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Current and Future Directions in MS Treatments Kathleen Costello, MS,CRNP National MS Society Pavan Bhargava, MD Johns Hopkins MS Center Debra Frankel, MS,OTR National MS Society
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Multiple Sclerosis
• The most common chronic disease affecting the central nervous system in young adults
• Immune system malfunction • Inflammation, demyelination, damage to nerves,
inadequate repair mechanisms. • Relapses and remissions of neurologic symptoms with
progressive worsening over time
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Overall Management of MS
• Disease modifying treatments – Starting early and monitoring carefully
• Lifestyle – Smoking cessation – Diet – Activity – Emotional health
• Mental health interventions • Rehabilitation strategies
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Secondary-progressive
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Relapsing-remitting Preclinical
Time Adapted with permission from JS Wolinsky.
Measures of brain volume Relapses and impairment MRI burden of disease
MRI activity
Disease Progression
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Arrowheads = areas of active demyelination. Arrow = terminal axon ovoid. Trapp et al. N Engl J Med. 1998;338:278-285.
What happens to the nerves?
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Disease Modifying Treatments
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FDA-Approved Therapies (Approval time period)
1995 2000 2005 2009 2010 2011
IFNβ-1b7
(Extavia)
Fingolimod8 (Gilenya)
Natalizumab6 (Tysabri)
IFNβ-1b1
(Betaseron)
Glatiramer acetate3
(Copaxone)
IFNβ-1a2 (Avonex)
IFNβ-1a5
(Rebif )
Mitoxantrone4
(Novantrone )
2012
Teriflunomide9
(Aubagio)
Dimethyl fumarate10
(Tecfidera) )
2013
Expanding Landscape of MS Therapeutics
2014
Plegridy11 (pegylated IFNβ-1a)
Copaxone 3x/wk3
(glatiramer acetate)
1. IFNβ-1b [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2014; 2. IFNβ-1a [prescribing information]. Cambridge, MA: Biogen Idec Inc; 2014; 3. Glatiramer acetate [prescribing information]. Overland Park, KS: TEVA Neuroscience, Inc; 2014; 4. Mitoxantrone [prescribing information]. Rockland, MA: EMD Serono, Inc; 2012; 5. IFNβ-1a [prescribing information]. Rockland, MA: EMD Serono, Inc; 2014. 6. Natalizumab [prescribing information]. Cambridge, MA: Biogen Idec Inc; 2013; 7. IFNβ-1b [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2012; 8. Fingolimod [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2014; 9. Teriflunomide [package insert]. Cambridge, MA: Genzyme Corporation; September 2012; 10. Dimethyl fumarate [prescribing information]. Cambridge, MA: Biogen Idec Inc; 2013; 11. Pegylated IFNβ-1a [prescribing information]. Cambridge, MA: Biogen Idec Inc; 2013-2014.; 12. Alemtuzumab [package insert]. Cambridge, MA: Genzyme Corporation; October 2014.
Alemtuzumab12 (Lemtrada)
2015
Glatopa (glatiramer acetate)
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What do these treatments do?
• All of the current DMTs impact inflammation and by doing so:
– Reduce relapses – Reduce new inflammation in the brain and spinal cord – Delay progression
• None of the DMTs have been found to be helpful in the treatment of progressive forms of MS
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Where is the research focused now?
• Effect on inflammation by a different mechanism – Daclizumab
• Effect on progression – ocrelizumab
• Stimulate remyelination – Anti-Lingo – Thyroid hormone analogue – Stem cell therapy
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Possible new DMTs • Daclizumab
– Accepted on April 29, 2015 for FDA review for relapsing forms of MS
– MoA • monoclonal antibody • binds to a receptor on the T-cells (white blood cells) that become
abnormally activated in MS • daclizumab is believed to work by decreasing abnormally-activated T-
cells and pro-inflammatory lymphoid tissue inducer cells, and increasing certain cells that regulate the immune system.
