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 Battaglini M, Sormani M P, P0231 Session: ePoster Date:
in Patients With Relapsing Luchetti L, Gentile G,
11-13 September 2020
Multiple Sclerosis Treated Cortese R, Alexandri N, De
Time: Available from 9am
With Cladribine Tablets Stefano N
EDT on 11 September 2020
Presenter: Marco
Battaglini
Reduction in CUA MRI Lesions De Stefano N, Barkhof F, P0382 Session: ePoster Date:
in the First 6 Months of Montalban X, Achiron A,
11-13 September 2020
Cladribine Tablets Treatment Derfuss T, Chan A,
Time: Available from 9am
for Highly Active Relapsing Hodgkinson S, Prat A,
EDT on 11 September 2020
Multiple Sclerosis: Leocani L. Schmierer K,
Presenter: Nicola De
MAGNIFY-MS Study Sellebjerg F, Vermersch P,
Stefano
Wiendl H, Keller B, Roy S
Durable Efficacy of Giovannoni G, Rammohan K, P0202 Session: ePoster Date:
Cladribine Tablets: Leist T, Coyle P K, Keller
11-13 September 2020
Cumulative Relapse Incidence B, Jack D, Alexandri N
Time: Available from 9am
Over 5 years in CLARITY and
EDT on 11 September 2020
CLARITY Extension
Presenter: Gavin
Giovannoni
Disability Improvement in Sormani M P, Signori A P0201 Session: ePoster Date:
Relapsing-remitting Multiple Giovannoni G, Alexandri N
11-13 September 2020
Sclerosis Patients Receiving
Time: Available from 9am
Cladribine Tablets, Evaluated
EDT on 11 September 2020
by Expanded Disability Status
Presenter: Maria Pia
Scale
Sormani
Updated Post-Approval Safety Giovannoni G, Berger J, P0415 Session: ePoster Date:
of Cladribine Tablets in the Leist T, Jack D, Galazka
11-13 September 2020
Treatment of Multiple A, Nolting A, Damian D
Time: Available from 9am
Sclerosis, With Particular
EDT on 11 September 2020
Reference to Respiratory
Presenter: Gavin
Viral Infections
Giovannoni
Clinical Outcomes in Patients Karan R, Roy S, Alexandri LB1151 Session: Latebreaker
With COVID-19 Infection N
ePoster Date: 25-26
During Phase IV Studies of
September 2020 Time:
Cladribine Tablets for
Available from 9am EDT on
Treatment of Multiple
25 September 2020
Sclerosis
Presenter: Radmila Karan
Treatment Satisfaction in Brochet B, Hupperts R, P1066 Session: ePoster Date:
Patients With Highly-active Langdon D, Solari A, Piehl
11-13 September 2020
Relapsing Multiple Sclerosis F, Lechner-Scott J,
Time: Available from 9am
Treated With Cladribine Montalban X, Selmaj K,
EDT on 11 September 2020
Tablets: CLARIFY-MS Study Valis M, Rejdak K,
Presenter: Bruno Brochet
Interim Analysis Havrdova EK, Patti F,
Alexandri N, Nolting A,
Keller B
Initial Findings From a Sabidó, M, Batech M, Foch P0470 Session: ePoster Date:
Dynamic Cohort Study of C, Boutmy E, Verpillat P
11-13 September 2020
Patients With Multiple
Time: Available from 9am
Sclerosis: A Proactive
EDT on 11 September 2020
Approach for Safety and
Presenter: Meritxell
Comparative Effectiveness
Sabidó
Characteristics of Relapsing Zeng F, Harty G, Wong SL, P0846 Session: ePoster Date:
Multiple Sclerosis Patients Maslova E, Schade R, Row B
11-13 September 2020
Treated With Cladribine
Time: Available from 9am
Tablets in Five European
EDT on 11 September 2020
Countries: Multi-year Chart
Presenter: Feng Zeng
Review
Characterization of Relapsing Zeng F, Harty G, Wong SL, P0847 Session: ePoster Date:
Multiple Sclerosis Patients Uebler S, Maslova E,
11-13 September 2020
Treated With Cladribine Schade R, Row B,
Time: Available from 9am
Tablets in Germany Since Ellenberger D, Stahmann A
