Alcohol intake is not significantly associated with an increased risk of developing multiple sclerosis (MS), but specifically drinking beer may elevate the risk, according to a recent meta-analysis.
The association, however, was limited by a small number of included studies. “Further large-scale prospective studies should be conducted to verify this conclusion,” the researchers wrote.
The study, “Alcohol consumption is associated with excessive risk of multiple sclerosis: a meta-analysis observational study,” was published in the São Paulo Medical Journal.
Environmental and lifestyle factors are thought to contribute to MS risk, progression and/or severity. Alcohol use has been identified as a risk factor for autoimmune conditions, but whether it specifically influences MS risk has remained a matter of debate.
Researchers in China performed a meta-analysis of previously published studies on the topic to clarify this relationship.
Nine studies, including 211,396 subjects and 10,407 MS patients, were included. Of them, five studies were conducted in Europe, three in North America, and one in Iran.
In eight of the studies, alcohol use was surveyed among MS patients and control groups. The remaining study was a prospective study that followed a large group of women and monitored their alcohol use and whether they later developed MS.
A pooled analysis of all these studies revealed no link between overall alcohol intake and MS risk. But further subgroup analyses showed that specifically drinking beer was linked to an increased risk of autoimmune disease. The research team noted, however, that this analysis was based on findings from only two of the studies with contradicting results, which may limit conclusions.
The researchers noted that alcohol intake had a distinct association with MS risk in males and females, “although the protective or harmful effect trends were not associated with any statistically significant difference,” the researchers wrote.
Overall, “this study found that alcohol intake was not associated with the risk of multiple sclerosis, whereas beer intake was associated with an increased risk of multiple sclerosis,” the researchers wrote.
That most of the studies involved participants recalling previous alcohol use marks a limitation of the study, noting that their observation “needs further verification through a large-scale prospective cohort study.”
This article was originally released by: Multiple Sclerosis News today.
Written by: Lindsey Shapiro, PhD
“Men Living with Paralysis and Dating,” an open and honest panel discussion with four men living with paralysis sharing their experiences and perspectives on dating. Topics will include insecurities about using dating apps, finding confidence in oneself, being open and truthful with a partner, sex and intimacy, and learning to get out and meet new people. In addition, the panelists will offer real-life experiences and challenges associated with dating with paralysis.
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Many people with multiple sclerosis (MS) have questions about whether dental work and root canals can cause MS or trigger flares. Although there is still much to learn about MS, the available scientific evidence does not indicate that root canals directly cause MS or trigger MS flare-ups and relapses.
MyMSTeam members have shared their experiences and questions about root canals. One member inquired, “I’ve been having root canals since the age of 19. Just wondering how many more MyMSTeam members have had issues with their teeth before being diagnosed?”
Another member shared, “I have MS, and I am also diagnosed with trigeminal nerve pain on my lower right side. I developed a toothache on the lower right side, so my dentist suggested a root canal, which will need a crown.”
“I am scheduled for three root canals. I am in a relapse. Is this going to be a safe move?
for me with the trauma and healing of a root canal?” asked a third member.
Keep in mind that trigeminal neuralgia (pain from the trigeminal nerve, which sends signals from your face to your brain) may be confused with tooth pain. See your doctor to make sure the pain isn’t due to MS nerve pain. In this article, we’ll look at the relationship between MS, dental health, and dental procedures.
Root Canals and MS
Scientific evidence does not indicate that root canals cause MS or trigger MS flares. However, there has not been extensive scientific research that focuses specifically on dental procedures and MS.
A root canal is a common dental procedure needed when a tooth is badly decayed or seriously infected. To protect the tooth, the nerve and its surrounding dental pulp (soft tissue) are removed, and the tooth is sealed shut. Root canals are often necessary to save teeth that would otherwise have to be pulled.
A root canal is typically performed under local anesthesia and takes one to two hours to complete. Most people report little pain after the root canal and feel relief from their symptoms almost immediately. After a few days of rest, most people can resume their normal activities with no problems.
How Does MS Affect Oral and Dental Health?
MS and oral health are related both directly and indirectly.
People with MS are more likely to experience gum infections (periodontitis), dental cavities, and gingivitis. Periodontitis contributes to inflammation, which can trigger MS relapses. People with MS tend to have more extensive gum disease and an increased number of decayed, missing, or filled teeth compared with the general population.
These factors can increase the chance that people with MS will need dental procedures such as a root canal. If your dentist recommends a root canal, it is important not to delay or avoid it. A root canal can help prevent infection and inflammation from spreading and potentially worsening MS symptoms.
MS Symptoms and Oral Health
Properly brushing and flossing can be difficult when you’re experiencing active MS symptoms, such as balance problems, spasticity, fatigue, and reduced manual dexterity. Tips such as using an electric toothbrush and sitting while brushing your teeth can help. Poor dental hygiene leads to inflamed sores, oral infections, and irritated gums.
MS Medications and Oral Health
Some disease-modifying therapies (DMTs) and drugs used to manage MS symptoms have side effects that can cause or contribute to oral or dental health problems. DMTs can increase the risk of needing a root canal because they are linked to an increase in the risk of infections. Some medications used to treat MS symptoms have oral and dental side effects, such as dry mouth, which can lead to dental problems.
MS, Dental Surgery, and Anesthesia
Some people with MS worry about whether dental procedures, surgery, or anesthesia can increase their risk of relapse. Scientific studies have shown that they don’t. One study analyzed 281 people with MS who underwent 609 surgeries. The study found that only twelve people had a postoperative relapse, indicating that the risk of MS relapse was not increased with surgery and anesthesia.
Keep Up with Checkups and Cleaning
Make sure to get regular dental care and not delay necessary dental procedures. Delaying or avoiding necessary dentistry can worsen a dental problem — potentially leading to worsened MS symptoms, such as widespread inflammation, or complications like a serious infection.
