 0.30 | 0.21 | 0.41 | 0.24 | 0.45 | 0.26 | 0.12 | 0.17 |
Percentage reduction vs placebo | 42 | 53 | 56 | −38.6 | ||||
(95% CI) | (0.7–66.5) | (11.7–75.0) | (13.1–77.4) | (−364.0–58.6) | ||||
p value | 0.0472 | NT | NT | NT | ||||