Table 3.
Efficacy outcomes of patients enrolled in the CARE-MS-1 and CARE-MS-2 trials
| CARE-MS-1 (alemtuzumab as first-line treatment)16
|
CARE-MS-2 (alemtuzumab after failure of disease-modifying therapy)17
|
|||||
|---|---|---|---|---|---|---|
| IFN beta-1a (n=187) | Alemtuzumab 12 mg (n=376) | P | IFN beta-1a (n=202) | Alemtuzumab 12 mg (n=426) | P | |
| Relapses | ||||||
| Patients with relapse | 75 (40%) | 82 (22%) | 104 (53%) | 147 (35%) | ||
| Rate ratio (95% CI) | 0.45 (0.320.63) | <0.0001 | 0.51 (0.39–0.65) | <0.0001 | ||
| Risk reduction | 55% | 49% | ||||
| Yearly relapse rate (95% CI) | 0.39 (0.29–0.53) | 0.18 (0.13–0.23) | 0.52 (0.41–0.66) | 0.26 (0.21–0.33) | ||
| Relapse-free patients (95% CI) | 58.7% (51.1%–65.5%) | 77.6% (72.9%–81.6%) | <0.0001 | 46.7% (39.5%–53.5%) | 65.4% (60.7%–69.7%) | <0.0001 |
| Disability | ||||||
| Patients with sustained accumulationa | 20 (11%) | 30 (8%) | 40 (20%) | 54 (13%) | ||
| Percentage of patients (95% CI)b | 11.1% (7.3%–16.7%) | 8.0% (5.7%–11.2%) | 0.22 | 21.1% (16.0–27.7) | 12.7% (9.9%–16.3%) | |
| Hazard ratio (95% CI) | 0.70 (0.40–1.23) | 0.58 (0.38–0.87) | ||||
| Risk reduction | 30% | 42% | 0.0084 | |||
| Mean change in EDSS from baseline (95% CI) | −0.14 (−0.29–0.01) | −0.14 (−0.25–0.02) | 0.97 | 0.24 (0.07–0.41) | −0.17 (−0.29 to −0.05) | <0.0001 |
| Mean change in MSFC from baseline | 0.07 | 0.15 | 0.01 | −0.04 | 0.08 | 0.002 |
| MRI | ||||||
| Patients with new or enlarging T2-hyperintense lesions | 99/172 (58%) | 176/363 (48%) | 0.04 | 127/187 (68%) | 186/403 (46%) | <0.0001 |
| Patients with Gd-enhancing lesions at 24 months | 34/178 (19%) | 26/366 (7%) | <0.0001 | 44/190 (23%) | 38/410 (9%) | <0.0001 |
Notes:
a
Confirmed over 6 months
Abbreviations: CI, confidence interval; EDSS, expanded disability status scale; Gd, gadolinium; IFN, interferon; MRI, magnetic resonance imaging; MSFC, multiple sclerosis functional composite; P, P-value; CARE-MS, Comparison of Alemtuzumab and Rebif® efficacy in Multiple Sclerosis.