Tell your dentist about your MS and your medications. If you’re experiencing tooth pain or signs of infection, it’s important to see your dentist as soon as possible for evaluation and treatment.
Talk With Others Who Understand
MyMSTeam is the social network for people with multiple sclerosis and their loved ones. On MyMSTeam, more than 186,000 members come together to ask questions, give advice, and share their stories with others who understand life with MS.
Have you had root canal or dental work? How did it affect your MS? Has MS had an impact on your oral health? Share your experience in the comments below or start a conversation by posting on your activities page.
This article was originally released by: MyMSteam.com
Written and reviewed by: Medically reviewed by Joseph V. Campellone, M.D. Article written by Simi Burn, PharmD
Lyvispah — a dissolvable granular formulation of baclofen — is now commercially available in the U.S. for adults and adolescents, 12 and older, with spasticity associated with multiple sclerosis (MS) and other spinal cord disorders.
In people with MS, the strawberry-flavored formulation is particularly suitable to ease flexor spasticity and associated pain, muscular rigidity, and repetitive, involuntary up and down muscle movements. Flexor spasticity is the involuntary bending of the knees and hips toward the chest, which can be painful and incapacitating.
“We see a clear need for more options to treat spasticity resulting from multiple sclerosis and other spinal cord disorders based on individual patient’s needs,” Chirag and Chintu Patel, the co-CEOs of Amneal Pharmaceuticals, which will market the therapy, said in a press release. “We believe Lyvispah provides that option,” they added.
Lyvispah will be available through both specialty and retail channels, with a full patient support program, created in collaboration with BlinkRx, that will help patients with certain services, such as free home delivery of the therapy.
Baclofen (sold as Lioresal, among other generic brand names) is a muscle relaxant used to treat spasms and stiffness caused by MS, and spinal cord injuries. It was available previously for delivery only through a spinal canal injection or oral tablets.
Developed by Saol Therapeutics, now part of Amneal, Lyvispah is a bioequivalent to oral baclofen tablets, meaning that the two medications provide the same amount of the active ingredient at the proper site of action.
Its rapidly dissolving granules — available in packets of 5, 10, and 20 milligrams (mg) for more flexible dosing — provide a more convenient option for patients who also experience difficulties in swallowing pills.
This is particularly relevant for people with MS, as swallowing difficulties are estimated to affect 34–43% of these patients. Unlike other formulations of baclofen, Lyvispah can be taken with or without water, mixed with liquids or foods, and through an enteral feeding tube, which allows food to be delivered directly into the stomach or small bowel.
The U.S. launch comes about six months after the therapy was approved by the U.S. Food and Drug Administration for use. The decision was based on studies that confirmed Lyvispah-baclofen tablet bioequivalence in healthy adults.
The studies analyzed how much of the active ingredient entered circulation with either formulation and showed that in both forms, peak concentrations were reached about one hour after administration, and these levels dropped to half about 5.5 hours later.
With Saol’s acquisition, Amneal also acquired Lioresal (baclofen intrathecal injection), which comprises a pump implanted into the spinal canal to manage severe spasticity that is available for the institutional market.
Article originally released by: Multiple Sclerosis News Today
Written by: Marta Figueiredo, PhD
Like watching a scale tip up and down, I’m constantly assessing how any choices I make could affect how I feel tomorrow, or even later today.
Although my multiple sclerosis was as aggressive and unstable as a hurricane in my first few years with it, I’ve found a baseline since starting Lemtrada (alemtuzumab) treatment in 2018. Of course, I still have MS flare-ups — sometimes daily, sometimes less frequently.
If I’m having a good day physically, my baseline involves using a scooter to go out or into town alone. It’s strange now to need my wheelchair. But on bad days, you won’t see me at all because I can’t leave the house.
My baseline for more invisible symptoms, such as sensory issues and fatigue, is less predictable. I usually have some level of numbness from my chest to my feet, but I’ll experience sensations on a sliding scale between numbness and hypersensitivity. This may include feelings of burning, pins and needles, running water, and pain.
Fatigue is another given. For instance, despite my best intentions and medication, I was unable to write this column when I sat down to do it yesterday. Sometimes there is a trigger, but not always. This time, I can’t identify one. A fatigue trigger could be something as elusive as a long, deep conversation with an old friend several days earlier, or an issue that’s been causing me to overthink and worry.
My physical baseline, however, often resets overnight. If I’ve done too much, such as vacuuming, cleaning, or anything that renders me unable to walk in the evening, I’ll usually be back to my baseline by the next morning. But my tolerance for physical activities is low, and I don’t get much warning before reaching my limit. When I don’t see it coming, it’s like the opposite of a jack-in-the-box: One minute I’m cooking, and the next I’ve crumpled to my feet.
My tolerance has definitely improved since MS stormed into my life and left me paralyzed. Now I rarely let myself reach that point of tipping the scale over. It’s part of the reason my scooter has been revolutionary for me.
I struggle when there’s a lot of activity packed into a short time, such as when my husband and I visit family or friends or have people stay at our home. I often forget how tiring simply talking is. Coupled with the fact that I’m an introvert, I need my fair share of alone time to reset.
Big gatherings are also difficult to navigate. I’ll often be found seeking solace in a quiet corner rather than participating in the hubbub.
I tend to go off alone for a bit of respite from gatherings. If I don’t, I’ll find myself teetering on the edge of sensory overload, and that’s not a fun place to be.
People often ask me why I attend parties, see friends, or go out when I know it will have an impact on the following days. Simply put, if I didn’t shoulder the consequences of these things, I’d never do anything or go anywhere. And that’s a life I wouldn’t want to live.
This article originally released by: Multiple Sclerosis News Today
Acknowledging advances in early detection of multiple sclerosis (MS), the Paralyzed Veterans of America (PVA) is broadening its membership and inviting all veterans with the progressive neurodegenerative disorder to join the nonprofit organization.