EDT on 11 September 2020
Marketing Authorization
Presenter: Feng Zeng
CLASSIC-MS: Long-term Giovannoni G, Leist T, LB1229 Session: Latebreaker
Efficacy and Real-World Aydemir A, Verdun Di
ePoster Date: 25-26
Treatment Patterns for Cantogno E, on behalf of
September 2020 Time:
Patients Receiving Cladribine the CLASSIC-MS Steering
Available from 9am EDT on
Tablets – Interim Data with Committee
25 September 2020
8-14 Years Follow-up
Presenter: Thomas Leist
Age-related Efficacy of Freedman M, Pardo G, De P0284 Session: ePoster Date:
Cladribine Tablets in Stefano N, Aldridge J,
11-13 September 2020
Patients With Hyvert Y, Galazka A,
Time: Available from 9am
Relapsing-remitting MS in the Lemieux C
EDT on 11 September 2020
CLARITY Extension Study
Presenter: Mark Freedman
Cladribine Tablets in Miravelle A, Katz J, P0310 Session: ePoster Date:
Patients with RRMS and Active Robertson D, Hayward B,
11-13 September 2020
SPMS After Suboptimal Walsh JS, Harlow DE,
Time: Available from 9am
Response to Prior DMD Lebson LA, Sloane JA, Bass
EDT on 11 September 2020
(MASTER-2 and CLICK-MS): AD, Fox EJ
Presenter: Augusto
Initial Baseline Demographics
Miravelle
Treatment-emergent Adverse Oh J, Walker B, Giovannoni P0411 Session: ePoster Date:
Events Occurring Early in the G, Jack D, Dangond F,
11-13 September 2020
Treatment Course of Nolting A, Aldridge J,
Time: Available from 9am
Cladribine Tablets in two Lebson L, Leist TP
EDT on 11 September 2020
Phase 3 Trials in Multiple
Presenter: Jiwon Oh
Sclerosis
Identification and Cisternas MG, Rajagopalan P0967 Session: ePoster Date:
Characterization of Adherence D, Leszko M, Andrade K,
11-13 September 2020
Trajectory Subgroups in Phillips AL
Time: Available from 9am
Patients With MS Initiating
EDT on 11 September 2020
Once- or Twice-daily Oral
Presenter: Amy Phillips
Disease-modifying Drugs
Real-world Patient-level Kozma CM, Roberts NL, P1052 Session: ePoster Date:
Costs of Administering Phillips AL
11-13 September 2020
Infusion Disease-modifying
Time: Available from 9am
Drugs: A US Retrospective
EDT on 11 September 2020
Claims Database Analysis
Presenter: Chris Kozma
Value-added Benefits of a Morgan K, Vernon K, Ayer M P1069 Session: ePoster Date:
Nurse/Pharmacy-led Service
11-13 September 2020
for Patients With Multiple
Time: Available from 9am
Sclerosis Treated Over 2
EDT on 11 September 2020
Years With Cladribine Tablets
Presenter: Kate Morgan
in the UK
Demonstrating the Value of a Morgan K, Joseph B, P1015 Session: ePoster Date:
Patient Support Program for Williams V, Kelly M
11-13 September 2020
Multiple Sclerosis Patients
Time: Available from 9am
Prescribed Cladribine Tablets
EDT on 11 September 2020
in Ireland at the end of Year
Presenter: Kate Morgan
1
Low Discontinuation Rate and Oh J, Giacomini P, P0880 Session: ePoster Date:
Side-effect Burden After Devonshire V, Clift F,
11-13 September 2020
Switching to Cladribine Lemieux C, Sabido M,
Time: Available from 9am
Tablets: Canadian Experience Allignol A, Freedman M
EDT on 11 September 2020
from the adveva® Patient
Presenter: Jiwon Oh
Support Program
Cladribine Tablets Versus Piasecka-Stryczynska K, P0040 Session: ePoster Date:
Other Disease-modifying Rolka M, Kaczynski ?,
11-13 September 2020
Therapies in Achieving Górecka M, Wójcik R,
Time: Available from 9am
Disability Improvement in Adamek I, Kaczor MP,
EDT on 11 September 2020
Relapsing-remitting Multiple Rejdak K
Presenter: K.
