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Archive for the tag “chronic disease”

New Study: Resilience in People with Chronic Disease is Linked to Social Satisfaction and Quality of Life – Not Physical Function

Summary

  • A survey of more than 1500 people with MS and other chronic diseases shows that resilience (the ability to solve problems and bounce back from difficult situations) is linked to satisfaction with social roles (such as work and family responsibilities) and quality of life, but not to physical function.
  • Understanding factors that promote resilience may help people with MS to not only cope with unpredictable changes in health and abilities, but to thrive in spite of these changes.  Learn more about how the resilience factor can help you to thrive. Watch an education program on Resilience: Addressing the Challenges of MS.
  • The team (Samuel Battalio, BS, and colleagues at the University of Washington) has published results in Archives of Physical Medicine and Rehabilitation (2016 Dec 16).

Background: Research on psychosocial issues forms a cornerstone of finding life-changing solutions for people with MS. MS can have a significant impact on a person’s emotions, not only because MS is unpredictable and challenging to live with, but because it affects parts of the brain that control mood. This study specifically looked at factors that can affect resilience (i.e., the ability tackle problems, find solutions and bounce back from difficult situations).

The Study: The team reviewed information on 1574 people with MS, muscular dystrophy, post poliomyelitis syndrome, and spinal cord injury, which was gathered from an ongoing survey that is tracking people in the United States who are aging with physical disabilities. Information was collected on resilience using a clinical scale, and on other factors (including physical function, satisfaction with social roles – meaning work and family responsibilities, and quality of life) using questionnaires that assess how people report their own health status.

The results suggest that people who reported significantly greater satisfaction with social roles and significantly greater quality of life had significantly higher resilience. This relationship was slightly different between men and women, in that men who expressed greater levels of satisfaction with social roles reported higher levels of resilience. Surprisingly, noted the authors, resilience was not significantly greater in people who reported better physical function.

The team (Samuel Battalio, BS, and colleagues at the University of Washington) has published results in Archives of Physical Medicine and Rehabilitation (2016 Dec 16).

Next Steps: The authors note that resilience is complex, and that further research could help uncover particular aspects of resilience that may be most beneficial to individuals.  Understanding factors that promote resilience may help people with MS to not only cope with unpredictable changes in health and abilities, but to thrive in spite of these changes.

There are behaviors that can help promote individuals’ resilience:

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Finding Solutions for the Advanced Care Needs of People with MS

While researchers are working to identify new and better strategies to stop MS, restore function and end MS forever, people whose MS has become more disabling—and their family members and friends—need information right now about how to manage the challenges they face. With these goals in mind, the National MS Society convened a group of key stakeholders – including people with MS, support partners, Society staff and clinicians from the fields of neurology, primary care, rehabilitation medicine, psychology, nursing, physical therapy and speech pathology– to help inform the Society’s role in finding solutions for individuals and families who are facing advanced care needs.

“At the Society, when we face a challenge, we get the brightest minds together and put the problems on the table,” said Cyndi Zagieboylo, President & CEO of the National MS Society. “We need to pursue every opportunity to support people with advanced MS in living their best lives.”

What It’s Like

People living with MS lent a vital voice to the process. “It’s going to be very important as you think about this that you understand our lived experience,” urged Lisa Iezzoni, MD, a health services researcher who has MS. “It takes me about 10 times longer to do the most basic task.”
Karen Jackson, who lives with primary progressive MS, agreed. “Having advanced MS means I have lost the ability to be spontaneous,” she said. “I am forced to plan every minute of every day. The only thing more exhausting than planning my day, is not planning. It takes an annoying sequence of action steps to achieve even the smallest goal, like buying gas or parking the car.”

Resilience, however, rang through despite the challenges of advanced care needs, which for both of these women includes wheeled mobility. “When people ask me how I feel about my MS, I tell them that I’m not sick,” insisted Dr. Iezzoni. “I just can’t walk.” Ms. Jackson added, “Explain to people what your needs are. They want to help.” It’s worth the effort, she says. “Not participating in life is not an option.”

If I Have to Use a Wheelchair…
Getting a wheelchair was noted to be a “line in the sand” for many people living with MS, who often view the choice to use one as a loss of independence.  Meanwhile, by trying to stay on their feet, people might be curtailing activities because of increased fatigue, or concerns about stumbling or falling.

“One of our challenges is that the wheelchair is used to symbolize disability,” said physical therapist Jean Minkel (Independence Care System. New York). “The wheelchair should not be considered a failure of therapy.”

