Treatment in Relapsing MS: Choosing Among the Options. Donald Negroski, MD

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1 Treatment in Relapsing MS: Choosing Among the Options Donald Negroski, MD

2 Disclosures Research Grants Educational activities and lectures Consulting or other services including Continuing Medical Education and non-cme lectures Biogen, Teva, Bayer, Serono, Novartis, Genzyme, Questcor, Acorda, ONO, Chugia 3

3 Agenda I. Multiple Sclerosis Phenotypes II. Risk of Disease Progression III. Pathophysiology IV. Treatment Sequencing

4 What happens if you don t Treat MS? Difficulty with Thinking and Memory Loss of work Depression Sexual Dysfunction Stress on Relationships Relapsing Remitting MS years 50% SPMS and 50% need a cane 83% need cane 30 years from onset ~ 34% bed bound Weinshenker, 1989

5 MS Phenotypes RIS (radiological isolated syndrome) CIS (clinically isolated syndrome) CDMS (clinically definite MS) Relapsing forms and Progressive Forms: Active vs. Inactive Worsening vs No worsening of disability

6 1996 vs 2013 MS Phenotype Descriptions Progressive Disease 1995 MS Clinical Description Subtypes 2013 MS Disease Modifiers Phenotypes Progressive Disease Primary Progressive Progressive accumulation of disability from onset; with or without temporary plateaus, minor remissions and improvements Secondary Progressive Progressive accumulation of disability after initial relapsing course, with or without occasional relapses and minor remissions Progressive Relapsing Progressive accumulation of disability from onset but clear acute clinical attacks with or without full recovery Progressive accumulation of disability from onset PP Progressive Disease SP Progressive accumulation of disability after initial relapsing course Lublin FD, et al. Neurology. 2014;83(3): ; Miller AE. ACTRIMS/ECTRIMS 2014 [TC1]. Active* and with progression** Active but without progression Not active but with progression Not active and without progression (stable disease) *activity determined by clinical relapses assessed at least annually and/or MRI activity; ** progression measured by clinical evaluation, assessed at least annually

7 Factors Related to Risk of Disease Progression During First 5 Years after Diagnosis Non-Caucasian Multiple deficits at presentation Increased number of attacks Short interattack interval Disability High MRI lesion load Early motor/ cerebellar / bowel and bladder involvement Stroup, Neuro Report. 2014

8 1000-CIS: Factors that Determine Disease Course Early Changes to Predict Longterm Prognosis Study designed to determine factors that add value to clinical and brain MRI changes occurring during the first year, to predict conversion to CDMS and disability accumulation N = 1015 CIS patients (from 1995 till 2013) Demographic factors Topography CSF: OB Baseline Number of T2 12m New 12 Treatment factors Decreased Risk Increased Risk Key findings First year clinical and brain MRI changes further improve the estimation of individual prognosis Independent predictors of further attacks: Baseline lesions, new T2 during the first year, DMT before second attack Independent predictors of accumulation of disability: OB, new T2 and incomplete recovery Hour Tintore, et al. ACTRIMS-ECTRIMS; September 10-13, 2014; Boston, MA. PS9.4.

9 Relapse Recovery 18% (of 1562) patients with incomplete recovery reached EDSS 6 in ½ time of those with complete recovery Pyramidal, bowel/bladder, cognitive and cerebellar relapses had increased residual disability Relapses in patients on 1 st line therapy were often preceded by similar pre-treatment relapses. Confarvreau, Brain 2003, Kalincik, MSJ 2014, Deen, J Neuro Neurosur Psych 2008

10 Proposed Pathophysiology of MS VCAM = vascular cell adhesion molecule.

11 APC=antigen-presenting cells Pathophysiology of MS

12 Evolving MS Treatment Landscape (Alemtuzumab) Lemtrada Laquinimod Betaseron (IFNβ-1b) Tysabri (natalizumab) Plegridy TM (PEG-IFNbeta-1a) Ocrelizumab Avonex (IFNβ-1a) Copaxone (glatiramer acetate) Novantrone (mitoxantrone) Extavia (IFNβ-1b) Gilenya (fingolimod) Aubagio (teriflunomide) Copaxone (GA 40 mg TIW) Tecfidera (dimethyl fumarate/) Dac-HYP Ofatumumab Rebif (IFNβ-1a) FDA-Approved Therapies Phase III Injectable Therapy Oral Therapy

13 Different MOA s Influence immune cell functioning Inhibit immune cell trafficking Inhibit cell replication Immune cell depletion/destruction

14 Treatment Sequencing/ Optimization for Relapsing MS Goal: NEIDA (No Evidence of Inflammatory Disease Activity): no sustained disability after 3 months, no relapses, no MRI activity (new/enlarging T2 or gd+ lesions) Proposed: NEDA-4: no annual brain volume loss > 0.4%, no disability after 6 months

15 Theoretical Reasons to Switch Attempt to limit tissue damage Prevent irreversible disability Examples of switches: Lateral move Induction Escalation 16

