Highlights from the 29th Annual CMSC Meeting

Lifestyle Factors

Nutrition

The effects of a diet that is low in dietary cholesterol, as well as low in saturated and trans fat, was evaluated in a study of people with MS with an Expanded Disability Status Scale (EDSS) score between 2.0 and 6.5. (Please note that the EDSS is a 10-point scale – from 1 to 10 with half points – that measures degrees of disability. Points 1 to 3 on the scale are primarily used to measure function in individuals with little disability; points 4 to 9 measure mobility in individuals with more limitations.)

At the end of eight weeks, four out of five patients had a decrease in their body-mass index. All patients reported good adherence to their diet and daily food diary entries. The self-reported outcome measures all trended toward improvement, with the most improvement seen with subscales for fatigue and quality of life. The results of this study support the need for larger, randomized control trials looking at the role of diet in MS symptom management.

Sleep Problems

Understanding more about the documented association between sleep problems and greater disability in people with MS is important. Data from electronic diaries of 28 people with MS were collected and associations were found between sleep problems and pain, depression, frequent urination, and fatigue. Interventions aimed at improving sleep may positively impact these specific symptoms.

Walking Performance

A great deal of attention is currently given to what are called “modifiable risk factors” in MS – those factors over which the person with MS has some degree of control. A study of 31 people with MS aimed to see if an interrelationship could be found between walking performance and smoking, salt intake, and physical activity. In this study, moderate-to-vigorous physical activity was independently associated with improved walking performance. Although walking performance was not affected in this study by smoking or salt intake, both have been shown in other studies to have negative effects on other aspects of the disease.

Relationships between Body-Mass Index, Smoking, and Disability

As both MS and obesity are considered to be inflammatory diseases, a retrospective study (looking back at events that have taken place in the past) was undertaken to determine if the two processes are linked. The odds of having new brain lesions on an MRI were more than six-times greater in overweight subjects; the chance of having an EDSS increase by at least one point was eight-times greater in obese than non-obese patients; and current smokers had a five-times greater risk of increased disability than non-smokers.

Effects of Yoga

Participation in a yoga program had many positive effects, while no negative effects were observed in this study. Participants were people with MS who had EDSS scores of less than or equal to 4, which means they are able to walk four blocks without rest or aid. A review of seven randomized controlled trials found a beneficial impact on body function (including balance, pain, anxiety, and depression), activity limitations (walking endurance and speed), and participation restriction (reduced fatigue and improved quality of life).

Home-Based Exercise Intervention

People with MS with mild disability (with an average EDSS score of 3) who performed 10-to-30 minutes of exercise at home on a stationary bicycle, significantly improved aerobic fitness and performance on timed walking tests compared to those who only did stretching exercises. Participants in both groups engaged in weekly chats with a behavioral coach to help increase compliance. Previous research looking at home-based exercise programs did not show an effect – possibly because participants did not adhere to the exercise program.

Ballroom Dance

Participation in a recreational ballroom dance program resulted in improved motor performance, gait, endurance, and cognition in a group of seven individuals with MS, who were mostly women with an average EDSS of 2 (minimal disability). The control group of seven women with MS who did not participate in a dance program, showed no change in these parameters. Participants were paired with a partner without MS and took part in two, one-hour dance sessions per week for eight weeks. Preliminary results from this ongoing study appear to validate results of a similar pilot study.

Cognition and Psychosocial Aspects of MS

Vitamin D and Cognition

An analysis of 22 people who were included in a large database of MS patients demonstrated a slight relationship between low Vitamin D levels and executive function (one indicator of cognitive function). A larger sample is needed to determine whether a relationship exists between cognitive function and low Vitamin D levels.

Impact of Trekking Poles

Assistive devices to aid in walking may improve mobility, but their use may also have a negative psychosocial impact, resulting in sporadic use. Participants reported better self-esteem and adaptability (which is the willingness to take chances, eagerness to try new things, and ability to take advantage of opportunities) with the use of trekking poles as compared to the use of a single-point cane or a four-point cane. Walking and fatigue showed the greatest improvement with the use of trekking poles and the single-point cane, versus a four-point cane.

Depression and Cognitive Concerns

Sadness or low mood, as well as the inability to experience pleasure – referred to as anhedonia – are two symptoms common to both MS and depression. Depression has a known negative impact on cognition, which is a troublesome consequence of MS. Patients who reported sadness were three-and-a-half-times more likely to also report concerns with cognitive functioning, while a report of anhedonia was not significantly related to this concern. When treating depression with related cognitive concerns, interventions that directly affect mood, i.e., depression, may be more helpful than those interventions for anhedonia.

