For this first edition of eMS News, Dr. Timothy Vollmer, the medical director of the Rocky Mountain MS Center, shared breaking news on two recently completed drug trials in MS studying Alemtuzumab and Cladribine.
Alemtuzumab, which is already an approved leukemia treatment, produced exciting results in a study involving patients with relapsing-remitting MS. In the Phase II trial, Alemtuzumab cut the rate of relapse by 74% in study participants compared with patients treated with Rebif, an interferon. Additionally, the therapy differs from others in that it is only infused during one week a year - five days the first year and three days the second.
Despite the promising results, Dr. Vollmer said there are some safety issues that need to be further investigated. Side effects included certain autoimmune diseases, such as thyroid disorders - seen in 25% of study participants - and a rare blood-clotting disease called ITP.
A second study of an oral drug called Cladribine, a type of chemotherapy, also demonstrated significant reduction in relapse rates - of more than 50% in those who took Cladribine compared to patients who took placebo - in relapsing-remitting MS. The study included three groups: two Cladribine - one low dose and the other a higher dose - and a placebo. Participants who took Cladibine did so between 8 and 20 days a year during the two-year study. The lower 8-day dose resulted in reduction rates in relapse of 58% which equaled the effect of the higher dose. Cladribine benefited study participants in other ways as well.
Due to the fact that Cladribine is a chemotherapy treatment, Dr. Vollmer said it suppresses the immune system. This effect can increase the risk of complications such as certain kinds of infections and toxic effects on the organs. Despite this, the safety profile was reported as acceptable.
Anyone interested in participating in ongoing clinical trials involving Alemtuzumab or Cladribine can call the Rocky Mountain MS Center at Anschutz Campus Clinical Trials line at (303) 724-4177.
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4 comments:
I recently experienced a very bad exacerbation that resulted in me being hospitalized for 2 weeks. I was advised that my RRMS has progressed and I'm in need of a more aggressive medication. It was recommended that I begin Tysabri after being on Betaseron for a year. Later, I was also given the option by another Neuro to particpate in the Phase III trial for Alemtuzumab. At this point, I don't know what to do or what would be the best decision for me to make. I've researched both and I'm torn. I'm posting this because I'm open to hear suggestions from others.
I would advise for yout o get started on the Tysabri. A medication that we hear, works...
As for the Alemtuzumab, this is still in study, so who is to say it will work.??
Let me know in which direction you decide to turn.
All My Best,
Stuart
Thank you for your reply. I was informed of really good results of this medication. In fact I was advised that this medication is even better than Tysabri in that it reduces relapse by 75% and it rebuilds the immune system. However, I understand what you are saying by the medication still being in clinical trial. I will definitely inform you once I make a decision.
If the alemtuzumad is a double-blind placebo controlled study, you may not be the patient who receives the "real thing." Isn't it better to get something rather than gamble?
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