| |
CAMMS223 Primary analysis [29] |
CAMMS223 Extension study [37] |
CARE-MS I [30] |
CARE-MS II [31] |
| Study design |
Randomized (1:1:1 alemtuzumab 12 mg IV vs alemtuzumab 24 mg IV vs SC IFNB-1a 44 μg), parallel-arm, rater-blinded, multicenter |
Randomized (2:1 alemtuzumab 12 mg IV vs SC IFNB-1a 44 μg), parallel-arm, rater-blinded, multicenter |
Randomized (2:1 alemtuzumab 12 mg IV vs SC IFNB-1a 44 μg), parallel-arm, rater-blinded, multicenter |
| Study type |
Phase II |
Phase III |
Phase III |
| Study duration, yrs |
3 |
5 |
2 |
2 |
| Patient population |
Active RRMS; treatment-naïve; EDSS ≤ 3; onset ≤ 3 yrs |
Active RRMS; treatment-naïve; EDSS ≤ 3; onset ≤ 5 yrs |
Active RRMS; relapsing on prior therapy; EDSS ≤ 5; onset ≤ 10 yrs |
| Co-primary endpoint results |
SC IFNB-1a (n=111) |
Alemtuzumab 12 mg (n=112) |
SC IFNB-1a (n=111) |
Alemtuzumab 12 mg (n=112) |
SC IFNB-1a (n=187) |
Alemtuzumab 12 mg (n=376) |
SC IFNB-1a (n=202) |
Alemtuzumab 12 mg (n=426) |
| ARR Relative reduction vs SC IFNB-1a |
0.36 |
0.11 69% (p<0.0001) |
0.35 |
0.12 66% (p<0.0001) |
0.39 |
0.18 55% (p<0.0001) |
0.52 |
0.26 49% (p<0.0001) |
| Patients with SAD, % Relative reduction vs SC IFNB-1a |
24 |
8 75% (p<0.001) |
30 |
13 69% (p=0.0005) |
11 |
8 NS |
21.1 |
12.7 42% (p=0.0084) |
| Additional clinical efficacy outcomes |
| Proportion of relapse-free patients, % |
52 |
77 |
41 |
68 |
59 |
78 (p<0.0001) |
47 |
65 (p<0.0001) |
| EDSS score change from baseline |
|
|
|
|
No significant treatment difference |
|
0.24 |
-0.17 (p<0.0001) |
| Proportion of patients with SRD, % |
NA |
NA |
NA |
NA |
25 |
23 (HR=0.87) (p=NS) |
13 |
29 (HR=2.57) (p=0.0002) |
| MSFC score change from baseline |
NA |
NA |
NA |
NA |
0.03 |
0.11 (p=0.011) |
-0.04 |
0.08 (p=0.0022) |
ARR: Annualized relapse rate; EDSS: Expanded Disability Status Scale; HR: Hazard ratio; IFNB: Interferon beta; IV: Intravenous; MSFC: MS Functional Composite; NA:
Not available; NS: Nonsignificant; RRMS: Relapsing-remitting MS; SAD: Sustained accumulation of disability; SC: Subcutaneous; SRD: Sustained reduction in disability