Dr. Iezzoni heartily agrees. “When I finally started using a wheelchair 14 years after my first MS symptom, it was like spring after a housebound winter,” she said. “Silliness – that I was afraid people wouldn’t think I was strong because I was using a wheelchair.” Ms. Jackson agreed. “I’m learning to navigate a new normal,” she said. “My goal when I meet you is to have my chair disappear in 10 minutes, so that you only see me!”

Evaluating the home environment is key to determining the type of mobility device needed. “A picture is worth a thousand words and a home visit is a narrative,” said Ms. Minkel.  “To understand the need, we need to see the environment. For example, show me what the front door looks like.”

The wheeled device is not the only crucial factor – so is choosing the proper cushion to sit on. Some cushions can relieve pressure, thus preventing pressure sores (sites of damaged skin that can cause serious infections). “Thirty percent of our clients are at risk for pressure sores,” said Minkel. “Only two percent get them because they have pressure-relieving wheelchair cushions.”

The National MS Society provides guidance for people with MS and healthcare providers to navigate the process of choosing and obtaining coverage for a wheeled device.

Finding Solutions
Participants considered other key issues related to the advanced care needs of people with MS, naming some difficult problems and suggesting solutions.

  • Breathing easier — “Respiratory dysfunction begins very early in the disease process,” noted physical therapist Donna Fry, PhD (University of Michigan-Flint). But, she said, respiratory exercises can improve strength in respiratory muscles even late in the disease. Dr. Fry’s team has shown these improvements using “threshold inspiratory muscle trainers,” inexpensive devices that can help breathing muscles to get stronger. “Most clinicians are not aware of the potential early involvement of the respiratory system in people with MS and of accessible, inexpensive equipment that can enhance muscle strength,” she added.
  • Muscle spasticity — “Quite a few people with MS are experiencing significant problems from spasticity,” said neurologist Francois Bethoux, MD (Cleveland Clinic). Spasticity may be as mild as the feeling of tightness of muscles or may be so severe as to produce painful, uncontrollable spasms in the extremities, usually the legs. Dr. Bethoux believes spasticity can often be managed without specialized care. “Optimal care would involve an early diagnosis, setting realistic goals, and re-evaluation,” he said. Plus, stretching is vital, even if mobility is impaired
  • Swallowing — “We all swallow 400-500 times a day, often without knowing,” said speech-language pathologist Alex Burnham (The Boston Home). “But 30-40% of people with MS can have problems with swallowing.” The consequences can be serious – breathing in food or fluids, choking, malnutrition, dehydration, and not taking medicine. Especially later in the disease, says Mr. Burnham, swallowing and feeding issues can have dramatic effects on quality of life, especially if it limits enjoying a meal with friends and family or prevents someone from eating favorite, culturally-significant foods. Mr. Burnham advocated for screening for these problems during regular visits. “Ask patients, have you had any trouble eating? Swallowing your pills?” Burnham also mentioned novel therapies that may prove helpful, such as the “free water protocol,” in which patients are allowed to have water by itself to improve hydration. Another method is neuromuscular electrical stimulation, applied in low doses to the neck
  • Speech — Swallowing disorders can occur hand-in-hand with speech difficulties. “It’s never too early to start thinking about assistive technology, especially for people with a wide fluctuation of symptoms,” noted Mr. Burnham. “They might be fine in the morning, but then if they don’t get a nap, fatigue makes it hard for them to speak intelligibly later in the day.” Give people with MS an opportunity to use as many different modes of communication as possible, he advised. “Miscommunication can lead to frustration, social isolation, and a loss of independence,” said Mr. Burnham. “Maintaining any form of communication is critical for empowerment, relationships, and appropriate disease management.”  , including the use of smartphone applications.
  • Thinking and mood problems – “Cognitive changes are among the most prevalent reasons that people with MS are admitted to nursing homes,” said Rosalind Kalb, PhD, Vice President, Healthcare Information and Resources at the Society. “We need to be providing strategies to help people compensate for cognitive changes, and we need to speak to family members, since families may help to pick these changes up earlier.” With mood, it’s vital to understand that although depression in common in MS, some mood changes may be a natural consequence of the process of an advancing chronic disease. “People may be grieving over changes,” said Dr. Kalb. “We need to treat depression when it is present and also be respectful and comfortable with talking with people who are not depressed about how they want to live the rest of their lives.”

