October 26, 2008
Alemtuzumab Stops Multiple Sclerosis?
We might be looking at a cure for a major auto-immune disorder and the treatment might eventually work for other auto-immune diseases. Monoclonal antibody drug Alemtuzumab prevents M.S. recurrence in a substantial portion of patients.
A drug which was developed in Cambridge and initially designed to treat a form of leukaemia has also proven effective against combating the debilitating neurological disease multiple sclerosis (MS).
The study, led by researchers from the University of Cambridge, has found that alemtuzumab not only stops MS from advancing in patients with early stage active relapsing-remitting multiple sclerosis (RRMS) but may also restore lost function caused by the disease. The findings were published today in the New England Journal of Medicine.
Alemtuzumab has a long connection with Cambridge, England. In 1984, Cambridge scientist Cesar Milstein was awarded the Nobel Prize for Physiology or Medicine, jointly with George Kohler, for inventing the technology to make large quantities of a desired type of monoclonal antibody. Further work in Cambridge, by Herman Waldmann and Greg Winter, led to the production of the first humanised monoclonal antibody for use as a medicine, Campath-1H, now known as alemtuzumab. It has been licensed for the treatment of chronic lymphocytic leukaemia, and has also been tested in several diseases where the immune system is overactive, such as multiple sclerosis.
The new study, which was funded by Genzyme and Bayer Schering Pharma AG, Germany , found that alemtuzumab reduces the number of attacks experienced by people with relapsing-remitting multiple sclerosis by 74 per cent over and above that achieved with interferon beta-1a, one of the most effective licensed therapies for similar cases of MS. More importantly, alemtuzumab also reduced the risk of sustained accumulation of disability by 71 per cent compared to interferon beta-1a.
Additionally, the investigators showed that many individuals in the trial who received alemtuzumab recovered some of their lost functions and so were less disabled after three years than at the beginning of the study, in contrast to worsening disability in the interferon beta-1a treated patients. These findings suggest that alemtuzumab may allow damaged brain tissue to repair, enabling the recovery of neurologic functions lost following poor recovery from previous MS attacks.
One patient died from a complication (idiopathic thrombocytopenic purpura (ITP)) of the treatment. But now that the complication is known the hope is that it can be recognized sooner and better managed.
The drug works by wiping out lymphocytes. This has to cause problems with greater risk from infectious diseases. It is a rather broad wiping out since the drug doesn't have specificity for just those immune cells that are attacking the brain.
The treatment works by destroying all the patients' lymphocytes, the T-and B-cells that normally fight infections, but which mistakenly attack nerves and brain tissue in MS patients.
Following the treatment, the immune system grows back, but without the cells that cause MS. "It's as though you've re-booted the immune system, so it's better behaved," Coles says.
The whole process takes about three to four years, adds Coles, who is hopeful that the drug might also be able to help patients with other auto-immune diseases such as diabetes and lupus.
The Phase III trial for this therapy is currently recruiting patients.
A more ideal auto-immune disease treatment would target only those immune cells attacking the body. But that's a much harder problem to solve than the problem of wiping out all T and B cells.
How is this drug superior to natalizumab?
Natalizumab doesn't go as far as to "reboot" the immune system. While it can prevent some relapses, it's not the same thing that happens with Alemtuzumab. Natalizumab also doesn't promote remyelination, and therefore does not help recover lost function.
Did the study include Chronic Progessive MS patients and what results did they find for those sufferers?
David Harried, No, I think the patients all had only one episode or very few. They were early stage.
I have RRMS and live in Abha, Saudi Arabia. How can I participate in this trial? And when the medicine will be available to the patients?
I'm in southern texas, are there any case studies happening here? let me know ok?
Hi, I have Systemic sclerosis with Pulmonary fibrosis and wonder if the Phase III trial would consider someone with my problems? I live in the UK. Where are the trials being held?
Hi I live in South Africa , Johannesburg, I have RRMS. How can I participate in this trial? And when the medicine will be available to the patients?
