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 | |||
| Title | Authors | Presentation ID | Presentation Details |
| Reduced Grey Matter Atrophy in Patients With Relapsing Multiple Sclerosis Treated With Cladribine Tablets | Battaglini M, Sormani M P, Luchetti L, Gentile G, Cortese R, Alexandri N, De Stefano N | P0231 | Session: 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 Study | De 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 | P0382 | Session: 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 Extension | Giovannoni G, Rammohan K, Leist T, Coyle P K, Keller B, Jack D, Alexandri N | P0202 | Session: 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 Scale | Sormani M P, Signori A Giovannoni G, Alexandri N | P0201 | 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 D | P0415 | Session: 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 Sclerosis | Karan R, Roy S, Alexandri N | LB1151 | 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 Analysis | Brochet 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 B | P1066 | Session: 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 Effectiveness | Sabidó, M, Batech M, Foch C, Boutmy E, Verpillat P | P0470 | 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 Review | Zeng F, Harty G, Wong SL, Maslova E, Schade R, Row B | P0846 | 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 Authorization | Zeng F, Harty G, Wong SL, Uebler S, Maslova E, Schade R, Row B, Ellenberger D, Stahmann A | P0847 | 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 Committee | LB1229 | Session: 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 Study | Freedman M, Pardo G, De Stefano N, Aldridge J, Hyvert Y, Galazka A, Lemieux C | P0284 | Session: 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 Demographics | Miravelle A, Katz J, Robertson D, Hayward B, Walsh JS, Harlow DE, Lebson LA, Sloane JA, Bass AD, Fox EJ | P0310 | 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 Sclerosis | Oh J, Walker B, Giovannoni G, Jack D, Dangond F, Nolting A, Aldridge J, Lebson L, Leist TP | P0411 | 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 Drugs | Cisternas MG, Rajagopalan D, Leszko M, Andrade K, Phillips AL | P0967 | 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 Analysis | Kozma CM, Roberts NL, Phillips AL | P1052 | 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 M | P1069 | 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 1 | Morgan K, Joseph B, Williams V, Kelly M | P1015 | Session: 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 Program | Oh J, Giacomini P, Devonshire V, Clift F, Lemieux C, Sabido M, Allignol A, Freedman M | P0880 | 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-analysis | Piasecka-Stryczynska K, Rolka M, Kaczynski ?, Górecka M, Wójcik R, Adamek I, Kaczor MP, Rejdak K | P0040 | Session: 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 Patients | Ziemssen T, Penner IK, Wagner T, Huebschen M, Mueller B, Buescher T, Richter J, Posevitz-Fejfar A | 566 | 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 M | P0401 | Session: 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 Tablets | Penner IK, Pul R, Kallmann BA, Raji A, Richter J, Wagner T, Mueller B, Buescher T, Posevitz-Fejfar A | P0849 | 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 Astrocytes | Eixarch H, Calvo-Barreiro L, Fissolo N, Boschert U, Comabella M, Montalban X, Espejo C | P0330 | Session: 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 Harty | P0907 | Session: 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 J | P0270 | Session: 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 S | P0196 | 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 Trial | Sharmin S, Bovis F, Sormani MP, Butzkueven H, Kalincik T and the MSBase study group | P0131 | 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 T | P0276 | Session: 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 MS | Raji A, Winkler G | P0586 | 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 Oh | P0319 | Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: J Bain |
| Switching From Ocrelizumab to Cladribine: Real-world Data | O'Neill DTD, Sharma M, Gonzales B, Vandenheuvel M, Tse B, Hodgkinson SJ | P0399 | Session: 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 Patients | Verma ND, Al-Atiyah R, O'Neill D, Sharma M, Tran CT, Hall BM, Hodgkinson SJ | P0406 | Session: 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 J | P0278 | 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 Infections | Freedman 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 REFLEXION | Freedman MS, Holmberg KH, Fluck M, Hyvert H, Stinchi S, D'Urso V, Dangond F | P0323 | 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 REFLEX | Kuhle J, Leppert D, Comi G, De Stefano N, Kappos L, Freedman MS, Issard D, Roy S | P0032 | 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 Sclerosis | Sabidó M, Allignol A Marhardt K, Vermersch P, Boutmy EF | P0320 | 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 Data | Bove R, Kozma C, Phillips AL, Harlow DE, Lobo C | P0451 | 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 B | P1095 | 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 Rate | Tokic M, Thiel S, Litvin N, Ciplea A, Gold R, Hellwig K | P1126 | 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 Study | Montalban X, Arnold D L, Weber MS, Staikov I, Piasecka-Stryczynska K, Martin E C, Mandel M, Ona V, Dangond F, Wolinsky JS | P0197 | 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 Study | Montalban, 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 JS | P0235 | 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 Study | Montalban X, Shaw J, Dangond F, Martin EC, Grenningloh R, Ying Li, Weber MS | P0070 | 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 MS | P0334 | 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 MS | Kebir H, Ceja G, Miller MC, Li C, May MJ, Vite CH, Church ME, Grenningloh R, Boschert U, Alvarez JI | P0962 | Session: 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 Evobrutinib | Rijvers L, Melief MJ, van Langelaar J, Wierenga-Wolf AF, Marieke van Ham S, Boschert U, Grenningloh R, Smolders J, van Luijn MM | P0403 | 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 Encephalomyelitis | Kim S, Boschert U Grenningloh R, Bhargava P | P0404 | 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 Types | Kamudoni 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 C | P1062 | 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 Sclerosis | Kamudoni 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 D | P1061 | Session: 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 Care | Schmierer K, Peniuta M, Oh J, Leist T, Lazure P, Péloquin S | P1100 | Session: 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 MS | Langdon D, Sumelahti M L, Potra S, Alroughani R, on behalf of the MS in the 21st Century initiative, Verdun Di Cantogno E | P1006 | Session: 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 Study | Zuroff LR, Li R, Shinoda K, Rezk A, Bar-Or A | P0952 | 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 Analysis | Freeman L, Lucas A, Zhou J, Hayward B, Livingston T | P0176 | Session: 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.
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