Achieving Optimal Care
The group discussed how to achieve optimal care for people with advanced MS.  Nicholas LaRocca, PhD, Vice President of Healthcare Delivery and Policy at the Society, noted that health care concerns are changing as the MS population gets older. “The average age of people with MS has increased by over 30 years since 1984,” he said. “Coexisting conditions, such as hypertension, increase with age and appear to be increasing in MS. Furthermore, people with MS who have some of these conditions at diagnosis reach the most severe level of mobility impairment faster than those who don’t.”

The group agreed that education is needed on both ends of this spectrum. Primary care providers need to be educated about MS so that they can distinguish MS symptoms from conditions that require primary care. And people with MS need to be educated about the importance of watching out for their own health. “A person with a disability still needs their cholesterol checked,” said Ms. Minkel. ”They still need their blood pressure checked.” Neurologists and primary care providers need to communicate, collaborate and coordinate their care of a person with MS.

Early and ongoing evaluation of symptoms also is key. “We need to educate people with MS and their caregivers about advocating for chronic care issues,” said Ruth Whitham, MD (Oregon Health& Science University). “Perhaps we can develop an advanced MS care checklist that would include symptoms to think about and what to do if you notice them.” The goal is to help people with MS to advocate for early and ongoing assessment, and for healthcare providers to ask routinely about changes that may be occurring throughout all bodily systems.
Importantly, people with MS need to know they have the right to advocate for care, regardless of how advanced their MS. “We don’t ever want a person to hear, ‘There’s nothing more we can do for you,’” added Dr. Kalb.

Caring for Caregivers
Speakers paid careful attention to how advanced care needs can affect caregivers.
“Families can become isolated,” said psychologist David Rintel, EdD, whose father lived with MS. “You feel pretty different from everyone else, and that isolation is harmful to your physical and mental health.” He advised that healthcare providers should see the caregiver occasionally along with the patient, if the patient grants permission, to get their perspective, and also see how the caregiver themselves are doing. “We need to learn the signs of burnout, such as depression, and increased use of alcohol,” he said. “Caregiver burden is real.”

There also is much that a caregiver needs to learn – navigating the healthcare system, how to transfer people safely, and management of bladder and bowel problems. “Dealing with bowel/bladder issues is actually a leading cause of caregiver burnout,” added nurse Cindy Walsh (The Boston Home).

“Families have to learn how to ask for help,” said Dr. Rintel. “They have to ask in a way where they say what, where, when and how long. Most people would help if they understood specifically what you need.”

Next Steps
The group identified the highest priority research questions that need to be answered concerning the care and support of people with advanced care needs and their families, pinpointing questions in the areas of assistive technology; comorbidities and primary care; health care system issues (e.g., insurance coverage); long-term care; symptoms and complications; skin care; speech, swallowing, and pulmonary functions; and the benefits of wellness/lifestyle interventions. They are now formulating a prioritized list of these questions to help inform the Society’s next steps.

A white paper describing the meeting’s discussion highlights and recommendations regarding the Society’s response to the needs of those affected by advanced MS will be posted on the Society’s web site, and a similar paper will be submitted for publication in a peer-reviewed journal.

Help is Available Now
Individuals nationwide may contact the Society’s MS Navigator® program via the Society’s toll-free help line 1-800-344-4867 (1-800-FIGHT MS) or via email (contactusNMSS@nmss.org). The MS Navigator Program connects people to resources,, helps people access optimal healthcare and understand benefits such as health insurance, face financial challenges and planning for the future, and find support when MS progresses.

Right now, MS activists are engaged on a number of fronts to improve quality of life and access to care. Among these is advancing home modification tax credit legislation, to provide financial relief for home modifications to promote safety and mobility.
The National MS Society provides support to people living with advanced MS, including care guides for families, information about symptom management, a guide to financial planning, and information on advanced directives. Read more

The Society also provides support for healthcare professionals who are seeking to help people with MS obtain care at home, in nursing homes, assisted living facilities, or adult day homes. Read more

 

Positive Results from Study of Bone Marrow-Derived Stem Cells in People with Aggressive, Relapsing MS

Summary

  • Researchers in Canada have published results of a long-term trial of an individuals’ own (autologous) hematopoietic (blood cell-producing) stem cell transplantation. The study involved 24 people with aggressive relapsing-remitting MS whose disease was not controlled with available therapies.
  • Three years after the procedure, 70% remained free of disease activity, with no relapses, no new MRI-detected inflammatory brain lesions, and no signs of progression.
  • None of the surviving participants, who were followed for 4 to 13 years after the procedure, experienced clinical relapses or required MS disease-modifying therapies to control their disease, and 40% experienced reductions in disability.
  • One of the participants died and another required intensive hospital care for liver complications. All participants developed fevers, which were frequently associated with infections, and other toxicities.
  • Additional research is focusing on figuring out who might benefit from this procedure and how to reduce its risks.

