DARMSTADT Germany--3 Sep--PRNewswire/InfoQuest
Not intended for UK and US based media
- Company to present 54 abstracts across its MS portfolio - MAVENCLAD(R) (cladribine tablets), Rebif(R) (interferon beta-1a) and investigational evobrutinib
- New long-term data and real-world evidence further characterise efficacy and safety of MAVENCLAD(R)
- New MAVENCLAD(R) and Rebif(R) 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: 8thJoint 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(R)(cladribine tablets) and new safety data for Rebif(R)(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(R) and Rebif(R) 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 (R) (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(R) 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(R)
- Late-breaking interim data from the CLASSIC-MS study on the long-term efficacy and real-world treatment patterns for patients receiving MAVENCLAD(R), with eight to 14 years of follow up, will be available as part of the late-breaker sessions from 25 September 2020Disability improvement: Results from a post hoc analysis from the CLARITY Extension, showing patients receiving early treatment with MAVENCLAD(R) 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(R) 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(R) 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 (R) (interferon beta-1a) data include:
Post-approval results on the safety of Rebif(R) 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 dosingSafety 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 conditionsPreclinical 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, MerckAn overview of MAVENCLAD(R) MAGNIFY data: Prof. Nicola De Stefano, PhD, Professor of Neurology, Department of Medicine, Surgery & Neuroscience, University of Siena, ItalyEvobrutinib 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(R) (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, P0231 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Marco Battaglini
Luchetti L, Gentile G, Cortese R,
Alexandri N, De Stefano N
Reduction in CUA MRI Lesions in the First De Stefano N, Barkhof F, P0382 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Nicola De Stefano
6 Months of Cladribine Tablets Treatment Montalban X, Achiron A,
for Highly Active Relapsing Multiple Sclerosis: Derfuss T, Chan A, Hodgkinson S,
MAGNIFY-MS Study Prat A, Leocani L. Schmierer K,
Sellebjerg F, Vermersch P, Wiendl H,
Keller B, Roy S
Durable Efficacy of Cladribine Tablets: Giovannoni G, Rammohan K, P0202 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Gavin Giovannoni
Cumulative Relapse Incidence Over Leist T, Coyle P K, Keller B,
5 years in CLARITY and CLARITY Extension Jack D, Alexandri N
Disability Improvement in Relapsing-remitting Sormani M P, Signori A Giovannoni G, P0201 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Maria Pia Sormani
Multiple Sclerosis Patients Receiving Cladribine Alexandri N
Tablets, Evaluated by Expanded Disability
Status Scale
Updated Post-Approval Safety of Cladribine Giovannoni G, Berger J, Leist T, P0415 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Gavin Giovannoni
Tablets in the Treatment of Multiple Sclerosis, Jack D, Galazka A, Nolting A, Damian D
With Particular Reference to Respiratory
Viral Infections
Clinical Outcomes in Patients With COVID-19 Karan R, Roy S, Alexandri N LB1151 Session: Latebreaker ePosterDate: 25-26 September 2020Time: Available from 9am EDT on 25 September 2020Presenter: Radmila Karan
Infection During Phase IV Studies of Cladribine
Tablets for Treatment of Multiple Sclerosis
Treatment Satisfaction in Patients With Brochet B, Hupperts R, Langdon D, P1066 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Bruno Brochet
Highly-active Relapsing Multiple Sclerosis Solari A, Piehl F, Lechner-Scott J,
Treated With Cladribine Tablets: CLARIFY-MS Montalban X, Selmaj K, Valis M,
Study Interim Analysis Rejdak K, Havrdova EK, Patti F,
Alexandri N, Nolting A, Keller B
Initial Findings From a Dynamic Cohort Study Sabid?, M, Batech M, Foch C, P0470 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Meritxell Sabid?