Sclerosis Patients – Network
Piasecka-Stryczynska
Meta-analysis
MS Disease-modifying Therapy Ziemssen T, Penner IK, 566 Session: ePoster Date:
Sequencing – Natalizumab to Wagner T, Huebschen M,
11-13 September 2020
Cladribine Tablets – Mueller B, Buescher T,
Time: Available from 9am
Experience in 46 Patients Richter J, Posevitz-Fejfar
EDT on 11 September 2020
A
Presenter: Tjalf Ziemssen
Switching disease modifying Saiz A, Aguera E, Moral E, P0401 Session: ePoster Date:
treatment in relapsing Brieva L,
11-13 September 2020
multiple sclerosis: Delphi Rodriguez-Antiguedad A,
Time: Available from 9am
consensus of the Casanova-Estruch B, Jordi
EDT on 11 September 2020
Demyelinating Group of the R, Meca-Lallana V,
Presenter: Luis Brieva
Spanish Society of Neurology 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
CLADQoL (CLADribine Tablets – Penner IK, Pul R, Kallmann P0849 Session: ePoster Date:
evaluation of Quality of BA, Raji A, Richter J,
11-13 September 2020
Life) Study: Evaluating QoL Wagner T, Mueller B,
Time: Available from 9am
12 Months After Treatment Buescher T,
EDT on 11 September 2020
Initiation with Cladribine Posevitz-Fejfar A
Presenter: Iris-Katharina
Tablets
Penner
Effects of Cladribine on Eixarch H, Calvo-Barreiro P0330 Session: ePoster Date:
Proliferation, Survival and L, Fissolo N, Boschert U,
11-13 September 2020
Cytokine Release of Human Comabella M, Montalban X,
Time: Available from 9am
Astrocytes Espejo C
EDT on 11 September 2020
Presenter: Herena Eixarch
Real-world Experience With Butzkueven H, Spelman T, P0907 Session: ePoster Date:
Cladribine in the MSBase Verdun di Cantogno E,
11-13 September 2020
Registry Fabris J, Zeng F, G Harty
Time: Available from 9am
EDT on 11 September 2020
Presenter: Helmut
Butzkueven
2-Chlorodeoxyadenosine Aybar F, Marcora S, P0270 Session: ePoster Date:
(Cladribine) Preferentially Eugenia Samman M, Perez
11-13 September 2020
Inhibits the Biological MJ, Pasquini JM, Correale
Time: Available from 9am
Activity of Microglia Cells J
EDT on 11 September 2020
Presenter: Jorge Correale
Cladribine to Halt Lieberman D, Mangat H, P0196 Session: ePoster Date:
Deterioration in People With Allen-Philby K, Baker D,
11-13 September 2020
Advanced Multiple Sclerosis Barkhof F, Chandran S,
Time: Available from 9am
(ChariotMS) Chapman C, Chataway J,
EDT on 11 September 2020
Ford H, Giovannoni G,
Presenter: David
Hobart J, Hooper R,
Lieberman
Hussain T, Walker N,
Macmanus D, Mihaylova B,
Pavitt S
Predicting Long-term Sharmin S, Bovis F, P0131 Session: ePoster Date:
Sustained Disability Sormani MP, Butzkueven H,
11-13 September 2020
Progression in Multiple Kalincik T and the MSBase
Time: Available from 9am
Sclerosis: Application in the study group
EDT on 11 September 2020
CLARITY Trial
Presenter: S Sharmin
A Clinical Data Summary for Forsberg L, Kågström S, P0276 Session: ePoster Date:
Cladribine Patients Treated Hillert J, Nilsson P,
11-13 September 2020
at least 12 Months – A Dahle C, Svenningsson A,
Time: Available from 9am
Swedish Nationwide Study of Lycke J, Landtblom AM,
EDT on 11 September 2020
the Long-Term Effectiveness Burman J, Martin C,
Presenter: L Forsberg
and Safety of Cladribine Sundström P, Gunnarsson M,
(IMSE 10) Piehl F, Olsson T
Impact of Cladribine Tablets Raji A, Winkler G P0586 Session: ePoster Date:
on Brain Volume Protection in
11-13 September 2020
Highly Active MS
Time: Available from 9am
EDT on 11 September 2020
Presenter: A Raji
Early Real-World Safety, Bain J, Jones A, Overholt P0319 Session: ePoster Date:
Tolerability, and Efficacy of S, Guenette M, Selchen D,
11-13 September 2020
Cladribine Tablets: A Single Jiwon Oh
Time: Available from 9am
Center Experience
EDT on 11 September 2020
Presenter: J Bain
Switching From Ocrelizumab to O’Neill DTD, Sharma M, P0399 Session: ePoster Date:
Cladribine: Real-world Data Gonzales B, Vandenheuvel
11-13 September 2020
M, Tse B, Hodgkinson SJ
Time: Available from 9am
EDT on 11 September 2020
Presenter: D O’Neill
The Effect of Cladribine Upon Verma ND, Al-Atiyah R, P0406 Session: ePoster Date:
Naïve and Activated CD4+ T O’Neill D, Sharma M, Tran
11-13 September 2020
Regulatory Cells in MS CT, Hall BM, Hodgkinson SJ
