Progress in MS: Current and Emerging Therapies

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1 Progress in MS: Current and Emerging Therapies Presented by: Dr. Kathryn Giles, MD MSc FRCPC The MS Society gratefully acknowledges the grant received from Biogen Idec Canada, which makes possible the Progress in MS: Current and Emerging Therapies session. The MS Society does not approve, endorse or recommend any specific product or therapy but provides information to assist individuals in making their own decisions.

2 Today s Discussion Treating MS Management of the Disease Questions & Answers 2

3 Clinical Symptoms Neuronal Damage Begins Prior to Clinical Presentation Clinically Isolated Syndrome Relapsing Remitting Secondary Progressive First Clinical Attack Axonal Loss Demyelination Clinical Threshold Time (Years) 3

4 MS: Brain Volume and MRI Changes Preclinical C. I. S. Relapsing Remitting Secondary Progressive Brain volume Relapses and Impairment MRI Burden of Disease New lesions Time (Years) C.I.S., clinical isolated syndrome 4 Adapted from Goodkin DE. UCSF MS Curriculum. January 1999

5 Disease Progression Over years, 80-85% of MS will progress from CIS to relapsing-remitting MS to secondary progressive MS IT IS IMPORTANT TO TREAT EARLY 5

6 TREATING MS 6

7 MS Treatment Requires a 3-Pronged Approach 1. Management of acute attacks 2. Management of symptoms 3. Management of underlying disease 7

8 Steroids Management Options for Acute Attacks I.V. (methylprednisolone 1 g daily x 3-5 days) High-dose oral (prednisone 1250 mg daily x 3-4 days) Either is acceptable 1 Choice depends on regional facility and physician preference Steroids do not alter course of MS; only the duration and severity of that attack 8 Morrow SH et al. Neurology 2004;63(6):

9 Depression Spasticity Bladder and bowel Pain Fatigue Mobility Sexual dysfunction Management of Symptoms 9

10 Fampyra New mobility drug Can be used in both relapsing and progressive MS Increases walking speed Other effects energy, cognition, stamina, arm function 30% are super-responders, 30% some response, 30% no response Determine effectiveness in 2 weeks Common side effects (affect between 1 and 10 in every 100 patients): Feeling unsteady, dizziness (risk of falling), headache, feeling, weak and tired, difficulty sleeping, anxiety, tremor (minor shaking), numbness or tingling of the skin, sore throat, shortness of breath, feeling sick (nausea), being sick (vomiting), constipation, upset stomach, back pain 10

11 MANAGEMENT OF THE DISEASE 11

12 Management of Disease Goals of First Line MS Therapy (Avonex, Betaseron/Extavia, Copaxone, Rebif, Aubagio, Tecfidera) Reduce the frequency, severity and duration of relapses Preserve cognitive function Slow or delay accumulation of disability due to disease progression Prevent development of new lesions as seen on MRI scans Keep people with MS functioning normally 12

13 Injectable First Line Therapy Avonex (interferon beta-1a), Betaseron (interferon beta-1b), Copaxone (glatiramer acetate), Extavia (interferon beta-1b), Rebif (interferon beta-1a) Comparable effectiveness (30% reduction in relapse frequency and severity; 80% reduction in MRI activity; modest slowing of disability progression) Differences in side effects and injection frequency Choose according to lifestyle, and patient choice Safe and years of experience 13

14 Tecfidera: New Oral First Line Therapy Tecfidera (BG-12; dimethyl fumarate) Oral Two pills, twice daily (120 mg) for a total of 480mg/day One pill, taken twice daily (240 mg) for a total of 480mg/day Side effects in first month of treatment include flushing, diarrhea, abdominal cramping, nausea Minimal monitoring Good early safety data Likely as (or more?) effective than standard injectable drugs (49% relapse rate reduction; 90% reduction in MRI activity; slows disability progression over 2 years; reduction in brain atrophy; comparator arm with Copaxone in CONFIRM) 14

15 Second New Oral: Aubagio (teriflunomide) Daily oral agent, 14 mg pill once daily Has recently obtained first line approval Easy to use, easy to monitor and well-tolerated Hair thinning, nausea, diarrhea Possible effect on the developing fetus women and men must use contraceptives Need for washout if pregnancy or drug switch Liver toxicity but otherwise good early safety Effective (approximately equal to injectable DMT; 31% ARR reduction; 20% disability progression) 15

16 Second Line Therapies Tysabri (natalizumab) Monthly infusion $$$$$, limited access PML (new JC virus testing and now titre testing) we can now manage risks Effective (68% relapse rate reduction; 90% MRI activity reduction; slows disability progression) Well-tolerated 16

17 Second Line Therapies Gilenya (fingolimod) Daily oral agent $$$$, limited access Significant need for monitoring macular edema, cardiac, dermatalogic Effective (54% ARR reduction; 30% progression; robust MRI effect) Immunosuppressant Limited safety data (varicella, zoster, macular edema, cardiac effects, PML, malignancies) 17

18 Second Line Therapies Just Approved: Lemtrada (alemtuzumab) IV human monoclonal antibody Very easy to give first treatment course is administered by intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later Highly effective c/w Rebif 44 (68% reduction in relapse rate; decreased MRI activity and brain atrophy; trend to decreased disability) Seems to have sustained benefit at three years in extension trials Immunosuppressant don t know how long effects last no way to reverse Long-term monitoring required ITP, serious infection, thyroid, kidney 18

19 Pipeline: 1-3 Years Pegylated Interferon Monthly or bi-monthly injections Similar effectiveness to Avonex Lingo May help remyelination and reverse previous injury Daclizumab Another monoclonal antibody Infrequent IV injections 19

20 This Neurologist s Approach to DMT: Old and New Disease Factors Severity of clinical disease (number and severity of attacks, EDSS score, cognitive function) Appearance of MRI Risk factors (age, gender) Failure of first line DMT Patient Factors Age, gender, other health issues Preference, lifestyle Extended health plan, employment issues Risk tolerance 20

21 This Neurologist s Approach to DMT: Old and New Older DMT as First Line Therapy Young Female, wanting to have children Mild disease, and relatively inactive MRI No extended health benefits Risk averse New Orals as First Line Therapy Older, Males More severe disease Tecfidera over Aubagio Preference, lifestyle, injection phobia Extended health plan, employment issues Risk tolerance 21

22 DMTs may: Realistic Treatment Expectations for All DMT, Delay progression to CDMS Both Old and New Reduce the number and severity of acute attacks Preserve ability to work, drive, and maintain and enjoy social relationships, leading to an improved quality of life Slow down disease progression DMTs will not: Cure MS Eliminate MS symptoms Reverse existing damage to the CNS Completely eliminate future disease 22

23 Food For Thought: Orals: No more injections!!!! But: No DMT will cure MS or eliminate MS symptoms We cannot compare agents one with another because of the design of clinical trials ( are new agents truly better?) First line injectable therapies have over 20 years of safety data, and we understand the risks of adding in second line drugs when first line therapy fails New agents have unknown risks 23

24 THANK YOU 24

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