Brain health presentation charcot baveno 2015

Health & Medicine

gavin-giovannoni
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  • 1 27 November 2015, Milan, Italy 23rd Annual Meeting of the European Charcot Foundation Brain health: why time matters in multiple sclerosis This event is hosted by the Oxford Health Policy Forum and is funded by grants from AbbVie and Genzyme and by educational grants from Biogen, F. Hoffmann-La Roche and Novartis, all of whom had no influence on the content #MSTimeMatters
  • 2 Queen Mary University London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK Gavin Giovannoni Brain health: why time matters in multiple sclerosis This event is hosted by the Oxford Health Policy Forum and is funded by grants from AbbVie and Genzyme and by educational grants from Biogen, F. Hoffmann- La Roche and Novartis, all of whom had no influence on the content
  • 3 Disclosures ■ G Giovannoni has received consultancy fees for advisory board meetings from Biogen Idec, Genzyme Sanofi, Merck Serono and Novartis, relating to a phase 3 trial programme in MS from GSK, relating to data safety monitoring board activities from Synthon BV, and for his role as an author of the report, Brain health: time matters in multiple sclerosis, from Oxford PharmaGenesis, UK, funded by F. Hoffmann-La Roche; has served on steering committees for AbbVie, Biogen Idec, Novartis, Roche and Teva; and has received honoraria for speaking at medical education meetings from Genzyme Sanofi and at a physicians’ summit from Biogen Idec
  • 4 The MS journey Epstein Bar Virus Genetics Vitamin D Smoking Risks Adverse events Differential Diagnosis MRI Evoked Potentials Lumbar puncture Blood Tests Diagnostic Criteria Cognition Depression Fatigue Bladder Bowel Sexual dysfunction Tremor Pain Swallowing SpasticityFalls Balance problems Insomnia Restless legsFertility Clinical trials Gait Pressure sores Oscillopsia Emotional lability Seizures Gastrostomy Rehab Suprapubic catheter Intrathecal baclofen Physio- therapy Speech therapy Occupational Therapy Functional neurosurgery Colostomy Tendonotomy Studying Employment Relationships Travel Vaccination Anxiety Driving Nurse specialists Family counselling Relapses 1st line 2nd line Maintenance Escalation Induction Monitoring Disease-free Disease progression DMTs Side Effects Advanced Directive Exercise Diet Alternative Medicine Pregnancy Breast Feeding Research Insurance Visual loss Palliative Care Assisted suicide Social services Legal aid Genetic counselling Prevention Diagnosis DMT Symptomatic Therapist Terminal Counselling Intrathecal phenol Fractures Movement disorders Osteopaenia Brain atrophy Hearing loss Tinnitus Photophobia Hiccoughs DVLA Neuroprotection Psychosis Depersonaliation Brain Health Cognitive Reserve Sudden death Suicide OCD Narcolepsy Apnoea Carers Respite Hospice Respite Dignita s Advanced Directive Rhiztomy Wheelchair Walking aids Blood/Organ donation Brain donation Exercise therapy NABs Autoimmunity Infections Outcome measures Web Resources Pathogenesis Double vision What is MS? NEDA T2T OCT Neurofilaments JCV status Pharma Anaesthesia www.ms-res.org
  • 5 Rapid adoption of innovations has the potential to improve MS care Reproduced and adapted from Rogers EM. Diffusion of innovation. New York: Simon and Schuster, 2003 100 80 60 40 20 0 P ro p o rt io n o f a d o p te rs ( % ) Innovators Early adopters Majority adopters Late adopters Laggards 30% tipping point Time
  • 6 Slow adoption of innovations results in healthcare inequity P e rf o rm a n c e Time1 2 1st line 2nd and 3rd line Old New Newer 3rd line 2nd line 1st line
  • 7 Australia Norway Denmark Sweden Belgium Austria Germany France Finland Spain Italy Slovenia United Kingdom Poland 0 20 40 60 80 100 Large disparities exist in access to disease-modifying therapies DMT, disease-modifying therapy 1. Hollingworth S et al. J Clin Neurosci 2014;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 Newer DMT Established DMT No DMT All people with MS (%) All data are from 2013 4 4 4 4 4 4 4 4 4 4 4 4 4 1–3 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.
