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03.09.2020 – 14:00

Merck Serono GmbH

Merck to Showcase New Data at ACTRIMS-ECTRIMS MSVirtual2020 Meeting, Furthering Innovation in Multiple Sclerosis

Darmstadt, Germany (ots/PRNewswire)

Not intended for UK and US based media

- Company to present 54 abstracts across its MS portfolio - MAVENCLAD® (cladribine tablets), Rebif® (interferon beta-1a) and investigational evobrutinib

- New long-term data and real-world evidence further characterise efficacy and safety of MAVENCLAD®

- New MAVENCLAD® and Rebif® safety data to be shared demonstrating no increased risk of respiratory viral infections

Merck, a leading science and technology company, today announced it will present data on its approved and investigational multiple sclerosis (MS) treatments at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting. Merck will present 54 abstracts at the meeting, taking place virtually from 11-13 September 2020, including new efficacy and real-world safety data on MAVENCLAD® (cladribine tablets) and new safety data for Rebif® (interferon beta-1a).

In addition, data will be presented demonstrating investigational evobrutinib is the first and only Bruton's Tyrosine Kinase inhibitor (BTKi) to demonstrate high and sustained efficacy through 108 weeks in clinical studies. Preclinical data will also be presented providing insights into evobrutinib`s potential impact on progression in MS.

"The broad range of research revealed through these data demonstrate our strategic approach to advancing the MS treatment landscape through new medicines and patient-focused research initiatives," said Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck. "Much of our data provide insights on how MAVENCLAD® and Rebif® affect the risk of respiratory viral infections and COVID-19 outcomes in MS patients. These insights will help support clinicians as they make treatment decisions for their patients living with MS."

Key MAVENCLAD®(cladribine tablets) data include:

  • Early onset of action: Efficacy results from the Phase IV MAGNIFY-MS study, demonstrating an early onset of action from end of month one through a reduction in mean combined unique active (CUA) lesion count in the first six months of MAVENCLAD® treatment for highly active relapsing multiple sclerosis (RMS)
  • Sustained efficacy: - New data evaluating cumulative relapse incidence over five years in patients enrolled in the CLARITY and CLARITY Extension trials, showing the sustained efficacy of MAVENCLAD® - Late-breaking interim data from the CLASSIC-MS study on the long-term efficacy and real-world treatment patterns for patients receiving MAVENCLAD®, with eight to 14 years of follow up, will be available as part of the late-breaker sessions from 25 September 2020
  • Disability improvement: Results from a post hoc analysis from the CLARITY Extension, showing patients receiving early treatment with MAVENCLAD® had a greater prevalence of disability improvement over five years, as measured by the Expanded Disability Status Scale (EDSS)
  • COVID-19 patient cases: Results from the MAGNIFY and CLARIFY studies, demonstrating clinical outcomes in patients with COVID-19 infection during these Phase IV studies of MAVENCLAD® for the treatment of MS will be available as part of the late-breaker sessions from 25 September 2020
  • Updated post-approval safety data of MAVENCLAD® in the treatment of MS showing that respiratory viral infections were typically non-serious, and consistent with that from the clinical development program

Key Rebif®(interferon beta-1a) data include:

  • Post-approval results on the safety of Rebif® in the treatment of MS, showing no new safety signals, including no increased risk for respiratory viral infections

Key evobrutinib data include:

  • Results of the Phase II open-label extension (OLE) in patients treated with evobrutinib 75 mg BID (twice a day), showing the efficacy at Week 48 was maintained at 108 weeks (ARR, 0.11) and the maximum efficacy observed with BID dosing correlated with optimal BTK occupancy achieved with BID dosing
  • Safety results from the >=60 week Phase II OLE showing no new safety signals identified, consistent with data seen in more than 1,200 patients who have received evobrutinib to date, across MS and other conditions
  • Preclinical data demonstrating evobrutinib's potential to reduce CNS compartmentalized inflammation thought to drive the progression of disability seen in MS

Additional Merck activities at MSVirtual2020:

  • Live presentation "Exploring the role of real-world data in multiple sclerosis" chaired by Prof. Gavin Giovannoni, Chair of Neurology, Barts and The London School of Medicine and Dentistry (12 September 2020, 14:30-15:30 EDT / 20:30-21:30 CEST; recording available after the event)
  • Two product theatres on demand throughout the congress starting from 11 September 2020, 11:45 EDT / 17:45 CEST - "Multiple sclerosis patient management: update from the UK" by Dr. Wallace Brownlee, MS Specialist Neurologist, National Hospital for Neurology and Neurosurgery, and MS researcher at Queen Square MS Centre, University College London Institute of Neurology- "Real-world multiple sclerosis management: what can we learn from MSBase?" by Dr. Suzanne Hodgkinson, Associate Professor, University of New South Wales, and a senior consultant neurologist at Liverpool Hospital, New South Wales, Australia

Today, Merck has launched a newsroom for journalists interested in the company`s latest developments and news - merckneurology.com/newsroom - where, among other information, background information on Merck MS treatments, and video presentations from the below will be available:

  • Merck's commitment to MS: Andrew Paterson, Senior Vice President, Head of Global and US Multiple Sclerosis Franchise, Merck
  • An overview of MAVENCLAD® MAGNIFY data: Prof. Nicola De Stefano, PhD, Professor of Neurology, Department of Medicine, Surgery & Neuroscience, University of Siena, Italy
  • Evobrutinib clinical trial update: Robert Henderson, Vice President, Global Program Leadership, Neurology & Immunology, Merck

Following the conclusion of MSVirtual2020, Merck will be hosting "Mastering the Neuroscience of Unconscious Bias," the inaugural virtual event for Merck's I'M IN initiative, a diversity, equity and inclusion effort started in February 2019. I'M IN is an initiative started by Merck`s Neurology & Immunology franchise, which aims to explore solutions together with healthcare providers to improve equity within the healthcare ecosystem.

Below is the full list of Merck abstracts accepted for presentation at ACTRIMS-ECTRIMS 2020:

MAVENCLAD® (cladribine tablets) Presentations
TitleAuthorsPresentation IDPresentation Details
Reduced Grey Matter Atrophy in Patients With Relapsing Multiple Sclerosis Treated With Cladribine TabletsBattaglini M, Sormani M P, Luchetti L, Gentile G, Cortese R, Alexandri N, De Stefano NP0231Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Marco Battaglini
Reduction in CUA MRI Lesions in the First 6 Months of Cladribine Tablets Treatment for Highly Active Relapsing Multiple Sclerosis: MAGNIFY-MS StudyDe Stefano N, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L. Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Roy S P0382Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Nicola De Stefano
Durable Efficacy of Cladribine Tablets: Cumulative Relapse Incidence Over 5 years in CLARITY and CLARITY ExtensionGiovannoni G, Rammohan K, Leist T, Coyle P K, Keller B, Jack D, Alexandri NP0202Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Gavin Giovannoni
Disability Improvement in Relapsing-remitting Multiple Sclerosis Patients Receiving Cladribine Tablets, Evaluated by Expanded Disability Status ScaleSormani M P, Signori A Giovannoni G, Alexandri NP0201 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Maria Pia Sormani
Updated Post-Approval Safety of Cladribine Tablets in the Treatment of Multiple Sclerosis, With Particular Reference to Respiratory Viral Infections Giovannoni G, Berger J, Leist T, Jack D, Galazka A, Nolting A, Damian DP0415Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Gavin Giovannoni
Clinical Outcomes in Patients With COVID-19 Infection During Phase IV Studies of Cladribine Tablets for Treatment of Multiple SclerosisKaran R, Roy S, Alexandri NLB1151 Session: Latebreaker ePosterDate: 25-26 September 2020Time: Available from 9am EDT on 25 September 2020 Presenter: Radmila Karan
Treatment Satisfaction in Patients With Highly-active Relapsing Multiple Sclerosis Treated With Cladribine Tablets: CLARIFY-MS Study Interim AnalysisBrochet B, Hupperts R, Langdon D, Solari A, Piehl F, Lechner-Scott J, Montalban X, Selmaj K, Valis M, Rejdak K, Havrdova EK, Patti F, Alexandri N, Nolting A, Keller BP1066Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Bruno Brochet
Initial Findings From a Dynamic Cohort Study of Patients With Multiple Sclerosis: A Proactive Approach for Safety and Comparative EffectivenessSabidó, M, Batech M, Foch C, Boutmy E, Verpillat PP0470 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Meritxell Sabidó
Characteristics of Relapsing Multiple Sclerosis Patients Treated With Cladribine Tablets in Five European Countries: Multi-year Chart ReviewZeng F, Harty G, Wong SL, Maslova E, Schade R, Row BP0846 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Feng Zeng
Characterization of Relapsing Multiple Sclerosis Patients Treated With Cladribine Tablets in Germany Since Marketing AuthorizationZeng F, Harty G, Wong SL, Uebler S, Maslova E, Schade R, Row B, Ellenberger D, Stahmann AP0847 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Feng Zeng
CLASSIC-MS: Long-term Efficacy and Real-World Treatment Patterns for Patients Receiving Cladribine Tablets - Interim Data with 8-14 Years Follow-up Giovannoni G, Leist T, Aydemir A, Verdun Di Cantogno E, on behalf of the CLASSIC-MS Steering CommitteeLB1229Session: Latebreaker ePosterDate: 25-26 September 2020Time: Available from 9am EDT on 25 September 2020Presenter: Thomas Leist
Age-related Efficacy of Cladribine Tablets in Patients With Relapsing-remitting MS in the CLARITY Extension StudyFreedman M, Pardo G, De Stefano N, Aldridge J, Hyvert Y, Galazka A, Lemieux CP0284Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Mark Freedman
Cladribine Tablets in Patients with RRMS and Active SPMS After Suboptimal Response to Prior DMD (MASTER-2 and CLICK-MS): Initial Baseline DemographicsMiravelle A, Katz J, Robertson D, Hayward B, Walsh JS, Harlow DE, Lebson LA, Sloane JA, Bass AD, Fox EJP0310 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Augusto Miravelle
Treatment-emergent Adverse Events Occurring Early in the Treatment Course of Cladribine Tablets in two Phase 3 Trials in Multiple SclerosisOh J, Walker B, Giovannoni G, Jack D, Dangond F, Nolting A, Aldridge J, Lebson L, Leist TPP0411 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Jiwon Oh
Identification and Characterization of Adherence Trajectory Subgroups in Patients With MS Initiating Once- or Twice-daily Oral Disease-modifying DrugsCisternas MG, Rajagopalan D, Leszko M, Andrade K, Phillips ALP0967 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Amy Phillips
Real-world Patient-level Costs of Administering Infusion Disease-modifying Drugs: A US Retrospective Claims Database AnalysisKozma CM, Roberts NL, Phillips ALP1052 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Chris Kozma
Value-added Benefits of a Nurse/Pharmacy-led Service for Patients With Multiple Sclerosis Treated Over 2 Years With Cladribine Tablets in the UK Morgan K, Vernon K, Ayer MP1069 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Kate Morgan
Demonstrating the Value of a Patient Support Program for Multiple Sclerosis Patients Prescribed Cladribine Tablets in Ireland at the end of Year 1Morgan K, Joseph B, Williams V, Kelly MP1015Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Kate Morgan
