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Archive for the tag “chronic diseases, disability, fatigue, genetics, MS, MS Focus, MS risk factor, multiple sclerosis, Progressive MS, Relapsing MS, treatment, trial”

Prevalence of MS More Than Doubles Estimate

A new study funded by the National MS Society has confirmed that nearly one million people are living with MS in the United States, more than twice the original estimate from a previous study. This breakthrough is a pivotal moment in the MS movement as a scientifically sound measure of prevalence helps us better understand the disease and its impact. With twice as many people living with MS, solutions for MS are now twice as important.

In addition to the main paper outlining these results, two companion papers providing background information on prevalence in the U.S. and reviewing the study methods were also published in the February 15, 2019, online issue of Neurology®, the medical journal of the American Academy of Neurology.

Q: What is prevalence and how is it different from incidence?
A: Prevalence is the number of people living with a disease. Incidence is the number of people newly diagnosed with a disease within a given period of time.

Q: How many people are living with MS in the U.S. according to the new prevalence estimate?
A: Nearly 1 million people (913,925)

Q: How is the new estimate different than numbers used before?
A: More than twice as many people are living with MS than was previously thought.

Q: Where did the earlier MS prevalence number of 400,000 come from?
A: The previous figure of 400,000 was an estimate calculated from population growth since the national study of MS prevalence that was published in 1981.

  1. How did the prevalence number jump from 400,000 to 913,925?
    A. As part of a Society-funded study, researchers developed a novel method for estimating the number of people who are living with MS using large medical claims datasets. This method has produced a higher, and likely more accurate, count.

Q: Why is this information important? And what does it mean for people affected by MS and the work of the National MS Society?
A: Having this scientifically sound prevalence estimate will facilitate a better understanding of the needs of people with MS and the economic burdens imposed by the disease on families and society. It will be a starting point for researchers to understand if MS is increasing, or if there are MS geographic clusters that hold clues to factors that trigger MS. These data will also help ensure that the National MS Society is able to connect to and support all people affected by MS.

Q: Does this mean more people are getting MS than before?
A. We don’t know. Since solid information on the number of people being diagnosed with MS has not been available, it has been difficult to tell whether more people are getting MS or if the total number is just a reflection of overall population growth, better diagnostic procedures, the availability of disease modifying drugs, or other changes in the MS landscape. Going forward, this should become easier. Outside of the U.S., some studies have reported increases in the incidence of MS. More work is needed to understand all the factors that led to this increase.

Q: What was the process to reach this new number and why has it taken so long to get an updated prevalence number of people living with MS in the U.S.?
A: After an examination of what it would take to identify a scientifically sound estimate, the Society funded the work and established a work group of experts across the fields of epidemiology, statistics and health care. This group labored for nearly four years to develop and implement a plan for estimating prevalence as rigorously as possible given the sources of information available. They obtained the proper mix of administrative datasets, developed and validated a formula to identify people with MS then applied it, and the findings were published in a peer-reviewed journal.

Q: Will this change the global number?
A: Yes, this will change the global number (which is most recently estimated at 2.3 million). The global number is calculated through input from MS societies across the globe to the MS International Federation. The MS International Federation is planning to do an update of the “MS Atlas” and when complete, the global number is likely to increase not just from the new U.S. estimate but from other nations as well.

Q: How confident are we in this number?
A: A team of experts led a thorough study based on a sound, scientific process and followed the peer-review process to affirm these results. We have trust and confidence in the approach and methodology that produced these results. In addition, the figures for the US are as high or higher than figures found in other countries using a variety of different methods to calculate the number.

Q: Will this new prevalence estimate help us get to a cure for MS faster?
A: Research breakthroughs related to what causes MS and how to cure it are happening at a faster pace than ever before. Having sound information on how many people are living with MS and who gets MS is an important pathway to a cure.

Q: When and how will the prevalence number be updated again?
A: The National Neurological Conditions Surveillance System, which was authorized in 2016 through the 21st Century Cures Act, has been funded and will be able to update prevalence estimates on a regular basis. This is a culmination of more than a decade of work by MS activists and others across the neurologic community. This system will provide important demographic data to help researchers move more quickly toward cures for the millions of people who live with diseases like MS and Parkinson’s.

Q: Why do we only have an estimate of the number of people with MS, versus knowing the exact figure?
A: Unlike for certain infectious disorders, there is no requirement for healthcare providers to report to health authorities when a person is diagnosed with MS. Although a nearly exact count could be made by contacting doctors, hospitals, and other health care facilities, such a study would be prohibitively expensive and almost impossible to implement.

