Table 1.
Summary of alemtuzumab's efficacy from the three commercially sponsored clinical trials
| Variables | Phase 2 CAMMS223 N = 333 | Phase 3 CARE-MS 1 N = 581 | Phase 3 CARE-MS 2 N = 840 |
|---|---|---|---|
| Previous DMT | No | No | Yes |
| Age, year mean (SD) | 32.3 (8.5) | 33.0 (8.2) | 35.1 (8.4) |
| EDSS score mean (SD) | 2.0 (0.7) | 2.0 (0.8) | 2.7 (1.2) |
| Disease duration, year median (range) | 1.3 (0.1–6.3) | 1.7 (0.1–6.0) | 3.7 (0.2–16.9) |
| Relapses in past 2 years mean (range) | 2.3 (1–7) | 2.4 (1–7) | 2.7 (1–9) |
| Pivotal results | 3-year study | 2-year study | |
| Relapse rate reduction | 69%** | 55%*** | 50%*** |
| Annualized relapse rate (alemtuzumab vs. interferon [IFN]) | 0.10 vs. 0.36 | 0.18 vs. 0.39 | 0.26 vs. 0.52 |
| Proportion relapse free | 77% vs. 52%** | 78% vs. 59%*** | 65% vs. 47%*** |
| Sustained disability confirmed at 6 months (%) | 9% vs. 26%** | 8% vs. 11% Nonsignificant | 13% vs. 21%** |
| Change in mean EDSS from baseline | Improvement of 0.39 compared to deterioration of 0.38 on IFN-β-1a** | No significant change | Improvement of 0.17 compared to deterioration of 0.24 on IFN-β-1a*** |
| Reduction in brain atrophy on alemtuzumab vs. IFN | 42% *** | 24% * | |
DMT, Disease-modifying therapy; EDSS, Expanded Disability Status Scale; SD, standard deviation.
*P < 0.05; **P < 0.01; ***P < 0.001.