“These results suggest that aggressive MS may be stopped with an effective but risky procedure, for a subset of people,” said Dr. Bruce Bebo, Executive Vice President, Research, at the National MS Society. “Additional research by investigators around the world is focusing on figuring out who might benefit from this procedure and how to reduce its risks, which can include death.”

Details
Background: An experimental procedure that has been explored for several years in MS is called “autologous hematopoietic (blood cell-producing) stem cell transplantation” – or HSCT. This procedure has been used in attempts to “reboot” the immune system, which launches attacks on the brain and spinal cord in people with MS.

In HSCT, the stem cells (derived from a person’s own bone marrow or blood) are stored, and the rest of the individual’s immune cells are depleted by chemotherapy. Then the stored stem cells are reintroduced by infusion into the vein. The new stem cells migrate to the bone marrow and over time produce new blood cells, including immune cells. The goal of this currently experimental procedure is to establish a new immune system that no longer recognizes myelin and other nervous system tissue as dangerous. In theory, this should stop the attacks that lead to tissue damage and disability.

There are a number of laboratories around the world testing variations of HSCT for the treatment of autoimmune diseases, including MS. Preliminary findings suggest this is a promising, but potentially risky strategy for the treatment of MS.

The Study: Drs. Harold Atkins, Mark Freedman and team at the Ottawa Hospital, University of Ottawa and other institutions in Canada conducted a Phase 2 trial of HSCT that involved 24 people with aggressive relapsing-remitting MS whose disease was not controlled with available therapies. No control group was used which would have enabled comparison against the results found in the treatment group. The procedure used by this group included complete destruction of bone marrow cells and an additional step that enriched the transplanted cells for stem cells.

Results – Safety: One of the participants died of transplantation-related complications that caused liver failure and another required intensive hospital care for liver complications. The treatment regimen was modified over the course of the study to reduce toxicity, but all participants still developed fevers, which were frequently associated with infections.

Results – Effectiveness: Three years after the procedure, 70% of the participants remained free of disease activity, meaning they had no relapses, no new MRI-detected inflammatory brain lesions, and no signs of progression. The remaining 30% experienced progression of disability. In addition, for the entire follow-up period ranging from 4 to 13 years after the procedure, of the 23 survivors:

  • None experienced clinical relapse, had new active inflammatory MRI brain lesions, or required MS disease-modifying therapies to control their disease.
  • The average rate of brain atrophy (shrinkage), a measure that has been linked to MS progression, returned to levels associated with normal aging.
  • 40 percent experienced some lasting reversal of disability such as vision loss, muscle weakness and balance problems.
  • Some were able to return to work or school.

The results were published online on June 9, 2016 in The Lancet.  Major funding for the study came from the MS Society of Canada and its affiliated Multiple Sclerosis Scientific Research Foundation.

Next Steps: Rigorous clinical trials of stem cell therapies are needed to determine their safety and effectiveness in people with MS. Trials of this and other stem cell therapy approaches are taking place in Canada, the United States, Europe and elsewhere. To help explore the potential of stem cell therapy, in November 2015, the International Conference on Cell-Based Therapy for Multiple Sclerosis was convened in Lisbon, Portugal under the auspices of the International Advisory Committee on Clinical Trials in MS (a group jointly sponsored by the National MS Society and the European Committee for Treatment and Research in Multiple Sclerosis). Seventy leading researchers and clinicians conferred on clinical trials needed to provide answers about which types of cells, which route of delivery, and which types and stages of disease, would be the most promising approach for treating MS. Read more about this meeting

Read more about stem cells and MS

German Study Suggests Leukemia and Colorectal Cancer Rates Increased with Mitoxantrone Use for MS

Summary

  • A study of 676 people with MS treated with the MS therapy mitoxantrone in Germany reveals that the rates of acute myeloid leukemia (a type of cancer) and colorectal cancer were significantly increased above what would be expected in the general population there. Rates of other cancers were not increased.
  • The authors note that if the findings are confirmed, recommending colonoscopy after treatment may be advisable, since if found early enough, colorectal cancer is curable.
  • The team (led by Dr. Mathias Buttmann, University of Würzburg, Germany) has published results in Neurology (published early online, May 11, 2016).

