Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the two-year Phase III REFLEX 1 study met its primary endpoint by demonstrating that Rebif(R) (interferon beta-1a) significantly delayed conversion to multiple sclerosis (MS) diagnosed according to the McDonald criteria 2 in patients with a first clinical event suggestive of the disease.
The international REFLEX study with 517 patients was conducted with the serum-free formulation of Rebif(R) 3, which was first introduced in 2007 and is now available in all European Union countries, Australia, Canada and Switzerland, as well as a number of countries in Asia, Latin America, Africa and the Middle East. The serum-free formulation of Rebif(R) is currently not available in the United States.
The risk of conversion to MS (McDonald criteria) over two years was reduced by 51% (p<0.00001) in patients who received Rebif(R) 44 mcg three times a week compared to placebo. A risk reduction of 31% (p=0.008) compared to placebo was observed in patients who received once-weekly administration of Rebif(R) 44 mcg. The probability of conversion to MS (McDonald criteria) over two years was 86% in the placebo group, 62% in patients who received Rebif(R) 44 mcg three times a week and 76% in patients who received once-weekly administration of Rebif(R) 44 mcg.
More details on this study
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ECTRIMS (European Committee for Treatment and Research In Multiple Sclerosis) hosts the world’s largest conference devoted to basic and clinical research in MS.
This year’s meeting took place in Gothenberg from 13-16 October and featured a wide range of presentations, posters and reports of new and ongoing research.
Below are brief reviews of some of the research reported.
ECTRIMS round up | News | MS Trust – Information, education, research and support
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Talking about Medical News: ECTRIMS: Glatiramer Acetate Beats Interferon for MS Fatigue – in Meeting Coverage, ECTRIMS from MedPage Today
Glatiramer acetate (GA) reduces fatigue in multiple sclerosis patients more than interferon beta-1b (IFN-1b) after 1 year of treatment, according to a new study.
IFN-1b had no impact on two clinical measures of fatigue, while GA (Copaxone) reduced the score on the Fatigue Severity Scale (FSS) by 20%, and the score on the Fatigue Descriptive Scale (FDS) by 34%, according to a study presented here at the European Committee for Treatment and Research in Multiple Sclerosis meeting.
Based on the results, the authors, Tatiana Shmidt and a colleague at the Kozhevnikov Clinic for Neurological Diseases in Moscow, Russia, concluded in their poster, “Copaxone is recommended as a first-line imunomodulating drug for patients with severe fatigue.” The authors were unavailable for comment at press time.
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‘Liberation therapy’ doctor now warning MS patients to wait – The Globe and Mail
According to NeuroSens, a subscription-based news service on neurological matters, Dr. Zamboni told an MS conference in Gothenburg, Sweden, that patients shouldn’t go ahead with such surgery, except in the case of clinical trials.
“Surgery is not recommended at this stage,” he said, during a presentation this week to the Congress of the European Committee for Treatment and Research in MS.
He also said he does not support “medical tourism” – the practice of some patients who travel overseas to clinics that will perform the surgery. Thousands of people are believed to have done this.
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Medical News: ECTRIMS: New MRI Criteria Have High Efficiency in MS – in Meeting Coverage, ECTRIMS from MedPage Today
New criteria for diagnosing multiple sclerosis with a single MRI have a sensitivity of up to 86% and a specificity of up to 75%, researchers said here.
Their study is one of the first by an independent group to test the criteria developed by MAGNIMS (Magnetic Imaging in Multiple Sclerosis), a consortium of European academic researchers.
“The goal of the new criteria is to save time, to allow treatment to be started earlier,” Mayra Gomez-Moreno, MD, of the Infanta Leonor Hospital in Madrid, Spain, told attendees at the European Committee for Treatment and Research in Multiple Sclerosis meeting
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MS-Leaders.org is an online educational resource for MS treating clinicians designed to provide cutting edge information and resources to help support patient care. MS-Leaders.org provides a variety of engaging and clinically relevant educational platforms to deliver a breadth of content to meet the needs of busy clinicians…
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MS patients with a different message – The Globe and Mail
Some people who receive liberation therapy describe results so insignificant that it almost sounds like wishful thinking. I spoke with a woman who, after heavy pressure from her family, went on the same trip to India. Now, she says, she can shake hands again. “The improvements have been small, but for me they’ve been huge.” She expects the improvements to continue, and she’s frustrated that governments have been so slow to act.
A lot of outfits are marketing hope these days. New “liberation” clinics are opening around the globe – in Mexico, Costa Rica, Poland, Bulgaria – and you can get quotes for travel packages on request. Mr. Oakey regularly gets Facebook ads that say, “Costa Rica now taking 75 patients a month!”
Both men expect they’ll get a bunch of hate mail for speaking out. But they worry about the devastation that can result from false hope, and the money being made from feeding it. Mark Pickup is confident that a real cure will come one day, though not in time for him. Meantime, he says, “we shouldn’t make decisions based on who’s yelling the loudest.”
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Edmonton scientists’ ID new gene in MS fight
Marek Michalak and Allison Kraus, scientists from the University of Alberta’s faculty of medicine and dentistry, were lead investigators on an international research team which identified a gene that plays a key role in the normal function of nerve cells and their ability to relay messages in the body. They discovered that shutting off an important gene causes mobility issues much like those seen in MS patients. The finding helps in the understanding of complex neurological diseases such as MS and Charcot Marie Tooth, both of which involve something called myelin impairment. Myelin is the protective coating around neurons which allow messages to travel quickly within the nervous system.
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CBC News – Health – J.K. Rowling donates $16M for MS research
Author J.K. Rowling has donated the equivalent of $16.4 million Cdn to help set up a centre to research multiple sclerosis, the disease that led to the death of her mother.
The creator of boy wizard Harry Potter said Tuesday that the Anne Rowling Regenerative Neurology Clinic, named after her mother, will be based at the University of Edinburgh in Scotland. It will also study other degenerative neurological conditions, including Alzheimer’s and Parkinson’s. Harry Potter author J.K. Rowling, seen in 2008, says she ‘cannot think of anything more important, or of more lasting value, than to help the university attract world-class minds in the field of neuroregeneration.’ (Louis Lanzano/Associated Press)Rowling said she hopes the clinic will become “a world centre for excellence in the field of regenerative neurology.”
The university said Rowling’s gift is the largest single donation it has received.
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MS activity may vary with seasons – The Chart – CNN.com Blogs
In the spring and summer months, some people with multiple sclerosis are at a two to three times greater risk for disease activity, according to research published Monday in the journal Neurology, the medical journal of the American Academy of Neurology.
The study, led by Dominik Meier, Ph.D. of Brigham and Women’s Hospital, examined MRI screenings and other data taken from 1991 to 1993. This was before the availability of current traditional therapies to modify the course of the disease. 44 people aged 25 to 52 living in Boston participated in the study. They had MRIs weekly to monthly over the course of a year. The researchers also included weather information in their study. MRIs are the primary tools used to monitor the disease progress, as they show the scarring, also called lesions.
“Not only were more lesions found during the spring and summer seasons, our study also found that warmer temperatures and solar radiation were linked to disease activity,” said Meier.
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