Now, all veterans with MS are eligible for PVA membership and the same support available to its traditional member ranks, which includes those with spinal cord injuries and diseases such as amyotrophic lateral sclerosis (ALS).
More than 28,000 MS cases are reported each year to the U.S. Department of Veterans Affairs.
“PVA has long helped veterans with MS involving the spinal cord who needed quality health care and disability benefits due to their diagnosis,” Charles Brown, national PVA president, said in a press release. “Our National Service Officers are experts in securing their benefits, navigating the VA system, and helping these veterans throughout their continuum of care.”
“It’s important we keep pace with the improvements in MRI technology, which provides more precise imaging resulting in the early detection of MS. We want to help even more veterans living with the disease and become their go-to resource,” Brown added.
Membership support includes MS-specific educational materials as well as assistance from on-staff licensed architects who can review home design plans and suggest ways to improve residential accessibility.
Membership also includes admission to the PVA’s private Facebook groups, which apprise members of news that affect them, as well as potential interaction with more than 33 chapters nationwide about MS advocacy efforts. Members also have opportunities to participate in virtual and in-person sporting and recreational events around the country.
“Every case of MS reported is a person … a mother, a father, a son, a daughter, a proud veteran who selflessly served our nation, and they deserve our care and support now,” Brown said. “By expanding PVA’s membership, we are not only helping more veterans but also honoring our roots, recognizing veterans like Gilford Moss — PVA’s first president, who also had MS. We want all veterans with MS, from those actively serving to those who already served, to know that PVA is here, and they are not alone. “Last August, the organization established its first MS committee, a permanent body comprised of eight PVA members and MS patients from around the country. The committee speaks out on legislative issues that affect veterans with MS and produces a weekly podcast that discusses those issues and more. The committee serves as an expert resource for all veterans who live with MS.
This article was originally released by: Multiple Sclerosis News Today
Worsening disability was associated with worry about COVID-19 in people with multiple sclerosis (MS) living in the U.S. and Italy, a study evaluating the pandemic’s impact has found.
In both countries, MS patients with greater psychological disabilities, such as depression, were more likely to have worrying thoughts, while those with fewer mobility issues reported more post-traumatic growth, meaning they had a higher sense of gratitude, faith, and social connection.
Findings also suggested that patients in the U.S. with more disabilities were more concerned with protecting themselves against COVID-19.
The study, “The impact of COVID-19 on people with multiple sclerosis: A comparison of Italian and United States cohorts,” was published in the journal Multiple Sclerosis and Related Disorders.
The COVID-19 pandemic has negatively affected the well-being and health of vulnerable groups, particularly those with pre-existing medical conditions. In fact, an Italian study reported that MS patients were twice as likely to be hospitalized compared with the general population after being diagnosed with COVID-19.
In the U.S., progressive forms of MS, which are characterized by symptoms that gradually worsen over time, have also been linked to poorer COVID-19 outcomes.
Several studies have also attempted to assess the pandemic’s mental and emotional impact. One such study found that depression, anxiety, and overall quality of life did not worsen for MS patients with progressive disease. However, the number of study participants was too low to reach a robust conclusion.
According to researchers, studies are lacking that have evaluated the differences in how people with MS living in different countries have dealt with the pandemic. To address this gap in knowledge, researchers investigated the relationship between three specific pandemic-related concepts — worry, protection, and post-traumatic growth — and disability outcomes in MS patients living in Italy and in the U.S.
Between late spring and midsummer of 2020, 708 patients were asked to complete an online survey. Questions and topics under “worry” included “How often do you feel isolated from others?”; “I am stressed around other people because I worry, I’ll catch the coronavirus”; and “Thoughts about the pandemic distract me or keep me from being able to concentrate.”
The concept “protection” discussed items such as “Washing hands and/or using sanitizer after returning home”; “Staying at least 6 feet away from others outside the home”; “Wearing a face mask in public”; and “Wiping down surfaces with disinfectant.”
“Post-traumatic growth” covered content such as, “I have a greater appreciation for the value of my own life”; “I more clearly see that I can count on people in times of trouble”; “I have a greater sense of closeness with others”; and “I have a stronger religious faith.”
MS disability was determined using performance scales, a self-reported health status measure that includes 11 domains: mobility, hand function, vision, fatigue, cognitive, bladder/bowel, sensory, spasticity (muscle tightness), pain, depression, and tremor/coordination.
A total of 292 patients in Italy and 416 in the U.S. participated in the study. MS patients in the U.S. were older and had a higher body mass index (a body fat measure) than the Italian group.
U.S. patients also had more comorbidities, or simultaneous health conditions. While in the U.S., back pain, depression, and arthritis were the comorbidities most commonly reported, in Italy, back pain, insomnia, and depression were the most frequent complaints.
Next, researchers conducted a statistical analysis to study the relationship between MS disability and the concepts of worry, protection, and post-traumatic growth.
In the U.S., all three concepts were found to be associated with MS disability. Worry was linked to higher mental and depression disability, while protection was associated with greater mobility, sensory, spasticity, and pain disability. Lower mobility disability was associated with post-traumatic growth.
In Italian patients, worry was associated with greater vision, fatigue, cognitive, and depression disability, while post-traumatic growth was associated with less mobility, vision, bladder/bowel, and spasticity disability.
“In summary, the pandemic’s negative aspects were associated with worse disability in both countries, and with more aspects of disability in Italy. In the [U.S.], however, MS-related disabilities were also associated with greater self-protection against COVID-19,” the authors wrote. “Individuals’ post-traumatic growth [… was] associated with lesser disability. This finding may suggest directions for clinical intervention,” they wrote.
This article was originally released by: Multiple Sclerosis News Today
And was written by:
Many people newly diagnosed with relapsing-remitting multiple sclerosis (RRMS) experience substantial “hidden disabilities,” such as depression or fatigue, a study highlights.
