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Benefit/Risk Strategies in Selecting Therapeutic Solutions for MS

Benefit/Risk Strategies in Selecting Therapeutic Solutions for MS

Benefit/Risk Strategies in Selecting Therapeutic Solutions for MS: HCP and Patient Viewpoints

Learning Objectives

Review the benefit/risk strategies in selecting therapy for MS patients while assessing treatment regimens that carry acceptable or diminished risk of disease progression
Explore emergent concepts in the management of MS, focusing on targeting T- and B-cells including:
- Risks associated with continuous immunosuppression
- Action on the inflammatory activity in the CNS compartment
Identify strategies that simplify patient dosing and side effects to:
- Increase treatment compliance
- Improve patients’ quality of life
- Slow disease progression

As Disability of MS Advances, Work Capacity Decreases

The proportion of MSers employed or on long-term sick leave is calculated as a percentage of MSers aged 65 or younger.
_{1. Kobelt G et al. J Neurol Neurosurg Psychiatry. 2006;77:918-926; 2. Pfleger CC et al. Mult Scler. 2010;16:121-126.}

The Traditional Approach to MS Treatment

Heterogeneity of disease course across different MSers and over time can affect treatment response^1-3
Depending on the definition used, up to 49% of MSers treated with a first-line injectable therapy (IFNB) still have clinical disease activity¹

^{1. Rio J et al. Ann Neurol 2006;59:344-52; 2. Miller A et al. J Neurol Sci 2008;274:68-75; 3. Rudick RA et al. Lancet Neurol 2009;8:545-59.
Figure adapted from Rio J et al. Curr Opin Neurol 2011; 24:230-7.}

Treating Beyond Symptoms with a View to Improving Outcomes in Inflammatory Bowel Diseases

T2T-NEDA ALGORITHM

MS prognosis based on clinical and MRI indices
Life style and goals
Shared goals for therapy

Patient’s preferences?
Your choice?

Only one licensed induction therapy at present

Rebaselining:

ifn-β, natalizumab, fingolimod, teriflunomide, dimethyl-fumarate=3-6 months
glatiramer acetate=9 months
alemtuzumab=24 months

Individual measures:

Evidence of disease activity?
Tolerability/safety?
Adherence?
Drug or inhibitory markers, e.g. NABs?

Interferon-beta Reduced Mortality by 46.8% vs Placebo Over 20 Years

Inflammation Drives Acute Axonal Loss and Primes Surviving Axons for Degeneration Later

Treatment Effect on Disability Predicted by Effect on T2-lesion Load and Brain Atrophy

Meta-analysis of treatment effect on EDSS worsening (y) vs effects on MRI lesions and brain atrophy, individually or combined, in 13 placebo-controlled RRMS trials (13,500 patients)

No Evident Disease Activity: NEDA

_{Gd, gadolinium.
1. Havrdova E, et al. Lancet Neurol. 2009; 8:254–260; 2. Giovannoni G, et al. Lancet Neurol 2011; 10:329–337.}

MS Pyramid

Risk vs Benefit

Theoretical Model: Treat Early and Effectively

Early – Highly Active Treatment Enhances Outcome

Cost of Delayed Access to Highly Active Treatment

Large Disparities Exist Among Countries in Access to Disease-Modifying Therapies

All data are from 2013

Established DMTs
DMTs approved for relapsing forms of MS during the 1990s and reformulations or generic versions of these substances

Newer DMTs
DMTs approved for relapsing forms of MS that have a different mechanism of action from established DMTs

_{DMT, disease-modifying therapy.
1.Hollingworth S et al. J ClinNeurosci2014;21:2083–7; 2. World Bank, 2015. http://data.worldbank.org/indicator/SP.POP.TOTL ; 3. MSIF, 2013. http://www.atlasofms.org ; 4.Wilsdon T et al. 2013. http://crai.com/sites/default/files/publications/CRA-Biogen-Access-to-MS-Treatment-Final-Report.pdf . Figure reproduced from Giovannoni G et al. Brain health: time matters in multiple sclerosis. Available at: www.msbrainhealth.org}

Multiple Sclerosis: Unmet Medical Needs

Disease-modifying drugs (DMDs) are not completely effective in all patients.
7 to 49% of relapsing–remitting MS (RRMS) patients do not adequately respond to DMDs
Current Options Injection/Infusion
- Needle phobia (25% of population)
- Clinic infusion visit required

_{Rudick RA, Polman CH. Lancet Neurol. 8, 545–559 (2009).}

The Goal of Treating MS Should Be to Maximize Lifelong Brain Health

Our Vision Is to Create a Better Future for People with MS and Their Families

Your voice will help to effect this change.

Be an early adopter

Pledge your support of the report’s recommendations at www.msbrainhealth.org

Therapeutic Hierarchy

Strategies to Reduce Time Spent with the Clinician and Enhance Adherence

Dosing Schedule – 10 days annually for 2 years
Oral administration – More appealing than needles
Low Discontinuation Rate – Less anxiety for the patient and demand for HCP time
Less Monitoring – Depends on the progression of MS and patient specific needs

Evolution In Disease Modifying Drugs For Relapsing Remitting Multiple Sclerosis

Disease modifying drugs: Benefit/risk evaluation

Established Inconveniences and Risks

Convenience
Monitoring
Tolerability
Safety

Established Benefits

Treatment efficacy