Exercise and Cognition

In this study, cognitive tests were performed both before and after 20 minutes of yoga, moderate-intensity cycling, moderate-intensity treadmill walking, and quiet rest. The participants were people with relapsing-remitting MS (RRMS) who did not have impaired cognitive-processing speed. In the 24 people tested, moderate-intensity treadmill walking had the greatest impact on executive control, which is a set of cognitive processes that relate to managing oneself and one’s resources in order to achieve a goal.

Anxiety

Symptoms of anxiety were reported in about one-third of people with MS visiting an outpatient MS center. In this report, younger patients and patients experiencing symptoms of depression were more likely to have symptoms of anxiety. For this reason, screening for anxiety – particularly in younger patients and patients who report symptoms of depression – may help to uncover this less-recognized symptom.

Disease-Modifying Therapies

Results from the DECIDE Study of Zinbryta

Daclizumab (Zinbryta™) high-yield process (DAC-HYP) is an experimental medication that is presently under review by the United States Food and Drug Administration (FDA) for possible approval for the treatment of relapsing forms of MS. Participants randomized to Zinbryta in the DECIDE study of 1,800 people with RRMS, showed greater improvement in tests of walking, hand-arm dexterity, and cognition. Participants in the Zinbryta group were compared to those taking Avonex® (interferon beta-1a).

Sustained Efficacy in the SELECTED Study of Zinbryta

Patients with RRMS who had previously completed up to two years treatment with Zinbryta in the Phase II SELECT and SELECTION trials, were enrolled in SELECTED, an extension study. Effectiveness was sustained over three years and no unexpected safety issues occurred.

Hair Thinning with Aubagio

Hair thinning was experienced by 13 percent of participants in the Phase III TEMSO and TOWER studies of oral Aubagio® (teriflunomide) compared to 4 percent in the placebo groups. A study utilizing photographs and a patient perception of severity scale was undertaken. This was done, in part, to help providers set appropriate expectations of this potential adverse event for individuals considering Aubagio as part of their treatment plan.

This small observational study followed 31 patients who complained of hair loss while taking Aubagio. Patients’ experiences with hair thinning were consistent with observations in the Phase III trials. The mean time to hair thinning was 81 days; 61 percent of those who experienced hair thinning were classified as mild and 39 percent were moderate. Marked improvement was reported by the majority of patients with complete or near-complete resolution, by nine months after the onset of hair thinning while still taking the medication. One patient discontinued treatment due to hair thinning.

First-Dose Effects with Gilenya

Administration of the first dose of Gilenya is known to be associated with transient bradycardia (low heart rate) that is usually not associated with symptoms. Symptomatic bradycardia and atrio-ventricular block (impaired electrical conduction) are less common and usually do not require intervention. Less than one percent of patients experience more serious cardiac effects. No patients discontinued therapy on day one. Results of this real-world study were consistent with previous controlled trials.

Lemtrada Studies Demonstrate Lasting Effect

Patients with RRMS participating in one of three prior Lemtrada® (alemtuzumab) trials – CAMMS223, CARE-MS I, or CARE-MS II – received the medication intravenously on five consecutive days and on three consecutive days one-year later. Participants in an extension study could receive additional treatment, if necessary, after 12 months following the previous treatment. A total of 68 percent of patients received only the initial two courses of treatment; 24 percent received one additional course; and 7 percent received two additional courses. In years three and four, the majority of patients, regardless of the number of treatment courses, remained free of new lesions (70 to 89 percent) and free of MRI activity (68 to 70 percent).

Switching to Lemtrada Improved Disability

Regardless of prior immunotherapy, individuals with MS – including those with progressive MS features but who also experience relapses – showed improvement in EDSS and MSSS (MS Severity Scales) after receiving Lemtrada. The data includes patients who experienced a relapse within two years while taking Avonex, Betaseron® or Extavia® (interferon beta-1b), Rebif® (interferon beta-1a), Copaxone® (glatiramer acetate), Gilenya, or Tysabri® (natalizumab).

Cognitive Function Preserved with Tysabri

In previous studies, Tysabri has been shown to be superior to placebo in preserving cognitive function during the initial two years of therapy. This observational study was undertaken to examine whether this effect would be sustained with longer treatment. Subjects who took Tysabri for up to two years were compared to those taking it for four years or more. Significant improvements in many parameters of cognitive function were observed in both groups, suggesting that Tysabri preserves cognitive function for four years and beyond.

Influence of JC Virus Status on Treatment Decisions with Tysabri

All 55 patients at a major neurology center in the United Kingdom who were on Tysabri treatment decided to continue treatment regardless of JC virus status. In this group, 21 tested positive for the virus and 34 tested negative. In a separate group of 45 patients who tested positive prior to making a decision to begin treatment with Tysabri, only nine decided not to start treatment.