Findings indicate that treatment with disease-modifying therapies generally does not affect the severity of these problems, at least in the short term.
“Considering the substantial impact that hidden disabilities have on patients, ranging from effects on relationships with family and caregivers to employment, it is vital that more research focuses on this unmet need,” the researchers wrote.
The study, “The influence of disease-modifying therapy on hidden disability burden in people with newly diagnosed relapsing-remitting multiple sclerosis,” was published in Multiple Sclerosis and Related Disorders.
Some kinds of MS-related disability, such as difficulty walking, may be apparent on sight. However, other problems associated with MS — such as depression, anxiety, fatigue, sleep difficulties, cognitive impairment, and pain — can be less obvious but still substantially affect daily life. These “hidden” disabilities have generally received less focus in MS research than physical impairments.
More than a dozen disease-modifying therapies (DMTs) are approved to treat RRMS. These medicines have been proven to alter the disease’s progression by reducing the risk of relapses and delaying the progression of physical disability. The impact of these treatments on hidden disability is less clear.
Using data from the Scotland-wide national database FutureMS, a team of scientists in the U.K. and Germany identified 440 people (mean age, 37.4) who had been diagnosed with RRMS within six months. The participants underwent an initial battery of evaluations (baseline measures), and nearly 90% (392 patients) were again evaluated one year later.
After the baseline evaluations, slightly more than two-thirds of the patients elected to start on a DMT. The specific DMTs used were chosen based on each individual’s unique situation, at the discretion of the treating clinician. The most commonly prescribed DMTs were Tecfidera (dimethyl fumarate, 148 patients), Copaxone (glatiramer acetate, 52 patients), and interferon therapies (29 patients).
Based on baseline assessments, 58% of the patients (255 out of 440) were classified as initially having a “low” burden of hidden disability, whereas 25.4% had “moderate,” and 16.8% had a “high” hidden disability burden.
“Almost half of participants experienced moderate to high levels of hidden disability burden at baseline,” the scientists wrote. “These individuals scored particularly highly on measures of fatigue, depression and anxiety whereas most performed well on the included cognitive measures.”
One year later, most patients — 70.2% — were still in the same category of hidden disability burden. A considerable number (26.1%, 115 patients) improved — for example, transitioning from a “high” to “moderate” hidden disability category — while 3.7% (16 patients) experienced a worsening in such burden. Notably, changes in hidden disability were not associated with changes in physical disability or measures of disease activity on MRI scans.
The researchers then conducted a battery of statistical analyses to look for associations between DMT use and changes in hidden disability. Results showed that treatment with the DMTs Gilenya (fingolimod) and Mavenclad (cladribine) were significantly linked with improvements in hidden disability burden after one year.
“Our analysis identified a significant association of category 2 DMT treatment [Gilenya and Mavenclad] with improvement in hidden disability burden. However, given the small number of participants and the comparatively short treatment duration, this finding should be interpreted with caution,” the team wrote.
For other DMTs, there was little association with changes in hidden disability severity.
“Our results indicate that, for the majority of DMTs used early in the disease, there is little evidence of a substantial impact on hidden disability burden in the short term,” the researchers wrote.
These findings have implications for how MS is treated in the clinic, since data suggest that escalating DMT treatment is unlikely to benefit patients who are mainly experiencing problems related to these hidden disabilities.
“Our results suggest that hidden disabilities do not constitute an indication for escalating therapy in the short term,” the team wrote.
The researchers stressed that this was an observational study, with use of various DMTs and a fairly short follow-up time. They stressed a broader need for research into ways to ease hidden disability for people with MS.
“Our exploratory data are observational, with scope for attendant biases, but highlight the need for further study including longer-term evaluation as well as randomized trials for non-motor disability,” the researchers concluded.
This article was provided by: Multiple Sclerosis News today.com
Written by: |
Extreme heat can be dangerous for all, but especially for older adults and people with chronic conditions. Take steps to prepare and stay safe using these tips from Ready.gov:
- Find air conditioning.
- Avoid strenuous activities.
- Wear light clothing.
- Check on family members and neighbors.
- Drink plenty of fluids.
- Watch for heat cramps, heat exhaustion, and heatstroke.
- Never leave people or pets in a closed car.
Disease severity, brain volume loss, and brain lesions are able to predict later cognitive declines in people with relapsing-remitting multiple sclerosis (RRMS), a study in China found.
The study, “Clinical and MRI predictors of cognitive decline in patients with relapsing-remitting multiple sclerosis: a 2-year longitudinal study,” was published in Multiple Sclerosis and Related Disorders. Brain tissue changes, including volume loss and lesions, which can be assessed with an MRI, are an established way to predict or monitor MS disease progression, particularly worsening motor symptoms. More than half of MS patients also experience cognitive problems, including issues with learning, problem-solving, and planning, but the relationship between brain tissue changes and later cognitive decline has not been thoroughly established.
A team of researchers monitored cognitive and MRI changes in 107 RRMS patients and 74 healthy participants, who served as a control group, over two years.
Among the patients, the average disease duration was 12 years. The disease attack rate at the study’s start was one per year in 39 people, two per year in 43 people, and three per year in the remaining 25 patients.
RRMS patients showed several MRI changes compared with the control group at the study’s start. Specifically, patients had a lower total brain volume, as well as less white and gray matter. White matter is brain tissue that contains mostly nerve cell projections, while gray matter is made up largely of nerve cell bodies.
Cognitive function tests showed that patients also had impairments in cognition compared with healthy controls.
Specifically, they had poorer verbal memory, visual memory, and visuospatial perception, or the ability to perceive an object’s location relative to one’s own body. Patients also showed deficits in executive function, which encompasses a set of skills such as working memory, flexible thinking, and self-control that help in everyday life. Information processing speed was similar in both groups, however.
