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Saturday, December 23, 2017
Dr. B has never prescribed narcotics. In this video he explained his personal opinions on why he chooses not to use narcotics in his multiple sclerosis practice. There are many different types of chronic neuropathic pain that can occur in the setting of multiple sclerosis. We believe that using narcotics to treat these pains is not the right decision. Dr. B provides two reasons: One is the national opioid crisis. The other reason relates to the biologic mechanisms of narcotics and some of the long term problems that can arise when using narcotics to treat chronic neuropathic pain.
Wednesday, December 20, 2017
Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings
Tuesday, December 19, 2017
Novartis multiple sclerosis therapy Fingolimod granted FDA Breakthrough Therapy designation for pediatric MS
- In a pivotal Phase III study, oral fingolimod significantly reduced relapses by 82% in a pediatric patient population vs. interferon beta-1a intramuscular injection(2)
- Currently, no disease-modifying therapies are approved for pediatric patients with MS, who often have more frequent relapses than adults with early MS(3)
EAST HANOVER, N.J., Dec. 18, 2017 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for fingolimod for the treatment of children and adolescents 10 years of age or older with relapsing multiple sclerosis (MS). Fingolimod, also known as Gilenya® in the US, is approved to treat relapsing forms of MS in adults. Gilenya is not currently approved for children and adolescents with relapsing MS.
The Breakthrough Therapy designation is based on data from the Phase III PARADIGMS study, which evaluated the safety and efficacy of fingolimod vs. interferon beta-1a in children and adolescents (ages 10 or older) with relapsing MS4. PARADIGMS, the first completed randomized, controlled clinical trial specifically designed for pediatric relapsing MS, found that treatment with fingolimod resulted in an 82% reduction in the rate of relapses (annualized relapse rate) in this patient population over a period of up to two years, compared to interferon beta-1a intramuscular injection (p <0.001)2. The safety profile of fingolimod in this study was overall consistent with that seen in previous clinical trials in adults5.
"Despite the fact that children experience approximately two to three times as many relapses as a typical adult onset MS patient, there are currently no disease-modifying therapies approved for the pediatric population," said Dr. Tanuja Chitnis, Director of the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston, US, and Scientist, Ann Romney Center, Brigham and Women's Hospital, Boston, US. "Children with MS differ from adults in important ways and additional treatment options for pediatric patients are needed," added Dr. Chitnis, who also served as principal investigator for the PARADIGMS study.
The FDA grants Breakthrough Therapy designation for therapies that are intended to treat a serious condition and that have preliminary clinical evidence indicating that the treatment may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints. This designation is a process designed to expedite the development and review of such therapies1.
"We're proud of this regulatory milestone, which represents part of our commitment to advance treatment options for young people with MS," said Fabrice Chouraqui, President of Novartis Pharmaceuticals Corporation. "Novartis is looking forward to working with the FDA to bring a therapy with a long track record in adults with relapsing MS to this younger patient population as soon as possible."
Mult Scler Relat Disord; ePub 2017 Nov 21; Fritz, et al
December 19, 2017
Near-fallers and fallers with multiple sclerosis (MS) reported similar circumstances surrounding fall events and demonstrated similar performance on standard timed walking tests, a recent study found. To that end, clinicians monitoring individuals with MS should consider evaluation of the circumstances surrounding falls in combination with quantitative walking measures to improve determination of fall risk and appropriate rehabilitation interventions. In a single visit, 135 MS participants completed the Hopkins Falls Grading Scale, a custom questionnaire investigating circumstances surrounding falls and near-falls, and performed the Timed Up and Go and Timed 25-Foot Walk tests.
30% of individuals reported falls, while 44% reported near-falls over a 1-year period.
Non-fallers completed the walking tests more quickly than near-fallers and fallers; near-fallers and fallers demonstrated similar motor profiles.
Individuals were more likely to sustain a fall rather than a near-fall under the following circumstances: transferring outside the home and tripping over an obstacle.
Performing 1-second slower on the walking tests increased the odds of a history of a fall by 6–20%.
