Remyelination Candidate Opicinumab Failed in Phase 2 Trial in MS, But Biogen Won’t Give Up

May 2017

Although a Phase 2b trial of the remyelination drug candidate opicinumab (also known as anti-LINGO-1 and BIIB033) failed to meet its primary goal of improving disability in relapsing and secondary progressive multiple sclerosis (MS), researchers believe the drug did cause “fairly strong” improvements.

The trial evaluated four doses of the treatment. Analyses indicated the two intermediate doses made patients better, while the highest and the lowest doses had no detectable effects.

Dr. Peter A. Calabresi, director of the Johns Hopkins Multiple Sclerosis Center, presented insights from the trial at the American Academy of Neurology (AAN) 2017 Annual Meeting, held April 22-28 in Boston. The study, “Efficacy Results from the Phase 2b SYNERGY Study: Treatment of Disabling Multiple Sclerosis with the Anti-LINGO-1 Monoclonal Antibody Opicinumab,” was part of a session on progressive MS therapeutics.

In the trial (NCT01864148) — called SYNERGY by opicinumab’s developer, Biogen — 418 participants were randomized to receive one of four opicinumab doses in combination with Avonex (interferon beta-1a), or placebo with Avonex; 334 of the 418 completed the study.

Opicinumab is believed to trigger remyelination by preventing the actions of LINGO-1 — a factor that suppresses myelination and axonal regeneration. In the trial, researchers measured the percentage of patients who improved during three months or more in the Expanded Disability Status Scale (EDSS), the 25-Foot Walk, the 9-Hole Peg Test and the 3-Second Paced Auditory Serial Addition Test.

At the beginning, participants were mildly to moderately disabled, with EDSS scores of 2 to 6.

According to the researchers, placebo-treated participants improved by 51.6 percent. Those in the highest-dose and lowest-dose groups saw estimated improvements of 51.1 and 41.2 percent, while patients receiving the intermediate doses seemed to benefit most from the treatment.

Those taking 10 mg of opicinumab per kilogram of body weight improved by 65.6 percent, while for the 30 mg/kg group, scores improved by 68.8 percent.

“The take-home message is that the very lowest and highest doses don’t appear to do anything, but that we saw a fairly strong signal in the intermediate doses,” Calabresi, an associate professor of neurology at Johns Hopkins University, said in an AAN update in Neurology Today.

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OhioHealth hospital was the first to use the FDA Approved Drug, Ocrevus

                                                                  

  
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Medical staff at OhioHealth's Neuroscience Center at Riverside Methodist Hospital became the first in the world to treat patients with a new FDA drug called Ocrevus in the battle against multiple sclerosis.

The significance of the drug lies in how it can slow what's called primary progressive multiple sclerosis. The manufacturer, Genentech, says it is the first and only disease-modifying therapy for primary progressive multiple sclerosis or PPMS.

Watch the WBNS 10-TV story about the drug above. 

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Understanding Multiple Sclerosis (MS) in Children and Teens

                                                                  

  
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How does Stony Brook treat children and teens with MS?

Our National Pediatric MS Center has a multidisciplinary team known for its comprehensive approach. The program begins with a comprehensive multidisciplinary evaluation conducted over one or two days.

The evaluation includes:

A neurological assessment by a pediatric neurologist and MS specialist

• Review of medical records

• A neuropsychological evaluation and psychological assessment to evaluate the impact of MS on cognition, academic performance and emotional functioning

• An MRI may possibly be performed and evaluated with our neuro-radiologist to assess the disease

• Ophthalmology exam

• Individual psychological support for patients and their family members

• Neuropsychological evaluation

• Assistance, if needed, with school issues

• Nursing support

Once a diagnosis is made, the team develops a treatment plan, which is shared with the family, the child’s primary care physician and the local neurologist. We have access to disease modifying therapies including infusion medications. The plan may also include developing a relationship with the local healthcare providers in order to coordinate care near the home. In addition, the plan may include physical, occupational and speech therapy, counseling and more. Note that we work closely with the child’s primary care physician and local neurologist, and serve as consultants in the ongoing care of the patient. Educational materials regarding MS and its treatment are also provided. And, because of our role as National Pediatric MS Center, we have access to a worldwide network of international experts. We consult on difficult cases around the world and we are pleased to offer this high level expertise in our own community.

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3 Travel Tips for Easier Flying with MS

                                                                  

  
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It’s the time of year for travel here in the U.S. Graduations, weddings and vacations are on all of our calendars.

