New News from MSF

In this post: How cool would it be if MS could be diagnosed just by exhaling, BG-12 is showing progress, and odd hours may be a increase the risk of MS in teens, and should we be discussing walking problems with our doctors more?

The following is from my most recent email from the Multiple Sclerosis Foundation.

Diagnosing MS from Exhaled Breath

Scientists are reporting the development and successful tests in humans of a sensor array that can diagnose MS from exhaled breath, an advance that they describe as a landmark in the long search for a fast, inexpensive, and noninvasive test for MS. Their report appears in the journal ACS Chemical Neuroscience.

Hossam Haick and colleagues report have identified volatile organic compounds that can be associated with MS from exhaled breath. Based on these findings, the researchers developed a new sensor array that can diagnose MS by analyzing the determined chemical compounds that appear in the breath of people with MS. Using the developed sensors, the researchers carried out a proof-of-concept clinical study on 34 people with MS and 17 healthy volunteers and found that the developed sensors are just as accurate as a spinal tap but without the pain or the risk of side effects. 

"The results presented here open new frontiers in the development of fast, noninvasive, and inexpensive medical diagnosis tools for detection of chronic neurological diseases," the scientists stated. "The results could serve as a launching pad for the discrimination between different subphases of stages of multiple sclerosis as well as for the identification of multiple sclerosis patients who would respond well to immunotherapy." 

A large clinical study with the sensors is underway and will be reported in the future. Haick is a Professor in the Department of Chemical Engineering and the Russell Berrie Nanotechnology Institute at the Technion – Israel Institute of Technology. 

BG-12 Moves Forward with Positive Data from Late-Stage Trials
Positive top-line results have been reported from CONFIRM, the second of two pivotal phase III clinical trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered twice a day (BID) or three times a day (TID), demonstrated significant efficacy and favorable safety and tolerability profiles. Further analyses of the CONFIRM study are ongoing, and Biogen Idec, the company developing BG-12, anticipates presenting detailed data at a future medical meeting.

BG-12 met the CONFIRM study's primary endpoint by significantly reducing annualized relapse rate (ARR) by 44 percent for BID and by 51 percent for TID versus placebo at two years. The CONFIRM study's reference comparator, glatiramer acetate (GA; 20 mg subcutaneous daily injection), reduced the ARR by 29 percent compared with placebo at two years. 

Initial results showed that BG-12 reduced 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS) by 21 percent for BID and 24 percent for TID at two years compared to placebo, and GA reduced confirmed disability progression by 7 percent. 

"We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients," said Doug Williams, Ph.D., Biogen Idec's Executive Vice President of Research and Development. "We are gratified by these strong efficacy and safety results, which, when combined with BG-12's oral route of administration, position it as a potentially important MS therapy. We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible." 

In CONFIRM, both dose regimens of BG-12 showed favorable safety and tolerability profiles, which were similar to those seen in the previous late-stage study known as DEFINE. Overall, the incidence of adverse events (AEs), serious adverse events (SAEs) including serious infections, and discontinuations due to AEs were similar across all study groups, including placebo. The incidence of hepatic and renal events was also comparable among all study groups. The most common AEs in the BG-12 groups were flushing and GI events. There were no malignancies in the BG-12 groups. 

Biogen Idec presented data from DEFINE, at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in October 2011.

 

Working Overnight or Odd Shifts May Increase MS Risk in Teens

Working overnight or odd shifts may increase teenagers' risk of developing MS, according to the results of an observational study. 

Researchers from Sweden who uncovered the link said interruption of circadian rhythms and disruption of normal sleep patterns may be partially responsible for the added risk.

In conducting the study, published in the Oct. 18th issue of Annals of Neurology, researchers examined two population-based studies of Swedish residents aged 16 to 70 (one with incident cases and one with prevalent cases) to compare the number of cases of MS among those who did and did not work overnight or shift hours on a regular or alternating basis during their teens.

Among the incident cases, the investigators found those who worked overnight hours for three years or more before the age of 20 were twice as likely to develop multiple sclerosis as those who never worked night shifts. Among the prevalent cases, they noted, the teens who worked overnight hours were slightly more than twice as likely to develop the disorder.

"Our analysis revealed a significant association between working shift at a young age and occurrence of MS," Dr. Anna Karin Hedstrom, of the Karolinska Institute in Stockholm, said in a journal news release. "Given the association was observed in two independent studies strongly supports a true relationship between shift work and disease risk." 

The researchers explained the sleep restriction associated with working the night shift has already been shown to increase the risk for certain health problems, including heart disease, thyroid disorders and cancer, likely by interfering with melatonin secretion and increasing inflammatory responses. 

The authors pointed out that since MS is a central nervous system autoimmune inflammatory disorder that is linked to a person's environment, other lifestyle risk factors, such as sleep loss due to shift work, should also be considered.

The study authors noted that more research is needed to explain why the disruption of circadian rhythm and sleep loss increase teenagers' risk for developing MS.

 

MS Walking Problems Rarely Discussed

Most people with MS who have difficulty walking say it is the most challenging part of the debilitating disease, U.S. researchers say. However, a survey by Harris Interactive indicated 40 percent of people with MS rarely or never discuss walking problems with their doctor. 

The recent survey of more than 1,200 adults living with MS indicated 65 percent reported having trouble walking, the inability to walk, or difficulty maintaining balance at least twice per week. Seventy percent of those with walking issues say that's the toughest symptom to deal with.

In addition, a majority of people living with MS reported they experienced walking problems within the first few years after diagnosis, while among people diagnosed with MS within the past five years, 58 percent reported experiencing a mobility issue at least twice a week.

On average, people with MS ages 41 or younger who do discuss trouble walking with their doctor initiate the conversation only 46 percent of the time. An estimated 78 percent of these women and 62 percent of these men report that trouble walking makes getting around dangerous, the survey indicated.

In light of the increasing menu of therapeutic options, assistive technology, and medication to aid walking problems, conversations with your doctor may lead to solutions.

 

As always, the ongoing studies and research is much appreciated!  Being able to diagnose MS with just a breath is incredible!  Disruption of normal sleep habits increasing the risk of MS makes me reevaluate my sleeping habits and makes me think back to my teenage sleep patterns (probably not the best, but what teenager truly has good sleeping habits?).  I am always happy to hear that clinical trials are going well for up and coming therapies!  Go BG-12!  

Thanks for reading!  Hope everyone is well!