Adherence to MS Treatment

The MS Treatment Adherence Questionnaire was administered to 209 individuals with MS during a two-month period. The percentage of patients reporting they had not missed a prescribed dose varied by means of administration. The number of total doses also varied across the three different routes of administration. Those receiving medications through IV infusions reported the greatest frequency of no missed doses (93 percent), followed by injectable at 71 percent and oral at 55 percent. Healthcare providers and care partners should be alert to non-adherence regardless of the route of administration.

Pregnancy and Multiple Sclerosis

Importance of Using Birth Control

An anonymous questionnaire, aimed at assessing knowledge about family planning, pregnancy, breastfeeding, medication safety, and the genetics of MS, was administered to 37 patients at an MS center in New York. The average overall correct score was 33 percent. Only 38 percent correctly answered a question about the importance of using birth control while on disease-modifying therapy and 34 percent reported not consistently using birth control. More education is needed about the importance of using birth control while on disease-modifying therapy.

Diversity

MS Care and Transgendered People

Surveys have found significant disparities in healthcare for transgendered individuals. The situation is no different in the care of transgendered people diagnosed with MS. There is a significant lack of best practice guidelines for this population. Many areas of practice are impacted, including communication issues and coordination of care among healthcare professionals within the MS-care setting and outside of this setting (health-psychology, social work, and endocrinology). Furthermore, the unique issues of the interaction of cross-sex hormone-replacement therapy, disease-modifying therapies (DMTs), and neuro-immunologic processes have not been examined in depth. Agreement is needed as to the best practices in these areas.

More Diversity Needed in MS Clinical Trials

Data from six randomized, placebo-controlled trials were used to examine the baseline characteristics and clinical outcomes in white, black, Asian, and Hispanic populations. Not enough data was available to include Hispanic subjects in the analysis. Baseline characteristics were similar in black and white populations, but black subjects had a higher risk of progression than white subjects. Asian subjects were younger and had higher EDSS scores than white participants. The results are challenging to interpret due to the low number of non-white participants and the combination of results of multiple trials. It was concluded that more non-white subjects should be recruited into MS clinical trials.

Other

Marijuana Use in MS

A survey conducted through an anonymous questionnaire demonstrated that 906 out of 5,665 respondents currently used marijuana. Those with stable RRMS were less likely to report using marijuana compared to those with active RRMS or secondary-progressive MS (SPMS). Those with higher current disability were also more likely to report current marijuana use.

Caregiver Stress

Depression and a lower quality of life are directly related to caregiver stress, which may be caused by physical, psychological, emotional, social, or financial concerns. Depression is experienced by 61 percent of “intense” caregivers and 50 percent of caregivers overall. Intense caregivers are defined as those required to perform personal-care tasks such as bathing, dressing, and feeding for an average of 12-to-87 hours per week.

An interdisciplinary approach to supporting caregivers was presented. The expertise of physicians, nurses, social workers, registered dieticians, and occupational therapists helped manage caregiver stress and improve quality of life for both the patient and the caregiver in the presented case study.

Microbiome and Gut Immunity

The relationship between MS and the gut microbiome (the population of microorganisms in the intestine) is being studied at several centers across the United States. An ongoing study at Partners MS Center, Brigham and Women’s Hospital Harvard Medical School is following 61 people with MS and 43 matched controls. Participants provided stool and blood samples, and a history that included (among other data points) disease activity, treatment, diet, age, gender, and race.

The study found that certain microbes were more prevalent in people with MS and others more predominant in healthy controls. Researchers theorize that the action of gut bacteria may alter the behavior of the immune system, which plays an important role in the pathology of MS. They also found that treatment with immunotherapy altered the make-up of the microbiome. Much work needs to be done in this exciting and emerging area of MS research, but understanding that the gut ecosystem in patients with MS differs from that seen in healthy controls is the first step.

Please see MSAA’s 2015 edition of the MS Research Update for additional details on the FDA-approved disease-modifying therapies, experimental treatments, and other MS research.

For more information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.

Written by Margaret M. McCormick, RN, BSN, MSCN
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer
Edited by Susan Wells Courtney, MSAA Senior Writer and Creative Director

Editor’s note: MSAA does not endorse or recommend any specific products or therapies. Readers are advised to consult their physician before making any changes to their medication, diet, exercise, or other treatment regimen. Initial study results from therapeutic agents under investigation should be considered as preliminary, since additional studies and/or evaluations may be needed to prove the safety and efficacy of these agents. Please note that the different lengths of text dedicated to each topic or treatment, and whether or not a certain topic or treatment was included, should in no way be considered as favoritism toward any one product. The information given in this article is just a sampling of various highlights from the CMSC meeting.