After two years, 38 patients were considered to have experienced cognitive decline from their baseline performance, while 69 were considered cognitively stable. Patients who had a longer disease duration, worse disease-associated disability, and more disease attacks per year at the study’s start were more likely to experience cognitive decline. All the healthy participants were cognitively stable.
Several MRI measurements were also associated with cognitive performance.
In particular, lower total brain volume at the study’s start was associated with cognitive decline, as was a lower volume in the brain’s frontal lobe — involved in complex cognitive functions — and the temporal lobe, which plays a known role in memory.
Lower baseline levels of total gray matter, and gray matter in several individual brain regions, including the cortex, hippocampus, and thalamus also predicted cognitive loss. Similarly, more of the brain’s white matter containing lesions at the study’s start was associated with worse cognitive function.”
The results highlight clinical and MRI parameters that may be useful predictors of cognitive outcomes in MS patients.
The study did not examine how MS treatments might have influenced cognitive or MRI findings during the study, nor did it account for disease attacks during the two-year follow-up, the research team pointed out. Nevertheless, the researchers said their “findings suggest that RRMS patients with more disease severity, higher [gray matter] atrophy, and increased [white matter] lesion volume are more susceptible to cognitive decline.”
Future studies should seek to address the longer-term relationships between cognition and MRI parameters, and to better understand what causes brain atrophy to lead to impaired cognition, the researchers said.
This article originally released by: Multiple Sclerosis News Today.
Tysabri (natalizumab) given every six weeks was found to be similarly effective as the standard four-week dosing schedule at stopping nervous system damage in people with relapsing-remitting multiple sclerosis (RRMS).
That’s according to the full results of the Phase 3b NOVA clinical trial, which compared Tysabri dosing schedules among nearly 500 RRMS patients with the aim of potentially reducing the risks of side effects tied to the therapy’s use.
“Our findings suggest that most patients who are stable on [Tysabri] 4-week dosing can switch to 6-week dosing without clinically meaningful loss of efficacy,” the researchers wrote.
“These results could provide important information for physicians who are making [Tysabri] treatment decisions,” they added.
Full results have now been published in The Lancet Neurology, in a study titled “Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial.”
Tysabri is widely approved to treat RRMS; in the U.S., it also is authorized to treat other relapsing forms of MS, including clinically isolated syndrome and active secondary progressive MS. The medication works to block inflammatory immune cells from getting into the central nervous system, thus reducing the inflammation that drives MS. Tysabri is administered via intravenous (into-the-vein) infusions, and the approved dosing schedule is 300 mg given every four weeks.
Because it blocks the activity of the immune system in the brain, Tysabri can increase the risk of a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML). Data from a prescribing database called TOUCH, which tracks outcomes for more than 35,000 patients treated with Tysabri, suggested that giving treatment at an extended dosing interval — every six weeks, rather than every four — can substantially reduce the risk of PML.
Biogen launched the NOVA study (NCT03689972) to evaluate the efficacy of the extended interval dosing schedule in patients. In the trial, 499 adults with RRMS who had been on stable Tysabri treatment for at least one year, under the approved every-four-week schedule, were randomly assigned to continue that dosing or to switch to receiving the therapy every six weeks instead.
The trial’s main goal was to compare the effect of the two regimens on disease lesions after 72 weeks, or just under a year and a half. For the most part, the results were comparable: after 72 weeks, 82% of patients in the every-six-weeks group had no new lesions, as did 78% of those given the therapy every four weeks. One new lesion was reported in 2% of the patients on the six-week regimen, and in 3% of those in the every-four-week group. Less than 1% of participants in either group had two new lesions. For most other patients, data on new lesions were not available.
“The proportions of participants with new or newly enlarging … lesions over 72 weeks of treatment were similar in both groups,” the researchers wrote.
However, there were two outliers, both in the every-six-weeks group. One patient tested positive for antibodies against the John Cunningham virus, which is a risk factor for PML. This patient elected to discontinue Tysabri, and did not switch to another treatment. A few months later, the patient had a relapse, and a subsequent MRI showed 30 new lesions.
The other outlier in the every-six-weeks group gradually developed 25 new lesions over the course of the clinical trial. Per trial protocol, all lesions were assumed to be related to MS, and were counted as such. However, at week 72, the patient tested positive for PML, despite having no obvious symptoms of infection. It is therefore not entirely clear whether these lesions were truly related to MS, or were a result of an insidious infection.
Overall, the average number of new lesions was 0.2 in the every-six-weeks group and 0.05 in patients given the standard dosing schedule. The difference was driven mainly by the two outliers, and it was not statistically significant in the primary analysis.
Other MRI-based measures were generally comparable between the two groups, and nearly all (97–98%) of the participants in both groups were relapse-free throughout the 72-week trial. The average relapse rate was 0.00013 relapses per year in the every-six-week group and 0.00010 relapses per year in the standard dosing group.
The proportion of patients who experienced disability progression lasting at least six months, as well as those with no evidence of disease activity at 72 weeks, also were similar between the groups.
“There were no clinically meaningful differences in secondary clinical or MRI endpoints at week 72 between the once every 6 weeks and once every 4 weeks dosing groups,” the scientists wrote.
“Taken together, the effect of the two participants with extreme lesion numbers, coupled with the secondary and exploratory findings, support the hypothesis that differences in the primary outcome are not clinically meaningful,” they added.
Safety-related outcomes were generally similar in both groups — roughly one in 10 patients in both groups reported any side effects deemed related to treatment, and rates of severe and serious adverse events were comparable. The only case of PML was the asymptomatic case identified in the patient with 25 lesions.
“The safety findings in this study were consistent with the known safety profile of [Tysabri],” the researchers wrote.
This News release is from: Multiple Sclerosis News Today.