Low Discontinuation Rate and Side-effect Burden After Switching to Cladribine Tablets: Canadian Experience from the adveva® Patient Support ProgramOh J, Giacomini P, Devonshire V, Clift F, Lemieux C, Sabido M, Allignol A, Freedman MP0880 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Jiwon Oh
Cladribine Tablets Versus Other Disease-modifying Therapies in Achieving Disability Improvement in Relapsing-remitting Multiple Sclerosis Patients - Network Meta-analysisPiasecka-Stryczynska K, Rolka M, Kaczynski ?, Górecka M, Wójcik R, Adamek I, Kaczor MP, Rejdak KP0040Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: K. Piasecka-Stryczynska
MS Disease-modifying Therapy Sequencing - Natalizumab to Cladribine Tablets - Experience in 46 PatientsZiemssen T, Penner IK, Wagner T, Huebschen M, Mueller B, Buescher T, Richter J, Posevitz-Fejfar A566 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Tjalf Ziemssen
Switching disease modifying treatment in relapsing multiple sclerosis: Delphi consensus of the Demyelinating Group of the Spanish Society of Neurology Saiz A, Aguera E, Moral E, Brieva L, Rodriguez-Antiguedad A, Casanova-Estruch B, Jordi R, Meca-Lallana V, Garcia-Merino JA, Costa-Frossard L, Arnal-Garice C, Landete L, Meca-Lallana J, Blanco Y, Matías-Guiu J, Ares A, Martínez-Ginés ML, Ara JR, Llaneza M, Castillo-Trivino T, Romero L, Perez-Sempere A, González-Platas M, Mendibe-Bilbao MP0401Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Luis Brieva
CLADQoL (CLADribine Tablets - evaluation of Quality of Life) Study: Evaluating QoL 12 Months After Treatment Initiation with Cladribine TabletsPenner IK, Pul R, Kallmann BA, Raji A, Richter J, Wagner T, Mueller B, Buescher T, Posevitz-Fejfar AP0849 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Iris-Katharina Penner
Effects of Cladribine on Proliferation, Survival and Cytokine Release of Human AstrocytesEixarch H, Calvo-Barreiro L, Fissolo N, Boschert U, Comabella M, Montalban X, Espejo CP0330Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Herena Eixarch
Real-world Experience With Cladribine in the MSBase Registry Butzkueven H, Spelman T, Verdun di Cantogno E, Fabris J, Zeng F, G HartyP0907Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Helmut Butzkueven
2-Chlorodeoxyadenosine (Cladribine) Preferentially Inhibits the Biological Activity of Microglia Cells Aybar F, Marcora S, Eugenia Samman M, Perez MJ, Pasquini JM, Correale JP0270Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Jorge Correale
Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis (ChariotMS) Lieberman D, Mangat H, Allen-Philby K, Baker D, Barkhof F, Chandran S, Chapman C, Chataway J, Ford H, Giovannoni G, Hobart J, Hooper R, Hussain T, Walker N, Macmanus D, Mihaylova B, Pavitt SP0196 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: David Lieberman
Predicting Long-term Sustained Disability Progression in Multiple Sclerosis: Application in the CLARITY TrialSharmin S, Bovis F, Sormani MP, Butzkueven H, Kalincik T and the MSBase study groupP0131 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: S Sharmin
A Clinical Data Summary for Cladribine Patients Treated at least 12 Months - A Swedish Nationwide Study of the Long-Term Effectiveness and Safety of Cladribine (IMSE 10) Forsberg L, Kågström S, Hillert J, Nilsson P, Dahle C, Svenningsson A, Lycke J, Landtblom AM, Burman J, Martin C, Sundström P, Gunnarsson M, Piehl F, Olsson TP0276Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: L Forsberg
Impact of Cladribine Tablets on Brain Volume Protection in Highly Active MSRaji A, Winkler GP0586 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: A Raji
Early Real-World Safety, Tolerability, and Efficacy of Cladribine Tablets: A Single Center Experience Bain J, Jones A, Overholt S, Guenette M, Selchen D, Jiwon OhP0319 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: J Bain
Switching From Ocrelizumab to Cladribine: Real-world DataO'Neill DTD, Sharma M, Gonzales B, Vandenheuvel M, Tse B, Hodgkinson SJP0399Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: D O'Neill
The Effect of Cladribine Upon Naïve and Activated CD4+ T Regulatory Cells in MS PatientsVerma ND, Al-Atiyah R, O'Neill D, Sharma M, Tran CT, Hall BM, Hodgkinson SJP0406Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Suzanne Hodgkinson
Rebif® (interferon beta-1a) Presentations
A Systematic Review and Meta-analyses of Pregnancy and Fetal Outcomes in Women with Multiple Sclerosis. IMI2 ConcePTION Lopez-Leon S, Geissbuehler Y, Sabidó M, Turkson, M, Wahlich C, Morris JP0278 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Meritxell Sabidó
Post-approval Safety of Subcutaneous Interferon ?-1a in the Treatment of Multiple Sclerosis, With Particular Reference to Respiratory Viral InfectionsFreedman M S, Guehring H, Murgasova Z, Jack D P0370 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Mark Freedman
Effect of Neutralizing Antibodies on Pharmacodynamic Biomarkers of Subcutaneous Interferon ?-1a in REFLEX and REFLEXIONFreedman MS, Holmberg KH, Fluck M, Hyvert H, Stinchi S, D'Urso V, Dangond FP0323 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Mark Freedman