  • 8 Conventional step care TNF antagonist ± IMS Corticosteroids + IMS Corticosteroids Corticosteroids + IMS Corticosteroids TNF antagonist ± IMS TNF antagonist ± IMS Conventional step care TNF antagonist ± IMS Corticosteroids + IMS Corticosteroids Conventional step care Accelerated step care Corticosteroids + IMS Treating to target in inflammatory bowel diseases IMS, immunosuppressant; TNF, tumour necrosis factor Reproduced from Gut, Ordás I, Feagan BG and Sandborn WJ, 1754–63, 2011 with permission from BMJ Publishing Group Ltd. Moderate Severe IMS + TNF antagonist Early top-down L e v e l o f d is e a s e Flipping the pyramid
  • 9 Brain health: time matters in multiple sclerosis ■ Brain health perspective ■ Multidisciplinary international author group ■ Structured discussions during 2015 ■ Evidence-based consensus recommendations on: □ diagnosis □ therapeutic strategies □ access to treatment
  • 10 Intervene early to maximize lifelong brain health
  • 11 Untreated MS progresses to increased disability ■ RRMS □ 85% of people with MS at onset1 ■ SPMS □ 70–90% of people with MS over lifetime if untreated ■ PPMS □ 15% of people with MS, with 1 in 3 ultimately relapsing2 1. McAlpine D. Multiple sclerosis: a reappraisal. In: McAlpine D et al. (eds), Diagnosis and classification of multiple sclerosis, 2nd ed. 1972. Churchill Livingstone, Edinburgh, UK; 2. Antel J et al. Acta Neuropathol 2012;123:627–38 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
  • 12 Cognitive impairment and brain atrophy predict disability progression ■ Cognitive impairment at diagnosis predicted 10-year disability progression and conversion to SPMS (155 patients)1 □ People with cognitive impairment at diagnosis were three times more likely to reach EDSS 4.0 and twice as likely to develop SPMS ■ Cognitive impairment at entry predicted disability progression in placebo- treated clinical trial participants (meta-analysis of 1562 patients)2 ■ Preserving brain volume protected against disability progression (meta- analysis of >13 500 patients)3 ■ Cognitive reserve and brain volume protected against disease-related cognitive decline (62 patients)4 1. Moccia M et al. Mult Scler J 2015. doi:10.1177/1352458515599075; 2. Raghupathi K et al. Poster presented at the 31st ECTRIMS congress, 7 – 10 October 2015, Barcelona, Spain 3. Sormani MP et al. Ann Neurol 2014;75:43–9; 4. Sumowski JF et al. Neurology 2013;80:2186–93;
  • 13 aLesion score was determined on unenhanced images by T2-weighting and a semiquantitative scoring system; the score represents the number of lesions on the initial scan Numbers in parentheses indicate the total number of new, persistently enhancing and re-enhancing lesions in cases where not all enhancing lesions were new lesions. Table adapted with permission from Barkhof F et al. Am J Roentgenol 1992;159:1041–7 Case number 1 2 3 4 5 6 7 Lesion scorea 79 11 97 129 27 50 50 Number of new contrast-enhancing lesions Month 1 0 0 5 0 2 0 1 Month 2 0 1 10 (13) 3 1 0 0 Month 3 1 0 2 (6) 2 1 0 0 Month 4 0 0 2 (3) 2 0 0 1 Month 5 – 0 1 (2) 1 3 0 0 Month 6 – 0 2 1 1 0 0 Month 7 – 0 2 1 0 0 – Month 8 – 0 0 0 (1) 0 – – Month 9 – 1 0 0 2 – – Month 10 – 0 1 – 0 – – Month 11 – 0 – – – – – Month 12 – 0 – – – – – MRI lesion associated with a clinical relapse No examination– ■ Monthly MRI in seven patients over 1 year □ 50 new contrast- enhancing lesions □ Only 5 relapses Most brain lesions are clinically silent
  • 14 Subclinical brain lesions drive brain atrophy in CIS and MS ■ As the number and volume of newly active brain lesions increases, the rate of brain volume loss increases1 ■ Brain atrophy (neurodegeneration) occurs early in CIS and MS and proceeds throughout the disease course2 CIS, clinically isolated syndrome 1. Paolillo A et al. J Neurol 2004;251:432–9; 2. De Stefano N et al. Neurology 2010;74:1868–76 Increasing number of newly active lesions Increasing volume of newly active lesions D e c re a s in g b ra in v o lu m e
  • 15 Treatment should begin as early as possible after diagnosis of MS 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