Quanterix’s ultra-sensitive blood test that measures a biomarker of nerve damage in people with multiple sclerosis (MS) has been granted a breakthrough device designation by U.S. regulators. It is thought that the test, which employs the company’s Simoa technology, can accurately predict the risk of disease activity in people with relapsing-remitting MS (RRMS) by measuring blood levels of neurofilament light chain (NfL).
The breakthrough device designation is granted by the U.S. Food and Drug Administration (FDA) to products that offer ways to more effectively diagnose or treat life-threatening diseases. While the designation is designed to accelerate the platform’s development toward regulatory approval, it does not guarantee that it will eventually be approved. “Obtaining FDA breakthrough device designation for our plasma NfL MS test was a key objective for 2022,” Kevin Hrusovsky, chairman and CEO of Quanterix and founder of Powering Precision Health, said in a press release. “We are pleased to have the opportunity to work with the FDA to help advance the Quanterix Simoa NfL test towards regulatory approval.”
NfL is a protein found on nerve cell projections, called axons, that is released into the bloodstream when nerve cell damage occurs. Its levels are elevated in the blood of MS patients, and have been shown to be correlated with signs of disease progression in RRMS.
The protein has thus emerged as a promising biomarker for identifying patients who are at risk for a more severe disease course. Simoa (standing for SIngle MOlecule Array) technology is a fully-automated platform that detects single molecules of proteins, DNA, or RNA when bound to antibody-coated beads. Several different biomarkers could be detected in a single experiment with the approach. The platform can detect NfL levels in human blood samples with up to 1,000 times greater sensitivity than conventional measurements, according to Quanterix. This means that subtle changes can be captured earlier and less invasively than with other approaches.
The company believes the test can identify RRMS patients who are at an increased risk of relapse within the next four years. This may help doctors tailor a more effective treatment strategy for each individual.
“For the more than two million people suffering from MS worldwide, there’s an important need for more informed and effective treatment options,” Hrusovsky said. Simoa’s utility was demonstrated in a large, international study recently published in The Lancet Neurology. In that study, an international team of researchers used the Simoa assay to analyze blood NfL levels in more than 5,000 healthy adults. The team used the data to establish reference ranges of NfL, which were corrected for age and body-mass index, a measure of body fat. They then created an online app that clinicians can use to calculate these reference ranges for each patient.
Among 1,313 people with MS, NfL levels were able to predict the risk of both acute (i.e. relapses, brain lesions) and chronic (i.e. disability worsening) disease activity. Researchers noted that NfL levels might also be used as a way of monitoring the effectiveness of some MS treatments. Quanterix also noted the Simoa platform was referenced in at least 20 studies recently presented at the American Academy of Neurology annual meeting, further validating its potential utility.
“There has been an ever-growing body of research with the Simoa NfL blood test supporting NfL as a reliable biomarker for MS disease activity prognosis and treatment response monitoring,” said Mark S. Freedman, MD, professor of neurology and director of multiple sclerosis research at the Ottawa Hospital.
“The FDA’s grant of Breakthrough Device designation for this test has the potential to help the multiple sclerosis community further advance the optimal use of NfL measurements in both research and clinical practice aimed at more effective therapeutic management of the disease for the millions of patients suffering from the condition,” added Freedman. Last year, Quanterix’s phospho-Tau 181 test, which also uses Simoa technology, received breakthrough device status for its use in monitoring disease progression in people with Alzheimer’s disease.
This News released by :Multiple Sclerosis News Today.
Written by: |
Drug targeting Epstein-Barr virus shows promise
- Researchers are investigating the effects of a drug that targets the Epstein-Barr virus in people with multiple sclerosis (MS) in an ongoing phase 1 clinical trial.
- The drug improves MS symptoms and may even reverse the condition.
- The researchers are now recruiting for a Phase 2 clinical trial to further study the drug’s effects.
Multiple sclerosis (MS) is a chronic condition that affects the central nervous system (CNS). It is characterized by the immune system attacking myelin sheaths — fatty layers that surround nerve fibers and enable them to communicate. A study published in early 2022 found that contracting the Epstein-Barr virus (EBV), a herpes virus, significantly increases a person’s risk of MS. Multiple studies Trusted Source have also found EBV-infected immune B cells in patients with MS.
Researchers still don’t know how EBV may increase MS risk. However, one study Trusted Source suggests that EBV proteins may mimic human myelin proteins and induce an immune reaction against myelin by CNS antigens. Therapeutics that target EBV-infected B cells and plasma cells may be able to improve MS symptoms. Atara Biotherapeutics, Inc., an allogeneic T-cell immunotherapy company, recently began an ongoing Phase 1 clinical trial to examine an experimental T-cell immunotherapy drug called ATA118 that targets EBV-infected cells in people with MS. Of the trials of 24 volunteers, 20 showed signs of improvement or a halt in progression after a year of treatment. Among 18 patients who agreed to take the drug for up to 39 months, 9 achieved sustained disability improvement, and 7 showed signs of remyelination. The trial is ongoing; however, it will be presented at a conference by Atara on October 13th, 2022.
Phase 1 trial
For the trial, the researchers treated 24 patients with MS with varying doses of ATA188 for a year. Improvements began within six months of treatment. After 12 months, 20 reported either improvement in their condition or a halt in decline. None of the patients experienced serious side effects. Of the original 24 trial participants, 18 continued ATA188 treatment for up to 39 months. Seven achieved sustained disability improvement (SDI) at 12 months and two in the extended treatment period. Researchers found that those seven participants also showed signs of remyelination, a natural mechanism to repair damage to the protective covering around nerve fibers in your central nervous system, which includes the brain and spinal cord.
“When a patient reaches a certain level of advanced disability, it is rare for them to naturally revert, and any improvement that is sustained would not be expected from the natural history of the disease,” said Mark Freedman, MD, Professor of Neurology, University of Ottawa. “With progressive MS, spontaneous remyelination without therapeutic intervention is unlikely, highlighting the impact that these MTR data provide suggesting remyelination may be driving the prolonged sustained [Expanded Disability Status Scale] EDSS improvement,” he added.
