EXCEMED Neurology Extracts, Fall-Winter 2014

Fall-Winter 2014

HIGHLIGHTS on EXCEMED activities in neurology

IMPROVING MS PATIENT OUTCOMES

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ANNUAL CONFERENCE outcomes Focused on improving patient outcomes YOUR EXCEMED EXCEMED: Improving MS management through medical education RECENT EXCEMED EVENTS in MS New frontiers in MS management

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preceptorship outcomes Updating clinical knowledge EXCEMED e-learning MS therapies, inflammation, synaptic transmission and neurodegeneration Upcoming IN EXCEMED NEUROLOGY Educational activities on the horizon

MS education focused on cutting-edge research 9-10 May, Dubai, UAE Around 260 neurologists involved in the management of MS participated in the 2014 CMEaccredited Annual Conference in MS. Organised

by EXCEMED, the conference took place on 9-10 May, in Dubai, UAE. This live educational conference is held annually and has developed into a key event for neurologists specialising in MS, from all over the world.

Presentations, workshops and roundtable sessions focused on the following important aspects of MS relating to epidemiology, genetics and patient-centred clinical management: • Latest advances in MS pathogenesis • Genetic susceptibility and environmental factors in MS pathogenesis • Optimum treatment selection, based on MS disease phase Follow us http://twitter.com/EXCEMED_Neuro

• Identifying the main predictors of disease outcome • Assessing treatment and changing therapies in non-responding patients The sessions provided excellent opportunities for participants to expand their knowledge of MS management.

Materials from the Annual Conference – including the presentations and capsule videos (short, three-minute interviews with key conference speakers) – can be found on the EXCEMED website: www.neurology.excemed.org/ en/neurology.html This publication highlights the key presentations at the Annual Conference in MS. It also provides an update on other recent and forthcoming activities in neurology, developed by EXCEMED.

CME excellence Continuing medical education is our sole focus and our passion. We pour our energy and expertise into delivering the best for healthcare professionals, with patients as the ultimate beneficiaries.

This is CME excellence.

Our educational programmes in neurology are designed to suit the needs of healthcare professionals from all over the world who want to be at the cutting edge of research and patient care.

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Conference outcomes 9-10 May, Dubai, UAE

MS prevalence increasing

Professor Saeed Bohlega

Figure 1: Increase in female:male ratio of MS is growing at a global level

(King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia) emphasised that MS prevalence and the female:Â male ratio of patients is increasing

MS prevalence is increasing The epidemiology and pathogenesis of MS is gradually being more fully understood, through painstaking research and observations.

MS prevalence is increasing in many countries, and as the global population increases, greater numbers of people are therefore at heightened risk of developing MS. However, MS prevalence remains lower in regions with widespread helminth infection and poor sanitation.

Dr Bohlega confirmed that female:male ratio of MS cases is rising (Figure 1), highlighting the need to focus on lifestyle changes among women (e.g. smoking, obesity) to help reduce the number of women who develop the disease.

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Figure 2: MS – a complex disease

Abbreviations are defined in the Glossary, page 7

Conference outcomes 9-10 May, Dubai, UAE

MS risk factors

Dr Filippo Martinelli Boneschi

Dr Orhan Aktas (Heinrich-Heine-University, Düsseldorf, Germany) considered why the immune system is activated in MS, possibly in early life

MS risk largely established in first two decades of life Probably no single factor is responsible for immune system activation in MS. The disease largely results from a complex interplay between genes and the environment (Figure 2) that may start in early life.

Risk is largely established in the first two decades of life, with MS possibly occurring following exposure to a common infectious agent (e.g. EBV).

Non-genetic risk factors include smoking and obesity. Dr Aktas said that knowledge of genes and environment interactions in MS has expanded by new insights on epigenetic and epistatis.

People moving from an area where MS is common to one where it is rarer show a decreased rate of disease and vice versa.

(INSPE Scientific Institute San Raffaele, Milan, Italy) summarised how genes and pathways involved in the immune response are major drivers of MS risk

Genes and pathways involved in the immune response are major drivers of MS risk Genome-wide association studies (GWAS) first identified the genes involved in MS pathogenesis in 2007. Since then, 110 risk variants for MS have been identified outside the HLA region. Dr Boneschi summarised current knowledge: • Non-genetic risk factors include low vitamin D levels, smoking, obesity, EBV infection • Other mechanisms (epigenetics, interaction between genetic and non-genetic factors) could explain the influence of genetics on disease susceptibility • Role of genetic factors is unclear.

