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Final results from phase II Campath Trial
15 Oct 2007
Alemtuzumab (Campath-1H) is more effective than beta interferon, but has side-effects which have to be carefully managed.
Results from a phase II clinical trial show that alemtuzumab is much more effective than interferon-beta, but it also has significant side-effects. A total of 334 people with multiple sclerosis received either beta interferon (Rebif®) or alemtuzumab and were followed for three years. The relapse rate of those taking alemtuzumab was reduced by at least 74 per cent compared to those on interferon-beta. More importantly, the chance of accumulating disability over three years was reduced by at least 70 per cent for those taking alemtuzumab compared to being on beta interferon.
The main concern about alemtuzumab treatment from this trial was a 3 per cent risk of “immune thrombocytopenia”. One or two years after alemtuzumab treatment, people can develop this autoimmune disorder causing bleeding or bruising. In one tragic case, this proved fatal. This is a treatable condition, provided it is spotted early.
With these encouraging results, two phase 3 trials have been started in the UK, Europe, Australia, North and Latin America. These again compare alemtuzumab with interferon-beta treatment, either in patients who have received no treatment (CARE-MS1) or those who have had a relapse whilst on licensed therapies (CARE-MS2).
Although alemtuzumab has been used as an experimental treatment of multiple sclerosis since 1991, it took many years before its various commercial owners decided to set up a proper clinical trial. That finally happened in 2002 when Ilex (now taken over by Genzyme) organised the “CAMMS223” trial. And now its final results have just been made public, at the 2007 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting.
More information about these trials is available at www.ClinicalTrials.gov
More information about alemtuzumab is available at Campath-1H Phase II Clinical Trial
The main concern about alemtuzumab treatment from this trial was a 3 per cent risk of “immune thrombocytopenia”. One or two years after alemtuzumab treatment, people can develop this autoimmune disorder causing bleeding or bruising. In one tragic case, this proved fatal. This is a treatable condition, provided it is spotted early.
With these encouraging results, two phase 3 trials have been started in the UK, Europe, Australia, North and Latin America. These again compare alemtuzumab with interferon-beta treatment, either in patients who have received no treatment (CARE-MS1) or those who have had a relapse whilst on licensed therapies (CARE-MS2).
Although alemtuzumab has been used as an experimental treatment of multiple sclerosis since 1991, it took many years before its various commercial owners decided to set up a proper clinical trial. That finally happened in 2002 when Ilex (now taken over by Genzyme) organised the “CAMMS223” trial. And now its final results have just been made public, at the 2007 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting.
More information about these trials is available at www.ClinicalTrials.gov
More information about alemtuzumab is available at Campath-1H Phase II Clinical Trial
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