Fritz NE, Eloyan A, Baynes M, Newsome SD, Calabresi PA, Zachowski KM. Distinguishing among multiple sclerosis fallers, near-fallers and non-fallers. [Published online ahead of print November 21, 2017]. Mult Scler Relat Disord. doi:10.1016/j.msard.2017.11.019.
December 19, 2017
A recent study points to evidence of reduced function in older adults with multiple sclerosis (MS), and this might be partially managed by behavioral interventions that target physical activity and sedentary behavior for the promotion of healthy aging in this population. Participants initially underwent the cognitive assessments, followed by the physical function assessments. They were then instructed to wear an accelerometer and document wear time in a log book for a 7-day period after the testing session. Researchers found:
Older adults with MS (n=40) performed worse on all measures of physical function, and 1 measure of cognitive function (ie, information-processing speed), compared with healthy controls (n=40).
Older adults with MS engaged in less moderate-to-vigorous physical activity, more sedentary behavior, and longer duration of long sedentary bouts than healthy controls.
Levels and patterns of physical activity were significantly associated with a majority of physical function variables but not cognitive function variables in both older adults with MS and healthy controls but to a greater extent in older adults with MS.
Bollaert RA, Motl RW. Physical and cognitive functions, physical activity, and sedentary behavior in older adults with multiple sclerosis. [Published online ahead of print December 1, 2017]. J Geriatr Phys Ther. doi:10.1519/JPT.0000000000000163.
December 19, 2017
A healthy diet and a composite healthy lifestyle are associated with lesser disability and symptom burden in multiple sclerosis (MS), according to a recent study. In 2015, participants in the North American Research Committee on MS (NARCOMS) Registry completed a dietary screener questionnaire that estimates intake of fruits, vegetables and legumes, whole grains, added sugars, and red/processed meats. Researchers constructed an overall diet quality score for each individual based on these food groups; higher scores denoted a healthier diet. They assessed whether a composite healthy lifestyle measure, a healthier diet, healthy weight (body mass index <25), routine physical activity, and abstinence from smoking was associated with symptom severity. They found:
Of the 7,639 (68%) responders, 6,989 reported physician-diagnosed MS and provided dietary information.
Participants with diet quality scores in the highest quintile had lower levels of disability and lower depression scores.
Individuals reporting a composite healthy lifestyle had lower odds of reporting severe fatigue, depression, pain, or cognitive impairment.
Fitzgerald KC, Tyry T, Salter A, et al. Diet quality is associated with disability and symptom severity in multiple sclera. [Published online ahead of print December 6, 2017]. Neurology. doi:10.1212/WNL.0000000000004768.
December 19, 2017
December 19, 2017
Progressive multiple sclerosis (MS) is simply a later stage of the MS disease process and age is an essential modifier of a drug efficacy, according to a recent meta-analysis. Furthermore, higher efficacy treatments exert their benefit over lower efficacy treatments only during early stages of MS, and, after age 53, the model suggests that there is no predicted benefit to receiving immunomodulatory disease-modifying therapies (DMTs) for the average MS patient. Researchers performed a literature search with pre-defined criteria and extracted relevant features from 38 clinical trials that assessed efficacy of DMTs on disability progression. They found:
>28,000 MS subjects participating in trials of 13 categories of immunomodulatory drugs were included in the meta-analysis.
The efficacy of immunomodulatory DMTs on MS disability strongly decreased with advancing age.
Inclusion of baseline Expanded Disability Status Scale did not significantly improve the model.
The regression predicts 0 efficacy beyond approximately age 53 years.
The comparative efficacy rank derived from the regression residuals differentiates high- and low-efficacy drugs.
High-efficacy drugs outperform low-efficacy drugs in inhibiting MS disability only for patients aged <40.5 years.
Weideman AM, Tapia-Maltos MA, Johnson K, Greenwood M, Bielekova B. Meta-analysis of the age-dependent efficacy of multiple sclerosis treatments. [Published online ahead of print November 10, 2017]. Front Neuro. doi:10.3389/fneur.2017.00577.
Monday, December 18, 2017
December 18, 2017