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Dr Maria Assunta Rocca (Vita-Salute San Raffaele University, Milan, Italy) provided an update on MRI findings in MS diagnosis)

MRI studies offer new insights into MS pathogenesis and disease progression

Dr Rocca described how MRI studies provide new insights into MS pathogenesis and disease progression.

Scans demonstrate DIS and DIT, and identify neuroradiological red flags that are typical of other conditions resembling MS. Advanced MRI techniques can now identify brain lesions not previously thought to be involved in the MS pathogenic process, which is improving understanding of MS pathogenesis.

Leukocortical (type I) and subpial (III–IV) cortical lesions are potential biomarkers of cognitive and neurological disability.

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Conference outcomes 9-10 May, Dubai, UAE

Targeting disease-free status MS treatment has been revolutionised by new goals such as NEDA and the increasing possibility to individualise treatment.

The advent of DMDs has changed the course of MS by providing many benefits for patients: • Fewer and less-severe relapses • Better recovery after relapses • Prevented/postponed disability progression • Reduced accumulation of disease burden or decreased brain activity • Improved HRQoL and cognitive functioning • Less fatigue

Professor Robert J Fox (Cleveland Clinic, Cleveland, USA) explained the emergence of NEDA

DMD effectiveness demonstrated

by NEDA

A plethora of clinical trials demonstrates the effectiveness of DMDs by quoting findings in terms of achievement of NEDA which includes measures of the number of clinical relapses, MRI activity and disability progression.

At least 40% of patients achieve NEDA in two years with currently-available drugs, although disability progression may be confounded by previous injury.

Dr Fox emphasised that treating-totarget requires individualised treatment planning: assessment for each patient should consider symptom severity, recovery from relapses and lesion characteristics. Unresolved issues include optimal NEDA definition and its integration with treatment risks (Figure 3).

Figure 3: Evolving paradigm: individualised MS treatment based on projected disease course

The benefits of MS treatments over the past 20 years have led to evolving therapeutic goals, with the wellbeing of the patient now an important consideration in the therapeutic contract.

Speakers at the Annual Conference discussed the changing strategies for MS management.

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Abbreviations are defined in the Glossary, page 7

Conference outcomes 9-10 May, Dubai, UAE

Predicting outcome

Dr Letizia Leocani (Vita-Salute IRCCS San Raffaele University, Milan, Italy) outlined techniques for measuring MS-related damage

MEPs may predict disability in RRMS with 80% accuracy MS-related damage (caused by segmental demyelination and axonal degeneration) can be measured and monitored by conduction and amplitude, respectively.

Neurophysiological techniques, particularly EPs, show promise for identifying patients more likely to develop disability and will need intensive monitoring and treatment: • VEPs usually absent in NMO • VEPs less sensitive for CIS, but subclinical MEP abnormalities may positively predict future motor function involvement • MEPs may predict disability at 2 years in RRMS (80% accuracy) • OCT reliably diagnoses and monitors axonal loss after an ON episode Dr Leocani explained that EPS generally have good utility in MS diagnosis and monitoring.

Dr Roberto Bergamaschi

Dr Mar Tintoré

(National Neurological Institute C. Mondino, Pavia, Italy) introduced the concept of tailoring treatment based on BREMS

(Vall d’Hebron University Hospital, Barcelona, Spain) summarised the predictivity of treatment response

Clinical factors including male sex and an older age of RR phase onset may help to define MS prognosis. Dr Bergamaschi introduced BREMS as an important tool for predicting secondary progression and poor outcomes at an early stage of disease, particularly when assessing and comparing the effects of DMDs. BREMS is based on clinical factors including sex, pure motor onset, sphincter involvement and number of motor relapses. The BREMS tool might help clinicians to tailor treatments based on the presence or absence of negative prognostic factors

Response to MS treatment is highly heterogeneous. However, clinical, MRI and biological parameters can all define the predictivity.

