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Survey Identifies Opportunities for Improving MS Treatment Satisfaction

What makes a happy marriage between MS patient and neurologist? According to a new study, patients’ treatment expectations, degree of input into the treatment decision-making process, and communication with their physicians are among the three most important. 

The results (See below) reinforce the significance of a strong patient-physician collaboration and reveal opportunities for improving MS patient care, according to Biogen who partnered on the survey with an international steering committee of treating neurologists from five countries and representatives from patient advocacy groups.

Based on the survey, MS patients are divided when it comes to satisfaction with their current disease-modifying treatment (DMT)—58 percent report being “very satisfied/satisfied,” while 42 percent are “somewhat/not at all satisfied.” As might be expected, patients who are more satisfied with their DMT are more likely than those who are not to report that their expectations set forth prior to starting treatment were met closely or very closely.

Findings from the State of MS Initiative. Courtesy of Biogen.com

In fact, 67 percent of these very satisfied/satisfied patients report having their expectations met. However, of the 42 percent of patients who are somewhat/not at all satisfied with their treatment, 44 percent report having their expectations met. Satisfied patients also tend to play active roles in the treatment decision-making process and feel comfortable speaking with their physicians.

Hemorrhagic Stroke Patients Have Better Survival Rates at Stroke Centers

People with hemorrhagic strokes are more likely to survive if they are treated at a comprehensive stroke center, according to research published in the Journal of the American Heart Association.

Researchers examined the 90-day survival of 36,981 patients with hemorrhagic strokes treated at 87 hospitals in New Jersey between 1996 and 2012. Forty percent of the patients were treated at facilities designated as comprehensive stroke centers by 2012. The remainder were treated at non-stroke centers or at hospitals designated as primary stroke centers. Mortality rates included deaths from all causes and were adjusted for factors such as age.

Compared to primary care centers or non-stroke centers, researchers found that treatment at comprehensive stroke centers was associated with a seven percent reduced risk of death for patients with all hemorrhagic strokes; a 27 percent reduced risk of death in patients with subarachnoid hemorrhage; no difference in risk of death for patients with intracerebral hemorrhage.

Many patients with hemorrhagic strokes are diagnosed at a primary care centers or non-stroke centers and then transferred to a comprehensive stroke center for more comprehensive care. This practice showed a survival advantage in the New Jersey study, with patients transferred within 24 hours 36 percent less likely to die within 90 days than those who remained in a primary care center or non-stroke center.

Most Women Don’t Know Female-Specific Signs, Symptoms of Stroke

A new survey shows that most women don’t know the risks or symptoms females face when it comes to having a stroke.

The survey of 1,000 women, compiled by researchers at The Ohio State University Wexner Medical Center, found that only 11 percent of women could correctly identify pregnancy, lupus, migraine headaches and oral contraception or hormone replacement therapy as female-specific stroke risks.

“Women do not think they are going to have a stroke. They think of it as a man’s disease,” said Dr. Diana Greene-Chandos, a neurologist and director of neuroscience critical care at Ohio State’s Wexner Medical Center.

The survey also found that only 10 percent were aware that hiccups combined with atypical chest pain are among the early warning signs of a stroke in women when accompanied by or followed by typical stroke symptoms. Stroke is the third leading cause of death for women, according to the National Stroke Association.

“Women may have more headaches with their strokes. They actually can have hiccups with a little bit of chest pain with their stroke symptoms, sometimes sending them down the pathway of looking for either heart disease or indigestion,” said Greene-Chandos, who is also a member of Ohio State’s Neurological Institute. “Pregnancy also increases their risk of stroke, particularly in the final months and the immediate period after delivering the child.”

FDA Actions

FDA Approves First Generic Copaxone to Treat Multiple Sclerosis

FDA approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS). Sandoz has received FDA approval to market generic glatiramer acetate in a 20 mg/1 ml daily injection.

In the clinical trials for Copaxone, the most common adverse reactions reported by those taking Copaxone were skin problems at the injection site (redness, pain, swelling and itching), flushing (vasodilation), rash, shortness of breath and chest pain.

FDA: Medtronic Must Stop Most Sales of
Synchromed Drug Pumps

FDA filed a consent decree against Medtronic, Inc., and two of the company’s officers for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems. The medical devices deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity.

The consent decree cites violations of the quality system regulation for medical devices, which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe use. The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment.

The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.

Once Medtronic receives permission from the FDA to resume the design, manufacture and distribution of these products, the company must continue to submit audit reports so the agency can verify the company’s compliance. In addition to these audits, the FDA will monitor the company’s activities through its own inspections.