Background: Mitoxantrone is a powerful immune-suppressing therapy. Prior to its approval for use in MS, it was used only to treat certain forms of cancer. It acts in MS by suppressing the activity of immune T cells, B cells, and macrophages that are thought to lead the attack on nerve-insulating myelin. The U.S. Food and Drug Administration approved mitoxantrone for reducing neurologic disability and/or the frequency of relapses in people with secondary progressive MS or worsening relapsing-remitting MS. The total lifetime dose is limited to avoid possible heart damage. Acute myeloid leukemia has been previously reported in people treated with mitoxantrone for MS or cancer.

The Study: Investigators identified 677 people with MS seen at the University of Würzburg MS center between January 1994 and December 2007 who had received mitoxantrone. They were able to follow up with 676 of these patients.

The results show that 37 people developed cancer after taking mitoxantrone, including nine cases of breast cancer, seven cases of colorectal cancer, and four cases of acute myeloid leukemia. The rate of acute myeloid leukemia was 10 times that seen in the general population in Germany. The rate of colorectal cancer was three times that seen in the general population in Germany. The rate of breast and other cancers was not increased over that seen in the general population in Germany. Older age at treatment was associated with increased risk of cancer, but not prior use of other immunosuppressive treatments, or duration of treatment with mitoxantrone.

The team (led by Dr. Mathias Buttmann, University of Würzburg, Germany) has published results in Neurology (published early online, May 11, 2016).

Comment: The authors state that if the findings are confirmed, “posttreatment colonoscopy might improve the risk-benefit ratio of this highly active immunosuppressive drug,” since if found early enough, colorectal cancer is curable. They also note that mitoxantrone is currently the only MS therapy approved for treating secondary progressive MS, and that the overall rate of cancers may still justify the use of mitoxantrone in people who are severely affected with MS and where there are no better treatment options available.

Read more about mitoxantrone
Read more about treating secondary progressive MS
Read more about making treatment decisions in MS

 

Brain-training Video Games May Help MS Patients

A new study suggests that playing a certain kind of video game strengthens neural connections in the brains of people with multiple sclerosis, improving cognitive abilities. Researchers hope to study whether the plasticity induced by video games in MS patients is linked to improvements in other aspects of their daily lives. They also plan to look at how the video game can be integrated into a rehabilitation program.
Researchers, led by Dr. Laura De Giglio, from the Department of Neurology and Psychiatry at Sapienza University in Rome, studied the effects of a video game-based cognitive rehabilitation program on the thalamus in patients with MS. They used a collection of Nintendo video games, called Dr. Kawashima’s Brain Training, which train the brain using puzzles, word memory and other mental challenges.
Twenty-four MS patients with cognitive impairment were randomly assigned to either take part in an eight-week, home-based rehabilitation program — consisting of 30-minute gaming sessions, five days per week — or be put on a wait list, serving as the control group. Patients were evaluated by cognitive tests and by 3-Tesla resting state functional MRI at baseline and after the eight-week period. At follow-up, the 12 patients in the video-game group had significant increases in thalamic functional connectivity in brain areas corresponding to the posterior component of the default mode network, which is one of the most important brain networks involved in cognition.
The modifications in functional connectivity shown in the video game group after training corresponded to significant improvements in test scores assessing sustained attention and executive function. The results suggest that video-game-based brain training is an effective option to improve cognitive abilities of patients with MS.

Study suggests possible inside-out origin for MS

A new study suggests an inside-out theory of multiple sclerosis in which the disease may be triggered by the death of brain cells that make the insulation around nerve fibers, according to a new study from Northwestern Medicine and the University of Chicago researchers. Creating a mouse-model of progressive MS, scientists also used a specially developed nanoparticle that prevented MS even after the death of those brain cells.
The new study shows the possibility that MS can begin from the inside out, in which damage to oligodendrocytes in the central nervous system can trigger an immune response directly. Oligodendrocytes can possibly be destroyed by developmental abnormalities, viruses, bacterial toxins or environmental pollutants. Oligodendrocytes are responsible for the maintenance of myelin. If they die, the myelin sheath falls apart. The death of these cells can activate the autoimmune response against myelin, which is the main feature of MS. The inside-out hypothesis suggests that when myelin falls apart, the immune system interprets the products of its degradation as foreign bodies or antigens, erroneously viewing them as invaders and beginning a full-scale attack on myelin, initiating MS.
“Protecting oligodendrocytes in susceptible individuals might help delay or prevent MS from initiating. It’s likely that therapeutic strategies that intervene early in the disease process will have greater impact,” said Brian Popko, the Jack Miller Professor of Neurological Disorders at the University of Chicago and one of the lead investigators in the study.
The scientists also developed the first mouse model of the progressive form of the autoimmune disease, which will enable the testing of new drugs against progressive MS. In the study, nanoparticles creating tolerance to the myelin antigen were administered and prevented progressive MS from developing. The nanoparticles are being developed for clinical trials that could lead to new treatments – without the side effects of current therapies – in adults.
The study was published in Nature Neuroscience.