These include older age at disease onset, lower disability, and fewer GAD lesions at baseline MRI, however it is unclear whether they are predictors or prognostic factors. Dr Tintoré stated that, overall, clinical parameters show low sensitivity in defining the prognosis: • Disability risk greater in patients with increased MRI activity • Brain atrophy measurement is not always reliable • Clinical evaluation and MRI studies could define the prognosis more accurately (Figure 4).

Figure 4: Algorithm for assessing clinical response

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Conference outcomes 9-10 May, Dubai, UAE

Therapeutic goals and challenges People with MS often have complex treatment regimens

Professor Carlo Pozzilli (“La Sapienza” University of Rome, Rome, Italy) gave an overview of adherence to treatment

Therapeutic non-adherence remains an issue Patients do not always take their medication due to complex treatment regimens, intolerable side-effects or failure to understand the need for the treatment.

One in three MS patients discontinues IFNB treatment within 3–5 years, with 10–20% discontinuing within the first 3–6 months. Conversely, drop-out rates in clinical trials are only 8–14% (2–3-year data).

Dr Pozzilli reminded delegates why early treatment is important - it reduces inflammation and prevents disability and disease progression: • To be effective, a treatment should be administered correctly and at the right dosage • Treatment decisions should be shared with patients and relatives • Symptoms and side-effects should be managed immediately when they are identified because they may negatively impact on adherence

For decades MRI has been an important tool in MS assessment; EXCEMED presentations often cover new developments

At the Annual Conference, six interactive workshops were held where participants could share opinions and understanding on the following topics: • Treatment initiation and therapeutic contract • How to manage response to first-line therapies • Therapeutic options • Role of MRI in MS monitoring • Genes and the environment • Patient engagement in the decision-making process Lively discussions took place, with delegates exchanging views and benefiting from alternative experiences and viewpoints.

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Dr Bassem Yamout (American University of Beirut Medical Center Beirut, Lebanon] introduced a roundtable discussion on patients’ perceptions and PROs, highlighting that MS patients are active participants in the decision-making process. He emphasised that doctors and patients sometimes disagree on key aspects of their disease, with HRQoL being very important to patients. The MS in the 21st Century initiative defines how MS treatment and standards of care should look today, he added.

A panel of experts debated the issues and agreed that incorporating PRO measures in follow-up appointments should improve patient engagement and treatment adherence.

Debates on therapeutic management were dynamic. The discussion of treatment initiation explored the issue that early treatment can delay relapses, disability and brain volume loss in the long term, although participants acknowledged that not all patients with RIS or CIS will develop MS. The debate on assessing treatment failure focused on the use of MRI versus clinical response. Professor De Stefano highlighted the importance of MRI assessment to predict prognosis and he also described the key role of the Rio score to predict treatment response.

Professor Martinelli countered that MRI studies are not fully objective, with clinical evaluation remaining the only way to diagnose and monitor the various forms of MS and CIS comprehensively •

Abbreviations are defined in the Glossary, page 7

Glossary

YOUR EXCEMED

EXCEMED: Improving MS management through medical education EXCEMED – Excellence in Medical Education is the new name of Serono Symposia International Foundation (SSIF). Our new name marks an exciting point in our evolution, but our focus on education in oncology remains paramount.

The Foundation has provided worldclass education to thousands of healthcare professionals over the past four decades. During this time, over 1500 international scientific congresses have been organised, with more than 500 proceedings published in leading international journals.

EXCEMED has pioneered online CME courses since 2000; the organisation oversees an expanding portfolio of e-learning activities including video lectures, CME-accredited online courses and symposia. These digital ventures reach over 12,500 people per month via the EXCEMED website or through e-newsletters.

As a non-profit global organisation, EXCEMED is dedicated to improving the patient’s life through the provision of independent, high-impact CME to scientists, physicians, nurses, pharmacists and other healthcare professionals.

Upcoming EXCEMED events of relevance to specialists in neurology are summarised on page 11 of this publication.