Results Published from Trial of Siponimod in Secondary Progressive MS

  • Results of a 60-month, phase III clinical trial of the experimental oral therapy siponimod (BAF312, Novartis Pharmaceuticals AG) involving 1,651 people with secondary progressive MS have been published. The results were originally presented in September 2016 at the ECTRIMS conference.
  • The trial met its primary endpoint of reducing the risk of disability progression compared with inactive placebo. Those on active treatment had a 21% reduced risk of disability progression compared to those on placebo. Secondary endpoints suggested that those on active therapy had 23% lower average change in brain volume and reduced lesion volume. There was no significant difference seen between groups in the timed 25-foot walk.
  • The therapy was generally well tolerated and similar to adverse events reported for similar compounds. The serious adverse events reported to be more likely for those taking siponimod included nervous system disorders and infections.
  • Dr. Ludwig Kappos (University of Basel in Switzerland) and a large team of investigators report detailed results of the trial in The Lancet (online March 22, 2018). A commentary about the results by Drs. Luanne Metz and Wei-Qiau Liu (University of Calgary) is also published online.

DETAILS
Background: Siponimod (BAF312) is an experimental immune system-modulating therapy that was designed to be a more selective sphingosine 1-phosphate receptor modulator than Gilenya® (fingolimod, Novartis International AG). Gilenya, was approved in 2010 for adults with relapsing forms of MS to reduce the frequency of clinical relapses and to delay the accumulation of physical disability. Siponimod previously demonstrated safety and efficacy on MRI scans in a phase II study in people with relapsing-remitting MS (The Lancet Neurology, 2013 Aug;12(8):756-67).

Siponimod is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system. Siponimod also distributes effectively to the central nervous system (brain and spinal cord) where it may have direct anti-inflammatory or other effects.

The Study: Participants with secondary progressive MS were randomly assigned to take siponimod or placebo capsules daily for up to 60 months. The primary endpoint of the study was reducing the risk of disability progression, as measured by the EDSS scale that was sustained for at least 3 months. Secondary endpoints included reducing the risk of disability progression as measured by the EDSS at six months, the risk of worsening mobility as measured by the timed 25-foot walk test, disease activity as observed on MRI scans, relapse rate, and safety/tolerability.

Results: The results were originally presented in September 2016 at the ECTRIMS conference. The trial met its primary endpoint of reducing the risk of disability progression compared with inactive placebo. Those on active treatment had a 21% reduced risk of disability progression (confirmed at 3 months) compared to those on placebo. Secondary endpoints suggested that those on active therapy had a 23% lower average change in brain volume, and reduced MRI-detected brain lesion volume. There was no significant difference seen between groups in the timed 25-foot walk. Relapse rates were significantly lower in those taking siponimod.

Safety: The therapy was generally well tolerated and similar to adverse events reported for related compounds. Serious adverse events occurred in 16.7% of participants. The serious adverse events reported to be more likely for those taking siponimod included nervous system disorders and infections. More of those taking siponimod than the placebo experienced adverse events (89% vs 82% patients), such as a slower heart rate, high blood pressure, reduced white blood cell counts, macular oedema (swelling at the back of the eye), increased liver enzymes, and increased numbers of convulsions.

Dr. Ludwig Kappos (University of Basel in Switzerland) and a large team of investigators report detailed results of the trial in The Lancet (online March 22, 2018). A commentary about the results by Drs. Luanne Metz and Wei-Qiau Liu (University of Calgary) is also published online.

Comment: “While the magnitude of this response is somewhat modest, it represents a milestone in our unrelenting search for treatments that will benefit people living with progressive forms of MS,” said Bruce Bebo, PhD, Executive Vice President of Research at the National MS Society.

Resources
Read about secondary progressive MS
Read about the International Progressive MS Alliance, an unprecedented global collaboration of MS organizations, researchers, clinicians, pharmaceutical companies, and people with progressive MS, transforming the landscape of multiple sclerosis.

 

New research strengthens genetics, MS link

 

In a large-scale, genome-wide analysis of more than 110,000 samples, researchers identified 200 genetic loci associated with multiple sclerosis. The study authors said that while the research highlights the role of several different immune cells that contribute to the initiation of this inflammatory disease, the mechanisms that lead this inflammatory disease to target the brain and spinal cord remain unclear.

By comparing the genomes of people with and without MS, the researchers identified 200 variants that were significantly more common among those with the disease. Most of these variants implicate genes that are associated with immune cells and immune system function, including a few potentially specific to brain-related functions.

Interestingly, many of the genes identified were known to also be involved in other autoimmune diseases, such as rheumatoid arthritis, Type I diabetes, and ulcerative colitis. This raises intriguing questions about why these diseases target different organs and have different clinical manifestations.

The findings were presented at the American Society of Human Genetics (ASHG) 2016 annual meeting in Vancouver, B.C.

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