Baseline Serum Neurofilament Light Chain Levels Predict Conversion to McDonald 2005 MS Within 2 yrs of a First Clinical Demyelinating Event in REFLEXKuhle J, Leppert D, Comi G, De Stefano N, Kappos L, Freedman MS, Issard D, Roy SP0032 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Sanjeev Roy
Effect of age on Effectiveness and Discontinuation of Subcutaneous Interferon beta-1a, and Healthcare Utilization, in Patients With Multiple SclerosisSabidó M, Allignol A Marhardt K, Vermersch P, Boutmy EFP0320 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Patrick Vermersch
Comparing Infection-related Outcomes in Patients with Multiple Sclerosis and Matched Controls Using Administrative Claims DataBove R, Kozma C, Phillips AL, Harlow DE, Lobo CP0451 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Riley Bove
Assessment of the Effectiveness of a Cognitive Behavioral Program for Fatigue (FACETS +) in 110 French Patients with Relapsing Remitting Multiple Sclerosis (RR MS): A randomized, controlled trial (RCT)Hemelin F, Marie Claire G, Olivier H, Marie B, Frederic BP1095 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Fanny Hamelin
Impact of Interferon-beta Exposure During Early Pregnancy on Relapse RateTokic M, Thiel S, Litvin N, Ciplea A, Gold R, Hellwig KP1126 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: M Tokic
Evobrutinib Presentations
Clinical Relapse Rates in Relapsing MS Patients Treated with the BTK Inhibitor Evobrutinib: Results of an Open-Label Extension to Phase II StudyMontalban X, Arnold D L, Weber MS, Staikov I, Piasecka-Stryczynska K, Martin E C, Mandel M, Ona V, Dangond F, Wolinsky JSP0197 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Fernando Dengond
Safety of the Bruton's Tyrosine Kinase Inhibitor Evobrutinib in Relapsing Multiple Sclerosis During an Open-label Extension to a Phase II StudyMontalban, X Arnold D L, Weber M S, Staikov I, Piasecka-Stryczynska K, Martin E C, Mandel M, Ona V, Zima Y, Dengond F, Tomic D, Wolinsky JSP0235 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Fernando Dengond
Effect Of Evobrutinib, a BTK Inhibitor, on Immune Cell and Immunoglobulin Levels in Relapsing MS: An Open-Label Extension to a Phase II StudyMontalban X, Shaw J, Dangond F, Martin EC, Grenningloh R, Ying Li, Weber MSP0070 Session: ePosterTime: Available from 9am EDT on 11 September 2020 Presenter: Jamie Shaw
Evobrutinib, a Highly Selective BTK Inhibitor, Prevents Antigen-activation of B Cells and Ameliorates B Cell-mediated Experimental Autoimmune Encephalomyelitis Torke S, Pretzsch R, Häusler D, Grenningloh R, Boschert U, Brück W, Weber MSP0334 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Sebastian Torke
Expression of Bruton's Tyrosine Kinase in B Cell-rich Meningeal Infiltrates in two Models of Progressive MSKebir H, Ceja G, Miller MC, Li C, May MJ, Vite CH, Church ME, Grenningloh R, Boschert U, Alvarez JIP0962Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Kebir Hania
T-bet+ B-cell Development in MS: Association with Bruton's Tyrosine Kinase Activity and Targeting by EvobrutinibRijvers L, Melief MJ, van Langelaar J, Wierenga-Wolf AF, Marieke van Ham S, Boschert U, Grenningloh R, Smolders J, van Luijn MMP0403 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT 11 September 2020Presenter: Liza Rijvers
The Bruton's Tyrosine Kinase Inhibitor Evobrutinib Ameliorates Meningeal Inflammation in Experimental Autoimmune EncephalomyelitisKim S, Boschert U Grenningloh R, Bhargava PP0404 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Pavan Bhargava
The Validity and Applicability of the PROMIS SF v2.1 - Physical Function (MS) 15a: A new PROMIS® Short Form for Assessing Physical Function in Relapsing and Progressive Multiple Sclerosis TypesKamudoni P, Amtmann D, Johns J, Cook K, Salem R, Salek S, Raab J, Middleton R, Repovic P, Alschuler KN, von Geldern G, Wundes A, Henke CP1062 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Paul Kamudoni
The Interpretation and Clinical Application of the PROMIS® SF v1.0 - Fatigue (MS) 8b: A PROMIS Short Form for Assessing Fatigue in Relapsing and Progressive Multiple SclerosisKamudoni P, Johns J, Cook K, Salem R, Henke C, Salek S, Raab J, Middleton R, Repovic P, Alschuler KN, von Geldern G,Wundes A, Amtmann DP1061Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Paul Kamudoni
General MS Franchise
Identifying Gaps in Knowledge, Skills and Confidence Among MS Specialists to Facilitate Improved MS CareSchmierer K, Peniuta M, Oh J, Leist T, Lazure P, Péloquin SP1100Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Klaus Schmierer
An Investigation Into the Role and Impact That Carers Play in Consultations Between Healthcare Professionals and People With MSLangdon D, Sumelahti M L, Potra S, Alroughani R, on behalf of the MS in the 21st Century initiative, Verdun Di Cantogno EP1006Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020 Presenter: Dawn Langdon
Characterization of Age-related Changes in Circulating T cells in Multiple Sclerosis and Normal Controls: A Pilot StudyZuroff LR, Li R, Shinoda K, Rezk A, Bar-Or AP0952 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: LR Zuroff
Treatment and Care Management, Clinical Outcomes and Mobility Impairment in People With or Without MS Aged >=50 Years: Observational 6-year AnalysisFreeman L, Lucas A, Zhou J, Hayward B, Livingston TP0176Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Terrie Livingston