EXCEMED has an innovative educational programme in neurology

BICAMS, Brief International Cognitive Assessment for MS BREMS, Bayesian Risk Estimate for Multiple Sclerosis CIDP, chronic inflammatory demyelinating polyradiculoneuropathy CIS, clinically isolated syndrome CME, continuing medical education CNS, central nervous system CSF, cerebrospinal fluid DIS, dissemination in space DIT, dissemination in time DMTs, disease-modifying therapies EAE, experimental autoimmune encephalomyelitis EBV, Epstein Barr virus EPs, evoked potentials GAD, gadolinium GM1, ganglioside GM1 GWAS, genome-wide association studies HRQoL, health-related quality of life HLA, human leucocyte antigen IFNB, interferon beta IVIg, intravenous immunoglobulin MEP, motor evoked potential MR, magnetic resonance MRI, magnetic resonance image MS, multiple sclerosis OCT, optic coherence tomography ON, optic nerve NEDA, no evident disease activity NMO, neuromyelitis optica PRO, patient reported outcome PPMS, primary-progressive MS PST, Processing Speed Test RIS, radiologically isolated syndrome RRMS, relapsing-remitting MS TMS, Transcranial Magnetic Stimulation VEP, visual evoked potentials

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Recent EXCEMED events in MS

Joint Congress of European Neurology Satellite Symposium: Dysimmune neuropathies – from pathogenesis to treatment

Rehabilitation is always of tremendous importance in MS management and is frequently featured at EXCEMED events

1 June 2014, Istanbul, Turkey — Multifocal motor neuropathy (Dr Jean-Marc Léger, France) • Multifocal motor neuropathy is a rare and relatively new disease, belonging to the spectrum of dysimmune neuropathies.

• Achieving the right diagnosis is problematical due to the varying frequency of anti-GM1 found in patients and variability in clinical and neurophysiological findings.

• IVIg therapy is the best available treatment – there is no evidence for efficacy of immunosuppressants or steroids.

• The short- and long-term efficacy of drug treatments is difficult to determine, since there are uncertainties about the best outcome measures and a lack of a large population to study.

30 May 2014, Istanbul, Turkey — Genes and lifestyle/environmental factors (Dr Tomas Olsson, Sweden) • Optimum treatment requires further understanding of MS origins – interactions between lifestyle, environment and genes may be involved.

• Causes of MS are unclear – evidence supports an autoimmune origin.

• Genetic background can predispose MS development, although twin studies show only modest genetic impact.

• HLA and non-HLA genes related to the immune system are probably involved.

CIDP pathogenesis and treatment (Dr Eduardo Nobile-Orazio, Italy) • A treatment algorithm that lists the pros and cons of each pharmacological approach was presented.

• Clinical features of typical and atypical forms of CIDP are clear. Atypical cases are now included in the CIPD family, although some clinicians and researchers still debate their presence.

• Evidence for and against the pathogenic role of autoantibodies, and for the discovery of autoantibodies against Contactin-1 and neurofascin was presented.

• Contactin-1 and neurofascin may be useful biomarkers to identify subgroups of patients, however.

Overview of vasculitic neuropathies (Dr Hans-Peter Hartung, Germany) • Classification, clinical and pathological features and the diagnostic tools available for vasculitic neuropathies were described.

Workshop: New frontiers in MS management

Differential diagnosis: role of MRI (Dr Àlex Rovira, Spain) • Practical suggestions were given on interpreting brain and spinal cord MR – lesion distribution and shape are key elements for differential diagnosis.

• Corpus callosum lesions are important in distinguishing MS from similar conditions.

• Clinical-case sessions illustrated the main MR sequences/ techniques for clinical practice to rule out abscesses, brain tumours or other forms of brain vasculitis in atypical MS. Rehabilitation (Dr Mauro Comola, Italy) • The best outcome for rehabilitation in MS is achieved by improving everyday functionality and brain plasticity, by customising care to suit physical, social and psychological needs.

• New rehabilitation strategies (e.g.TMS) were described.

Cognitive dysfunction (Dr Maria Pia Amato, Italy) • Thinking, memory, vision and gait are perceived by MS patients as the most valuable functions.

• BICAMS is a new easy-to-use screening tool for clinical practice.

• PST, a self-assessment tablet-based tool, was also described.

Treatment options and clinical pipeline (Dr Aksel Siva, Turkey) • Clinical trials investigating the efficacy and features of first- and second-line drugs were described.

• Treatment algorithms were reviewed, focusing on the critical issue of drug safety in pregnancy.

• Clinical cases exemplified when to switch therapies, and outlined optimum treatment options.