Air travel, in particular, can be a real pain for someone with a handicap such as multiple sclerosis. Security, aircraft seats and legroom are all becoming increasingly tighter. I’ve flown quite a bit for business and pleasure, and I’ve learned a few things that make my life a little easier at the airport and in flight. Following are a few tips for flying you can use, too:

1. Get some wheels

Airports, particularly those handling international flights, can be huge. Even if you can walk you really don’t want to walk from check-in to the plane.

I travel with a scooter that’s very light and also can be folded like a baby stroller. I drive the scooter right up to the aircraft door. Its battery is taken on board (FAA regulations require that it be stowed in the overhead) and the scooter is stowed with baggage. When we arrive, the scooter is returned to the aircraft door and off I go. Note: This works well with a lightweight scooter. If your scooter is larger and heavier, or if you’re in an electric wheelchair, you’ll need to check it at the gate before flying rather than at the plane door. The airline will use an onboard wheelchair to move you from the gate to your seat.

If you’re not disabled enough to use a scooter, arrange for a wheelchair. The airline will provide this from check-in to the gate and in reverse when you arrive. (There is no charge, though tips are accepted.) Request the chair when you make your reservation either via the airline’s website or with an agent on the phone. If you’re buying your ticket through a travel agent or third-party website, it’s a good idea to phone the airline three days ahead of your flight to ensure they know you need a chair. This notification also should be done if you’re traveling with a scooter or an electric chair.

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Statins: How safe are they?

                                                                  

  
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Despite evidence that aims to quash controversy over the safety and effectiveness of statins, uncertainty remains. Is the safety of statins as debatable as some stories suggest, or is the controversy behind this group of medicines potentially harming more people than the drug itself? We find out.

Cholesterol is essential to keep the body in working order. However, having high levels of "bad cholesterol," called low-density lipoprotein (LDL), in the blood can cause fatty deposits to build up in the arteries. Eventually, this buildup results in the arteries narrowing and hardening (a condition called atherosclerosis), which leads to a greater risk of heart attack and stroke.

Statins are a commonly prescribed medicine that helps to lower harmful levels of LDL cholesterol to mitigate the risks of cardiovascular disease.

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Relapsing-remitting MS: Alemtuzumab boosts outcomes for black patients

                                                                  

  
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May 6, 2017

Alemtuzumab improves long-term clinical and radiological outcomes in black patients with relapsing-remitting multiple sclerosis, according to data presented at the 69th Annual Meeting of the American Academy of Neurology in Boston, MA.

The new findings were seen in a small cohort of patients enrolled in phase III studies comparing alemtuzumab with subcutaneous interferon beta-1a (SC IFNB-1a), all of whom had relapsing-remitting multiple sclerosis (RRMS) and were either treatment-naïve at enrollment or had responded inadequately to prior therapy.

Importantly, the results in black patients were on a par with those previously reported in the overall study population, said principal investigator Dr. Annette Okai, from the Multiple Sclerosis Treatment Center of Dallas in Texas.
Black patients typically have more severe MS than white patients, characterized by more rapid disability accumulation, greater MRI lesion volumes, increased risk for secondary progression, accelerated retinal nerve fiber layer and ganglion cell/inner plexiform layer thinning, and the potential for a poorer response to disease-modifying therapies (DMTs).

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Food Intolerance Nutrition / Diet Bones / Orthopedics Public Health Lactose intolerance linked to lower vitamin D levels

                                                                  

  
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May 16, 2017

A new study suggests that people with a genetic intolerance to lactose should increase their intake of non-dairy foods rich in vitamin D, after finding that they are more likely to have low levels of the essential nutrient.

Researchers have associated lactose intolerance with lower levels of vitamin D.

Study co-author Ahmed El-Sohemy, a professor of nutrition at the University of Toronto's Faculty of Medicine in Canada, and colleagues recently reported their findings in the Journal of Nutrition.

Lactose intolerance is defined as the body's inability to effectively digest lactose, a sugar found in dairy products, including milk, butter, and cheese.

The condition occurs when the small intestine fails to produce sufficient amounts of lactase, which is the enzyme that breaks down lactose.