The researchers noted that higher doses led to larger clinical responses. Of the nine patients who achieved SDI, seven received one of the two highest ATA188 doses in the first 12 months or the extended trial period. They further noted that eight patients who achieved SDI also participated in the extended trial and that seven of these reported SDI at all time points.
As of August 2021, the researchers reported no fatal adverse events, although one patient with secondary progressive MS who had initially achieved SDI experienced a non-treatment-related relapse at 18 months.
When asked how targeting EBV infections may treat MS, Barbara Giesser, MD, neurologist and MS specialist at Pacific Neuroscience Institute at Providence Saint John’s Health Center in Santa Monica, CA, told Medical News Today:
“A majority of persons with MS appear to have been exposed to EBV. There is a protein on the EBV that is the same as a protein in myelin. When the body’s immune system attacks the virus, it also ends up attacking the myelin. Clearing the virus would decrease the stimulus for the immune cells to attack the myelin.” Alex Chapman, vice president of Corporate Communications and Public Affairs at Atara, told MNT that A188 might affect two separate pathways in the brain thought to damage myelin:
“1) Interrupt the cell-mediated autoimmune cascade driven by EBV-infected B cells and 2) Reduce the production of myelin-targeted antibodies made by EBV-infected plasma cells.”
“T cells are able to access the central nervous system (brain and spinal cord) more readily than large antibodies. We already have good clinical evidence of this with one of our other programs using a different type of EBV T cell for cancer,” Chapman explained. The researchers say their findings demonstrate the potential to halt or reverse disability progression by targeting what may be the root cause of MS. When asked about the study’s limitations, both Chapman and Dr. Giesser stated that its sample size was small, and thus, further research is needed.
Chapman added that to address this, Atara is actively recruiting for a randomized, Phase 2, double-blind, placebo-controlled trial to further evaluate the efficacy and safety of ATA188 in patients with progressive MS.
This article was released by: Medical News Today.
Hot weather is on its way! But we have good news!
At the MS Alliance support group meeting Tuesday, April 12, our guest speakers Marcia Harris and Debra Forman, from MSF, shared information about their many programs and services for people with MS including their Cooling Program, open til June 1st. The other program is their Brighter Tomorrow Grant.
More often than not, heat and MS don’t mix. As body temperature rises, weakness, fatigue, visual disturbances, and other symptoms can become aggravated and temporarily worsen. While heat does not actually make MS worse, it does alter the passage of nerve impulses, causing a feeling of weakness, especially in the limbs
But keeping cool can help you work, shop, and maintain your home during the summer months. It can also help you reclaim countless activities associated with the warmer seasons, like gardening, fishing, walking, biking, family outings, barbecues, and baseball games. The MSF Cooling Program offers a variety of items, free of charge, that will help you stay cool in the heat. Available items include:
Candidates of the Cooling Program receive their items on a first-come basis; apply soon with complete information and confirmation of your MS diagnosis from your doctor. To apply go to: msfocus.org select the ‘Get help’ tab, and then ‘Cooling Program.’
Watch your email for upcoming surveys coming your way. Dr. Kidd, at the MS Center, wants to hear directly from people living with MS to better understand why or why not those with MS take Disease-Modifying Treatments (DMTs). Whether you take or do not take a DMT or have never taken a DMT it’s important to hear from you.
If you are not on our mailing list and want to participate in this local research opportunity and/or want to be on our contact list, to be first to hear about upcoming programs, events & speakers, please send your contact information to: MSAV4hope@gmail.com – subject “Include Me” with your name, email address, mailing address, text number, phone number – all information is kept 100% confidential, never shared. And we don’t send out junk mail- no jokes, gags, rumors and we don’t ask people living with MS for money.
The Multiple Sclerosis Alliance of Virginia is a group of people who “get it”, people living with MS volunteering to help each other, including caregivers, family and friends. If have MS, you are not alone. Our support groups, educational programs and fun events are designed by us……for us. Our office, located at the MS Center in Salem, houses our equipment loaner closet, ‘Cinderella’s Closet’ and upcoming craft sessions, movie night and confidential counseling.
Given this low number, however, it’s unclear if there is a true association between the two diseases, the research team from Brazil said.
The study, “Dry Oral and Ocular Manifestations and Autoantibodies Characteristic of Primary Sjogren’s Syndrome in Multiple Sclerosis,” was published in Multiple Sclerosis and Related Disorders.
Sjögren’s syndrome is an autoimmune disorder wherein the glands that produce tears and saliva are mistakenly attacked, leading to the characteristic symptoms of dry eyes and mouth.
MS is also an autoimmune disorder, characterized by the body’s attack on myelin — the protective fatty substance surrounding nerve cells — leading to demyelination.
A link between MS and Sjögren’s has been suggested, and the two diseases share some clinical signs. For example, some autoantibodies — those produced as part of the immune system malfunction in an autoimmune disease — that are characteristic of Sjögren’s can be seen in MS patients, and some Sjögren’s patients have demyelinating nerve lesions that look like those seen in MS.
The extent and nature of the relationship between the two conditions is poorly understood, however.
A research team in Brazil evaluated the presence of characteristic Sjögren’s symptoms — dry eyes and dry mouth — in MS patients between the ages of 18–65.
Overall, 202 patients completed a survey assessing dry eye and mouth symptoms, as well as the use of medications that could influence these symptoms.
A total of 43 patients had one or both symptoms and 27 were excluded due to co-existing conditions or medications that could cause the symptoms. The remaining 16 patients, 14 of whom were female, were selected to undergo diagnostic testing for Sjögren’s.
“To read this article in its entirety click this link: MS Patients May Meet Criteria for Sjögren’s Diagnosis, Study Reports”
Spring is rapidly approaching. It’s warming up outside. The trees are starting to bloom. And inside our home, I am once again plotting to refresh the place.