Mom’s Story, a Child Learns about MS is available in more formats

Mom’s Story can be found on the following sales channels:
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Also available on Kindle, Nook,

Available as .Mobi and .epub files from mjnickum@saguarobooks.com

An FDA Approved Generic Form of Copaxone® (Glatiramer Acetate) For Relapsing MS Called Glatopa™ Is Launched In the U.S.

A generic equivalent of daily Copaxone® (glatiramer acetate, 20 mg), called “Glatopa”™ (Sandoz, a Novartis company, developed in collaboration with Momenta Pharmaceuticals) that was approved by the U.S. Food and Drug Administration in April, has been launched in the U.S. Glatopa is a disease-modifying therapy for people with relapsing forms of MS, including those who have experienced a first clinical episode and have MRI features consistent with MS.

The generic medication is a 20mg dose injected under the skin every day. This approval means that the manufacturer provided evidence that this generic medication is equivalent to the brand-name drug (Copaxone®).

According to Novartis which owns Sandoz, Glatopa would have a wholesale list price of about $63,000 per year. This is an estimated 15- 18 percent less than the list price of daily Copaxone. Sandoz advises that it will offer support services that include financial assistance to qualified patients, personalized injection training and 24-hour access to nurses for non-clinical questions, services not typically offered for generic medications.

“Having a generic option for one of the MS disease-modifying therapies is an important milestone, and it has the potential to increase access to MS therapies,” commented Dr. Bruce Bebo, Executive Vice President, Research at the National MS Society. “As more generic and biosimilar options become available, we are hopeful that we will start to see some price relief for people living with MS” he added.

“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in an FDA press release. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.” The FDA’s press release provides additional details (available here) related to how the agency determined the generic’s equivalency.

Selecting a therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.

About Glatopa: The FDA has approved a generic medication that has been shown to be equivalent to 20mg daily glatiramer acetate. Glatopa is not a generic version of the 40mg dose of Copaxone taken every three days. Glatiramer acetate is a synthetic protein that mimics myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. The approved generic form of glatiramer acetate is given by subcutaneous (under the skin) injections every day.

Potential benefits: In clinical trials of glatiramer acetate, it was shown to significantly reduce annual relapse rates and new brain lesions as shown on magnetic resonance imaging (MRI), when compared to those who were given a placebo. This therapy has had a long track record of effectiveness and safety.

As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations. Clinical trials are generally not required to prove equivalence to a brand-name medication.

Potential risks and side effects: Side effects of glatiramer acetate that generally resolve on their own and do not require medical attention unless they continue for several weeks or are bothersome include injection-site reactions (e.g., swelling, the development of a hardened lump, redness, tenderness, increased warmth of the skin, itching at the site of the injection); runny nose; tremor; unusual tiredness or weakness; and weight gain. There is also the potential for local damage to the skin (necrosis) and underlying tissue (lipoatrophy).

Some people using glatiramer acetate experience, at one time or another, a very temporary reaction immediately after injecting glatiramer acetate. This reaction, which often occurs only once, includes flushing or chest tightness with heart palpitations, anxiety, and difficulty breathing. During the clinical trials, these reactions occurred very rarely, usually within minutes of an injection. They lasted approximately 15 minutes and resolved without further problem.

Unusual side effects of glatiramer acetate that should be discussed as soon as possible with your doctor include hives (an itchy, blotchy swelling of the skin) or severe pain at the injection site.

The National MS Society will provide more information about generic glatiramer acetate as it becomes available.

Download prescribing information (.pdf)
Read a press release from the FDA
Read more about disease-modifying therapies and other treatments for MS and MS symptoms.

Frequently Asked Questions: Approval of Generic Glatiramer Acetate

When will generic glatiramer acetate be available for prescription?

  • There is no information yet about when this medication, called Glatopa, will be available for prescription in the United States.

What will the generic glatiramer acetate cost?

  • Though we don’t have specific costs of Glatopa at this time, according to Novartis which owns Sandoz, the product would have a wholesale list price of about $63,000 per year.

