Second successful phase III Results for Alemtuzumab in MS

In the CARE MS II randomized trial involving 840 patients, a 49% reduction in relapse rate was observed in patients treated with alemtuzumab 12 mg compared to interferon beta-1a over two years of study (p<0.0001). There was also a 42% reduction in the risk of sustained accumulation (worsening) of disability as measured by the Expanded Disability Status Scale (EDSS) (p=0.0084). Analysis of the full CARE-MS II data is ongoing and results will be presented at a forthcoming scientific meeting.

“Alemtuzumab is the most effective DMT in late stage development. The first MS’er was treated with the drug in 1991 by Prof. Alastair Compston in Cambridge; if or when Alemtuzumab becomes available in the UK it will have taken over 20 years. The ‘if’ and ‘over 20 years’ is the depressing part of this story. ‘If’ as we have no idea how the EMA and NICE will deal with Alemtuzumab and ’20 years’ as that is what it takes to develop a drug for MS; although this is a bit longer than usual.”

Source: Genzyme press release

CoI: multiple

3 thoughts on “Second successful phase III Results for Alemtuzumab in MS”

  1. Prof G,I'm confused. I had this treatment (first infusion) 5 years ago and remain relapse free. I'm in contact with two others and they report the same. The phase II reported a c.70 per cent reduction in relapse rate compared with Rebif, Care MS 1 reported 55 per cent and Care MS 2 reports 49 per cent. A lecture by Prof C c.5 years ago hinted that Campath virtually shut down relapses (90 per cent reduction). I understand that Rebif reduces relapses by around 30 per cent – if Campath is 49 per cent better than Rebif it suggests that it reduces relapses by 45 per cent (50 per cent better than 30 per cent). Is it me or are the numbers all over the place? For me it's been brilliant.

  2. Based on the early phase II relapses were reduced 70% more than beta interferon which has a 30% inhibition rate so compared to nothing, this would equate to a 80-90% inhibition. This perhaps accounts for prof C's comments However, The Phase III studies contained people with less aggressive disease and the level of activity wasn't as great as in the earlier studies. This was dissappointing for the marketing folk, but it shows the importance of controlled clinical trials as the response rates do vary from study to study.Whilst the numbers are abit all over the place, the important point is that the drug is very active and it is great that it works for you.

  3. Have there been any results published as to what has happened to those who were treated in the 1990's. I know it is a small group, but have they had any relapses or progressed. It would be interesting to know.

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