Hi! I am from Bosnia and Herzegovina. My mother has a progressive MS, but she would also like to know something more about this medicine. When will this medicine be available to the patients? Is there a possibility to participate in this test program? Please, keep me up-to-dated about new information about this medicine. Thank you!
Hello, I live in Toronto Canada and have late onset PPMS. Symptoms began around 10 years ago (about age 45) and I have progressed slowly but consistently to the point that I can barely walk (badly), I have very little bladder control, chronic pain, no libido, extreme heat and cold sensitivity and other symptoms. I have had no remissions in spite of trying several alternative treatments I continue to get slowly worse. Regardless, I am in good shape, good health and good spirits. Just the same, it would be great to stop this. Does this therapy offer hope for PPMS patients?
I live in Girard, Kansas and have PPMS. I've had PPMS for around 10 years, but was finally diagnosed 5 years ago by a wonderful neurologist Waquar Waheed. I'm like Brian Light, I can see a slow decline in my mobility and balance. I still work and am a sales manager, which makes me travel occasionally. I'm desparate to keep walking and functioning for my lively hood. I, like Brian, am anxious to stop the progression while I can.
I'm near Kansas City, Joplin, MO, or even St Louis. Is there any possibilites for me to be in the trial?
I am currently in the Alemtuzumab Phase III trial. I was diagnosed in 2007 after my first identifiable relapse and had several more relapses in quick succession. Prior to starting the trial I had not received any other drugs to treat my MS. I have had my second annual treatment with Alemtuzumab. Since I began the treatment I have not had a relapse. There are some potential side effects to the treatment (Thyroid and ITP) but for me personally, I made the decision that the side effects were treatable and manageable if I am diligent about my health and that the benefits outweighed the risks. I go in once a month for blood test to monitor for ITP. It is a bit of a nuisance, but to be honest it only takes 5 minutes for the blood draw - I don't have to do weekly shots, take any pills or a monthly infusion that takes hours (5 minutes a month is really a small price to pay). Every three months they take a little more blood, 6 to 8 vials, and test for thyroid function and other blood levels. Since I began the treatment I have not had a relapse and to my knowledge it has been just as successful for others in the study. They are still recruiting for two of the trials. You can go to the Genzyme website to find out more details about the requirements for the trials and study locations.
I am not part of the trial but because I live in Cardiff where they are doing the trials I have been allowed to take part because my RRMS was getting aggressive. I've now had 2 doses of Alemtuzumab and I think it's a fantastic drug. I haven't had any relapses for almost 2 years now and I hope that they license it soon for use in MS. I was offered a choice of Alemtuzumab or Beta Interferon and as far as I'm concerned I definitely made the right choice. It's meant that I've been able to enjoy life relapse free with my 2 young children while they're still young. Whatever happens in the future with my MS I've had these 2 precious years with them and I'm so grateful for that.
you can get this medcine from Cambridge, Adenbrookes hospital...
I have just had my first dose of Alemtuzumab. I live in Devon, UK, where some of the original pioneers of this treatment for MS, have relocated. I am 50 years old - I had very minor MS symptoms 26 years ago!....tingling in hands, deadness weird feelings in legs. When it stopped, I assumed there had been a big mistake? I then lived in the Caribbean & Florida. I returned to the UK 2 years ago. One year after my return....9 months ago, wham!
After a 24 year remission, it came back ... and with a vengeance!
I have increasingly worsening walking, balance, hypersensitivity & hyperactivity of limbs. They can't decide yet if it is still RR or maybe now , is it PP or CP?? Anyway MRI's do show activity, but 2 shots of steroids did nothing, and I have not had any remission yet, 9 months on??
My doctor thought the Alemtuzumab would be a great option. I am now 6 weeks on, and so far I continue to deteriorate slowly??? I am very positive though, and still hope for some of the good results of others? Just keep positive, but it may not be a fix-all for everyone?? Fingers crossed!!
You might have taken a turn for the worse on return to England due to less sun exposure and therefore less vitamin D. Low vitamin D is a risk factor for MS and vitamin D helps regulate the immune system.
Thanks for your thoughts Randall. I did think of that, and have taken vitamin D since my return to MS - doesn't seem to have had any impact.....