Monday, 18 July 2011

Alemtuzumab results - further analysis

Re recent comment early relapses: "Despite the latest (Alemtuzumab) results I still hope it will help people who have been diagnosed longer than two years."

"This was not a negative study; Alemtuzumab is still a very promising disease-modifying therapy! The patients in this trial were less active than previously therefore the trial lacked power to detect a difference in relation to disability progression. The other possibility is that the new formulation of Rebif, used in the current trial, is better than the old formulation, which was used in the phase 2 study. There are theoretical reasons why the Rebif New Formulation may be better than the old formulation, which I will go into in another post."

Extracts from the Sanofi/Genzyme press release

"In the CARE-MS I trial, 2 annual cycles of alemtuzumab treatment resulted in a 55 percent reduction in relapse rate compared to Rebif® over the two years of the study (p<0.0001), hence satisfying the first primary endpoint, and therefore meeting the predefined protocol criteria for declaring the study a success. Statistical significance was not achieved for the second primary endpoint, time to six month sustained accumulation of disability, as compared to Rebif®. At the two year time point, 8 percent of alemtuzumab treated patients had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) as compared to 11 percent of those who received Rebif® (Hazard Ratio=0.70, p=0.22). The patients will have the option to be evaluated over the next 3 years as part of a separate protocol."

“The substantial effect of alemtuzumab on reduction of relapse rate over and above that seen with Rebif® confirms our experience gathered over many years and demonstrated in the Phase 2 study,” said Professor Alastair Compston, Chair of the Steering Committee overseeing the conduct of the study, and head of the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom. “We treated patients in CARE-MS I at a very early stage in the course of their illness when the natural history may be relatively quiet, and both groups were remarkably stable over the two years of observation. Very few patients accumulated disability at the rate expected from previous clinical trials, including our Phase 2 experience. Whilst welcome from the clinical perspective, this reduced our ability to detect a significant treatment effect on the disability endpoint."

2 comments:

  1. The problem is that "8 percent of alemtuzumab treated patients had a sustained increase in their Expanded Disability Status Scale (EDSS) score"
    Shows that even in the best case scenario alemtuzumab will not help everybody.

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  2. Re: "8 percent of alemtuzumab treated patients had a sustained increase in their Expanded Disability Status Scale (EDSS) score"

    8% even 11% is well within the measurement error of the EDSS. The EDSS is one of the problems we have with progressive MS; in my opinion it is not fit for purpose.

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