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Survey: Misdiagnosis, Myriad Symptoms Common for Patients with Multiple Sclerosis

                                                                  

  
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May 12, 2017

A new survey of 5300 patients with multiple sclerosis in the United States suggested nearly half had to visit a physician at least 5 times before being correctly diagnosed with MS, and 4 in 10 were initially misdiagnosed with another condition.   The survey findings from Health Union, a Philadelphia-based healthcare information service also showed that MS patients regularly encountered wide array of symptoms, far beyond those typically discussed in most news coverage of the disease. 

Of the 42% of patients who were initially misdiagnosed, one quarter were told they were depressed. Another 15% were diagnosed with migraines and 14% were diagnosed with fibromyalgia. Psychiatric disorders, chronic fatigue syndrome, and Vitamin B-12 deficiency were also common incorrect diagnoses.   Tim Armand, president and co-founder of Health Union, said the survey helps paint a fuller picture of the hurdles people with MS must overcome.   “The results of this survey clearly show that people with MS struggle with a disease that impacts all aspects of their life in ways that many around them simply cannot see,” said Armand, in a press release.   

Armand said patient support networks could be integral in sharing information among patients and with also helping patients feel validated.   Findings pointed out that once patients received the correct diagnosis, nearly two-thirds (65%) start treatment within the first three months post-diagnosis. However, the survey also revealed that some patients are apprehensive about MS drugs. 

Forty-two percent of respondents said they were worried about the side effects of MS treatments, and 35% said they worried about the safety of disease-modifying therapies.   

Devin Garlit, a patient advocate with Health Union, said it took 13 years for him to find the right therapy.   “Finding the right treatment can be a difficult process that requires significant trial and error. You may have side effects with one, the next may not work well, and another may not be covered by insurance,” said Garlit, in the press release. - 

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The impact of sexual dysfunction on the quality of life measured by MSQoL-54 in patients with multiple sclerosis

                                                                  

  
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Tepavcevic DK1, Kostic J, Basuroski ID, Stojsavljevic N, Pekmezovic T, Drulovic J.

Author information

Abstract

OBJECTIVE:

Sexual dysfunction (SD) is a common but often overlooked symptom in multiple sclerosis (MS). The aim of this study was to estimate the frequency, type, and intensity of SD in our patients with MS and to investigate its influence on all the domains of quality of life.

METHODS:

The study population comprised a cohort of 109 patients with MS (McDonald's criteria, 2001). SD was quantified by a Szasz sexual functioning scale. Health-related quality of life was measured by a disease-specific instrument MSQoL-54 (Serbian version).

RESULTS:

The presence of at least one symptom of SD was found in about 84% of the men and in 85% of the women. The main complaints in women were reduced libido, difficulties in achieving orgasm, and decreased vaginal lubrication; in men, the main complaints were reduced libido, incomplete erections, and premature ejaculation. In women, statistically significant negative correlations between the presence and level of SD and quality of life domains were reached for all subscales (P < 0.01), except for the Pain subscale (P = 0.112). In men, negative correlations were also observed for all domains, but they were statistically significant for physical health, physical role limitations, social function, health distress, sexual function, and sexual function satisfaction (P < 0.01). We found that the presence of all the analyzed types of sexual problems statistically significantly lowered scores on the sexual function and the sexual function satisfaction subscales in both men and women (P < 0.01). The most prominent impact on both domains was observed for the total loss of erection in men and for anorgasmia in women.

CONCLUSIONS:

Our results reveal that frequent occurrence of SD in MS patients prominently affects all aspects of their quality of life.

PMID:

 

18632783

 

DOI:

 

10.1177/1352458508093619

SOURCE


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Evaluation of sexual function in women at two stages of multiple sclerosis

                                                                  

  
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Firdolas F1, Ozan T, Onur R, Bulut S, Orhan I.

Author information

Abstract

PURPOSE:

In the present study, we aimed to evaluate the sexual function in patients with multiple sclerosis (MS) who were examined in two subgroups and compare the results to the control group with a validated questionnaire.

METHODS:

A total of 23 consecutive female MS patients divided into groups with relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) and 45 healthy control subjects were included into the study. The inclusion criteria were as follows: Definite MS, age between 18 and 60 years and an Expanded Disability Status Scale (EDSS) score of <8. The neurologic impairment, the disability and the independence of the patient, and cognitive performances were measured, and also the effect of MS is evaluated by EDSS.

RESULTS:

No statistically significant difference was found between two groups. FSFI scores in both groups were significantly lower than the control group. Domain scores for desire, arousal, orgasm, pain, lubrication and satisfaction measured between RRMS and SPMS patients showed no significant difference. Comparing each domain score for arousal, orgasm and satisfaction revealed significantly lower scores in RRMS and SPMS patients compared to control group.