What does it mean for a therapy to go generic – will Copaxone still be available for prescription?

  • As patent protections expire for Copaxone, other manufacturers are free to replicate it and seek drug regulatory agency approval to market it.
  • For many medications available as generics, the brand-name medications remain on the market. From the information currently available, it is expected that Copaxone will continue to be available by prescription in both the 20mg once daily dose, and the 40mg dose taken every three days.

What about insurance coverage for the generic or for Copaxone – will I be forced to switch from my current medication?

  • Coverage of prescriptions differs among various insurers. At this point we don’t know how insurers will handle coverage of Copaxone versus generic glatiramer acetate.

Does this generic medication 20mg dose have the same therapeutic benefit as 20 mg Copaxone?

  • The FDA has a thorough review process and guidelines in place to evaluate the equivalence of proposed generic drugs to brand name drug products.
  • If the FDA reviews and approves a generic medication, it means the medication’s maker has provided sufficient evidence that the generic will have the same therapeutic benefits as the brand-name product.
  • The U.S. FDA is empowered by Congress to evaluate generic drug candidates through Abbreviated New Drug Applications.
  • The National MS Society has confidence in the FDA’s processes.

Will patient support services be available to people who are prescribed Glatopa?

  • According to Sandoz, it will offer support services that include financial assistance to qualified patients, personalized injection training, and 24-hour access to nurses for non-clinical questions.

Frequently Asked Questions: Generic Therapies for the Treatment of MS

The MS therapy landscape is continuously evolving. Two decades ago there were no disease-modifying therapies available, and now there are more than a dozen. We have also reached the point where “generic” versions of MS therapies are entering the marketplace. The following provides information about generic drugs and what they may mean for the MS community.

What is a generic medication?

  • A generic medication is a product that is equivalent to a brand-name drug whose patent protections have expired.
  • As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations.
  • Generic makers are required to show that the generic drug delivers the same amount of active ingredients to the person’s bloodstream in the same amount of time as the brand-name product (referred to as “bioequivalency”).

What is the Society’s view of generic therapies for MS?

  • The National MS Society advocates for increased treatment options for people with all forms of MS. Early and ongoing treatment is currently the best known way to reduce future disease activity.
  • Having approved generics has the potential to increase individuals’ access to MS therapies and provides the MS community with more options.

Does the National MS Society recommend the use of this new generic MS therapy?

  • The National MS Society does not make individual treatment recommendations, but as we do for all other approved therapies, we make information available to constituents so that they can make informed decisions about their treatment choices.

Do generic medications have the same therapeutic benefit as name-brand medications?

  • The FDA has a thorough review process and guidelines in place to evaluate the equivalence of proposed generic drugs to brand name drug products.
  • If the FDA reviews and approves a generic medication, it means the medication’s maker has provided sufficient evidence that the generic will have the same therapeutic benefits as the brand-name product.
  • The U.S. FDA is empowered by Congress to evaluate generic drug candidates through Abbreviated New Drug Applications.
  • The National MS Society has confidence in the FDA’s processes.

Will there be equivalent medications for all MS therapies?

  • It’s possible that eventually there will be. But before any medication may be copied, the patents protecting the brand-name medication must expire. Then a maker of equivalent medications would need to apply to the FDA with a request for approval of its medication.
  • The term “generic” technically applies to products that are considered drugs made through a chemical manufacturing process. Some of the MS therapies are classified as chemical drugs, and so when their patents expire, they would likely be eligible to be manufactured as generics. These FDA-approved therapies are classified as chemical drugs: Aubagio, Copaxone, Gilenya and Tecfidera.
  • The other MS therapies — Avonex, Betaseron, Extavia, Lemtrada, Plegridy, Rebif, and Tysabri — are technically classified as “biologics.” Biologics are generally more complex and they are made from human or animal materials rather than chemical processes. The technical term for equivalent medications for biologics is “biosimilar” or “follow-on biologic.”
  • The FDA has long-established requirements for the approval of generic medications, and has recently released guidelines related to the approval of biosimilars.

What is the current progress toward developing equivalent medications for MS therapies?

  • The FDA just approved a generic form of glatiramer acetate, and the agency has received Abbreviated New Drug Applications for other generic forms of this medication.
  • With the exception of Novantrone and Copaxone, no other disease-modifying MS medications are available in a generic form.

Where can I get more information about generic drugs and biosimilars?

The FDA’s Website has information about generic drugs and biosimilars and processes for their approval.