– Administered once every 4 weeks by a subcutaneous injection – Phase 3 results
• 45% lower relapse rate with daclizumab HYP vs Avonex • 54% lower number of new MRI lesions vs Avonex
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Possible New DMTs • Ocrelizumab
• Phase 3 results from Relapsing trial and Progressive Trials in MS presented at ECTRIMS last month. Two trials in relapsing MS and one trial in primary progressive MS
• MoA • monoclonal antibody • binds to a molecule (CD20) on the surface of immune cells called B
cells, and depletes them from the circulation. B cells may play a role in the immune attacks on brain and spinal cord tissues in MS.
• Administered by IV infusion every 6 months in two infusion separated by 2 weeks
• Phase 3 results – relapsing MS • 46% reduction in relapse rate vs Rebif • 94-95% reduction in inflammatory brain lesions • 40% reduction in confirmed disability
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• Phase 3 results Primary Progressive MS • Reduction in confirmed disability at 12 weeks by 24 %
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New approaches • Remyelination
– Anti Lingo-1 • In MS remyelination is inefficient • Lingo-1 limits remyelination • Anti Lingo -1 has been shown in animal models to promote
remyelination – Phase 2 trial in acute optic neuritis
• designed to evaluate anti-LINGO-1's ability to enable repair of an optic nerve lesion through axonal remyelination after the onset of a first episode of AON.
• enrolled 82 patients across 33 sites in Europe, Canada and Australia, with patients receiving six intravenous infusions of 100 mg/kg anti-LINGO-1 or placebo every four weeks.
• 34 percent improvement in optic nerve conduction latency at week 24, compared with placebo (p=0.05).
• Further latency recovery was observed at the last study visit (week of 9.13 milliseconds, compared with placebo (p=0.01).
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New Approaches • Thyroid hormones – stimulating myelin making stem cells
– may play a direct role in remyelination and repair in the adult CNS by promoting maturation of oligodendrocytes.
– thyroid hormones have been shown to reduce oxidative stress and thus may have the capacity to prevent mitochondrial dysfunction as well.
– liothyronine (synthetic form of T3) has the potential to induce reparative mechanisms and limit secondary neurodegeneration in MS.
– GC-1 tested in laboratory animals was able to promote differntiation of oligodendrocyte precurser cells into myelin producing oligodendrocytes
– A Phase 1b trial: Open label study of liothyronine in MS is now recruiting at Johns Hopkins. – supported by the MS Society
• A safety and tolerability study of 20 people with MS
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New Approaches
• Stem Cells – HSCT to Reboot the Immune System: hematopoietic
(blood cell-producing) stem cell transplantation • attempts to “reboot” the immune system, which is believed to
launch attacks on the brain and spinal cord in people with MS. – Mesenchymal Stem Cells
• an individual’s own mesenchymal stem cells are isolated from the bone marrow or blood stream and multiplied in the lab, and then re-introduced in greater numbers into their body. This approach is being tested in several clinical trials
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Summary
• 13 FDA approved medications for MS • All target inflammation • DMTs potentially on the near horizon
– Daclizumab – Ocrelizumab
• New approached in the research arena – Remyelination
• Anti Lingo-1 • Thyroid • Stem cells
• What else may be part of MS management?
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Lifestyle modification for the management of MS Pavan Bhargava MD Johns Hopkins University MS Center
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What are people talking about?
• DMTs and medications used for symptomatic treatment have multiple adverse effects
• People with MS are interested in learning about what they can do to promote wellness
Dunn M et al. US Neurology, 2015.
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What are people with MS asking Dr. Google ?
Dunn M et al. US Neurology, 2015.
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Diet
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Why study the effect of diet in MS ?
Minnesota, 1905-2000
MS prevalence continues to rise
As does the prevalence of obesity
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Obesity is a risk factor for MS
• Obesity at age 18/20 is linked to increased MS risk (Munger, 2009)
• Higher BMI at ages between 7 to 13 linked to increased MS risk
Langer-Gould et al., Neurology 2013
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How Might Diet Influence MS Risk or Prognosis?