CONCLUSIONS:

In this study, we detected statistically significant decrease in FSFI scores in two groups of MS compared to healthy controls. We could not define a difference in sexual function in different stages of MS in women and a statistically significant negative correlation between EDSS and FSFI scores in the two subgroups of MS.

PMID:

 

22669360

 

DOI:

 

10.1007/s00345-012-0891-4

SOURCE

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Sexual Therapy for Women with Multiple Sclerosis and Its Impact on Quality of Life

                                                                  

  
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Abstract

Objective: Multiple Sclerosis (MS) is a disease with a detrimental effect on functional status. The present study investigated the effect of a sexual therapy program on the quality of life (QOL) of women with multiple sclerosis. 

Method: Women with multiple sclerosis and sexual dysfunction (n = 30) were selected, and were randomly assigned into the treatment (n = 15), or the control groups (n = 15). Participants of the treatment group (n = 15) received 12 weekly sessions of sexual therapy. Participants in both groups completed the Female Sexual Function Inventory (FSFI) and the MS Quality of Life- 54 (MSQOL-54) in the onset of the program and at the end of the program. 

Results: ANCOVA(s) using pre-test scores as covariate(s) revealed that in comparison to the control condition, MS patients within the treatment group showed a significant improvement in their sexual desire (0.0001), arousal (0.022), lubrication (0.001), orgasm (0.001), satisfaction (0.0001), overall quality of life (0.001), energy (0.023), cognitive function (0.005), and social function (0.001) at the end of the program. In addition, they were less limited in their roles due to the emotional and health problems. 

Conclusion: The present study revealed that addressing sexual dysfunction in MS patients could improve their quality of life. In the future, this research can extend its results, and apply the same method to men with MS to find whether sexual therapy enhances their quality of life

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Primary Progressive MS: Myths vs. Facts

                                                                  

  
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Primary progressive multiple sclerosis (PPMS) is a complex disease that varies between individuals. In other words, not everyone will have the same symptoms or experiences. The rates of progression also vary.

The mysteries surrounding PPMS have generated many myths about this condition. This can create a lot of confusion when you’re trying to research multiple sclerosis (MS) and its primary forms. Learn about some of the most common myths about PPMS here, as well as the real facts.

Myth: There will never be a cure for PPMS

Fact: Research is ongoing for medications

As of 2017, MS isn’t curable. Certain medications are approved by the U.S. Food and Drug Administration (FDA) for relapsing-remitting forms of MS, but but most of these don’t seem to work in PPMS. Recently, one new drug, Ocrevus (ocrelizumab), has been approved for PPMS.

This doesn’t mean that there will never be a cure. In fact, research is ongoing in terms of medications for PPMS, as well as possible cures for all forms of MS. Because genetics and environment are thought to contribute to MS development, research is looking into how to prevent some of these variables from affecting adults later in life.

Myth: PPMS primarily occurs in women

Fact: PPMS affects women and men at the same rate

Some forms of MS tend to occur more often in women than men — sometimes three times as much. Yet according to the National MS Society, PPMS seems to affect both women and men equally in number.

Diagnosing PPMS can be difficult, but you shouldn’t assume you have one specific form of MS just because of your sex.

Myth: PPMS is an elderly person’s disease

Fact: The condition may occur before middle age

The onset of PPMS tends to occur later than other forms of MS. However, there seems to be a misconception that it’s an elderly person’s disease. This may be in part due to the onset of disability being associated with age. According to the University of Rochester Medical Center, the average age of onset for PPMS is between 30 and 39 years of age.

Myth: A PPMS diagnosis means you’ll be disabled

Fact: Disability rates range in PPMS

Physical disability is a risk with PPMS — perhaps more so than other forms of MS. This is due to PPMS causing more lesions on the spine, which can in turn create gait issues. Some people with PPMS may need assistive devices for walking, such as canes or wheelchairs. The National MS Society estimates that about 25 percent of people with MS need this type of assistance.

Still, this doesn’t mean that you should expect disability after being diagnosed with PPMS. Rates of disability vary, much in the same way as symptoms do. You can help prevent the onset of walking problems by exercising regularly as part of an active lifestyle. Talk to your doctor about other options to help maintain your independence, such as physical and occupational therapy.

Myth: Having PPMS means you have to quit your job

Fact: Working won’t make PPMS worse

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