of Patients With Multiple Sclerosis: A Proactive Boutmy E, Verpillat P
Approach for Safety and Comparative
Effectiveness
Characteristics of Relapsing Multiple Zeng F, Harty G, Wong SL, P0846 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Feng Zeng
Sclerosis Patients Treated With Cladribine Maslova E, Schade R, Row B
Tablets in Five European Countries: Multi-year
Chart Review
Characterization of Relapsing Multiple Zeng F, Harty G, Wong SL, Uebler S, P0847 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Feng Zeng
Sclerosis Patients Treated With Cladribine Maslova E, Schade R, Row B,
Tablets in Germany Since Marketing Ellenberger D, Stahmann A
Authorization
CLASSIC-MS: Long-term Efficacy and Giovannoni G, Leist T, Aydemir A, LB1229 Session: Latebreaker ePosterDate: 25-26 September 2020Time: Available from 9am EDT on 25 September 2020Presenter: Thomas Leist
Real-World Treatment Patterns for Patients Verdun Di Cantogno E, on behalf of
Receiving Cladribine Tablets - Interim Data the CLASSIC-MS Steering Committee
with 8–14 Years Follow-up
Age-related Efficacy of Cladribine Tablets Freedman M, Pardo G, De Stefano N, P0284 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Mark Freedman
in Patients With Relapsing-remitting MS in the Aldridge J, Hyvert Y, Galazka A, Lemieux C
CLARITY Extension Study
Cladribine Tablets in Patients with RRMS Miravelle A, Katz J, Robertson D, P0310 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Augusto Miravelle
and Active SPMS After Suboptimal Response Hayward B, Walsh JS, Harlow DE,
to Prior DMD (MASTER-2 and CLICK-MS): Initial Lebson LA, Sloane JA, Bass AD,
Baseline Demographics Fox EJ
Treatment-emergent Adverse Events Oh J, Walker B, Giovannoni G, P0411 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Jiwon Oh
Occurring Early in the Treatment Course Jack D, Dangond F, Nolting A,
of Cladribine Tablets in two Phase 3 Trials Aldridge J, Lebson L, Leist TP
in Multiple Sclerosis
Identification and Characterization of Cisternas MG, Rajagopalan D, P0967 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Amy Phillips
Adherence Trajectory Subgroups in Patients Leszko M, Andrade K, Phillips AL
With MS Initiating Once- or Twice-daily Oral
Disease-modifying Drugs
Real-world Patient-level Costs of Kozma CM, Roberts NL, Phillips AL P1052 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Chris Kozma
Administering Infusion Disease-modifying
Drugs: A US Retrospective Claims Database
Analysis
Value-added Benefits of a Morgan K, Vernon K, Ayer M P1069 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Kate Morgan
Nurse/Pharmacy-led Service for Patients
With Multiple Sclerosis Treated Over 2 Years
With Cladribine Tablets in the UK
Demonstrating the Value of a Patient Morgan K, Joseph B, Williams V, P1015 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Kate Morgan
Support Program for Multiple Sclerosis Kelly M
Patients Prescribed Cladribine Tablets
in Ireland at the end of Year 1
Low Discontinuation Rate and Oh J, Giacomini P, Devonshire V, P0880 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Jiwon Oh
Side-effect Burden After Switching Clift F, Lemieux C, Sabido M,
to Cladribine Tablets: Canadian Experience Allignol A, Freedman M
from the adveva(R) Patient Support Program
Cladribine Tablets Versus Other Piasecka-Stryczy?ska K, Rolka M, P0040 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: K. Piasecka-Stryczynska
Disease-modifying Therapies in Achieving Kaczy?ski ?, G?recka M, W?jcik R,
Disability Improvement in Relapsing-remitting Adamek I, Kaczor MP, Rejdak K
Multiple Sclerosis Patients – Network
Meta-analysis
MS Disease-modifying Therapy Ziemssen T, Penner IK, Wagner T, 566 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Tjalf Ziemssen
Sequencing – Natalizumab to Cladribine Huebschen M, Mueller B, Buescher T,
Tablets – Experience in 46 Patients Richter J, Posevitz-Fejfar A
Switching disease modifying treatment Saiz A, Aguera E, Moral E, Brieva L, P0401 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Luis Brieva
in relapsing multiple sclerosis: Delphi Rodriguez-Antiguedad A,
consensus of the Demyelinating Group Casanova-Estruch B,
of the Spanish Society of Neurology Jordi R, Meca-Lallana V,
Garcia-Merino JA,
Costa-Frossard L, Arnal-Garice C,
Landete L, Meca-Lallana J, Blanco Y,
Mat?as-Guiu J, Ares A,
Mart?nez-Gines ML, Ara JR,
Llaneza M, Castillo-Trivino T,
Romero L, Perez-Sempere A,
Gonz?lez-Platas M, Mendibe-Bilbao M
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, P0849 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Iris-Katharina Penner
Raji A, Richter J, Wagner T, Mueller B,
Buescher T, Posevitz-Fejfar A
Effects of Cladribine on Proliferation, Survival and Cytokine Release of Human Astrocytes Eixarch H, Calvo-Barreiro L, Fissolo N, P0330 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Herena Eixarch
Boschert U, Comabella M, Montalban X,
Espejo C
Real-world Experience With Cladribine in the MSBase Registry Butzkueven H, Spelman T, P0907 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Helmut Butzkueven
Verdun di Cantogno E, Fabris J,
Zeng F, G Harty
2-Chlorodeoxyadenosine (Cladribine) Preferentially Inhibits the Biological Activity of Microglia Cells Aybar F, Marcora S, Eugenia Samman M, P0270 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Jorge Correale
Perez MJ, Pasquini JM, Correale J
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 Forsberg L, K?gstroem S, Hillert J, Nilsson P, Dahle C, Svenningsson A, Lycke J, Landtblom AM, Burman J, Martin C, Sundstroem P, Gunnarsson M, Piehl F, Olsson T P0276 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: L Forsberg
for Cladribine Patients Treated
at least 12 Months - A Swedish
Nationwide Study of the
Long-Term Effectiveness
and Safety of Cladribine (IMSE 10)
Impact of Cladribine Tablets Raji A, Winkler G P0586 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: A Raji
on Brain Volume Protection in
Highly Active MS
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 Na?ve 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(R) (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,Sabid? M, Turkson, M, Wahlich C, Morris J P0278 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Meritxell Sabid?