About MAVENCLAD®

MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been approved in 79 countries, including Canada, Australia and the US. Refer to the respective prescribing information for further details.

The clinical development programme for cladribine tablets includes:

  • The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients with RRMS.
  • The CLARITY extension study: a Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4.
  • The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
  • The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding cladribine tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
  • PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.

In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been established. Interferon ß is thought to help reduce inflammation. The exact mechanism is unknown.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*.

Rebif® can be administered with the RebiSmart® electronic auto-injection device (not approved in the US), or with the RebiDose® single-use disposable pen, or the manual multidose injection pen RebiSlide(TM). Rebif® can also be administered with the autoinjector Rebiject II® or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.

In January 2012, the European commission approved the extension of the indication of Rebif® in early multiple sclerosis. The extension of the indication of Rebif® has not been submitted in the United States.

Rebif® should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.

*The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

Rebif® (interferon beta-1a) is approved in the United States for relapsing forms of MS.

About Evobrutinib

Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS). It is an oral, highly selective inhibitor of Bruton's tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

Merck in Neurology and Immunology

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.

The company`s robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus osteoarthritis and psoriasis.

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About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices - the company is everywhere. In 2019, Merck generated sales of EUR 16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

Contact
tone-brauti.fritzen@merckgroup.com
+49 151 1454 2694

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