Out with old decorations, and in with the new! Declutter that closet! Donate the table and chairs that still look great because you never use them, and turn that dining room into something altogether different!
I’ve been feeling absolutely stuck lately. Granted, I’ve spent much more time at home over the last two years, like most folks, thanks to COVID-19. And that’s likely exacerbated my feelings. However, I probably would’ve felt this way even without pandemic stress. Rooms that are supposed to comfort and inspire leave me feeling trapped and stifled, especially my library/office.
I thought a fresh coat of paint would be a great idea, so rather than stare at four brick-red walls, I could enjoy cool gray ones. Thus, the hunt for the perfect color began. This just in: There are a lot of shades of gray. I mean, a lot.
“To read this article in its entirety click this link: More Than 50 Shades of Gray.”
#ACTRIMS2022 – Cognitive Training Paired With tDCS Aids Patients
Electrically stimulating the brain while doing at-home cognitive training games can help to prevent a decline in cognition for people with multiple sclerosis (MS), particularly those with more advanced disability, a study indicates.
“This could lead to a therapy that can remediate cognitive impairment, we just need to optimize” the intervention protocol, said Leigh Charvet, PhD, a professor in the neurology department of New York University. Charvet presented study findings at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2022, in the talk “Cognitive Functioning in MS Improves with At-Home Online Training Paired with Transcranial Direct Current Stimulation (tDCS): Results from a Sham-Controlled Randomized Clinical Trial.” Over three-quarters of MS patients experience cognitive difficulties as a symptom of the disease. These difficulties usually start off mild — like slight delays in processing speed — but worsen with progression, often leading to problems with learning, memory, and other cognitive domains.
Adaptive cognitive training is an intervention broadly aiming to boost skills by having a person play computer games specially “designed to target processing speed that then has a transfer effect to other aspects of cognitive functioning,” Charvet said. Charvet noted that the “adaptive” part of this kind of training is key: Based on how well a person is doing on the various exercises, the computer will adjust the difficulty of exercises to match.
“For instance, [the training] slows down when the user slows down or speeds up to drive the learning to maintain a level of engagement to get the most out of the training session,” she said. Charvet and colleagues previously ran a clinical trial that enrolled 135 MS patients with mild-to-moderate cognitive impairment, who were given 12 weeks of at-home adaptive cognitive training (from Brain HQ) or video games with no active component. Results showed a significant benefit in intervention group patients on measures of neuropsychiatric function after the 12 weeks.
In their new study, the researchers wanted to test whether applying transcranial direct current stimulation, or tDCS, might increase the benefits derived from adaptive cognitive training. tDCS is a non-invasive, painless procedure that involves using electrodes on the scalp to stimulate specific parts of the brain. In this case, it is used to stimulate the left dorsolateral prefrontal cortex, a brain region that is important for cognition. The overall goal is to help facilitate changes in the brain’s architecture that lead to cognitive benefits. tDCS is “a very safe and well-tolerated technique,” Charvet noted.
Researchers enrolled 120 people with MS, mostly female and white, who had clinically significant fatigue but not depression or severe cognitive impairment. All underwent 20-minute sessions of adaptive cognitive training daily for 30 days, and they were randomly divided to receive active tDCS or a sham procedure during the training sessions.
“To read this article in its entirety clink this link: Cognitive Training Paired With tDCS Aids Patients.”
Bafiertam is a new oral Disease-Modifying Therapy for relapsing forms of MS.
The active ingredient in Bafiertam is Monomethyl Fumarate or MMF.
It has the same active ingredient as other fumarates (Tecfidera and Vumerity).
Bafiertam has the same established efficacy and well understood safety profile as Tecfidera. Bafiertam reduces the number of relapses, delays the disability progression of MS, and slows the development of brain lesions in MS Patients.
Bafiertam is different from other fumarates, because it does not require metabolic conversion in the stomach to become active. It is directly active MMF.
One of the advantages of not having to be converted in the stomach, is that Bafiertam can be taken with or without food and there are no dietary restrictions.
For patients starting on Bafiertam, Banner Life Sciences can offer a comprehensive Patient Support Program for all patients regardless of insurance coverage. This includes Commercial and Government insurance, as well as under and non-insured patients with MS.
For more information, please visit Patient Homepage | BAFIERTAM® (monomethyl fumarate)
or call our patient support at 1-855-3BANNER
Multiple sclerosis (MS) treatments belonging to the class of sphingosine 1-phosphate (S1P) receptor modulators — such as Mayzent (siponimod) and Gilenya (fingolimod) — may be associated with a greater likelihood of skin cancer, results from a real-world study suggest.
The association was the greatest for a form of cancer called basal cell carcinoma, and was also observed for Lemtrada (alemtuzumab) and Mavenclad (cladribine), although to a lesser extent. Ocrevus (ocrelizumab) also seems to increase the likelihood of melanoma.
The findings, which stem from an analysis of skin cancers reported as treatment adverse events in the FDA Adverse Event Reporting System (FAERS), highlight the need for close skin monitoring in patients receiving such therapies, the researchers wrote.
The study, “S1P receptor modulators in Multiple Sclerosis: Detecting a potential skin cancer safety signal,” was published in the journal Multiple Sclerosis and Related Disorders.
S1P receptor modulators are a class of oral disease-modifying therapies (DMTs) that work to “trap” immune cells inside lymph nodes, preventing them from getting into the nervous system and causing damage.
Gilenya became the first treatment of this class to be approved by the U.S. Food and Drug Administration in 2018, and was closely followed by Mayzent in 2019, Zeposia (ozanimod) in 2020, and Ponvory (ponesimod) in 2021.
“To Read this article in its entirety click this link: More Skin Cancer Reported to FDA From MS Patients on Some Oral DMTs.”