These are the “headline results” from the three sponsored clinical trial results.
Unlike any other drug development plan in multiple sclerosis, the trials of alemtuzumab :
- have all been compared against an active drug, Rebif (interferon beta-1a)
- have all shown a positive effect on clinical and MRI endpoints
Phase 2 trial: CAMMS223
This trial lasted three years for each of the 334 participants, who had not had any previous treatment and were randomised to receive alemtuzumab at one of two doses (12 or 24mg/day) or Rebif.
- Alemtzumab reduced relapse rate by 74% compared to Rebif.•
- lemtuzumab reduced the risk of 6-month sustained disability by 71%
- 23% alemtuzumab patients developed thyroid disease
- 3% alemtuzumab patients developed immune thrombocytopenia (one died)
(Reported in 2008 in the New England Journal of Medicine)
Phase 3 trial: CARE-MS1
This trial lasted two years for each of the 581 participants, who had not had any previous treatment, and were randomised to receive alemtuzumab at 12 mg/day or Rebif.
- Alemtzumab reduced relapse rate by 55% compared to Rebif.
- Alemtuzumab did no reducethe risk of 6-month sustained disability
- 18% alemtuzumab patients developed thyroid disease
- 1% alemtuzumab patients developed immune thrombocytopenia
(Reported in 2012 in the Lancet)
Phase 3 trial: CARE-MS2
This trial lasted two years for each of the 840 participants, who had already had a relapse on previous treatment, and were randomised to receive alemtuzumab at 12 mg/day, 24mg/day or Rebif.
- Alemtzumab reduced relapse rate by 49% compared to Rebif.
- Alemtuzumab reduced the risk of 6-month sustained disability by 42%
- 17% alemtuzumab patients developed thyroid disease
- 1% alemtuzumab patients developed immune thrombocytopenia
(Reported in 2012 in the Lancet)