  • 16 Implement a shared decision-making process
  • 17 Engaged patients do better 1. Rieckmann et al. Mult Scler Relat Disord. 2015;4:202–18. Patient engagement in their own healthcare has been described as the ‘blockbuster drug of the century’1 ■ Take time to engage patients ■ Facilitate two way communication ■ Encourage patients to manage their MS
  • 18 Monitor disease activity and treat to a target
  • 19 Candidate parameters for treating to target in multiple sclerosis Disability progression Relapses Unreported relapses Patient-reported outcomes Brain atrophy Neurofilament levels Lesions detectable using standard clinical MRI techniques (white matter) Lesions currently undetectable using standard clinical MRI techniques (white and grey matter)
  • 20 Treat to target as a therapeutic strategy in MS MRI,magnetic resonance imaging The best drug for the patient is the drug that:  stops relapses  stops disability progression  stops (or minimizes) new MRI lesion development and brain atrophy
  • 21 Regular MRI scans have multiple benefits ■ Measure new lesion development ■ Assess brain volume loss (atrophy) ■ Provide evidence of treatment failure as a prompt for switching □ Increase T2 lesion load □ New Gd-enhancing lesions □ Possibly a high rate of brain atrophy
  • 22 Generate and consult real world evidence
  • 23 Registry data can be used to investigate therapeutic strategies ■ Switch to a higher efficacy DMT vs switch between established platform DMTs DMT, disease-modifying therapy Spelman T et al. Ann Clin Transl Neurol 2015;2:373–87 Injectable DMT Relapse Change to another injectable DMT Change to a higher efficacy DMT
  • 24 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 Newer DMT Established DMT Annualized relapse rates were lower after switching to a higher efficacy DMT ARR, annualized relapse rate Spelman T et al. Ann Clin Transl Neurol 2015;2:373–87 66% relative reduction in ARR, p < 0.0001 A R R i n t h e f ir s t y e a r a ft e r tr e a tm e n t s w it c h in g Injectable DMT Higher efficacy DMT
  • 25 Adopt a comprehensive economic approach
  • 26 The economic perspective ■ Long-term outcome is what matters in economic assessments of chronic progressive diseases ■ The value of disease treatment and management is assessed from the change in the long-term outcome ■ In Brain health: time matters in multiple sclerosis we argue that: □ the biggest change in long-term outcome will come from targeted early intervention to maximize lifelong brain health □ we should generate and use real-world registry data to prove that this is the case
  • 27 Effects on employment occur early in the disease course EDSS, Kurtzke Extended Disability Status Scale Reproduced and adapted from J Neurol Neurosurg Psychiatry, Kobelt G et al., 77, 918–26, 2006 with permission from BMJ Publishing Group Ltd
  • 28 Disability progression drives long-term costs EDSS, Kurtzke Extended Disability Status Scale; PPP, purchasing power parity Reproduced from J Neurol Neurosurg Psychiatry, Kobelt G et al., 77, 918–26, 2006 with permission from BMJ Publishing Group Ltd 0 10 000 20 000 30 000 40 000 50 000 60 000 70 000 80 000 90 000 AU BE GE IT NL ES SE CH UK AU BE GE IT NL ES SE CH UK AU BE GE IT NL ES SE CH UK P P P ( € ) Indirect costs Direct costs EDSS 0–3 EDSS 4–6.5 EDSS 7–9 Direct costs Indirect costs
  • 29 Real-world evidence Early referral and diagnosis Comprehensive economic approach Shared decision-making Access to DMTs Swift action on evidence of disease activity Early treatment Monitoring Use Generate Consult Goal: maximize lifelong brain health Leads toTherapeutic strategyRecommendation The goal of treating MS should be to maximize lifelong brain health Lifestyle and other factors
  • 30 Be an early adopter www.msbrainhealth.org Pledge your support of the report’s recommendations at www.msbrainhealth.org “Our vision is to create a better future for people with MS and their families” Your voice will help to effect this change
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