The CARE-MS 2 trial studied MS patients who had received MS treatments in the past and after at least 6 months of therapy they had a relapse.
This trial was positive and in line with previous trials (CARE-MS 2 and CAMMS223) that showed that Alemtuzumab is twice as effective a Rebif.
The annualized relapse rate of the Alemtuzumab arm was 0.26 and in Rebif 0.52 (49% reduction as compared to Rebif -- NOT placebo).
In addition, as opposed to CARE-MS 1
there was also a statistically significant reduction in 6 month disability progression. At two years, 29 percent of patients treated with alemtuzumab had experienced a six-month sustained reduction in disability, meaning their level of disability improved, as compared to only 13 percent with Rebif (p=0.0002).
The mean EDSS score for patients treated with alemtuzumab decreased over a two-year period, indicating an improvement in their physical disability, while the mean score for patients given Rebif increased, indicating a worsening of disability (-0.17 vs. 0.24; p <0.0001).
65 percent of patients treated with alemtuzumab were relapse-free at two years, meaning they did not experience any relapses in the trial, compared to 47 percent with Rebif (47 percent risk reduction; p<0.0001).
So why was the annualized relapse rate in Alemtuzumab similar to newer medications like natalizumab (0.25 from the AFFIRM trial)? Looking at the placebo arm annualized relapse rate of 0.52 is key -- the patients in this trial were sicker than in more recent trips (more akin to the older beta interferon trials but placebo annualized relapse rate of 0.74). So despite this, Alemtuzumab was STILL 49% better than current medications.
Tuesday, April 24, 2012
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