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DRAFT SLIDES
Assistance with the preparation of this presentation was funded by a grant from AbbVie and by an educational
grant from Novartis, both of whom had no influence on the content 2
DRAFT SLIDES
Report published October 2015 DRAFT SLIDES
■ Importance of brain health in MS and
the need for urgency at every stage
of the disease
■ Evidence-based international
consensus recommendations
1. Diagnosis
2. Monitoring and therapeutic strategies
3. Generating and consulting robust evidence
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DRAFT SLIDES
Authored by international experts
DRAFT SLIDES
■ Professor Gavin Giovannoni (Chair), London, UK
■ Professor Helmut Butzkueven, Parkville, VIC, Australia
■ Professor Suhayl Dhib-Jalbut, New Brunswick, NJ, USA
■ Professor Jeremy Hobart, Plymouth, UK
■ Dr Gisela Kobelt, Mulhouse, France
■ Mr George Pepper, Leeds, UK
■ Dr Maria Pia Sormani, Genoa, Italy
■ Mr Christoph Thalheim, Brussels, Belgium
■ Professor Anthony Traboulsee, Vancouver, BC, Canada
■ Professor Timothy Vollmer, Aurora, CO, USA
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Report endorsed by professionalDRAFT
societies SLIDES
and
advocacy groups DRAFT SLIDES
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DRAFT
DRAFT SLIDES
SLIDES
Assistance with the preparation of this presentation was funded by a grant from AbbVie and by an educational
grant from Novartis, both of whom had no influence on the content
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The brain health perspective onDRAFT
MS showsSLIDES
that
time matters DRAFT SLIDES
Disease activity can persist even if symptoms are absent
CIS, clinically isolated syndrome; CNS, central nervous system; RIS, radiologically isolated syndrome
1. Filippi M, Rocca MA, 2005; 2. De Stefano N et al., 2010 8
Disease activity persists: DRAFT SLIDES
brain atrophy is accelerated DRAFT SLIDES
This example illustrates how brain atrophy may be accelerated in a person with untreated MS,
with disease onset at 25 years of age, compared with a healthy individual
Figure reproduced with permission from Oxford PharmaGenesis from Giovannoni G et al. Brain health: time matters in multiple sclerosis.
© 2015 Oxford PharmaGenesis Ltd. Available at: www.msbrainhealth.org 9
Disease activity persists: DRAFT SLIDES
but only 1 in 10 lesions results inDRAFT
a relapseSLIDES
■ Only 1 in 10 lesions results in
a relapse,1,2 but all contribute to
loss of neurological reserve
+ =
Brain volume Cognitive reserve Neurological reserve
PPMS, primary progressive multiple sclerosis; RRMS, relapsing–remitting multiple sclerosis; SPMS, secondary progressive multiple sclerosis
1. Sinay V et al., 2015; 2. Raghupathi K et al., 2015; 3. Moccia M et al., 2015 14
Cognitive impairment predicts DRAFT SLIDES
disability progression (2/2) DRAFT SLIDES
■ Short-term clinical disability progression1
□ 1582 people with RRMS treated with placebo were monitored for up to 2 years
□ Baseline cognitive function predicted clinical disability progression, as assessed using:
– EDSS
– Multiple Sclerosis Functional Composite
– Visual Function Test
■ Long-term clinical disability progression2
□ 155 people with RRMS receiving treatment were included in a retrospective longitudinal study
□ After 10 years, compared with those with preserved cognition at diagnosis, people with
cognitive impairment at diagnosis were:
– more than three times as likely to have reached an EDSS score of 4.0
– more than twice as likely to have progressed to secondary progressive MS
Assistance with the preparation of this presentation was funded by a grant from AbbVie and by an educational
grant from Novartis, both of whom had no influence on the content
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DRAFT SLIDES
Three key recommendations forDRAFT
change SLIDES
Maximize
lifelong brain
health
Speed up diagnosis
Leads to
Therapeutic
strategy
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DRAFT SLIDES
2. Monitor disease activity and treat to a target
Share decision-making
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Make the full range of DMTs available
■ RWE regarding the long-term effectiveness of established DMTs is mixed
□ Most studies report that a particular class of established DMT can slow (but not prevent)
disability progression;1,2 others report no effect on disability progression3
Established DMTs A group of DMTs for relapsing forms of MS mostly approved in the 1990s, and
reformulations and generic versions of these substances
Newer DMTs A group of DMTs approved for relapsing forms of MS after the 1990s, with different
MoAs from those of established DMTs
DMT, disease-modifying therapy; MoA, mode of action; RWE, real-world evidence
1. Trojano M et al., 2009; 2. Trojano M et al., 2007; 3. Shirani A et al., 2012; 4. Rudick RA et al., 2006; 5. Coles AJ et al., 2008; 6. Cohen JA et al., 2010;
7. Cohen JA et al., 2012; 8. Coles AJ et al., 2012; 9. Coles AJ et al., 2012; 10. Polman CH et al., 2006; 11. O’Connor P et al., 2011 27
DRAFT SLIDES
Select the most appropriate treatment
■ Make the full range of DMTs available to people with active
relapsing forms of MS, regardless of treatment history, to help to:
□ speed up adoption of the most appropriate treatment
□ optimize effectiveness and safety for each individual
■ Make a shared decision about the DMT that best fits the disease
course, values, needs, limitations and lifestyle of each patient
Therapeutic strategy
Leads to Shared
Monitoring Access to DMTs
decision-making
Swift action on
evidence of
disease activity
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DRAFT SLIDES
Use long-term real-world evidence
■ Regulatory authorities, HTA
bodies and payers make Facilitate
treatment
initial decisions about DMTs decisions
using data from short-term
clinical trials
DMT, disease-modifying therapy; HTA, health technology assessment; RWE, real-world evidence 35
DRAFT SLIDES
Consult the most robust evidence about DMTs
■ Consult the most robust evidence available about the long-term
effectiveness and safety of DMTs and therapeutic strategies
DMT, disease-modifying therapy; HTA, health technology assessment; RWE, real-world evidence 36
DRAFT SLIDES
Overview of key recommendation
Key
Consult the most robust evidence base possible, and generate
recommendation further evidence, in order to make good decisions about
therapeutic and management strategies in MS
Goal: maximize lifelong brain health
Comprehensive
Early referral and
Early treatment Use economic
diagnosis
Recommendation approach
Therapeutic strategy
Shared
Monitoring Access to DMTs
Leads to decision-making
Swift action on
Generate evidence of Consult
disease activity
Real-world evidence
DMT, disease-modifying therapy 37
DRAFT SLIDES
Three key recommendations forDRAFT
change SLIDES
Maximize
lifelong brain
health
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