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Abbreviations are defined in the Glossary, page 7

Professor Xavier Montalban

Preceptorship outcomes

(Unit of Clinical Neuroimmunology, Vall d´Hebron University Hospital, Barcelona) was one of the scientific organisers of the EXCEMED preceptorship in June 2014, held in Barcelona, Spain. This article summarises the broad range of subjects included in this preceptorship

Preceptorship: Updating knowledge in MS 17-19 June 2014, Barcelona, Spain — Epidemiology, pathogenesis and diagnosis of MS • MS incidence and prevalence are both increasing globally, possibly due to changes in risk factors interacting with genetic predispositions.

• Analyses can identify genes involved in MS susceptibility and genetic modifiers predictive of treatment response.

• Pathological specimens reveal structural changes in normal-appearing brain, which increase with disease progression and ageing.

• T- and B-cell responses drive MS development – new techniques (e.g. two-photon imaging) allow quantitative analysis.

• The discovery of axonal autoantigens has improved understanding of mechanisms of axonal damage.

New revision of McDonald’s criteria • A detailed analysis of different MRI features is critical to distinguish MS from syndromes that mimic MS. • VEP and OCT may help to diagnosis and monitoring of MS. • VEP can pinpoint the dynamic change of ON dysfunction during acute inflammation, and may detect clinically-silent ON damage.

Different forms of demyelinating disease • Treatment options are limited for NMO. • CSF analysis has a role in the diagnosis of PPMS. • Immunomodulatory agents have a favourable safety profile, and appear to be well tolerated and effective in paediatric MS. • Rehabilitation is important in restoring MS-related fatigue and bladder function.

• Specific treatment of gait dysfunction can improve the patient’s activity and participation in everyday events.

Cognitive disorders in MS • Addressing cognitive issues is now considered a quality indicator in MS care.

• Cognitive reserve is critical to compensate for cognitive deficits and preserve functionality in daily life.

• Computer-based testing should play a greater future role in assessing cognitive deficits in MS. • Pharmacological and non-pharmacological interventions can positively effect cognitive function: non-pharmacological therapies act on attention, immediate verbal memory and delayed memory.

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Treatment costs and compliance issues are important aspects of MS management

Targeting ‘freedom from disease’ for MS patients • NEDA is the new goal for MS treatment • It is important to start treatment early and to regularly monitor its efficacy, to avoid missing the opportunity for escalating treatment in patients with suboptimal response.

Defining treatment success • Defining treatment response using clinical and radiological measures is complex.

• A combined score (comprising clinical activity, progression and new MRI lesions) may have better prognostic value for identifying those patients likely to have further disease activity.

• Genetic and transcriptomic studies are investigating genetic features and biomarkers predictive of response to current MS therapies.

• Improving compliance is critical to treatment success – several strategies exist.

• Safety concerns remain high, but future therapeutic options will allow neurologists to individualise treatment and possibly achieve the goal of ‘freedom from disease’.

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EXCEMED e-learning

Professor David Bates (University of Newcastle upon Tyne, UK)

Online CME activities combine timely, insightful content with the convenience of home or workplace study. Courses are available for anyone wishing to participate.

Participants who obtain satisfactory scores on posttest questions can receive certificates of completion.

Two new online courses in the EXCEMED neurology portfolio are set to offer unique opportunities to learn about key aspects of MS. The first online course has been prepared

by Professor David Bates (Newcastle upon Tyne, UK) and reviews the mechanisms of action of the main MS treatments, together with emerging DMTs. The second online course, due to launch later this year, has been developed by Professor Diego Centonze (University of Tor Vergata, Rome, Italy). This course will cover inflammation, synaptic transmission and neurodegeneration in MS.

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Professor Diego Centonze (University of Tor Vergata, Rome, Italy)

Multiple sclerosis therapy: Inflammation, synaptic transmission and Mechanisms of action neurodegeneration in Therapeutic options for MS have seen multiple sclerosis tremendous expansion in recent years, providing physicians and patients with an array of options and the challenging responsibility of choosing the optimal therapy for each patient.

Extensive clinical evaluation of patient, clinical phenotype and disease progression are fundamental for selecting the best therapeutic option.

However, a full comprehension of mode of action of currently available MS drugs and emerging DMTs is crucial in order to achieve the best therapeutic effectiveness with minimal side-effects.

The course can be accessed via the EXCEMED website at www.neurology. excemed.org/en/coursedescription/ bates01.html Full instructions for participation are included.