16 Use of MRI for Decisions Likely nonresponder to Interferon Tx if >1 relapse or 1 relapse and 4 new T2 lesions Patients with one or more new or enlarging T2 lesion during first year were twice as likely to experience a relapse during the second year (PBO pt in 3 trials) Rio, Mult Scler, 2009, Sormani, Nat Rev Neur 2013, Richert, Neurology, 2014

17 Limited Switch Studies Some benefit for treatment failure Less clear for tolerability Limited between classes Some evidence (2 studies) from injectable to Fingolimod Majority of Neurologists wait 6-12 months as a minimum tx duration before switching 57% of neurologist would switch with 3-5 new asymptomatic T2 lesions Stuve, JAMA Neuro, 2015, Tornatore, Neur Cl Pra 2012

18 Switching Therapy is Not Without Risks Breakthrough disease activity Timing of treatment Washout concerns Rebound disease Leaving patient untreated Montalban X. Presented at: ACTRIMS-ECTRIMS; September 10-13, 2014; Boston, MA; Parallel Session 9.2; Havla J, et al. Ther Clin Risk Manag. 2013;9:

19 Transitioning Between Therapies: Washout Considerations From Transitioning To Washout IFNβ or GA Any drug No washout period required Any drug IFNβ or GA No washout period required Natalizumab Teriflunomide Fingolimod DMF Fingolimod/natalizumab Fingolimod Teriflunomide DMF Other MS therapies Teriflunomide Natalizumab Alemtuzumab Natalizumab Fingolimod Alemtuzumab months after discontinuation of natalizumab At least 3.5 months is required to prevent possibility of concomitant immune effects. Caution is required if other therapies are started within this time period. Accelerated Elimination Procedure 1-2 month period needed for lymphocytes to return to normal range following discontinuation of fingolimod No washout period required 2-3 months for natalizumab Until > 800 lymphocytes for fingolimod Montalban X. Presented at: ACTRIMS-ECTRIMS; September 10-13, 2014; Boston, MA Parallel Session 9.2.

20 Treatment Decision Making in MS Define the MS Choose therapy Patient and disease profile MS prognosis Disease activity / type Shared goals for treatment Disease factors (stage, activity, severity) Patient factors (preference, comoribidities) Drug factors (efficacy, safety, cost, route) X Y Z yes no Monitor Monitor Clinical (relapse, disability progression, tolerability) MRI (T2 and T1-Gd, brain atrophy) Biomarkers (anti-jcv Ab, NAbs) Change therapy? Suboptimal response? Intolerable side effects? Giovannoni G, et al. Curr Opin Neurol. 2012;25(suppl1):AS20-S27; Dhib-Jalbut S. Presented at: ACTRIMS-ECTRIMS; September 10-13, 2014; Boston; Parallel Session 7.2

21 MS Treatment Algorithm (Europe) CIS at high risk of developing MS CIS fulfilling MS criteria (McDonald 2010) RRMS Interferon beta 1b Interferon beta 1a sc Interferon beta 1a im Glatiramer Acetate Teriflunomide DMF Rapidly evolving severe RRMS MILD Disease activity Natalizumab Fingolimod Alemtuzumab Montalban X. Presented at: ACTRIMS-ECTRIMS; September 10-13, 2014; Boston, MA. Parallel Session 9.2.

22 MS Treatment Algorithm (Europe) CIS at high risk of developing MS CIS fulfilling MS criteria (McDonald 2010) RRMS Interferon beta 1b Interferon beta 1a sc Interferon beta 1a im Glatiramer Acetate Teriflunomide DMF Rapidly evolving severe RRMS MODERATE/SEVERE Disease activity Natalizumab Fingolimod Alemtuzumab Montalban X. Presented at: ACTRIMS-ECTRIMS; September 10-13, 2014; Boston, MA. Parallel Session 9.2.

23 Practice Patterns Consensus of US Neurologists : Summary of 2014 Survey US MS specialists (n=239) 2 surveys developed by a steering committee of 6 MS experts independent of the CMSC and 2 representatives from large national health plan and pharmacy benefits managers Results show an earlier more aggressive approach to MS treatment RIS Treat if >2 new Gd+ lesions (80%) Follow-up MRI within 12 months (84%) Diagnosis CIS RRMS: Initiate treatment Treat if 2 nonenhancing T2 lesions (95%) or 1 Gd+ lesion in addition to nonenhancing T2 lesions (98%) Treat mild disease with injectable treatment (38%) or DMF (30%) (100%) JCV-, aggressive disease, treat with natalizumab Follow-up MRI within 12 months (75%) Follow-up MRI within 12 months (97%) Follow-up MRI within 12 months (97%) Consider switching to oral/iv DMT if 2 new T2 lesions (67%) or 1 new Gd+ lesion (52%) on therapy Tornatore C et al. Presented at: ACTRIMS-ECTRIMS; September, 2014; Boston; Poster 295.

24 Treatment in Relapsing MS: Choosing Among the Options

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