“Patients with the Synchromed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement,” Medtronic said in a statement.

Data At-a-Glance

• 11% of women surveyed were able to identify female-specific stroke risks.

• 10% identified hiccups and chest pain as stroke symptoms unique to women.

• 47% did not know what post-stroke symptom females are at a higher risk of suffering

Phase III ATTAIN Extension Data Supports Long-Term Safety and Efficacy of Plegridy

New data from the ATTAIN study demonstrates the long-term safety and efficacy of Plegridy (peginterferon beta-1a) over three years in people with relapsing-remitting multiple sclerosis (RRMS). The interim results from the first year of ATTAIN, a two-year extension study of the Phase III ADVANCE study, show the benefits of continued Plegridy treatment on clinical outcomes and further define its safety profile.

The safety and tolerability of Plegridy observed in all patients enrolled in the ATTAIN study were in line with the profile demonstrated in the ADVANCE study. The most common AEs reported were injection site reactions and flu-like symptoms, the majority of which were mild or moderate. The rate of neutralizing antibodies was one percent after three years.

The efficacy data from the first year of the ATTAIN study represent patients who have three years of continuous, fixed-dose treatment with Plegridy. The efficacy findings are consistent with the Phase III ADVANCE study and continue to support the robust efficacy over time:

  • Patients with RRMS who were administered Plegridy subcutaneously every two weeks over the three year period maintained positive efficacy results on clinical outcomes including annualized relapse rate (ARR), the proportion of patients suffering a relapse, and the proportion of patients with 24-week confirmed disability progression.
  • The drug also showed continued efficacy over the three year period across important MRI measures: number of gadolinium (Gd+) enhanced lesions, new T1-hypointense lesions, and new or newly enlarging T2-hyperintense lesions.

Additionally, the results from the study included a post-hoc analysis on NEDA outcomes, which in ATTAIN were defined as no evidence of disease activity on clinical and MRI measures, indicating no relapses and no onset of 24-week disability progression, no Gd+ lesions, and no new or enlarging T2-hyperintense lesions.

Demanding Jobs May Increase Survival in Frontotemporal Dementia

People with more demanding jobs may live longer after developing frontotemporal dementia (FTD) than people with less skilled jobs, according to a new study published in the April 22, 2015, online issue of Neurology

For the study, researchers reviewed the medical charts of 83 people who had an autopsy after death to confirm the diagnosis of frontotemporal dementia or Alzheimer’s disease. They also had information about the people’s primary occupation. Occupations were ranked by US Census categories, with jobs such as factory workers and service workers in the lowest level; jobs such as tradesworkers and sales people in the next level; and professional and technical workers, such as lawyers and engineers, in the highest level.

Researchers measured when the symptoms began by the earliest report from family members of persistently abnormal behavior. Survival was defined as from the time symptoms began until death. 

The 34 people with frontotemporal dementia had an average survival time of about seven years. The people with more challenging jobs were more likely to have longer survival times than those with less challenging jobs. People in the highest occupation level survived an average of 116 months, while people in the lower occupation group survived an average of 72 months, suggesting that individuals who had been in the professional workforce may live up to three years longer. 

The study found that occupational level was not associated with longer survival for the individuals with Alzheimer’s disease dementia. The number of years of education a person had did not affect the survival time in either disease. 

Free Concussion Testing Platform Available to Schools

Concussion Vital Signs, an online neurocognitive testing platform designed to integrate with concussion management protocols, will provide its services at no cost to any school, college or university. Kevin Guskiewicz, one of the nation’s leading concussion researchers, said the testing program could serve as an important cost-effective assessment tool for clinicians, according to Concussion Vital Signs.

“As researchers in this field, our mission is to improve concussion prevention, evaluation, and management,” said Guskiewicz. “Limited fiscal resources are often a barrier to including cognitive testing as part of a multi-faceted concussion management program. It will be exciting to see how the recent announcement by Concussion Vital Signs might change the landscape.”

Any school, college or university can sign up at www.concussionvitalsigns.com for their free online account, which offers baseline and post injury neurocognitive testing as well as patient reported questionnaires. n

 

Contact Info

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About Practical Neurology

Launched in 2002, Practical Neurology is a publication uniquely dedicated to presenting current approaches to patient management, synthesis of emerging research and data, and analysis of industry news with a goal to facilitate practical application and improved clinical practice for all neurologists. Our straightforward articles give neurologists tools they can immediately put into practice.

 
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