• Direct effects on the immune system - metabolism of immune cells can influence their function - immune cells have receptors for Vitamin D, fatty acids • Altering the gut microbiota
- gut bacteria may be associated with MS - diet can alter the gut bacterial composition
• Effects on components of the central nervous system - certain foods might be protective for cells in the CNS
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Scientific “Levels of Evidence”
• Example
Level I: Well-designed, randomized controlled trial Level II-1: Well-designed trial without randomization Level II-2: Cohort/case-control study Level II-3: Comparing times (or places) with and without the intervention Level III: Opinions of experts, committees, etc.
To prevent “chicken or the egg” problem and other major bias
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Why Are Impacts of Diets and Supplements Reported by Media So Confusing? Vitamin D and MS
Example 1. We think:
Low vitamin D MS risk Worse outcomes for people who already have MS What if: More severe MS → less time in sun → low vitamin D Example 2. People with lower vitamin D levels also have lower levels of …. (sodium, zinc, chocolate intake) AND Chocolate intake improved MS
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Cautionary Lessons from Supplements for Other Diseases
Folic Acid Beta Carotene
Observational (overall population)
Colon cancer Heart disease
Randomized Trial (at-risk populations)
Advanced pre-cancerous colon lesions
Lung cancer Heart disease deaths
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Diets that have been proposed for MS
• Paleolithic diet
• Mediterranean diet
• McDougall diet
• Gluten free diet
• Swank diet
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Diets that have good evidence for an effect in MS
NONE
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Vitamin D Levels and MS Risk / activity
Munger, JAMA 2006
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
New T2 Gad Relapses
New brain lesions Active lesions Relapses
Risk per 10 units higher vitamin D Adults Children
Mowry EM, Annals of Neurology 2010, 2012
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VIDAMS trial
Bhargava P et al. Contemp Clin Trials. 2014 Nov; 39(2): 288-93.
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Does the amount of calories we eat matter ? • Mouse models of other neurological disorders
improved by calorie restriction, with less inflammation in the brain
• In mouse models of MS restricting calories or fasting prior to disease induction:
Lower risk of disease Less severe disease in the mice that do get it
1. Manzanero S J Cereb Blood Flow Metab 2014 2. Piccio L, J Leukocyte Biology 2008 3. Sanna V, J Clinical Invest 2003
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Intermittent Calorie Restriction Trial
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Future directions for Diet in MS
• There is a need to study diet and supplements in MS
• Currently insufficient high-quality data to recommend a specific diet or supplement for the treatment/ prevention of MS
• Though studies are challenging to do, they are necessary in the light of prior experience with other supplements
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Exercise
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Why exercise ?
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Effect of exercise on fatigue
• Meta-analysis of 36 trials with 1603 people with MS
• Endurance training, mixed training (endurance with muscle power training) and other training (yoga and tai-chi) appeared to reduce fatigue
• However, the quality of trials was not high – small numbers, lack of good outcome measures, ? appropriate population
• People with severe fatigue may not have participated in the trials
Heine M et al. Cochrane Database of Systematic Reviews 2015, Issue 9.
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Functional improvement with exercise
• Exercise interventions improve balance measures • Exercise improves muscle strength and increases
maximal walking distance • Aerobic exercise appears to increase hippocampal
volume – this effect was also seen in a report of a single patient with MS
1. Sa M. J Neurol. 2013; 261: 1651-61. 2. Erickson KI et al. Proc Natl Acad Sci. 2011 Feb; 108(7): 3017-22. 3. Leavitt VM et al. Neurocase. 2014; 20(6): 695-7.
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Individualized program
Includes: • Specific exercises • Therapeutic treatments • Equipment recommendations • Referrals
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Published recommendations for exercise
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Rehabilitation options to improve function: 1. Adapted recreation 2. Treadmill training 3. Aquatic therapy 4. Hippotherapy 5. Neuromuscular electrical stimulation 6. Functional electrical stimulation 7. Bracing 8. Taping 9. Partial weight bearing 10. Botox – with splinting vs stretching 11. Alternative therapy optionsptions – massage, acupuncture, etc.