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 2020Presenter: 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 2020Presenter: 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 2020Presenter: Sanjeev Roy
Effect of age on Effectiveness and Discontinuation of Subcutaneous Interferon beta-1a, and Healthcare Utilization, in Patients With Multiple Sclerosis Sabid? M, Allignol A Marhardt K, Vermersch P, Boutmy EF P0320 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: 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 2020Presenter: 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 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 2020Presenter: Fernando Dengond
Relapsing MS Patients
Treated with the BTK Inhibitor
Evobrutinib: Results of an
Open-Label Extension to
Phase II Study
Safety of the Bruton's Tyrosine 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 2020Presenter: Fernando Dengond
Kinase Inhibitor Evobrutinib in
Relapsing Multiple Sclerosis During
an Open-label Extension to a
Phase II Study
Effect Of Evobrutinib, a BTK Montalban X, Shaw J, Dangond F, Martin EC, Grenningloh R, Ying Li, Weber MS P0070 Session: ePosterTime: Available from 9am EDT on 11 September 2020Presenter: Jamie Shaw
Inhibitor, on Immune Cell and
Immunoglobulin Levels in Relapsing
MS: An Open-Label Extension to
a Phase II Study
Evobrutinib, a Highly Selective BTK Torke S, Pretzsch R, Haeusler D, Grenningloh R, Boschert U, Brueck W, Weber MS P0334 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Sebastian Torke
Inhibitor, Prevents Antigen-activation
of B Cells and Ameliorates B
Cell–mediated Experimental
Autoimmune Encephalomyelitis
Expression of Bruton's Tyrosine 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
Kinase in B Cell-rich Meningeal
Infiltrates in two Models of
Progressive MS
T-bet+ B-cell Development in MS: 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
Association with Bruton's Tyrosine
Kinase Activity and Targeting by
Evobrutinib
The Bruton's Tyrosine Kinase Inhibitor Kim S, Boschert U Grenningloh R, Bhargava P P0404 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Pavan Bhargava
Evobrutinib Ameliorates Meningeal
Inflammation in Experimental Autoimmune
Encephalomyelitis
The Validity and Applicability of 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 2020Presenter: Paul Kamudoni
the PROMIS SF v2.1 - Physical Function
(MS) 15a: A new PROMIS(R) Short Form for
Assessing Physical Function in Relapsing
and Progressive Multiple Sclerosis Types
The Interpretation and Clinical 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 2020Presenter: Paul Kamudoni
Application of the PROMIS(R) SF
v1.0 - Fatigue (MS) 8b: A PROMIS
Short Form for Assessing Fatigue in
Relapsing and Progressive Multiple
Sclerosis
General MS Franchise
Identifying Gaps in Knowledge, Schmierer K, Peniuta M, Oh J, Leist T, Lazure P, Peloquin S P1100 Session: ePosterDate: 11-13 September 2020Time: Available from 9am EDT on 11 September 2020Presenter: Klaus Schmierer
Skills and Confidence Among MS
Specialists to Facilitate Improved
MS Care
An Investigation Into the Role 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 2020Presenter: Dawn Langdon
and Impact That Carers Play in
Consultations Between Healthcare
Professionals and People With MS
Characterization of Age-related 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
Changes in Circulating T cells in
Multiple Sclerosis and Normal
Controls: A Pilot Study
Treatment and Care Management, 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
Clinical Outcomes and Mobility
Impairment in People With or Without
MS Aged ?50 Years: Observational
6-year Analysis
About MAVENCLAD(R)
MAVENCLAD(R) 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(R) 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(R) 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(R)
Rebif(R) (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(R) in chronic progressive MS has not been established. Interferon ss is thought to help reduce inflammation. The exact mechanism is unknown.
Rebif(R), which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif(R) has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*.
Rebif(R) can be administered with the RebiSmart(R) electronic auto-injection device (not approved in the US), or with the RebiDose(R) single-use disposable pen, or the manual multidose injection pen RebiSlide(TM). Rebif(R) can also be administered with the autoinjector Rebiject II(R) 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(R) in early multiple sclerosis. The extension of the indication of Rebif(R) has not been submitted in the United States.
Rebif(R) 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(R) with their doctors.
*The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
Rebif(R) (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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