This online course is accredited by the European Accreditation Council for Continuing Medical Education (EACCME) for 1 European CME credit (ECMEC).

Although MS has been regarded as a disorder of CNS white-matter, early alterations of the neuronal compartment are partially independent of demyelination.

Soluble inflammatory cytokines and glutamate have been proposed as major determinants of neurodegeneration. The relationship between these two major determinants has been largely elusive.

Unexpected connections between immune cells and soluble cytokines, and synaptic transmission and neurodegeneration have been identified.

In addition, glutamate-mediated excitatory postsynaptic currents are known to be enhanced during the early phase of EAE. Synaptic alterations occurring during neuroinflammatory diseases are largely mediated by inflammatory cytokines released from infiltrating T-cells and activated microglia and are partly responsible for irreversible dendritic pathology.

These data suggest that CNS-confined inflammation in MS is associated with the release of soluble molecules which can alter excitatory synaptic transmission and stimulate secondary neurodegenerative gray matter pathology.

This upcoming online course will explore all these novel aspects of MS and is expected to launch on the EXCEMED website by the end of 2014. EXCEMED will submit a request for EACCME accreditation for this course. Stay tuned.

Abbreviations are defined in the Glossary, page 7

Upcoming in EXCEMED neurology

EXCEMED is offering excellent online and live educational events in the coming months. Please visit www.excemed.org to see the latest news on the neurology educational programme

Preceptorship course on rehabilitation in MS Valens, Switzerland 25-26 September, 2014 Scientific Organiser J Kesselring, Switzerland

Aim this preceptorship course will update the newest insights into MS rehabilitation, including neuromodulation and cognitive rehabilitation Key topics biological basis of neurorehabilitation, applied neuroplasticity, PROs and shared decision in rehabilitation, treatment for spasticity and other common symptoms, cognitive rehabilitation, water and sports therapy Target audience neurologists and physiatrists currently involved in MS rehabilitation management Format Lectures, clinic visits, case reports

2014 Pre LACTRIMS conference on progressive MS

Preceptorship on MRI in multiple sclerosis Milan, Italy 12-13 February 2015 Scientific Organiser M Filippi, Italy

Lima, Peru 26 November 2014 Scientific Organisers E Cristiano, Argentina; Ó Fernández, Spain Aim this live educational conference will review the scientific insights about pathogenesis, diagnosis and treatment for the progressive forms of MS and will discuss how to improve the current clinical management of this clinical variant

Aim this live educational preceptorship will feature lectures from world-renowned experts in MR and MS and hands-on training, held at the Neuroimaging and Neuroimmunology Research Unit

Key topics immunopathogenesis, clinical aspects, treatments, symptomatic treatment and rehabilitation

Key topics MR diagnostic criteria for diagnosing MS, distinguishing clinical conditions that can mimic MS in at the MR scan, structural markers of disease severity, interpret MRI scans

Target audience Neurologists involved in MS patient management and physicians with a particular interest in MS, mainly from Latin America Format lectures, real time survey session and Q&A sessions

Target audience young clinicians and scientists currently involved in MS management and radiologists interested in MS Format lectures, hands-on experience

www.excemed.org EXCEMED is a non-profit organization dedicated to providing CME to healthcare professionals. This newsletter is intended for healthcare professionals and provides a brief summary of a selection of previous educational events. EXCEMED will make reasonable efforts to include accurate and current information, wherever possible, but makes no warranties or representations as to its accuracy or completeness. This information is provided “as is” without warranty of any kind, either express or implied, including but not limited to implied warranty of fitness for particular purpose. EXCEMED has implemented and maintains a Quality Management System which fulfils the requirements of the ISO 9001:2008 standard for the activity of design and provision of training events in the healthcare sector. © EXCEMED, 2014. All rights reserved.

EXCEMED Excellence in Medical Education, Salita di S. Nicola da Tolentino, 1/b, 00187 Rome, Italy.

Editorial development: Ray Ashton, Linda Edmondson, Michèle Piraux, Serena Dell’Ariccia, Emma Wadland

Design: katehouben.com Photos on pages 1, 3, 6, 8 and 10 courtesy of www.bigstockphoto.com

© Copyright 2014 EXCEMED. All rights reserved.

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