Copaxone is a registered trademark of Teva Pharmaceutical Industries LTD.
Glatopa is a trademark of Novartis AG

Study Uncovers Gene Variation Linked to Response to MS Therapy; May Open Up New Treatment Approaches

Collaborating researchers in the U.S. and Italy have uncovered a gene variant that appears to influence whether a person responds well to interferon beta, a commonly used therapy for relapsing forms of MS. More broadly, the gene may regulate immune activity in unexpected ways, and its discovery may lead to new approaches to stopping inflammation and immune attacks in MS. Drs. Federica Esposito and Filippo Martinelli Boneschi (San Raffaele Scientific Institute, Milan), Philip L. De Jager (Brigham and Women’s Hospital, Boston) and colleagues have published their results in the Annals of Neurology (Early online May 14, 2015). The study was supported by the National MS Society and several other agencies.

Background: For reasons that are unclear, some people with relapsing forms of MS do not respond well to therapy and continue to experience disease activity despite being on a disease-modifying therapy. Previous genetic studies in MS have uncovered over 159 genetic variations that contribute to making people susceptible to developing MS, but these studies haven’t identified genetic variations that influence how a person responds to treatment. Finding a way to identify early in the disease course the best therapy for an individual – a “personalized medicine” approach – is likely to improve outcomes of treatment and quality of life for people living with MS. One of the lead authors of this study, Dr. De Jager, recently won the Barancik Prize for Innovation in MS Research for tackling critical questions like this with the goal of developing personalized treatments and prevention of MS.

This Study: Trying a different approach to search for genetic influences on treatment responses, the investigators first studied a group of individuals with MS who were taking interferon beta or glatiramer acetate. The individuals were classified as being responders, partial responders, or non-responders to their medication based on specific criteria. Then the researchers analyzed their full complement of genes (genome-wide association study) and found one genetic variant that was consistently associated with lack of response to interferon beta. When the researchers repeated this in three other groups of people with MS from Italy, France and the U.S., this finding held up.

The genetic variant (rs9828519) is near a gene (SLC9A9) that controls pH levels (acidity) within cells. The team explored functions of this gene, and found that its activity was diminished in people more likely to have MS relapses. They also conducted laboratory work, finding suggestions that the gene appears to play a role in regulating immune cell activity, and that its loss leads to damaging immune reactions. This suggests the gene may play a broader role in regulating immune activity.

Comment: Although the results of this study are not yet ready for applying to the management of MS, this discovery may lead to new approaches for stopping inflammation and immune attacks in MS. In addition, this study is an important step toward the goal of personalized medicine. The researchers point out that additional research is warranted to confirm their findings and to determine whether the genetic variant is relevant to how well people respond to other MS medications.

Study on Escalating MS Therapy Costs in the US Reported in the Journal Neurology

The journal Neurology has recently published a compelling report on a study conducted by a research team at Oregon State University and Oregon Health & Science University that examines the pricing trajectories in the US of disease modifying therapies over the last 20 year and assesses the influence of what appear to be unexplained rising prices.

Access to affordable, high quality healthcare is essential for people with MS to live their best lives. The evidence tells us that early and ongoing treatment with an MS disease modifying therapy is vitally important to controlling disease activity, delaying the accumulation of disability and protecting quality of life. However, today’s healthcare reality is that the high cost of these important therapies prevents full access to them.

The Society is deeply concerned by the rising costs of MS therapies and the negative impact that this has on individuals being able to access these treatments. People with MS must have full access to affordable health care. The Society is committed to bringing together all the stakeholders on this issue to find viable solutions to lower the overall costs of MS care and expand the medication formularies available to people with MS, which too are affected by the escalating prices.

While Society endeavors continue to advance on addressing policy and pricing issues, the Society focuses on helping to ensure that people with MS have access to the therapies they need by assisting them to tap into available options and assistance programs. Our work is grounded in our Access to High Quality Healthcare Principles, which are the foundation for all of our actions.

To establish these strategic principles, the Society convened a task force comprised of people with MS, family members, health policy experts and healthcare providers. The task force also listened to the concerns and thoughts of people with MS through extensive social media monitoring, surveys, and feedback opportunities. The principles were adopted by the Society’s National Board of Directors in November 2014.

We are currently working to understand the complexities of the healthcare system, the interrelationships and points of influence. We have explored data on the formulary restrictions, met with numerous potential partners on these issues and created an extensive database of legislation at both the state and federal levels designed to increase access to medications in order to determine the best path forward for people with MS.

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