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Future directions for exercise in MS
• Exercise can strengthen muscles and improve walking distance in MS
• Exercise might also improve depression and fatigue in MS
• The effects of exercise on neuroplasticity need further study
• Individualization of exercise programs and measures to improve compliance with exercise regimens is important
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Stress management
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Why mindfulness ?
• MS is an unpredictable disease
• With the disease comes – a burden of anxiety and depression
• This can lead to: - reduced compliance with treatment - increased symptoms - worsened functional status - poorer quality of life
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Why mindfulness ?
• A feeling of control and acceptance may reduce some of the psychological burden
• Additionally some evidence suggests that reductions in stress may actually have a beneficial biological effect
“..paying attention in a particular way: on purpose, in the present moment, and nonjudgementally.”
- Jon Kabat-Zinn
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Stress and MS
• Acute psychological stress was linked to increased circulating levels of pro-inflammatory molecules (IL-6, IL-1b) in a meta-analysis of 30 studies.
• Negative stressful life events have been associated with increased risk of new and active lesions on MRI.
• Stressful events were also linked in another study with a 2 fold increased risk of clinical relapse in the subsequent four weeks.
1. Steptoe A et al. Brain Behav Immun. 2007 Oct; 21(7): 901-12. 2. Burns MN et al. Psychol Med. 2014 Jan; 44(2): 349-59. 3. Buljevac D et al. BMJ. 2003 Sep; 327(7416): 646.
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What are mindfulness techniques ?
• Mindfulness Based Stress Reduction
- Breath awareness - Body awareness - Yoga postures
• Mindfulness Based Cognitive
Behavioral Therapy - Greater emphasis on cognitive techniques
1. Tang Y et al. Nat Rev Neurosci. 2015 Apr; 10: 213. 2. Simpson R et al. BMC Neurol. 2014; 14:15.
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Mindfulness training has biological effects
• Mindfulness meditation can have beneficial effects on brain function
• Mindfulness interventions could also cause alterations in immune responses to stress
• However, whether this
would be similar between MS and healthy individuals is not known
1. Tang Y et al. Nat Rev Neurosci. 2015 Apr; 10: 213. 2. Rosenkranz MA et al. Brain Behav Immun. 2013 Jan; 27C: 174-184.
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Do mindfulness techniques help ?
• Meta-analysis of 3 trials • Improvements in anxiety, depression, fatigue and pain
scores Issues • Several methodological flaws • No comparison with an active treatment • Did not include robust outcome measures • Some of the trials did not have adequate blinding Conclusion • Need for better designed studies
Simpson R et al. BMC Neurology. 2014; 14: 15.
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Mindfulness for progressive MS
• Pilot trial with a virtual classroom – Skype
• Primarily behavioral intervention
• Primary and secondary progressive MS
• Reduced distress scores
• Also reduced scores for depression, anxiety, fatigue and pain compared to no intervention group
• Suggests that mindfulness interventions should be tailored according to the patient group being targeted and could be delivered on-line
Bogosian A et al. Mult Scler. 2015 Aug; 21(9): 1184-94.
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Future directions for mindfulness techniques • Better designed studies – appropriate numbers, active
control groups, better outcome measures
• Ascertaining effects of individual components of mindfulness techniques
• Tailoring these techniques to people with MS at different stages of the disease – accounting for issues such as cognitive impairment
• Innovative delivery methods to make these techniques readily available and economical
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Conclusions
• There is emerging evidence that lifestyle modification could have beneficial effects in MS
• Eating a healthy diet, following an individualized exercise plan and utilizing mindfulness techniques could help people with MS manage their disease better
• Rigorous studies to determine the true benefits of various lifestyle interventions and how they should be incorporated into routine MS care are required and should be a research priority
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Acknowledgments
• Dr. Ellen M Mowry • Dr. Kathleen Zackowski
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Thank you