Time: Available from 9am
Patients
EDT on 11 September 2020
Presenter: Suzanne
Hodgkinson
Rebif® (interferon beta-1a) Presentations
A Systematic Review and Lopez-Leon S, Geissbuehler P0278 Session: ePoster Date:
Meta-analyses of Pregnancy Y, Sabidó M, Turkson, M,
11-13 September 2020
and Fetal Outcomes in Women Wahlich C, Morris J
Time: Available from 9am
with Multiple Sclerosis. IMI2
EDT on 11 September 2020
ConcePTION
Presenter: Meritxell
Sabidó
Post-approval Safety of Freedman M S, Guehring H, P0370 Session: ePoster Date:
Subcutaneous Interferon ?-1a Murgasova Z, Jack D
11-13 September 2020
in the Treatment of Multiple
Time: Available from 9am
Sclerosis, With Particular
EDT on 11 September 2020
Reference to Respiratory
Presenter: Mark Freedman
Viral Infections
Effect of Neutralizing Freedman MS, Holmberg KH, P0323 Session: ePoster Date:
Antibodies on Pharmacodynamic Fluck M, Hyvert H, Stinchi
11-13 September 2020
Biomarkers of Subcutaneous S, D’Urso V, Dangond F
Time: Available from 9am
Interferon ?-1a in REFLEX and
EDT on 11 September 2020
REFLEXION
Presenter: Mark Freedman
Baseline Serum Neurofilament Kuhle J, Leppert D, Comi P0032 Session: ePoster Date:
Light Chain Levels Predict G, De Stefano N, Kappos L,
11-13 September 2020
Conversion to McDonald 2005 Freedman MS, Issard D, Roy
Time: Available from 9am
MS Within 2 yrs of a First S
EDT on 11 September 2020
Clinical Demyelinating Event
Presenter: Sanjeev Roy
in REFLEX
Effect of age on Sabidó M, Allignol A P0320 Session: ePoster Date:
Effectiveness and Marhardt K, Vermersch P,
11-13 September 2020
Discontinuation of Boutmy EF
Time: Available from 9am
Subcutaneous Interferon
EDT on 11 September 2020
beta-1a, and Healthcare
Presenter: Patrick
Utilization, in Patients With
Vermersch
Multiple Sclerosis
Comparing Infection-related Bove R, Kozma C, Phillips P0451 Session: ePoster Date:
Outcomes in Patients with AL, Harlow DE, Lobo C
11-13 September 2020
Multiple Sclerosis and
Time: Available from 9am
Matched Controls Using
EDT on 11 September 2020
Administrative Claims Data
Presenter: Riley Bove
Assessment of the Hemelin F, Marie Claire G, P1095 Session: ePoster Date:
Effectiveness of a Cognitive Olivier H, Marie B,
11-13 September 2020
Behavioral Program for Frederic B
Time: Available from 9am
Fatigue (FACETS +) in 110
EDT on 11 September 2020
French Patients with
Presenter: Fanny Hamelin
Relapsing Remitting Multiple
Sclerosis (RR MS): A
randomized, controlled trial
(RCT)
Impact of Interferon-beta Tokic M, Thiel S, Litvin P1126 Session: ePoster Date:
Exposure During Early N, Ciplea A, Gold R,
11-13 September 2020
Pregnancy on Relapse Rate Hellwig K
Time: Available from 9am
EDT on 11 September 2020
Presenter: M Tokic
Evobrutinib Presentations
Clinical Relapse Rates in Montalban X, Arnold D L, P0197 Session: ePoster Date:
Relapsing MS Patients Treated Weber MS, Staikov I,
11-13 September 2020
with the BTK Inhibitor Piasecka-Stryczynska K,
Time: Available from 9am
Evobrutinib: Results of an Martin E C, Mandel M, Ona
EDT on 11 September 2020
Open-Label Extension to Phase V, Dangond F, Wolinsky JS
Presenter: Fernando
II Study
Dengond
Safety of the Bruton’s Montalban, X Arnold D L, P0235 Session: ePoster Date:
Tyrosine Kinase Inhibitor Weber M S, Staikov I,
11-13 September 2020
Evobrutinib in Relapsing Piasecka-Stryczynska K,
Time: Available from 9am
Multiple Sclerosis During an Martin E C, Mandel M, Ona
EDT on 11 September 2020
Open-label Extension to a V, Zima Y, Dengond F,
Presenter: Fernando
Phase II Study Tomic D, Wolinsky JS
Dengond
Effect Of Evobrutinib, a BTK Montalban X, Shaw J, P0070 Session: ePoster Time:
Inhibitor, on Immune Cell and Dangond F, Martin EC,
Available from 9am EDT on
Immunoglobulin Levels in Grenningloh R, Ying Li,
11 September 2020
Relapsing MS: An Open-Label Weber MS
Presenter: Jamie Shaw
Extension to a Phase II Study
Evobrutinib, a Highly Torke S, Pretzsch R, P0334 Session: ePoster Date:
Selective BTK Inhibitor, Häusler D, Grenningloh R,
11-13 September 2020
Prevents Antigen-activation Boschert U, Brück W, Weber
Time: Available from 9am
of B Cells and Ameliorates B MS
EDT on 11 September 2020
Cell-mediated Experimental
Presenter: Sebastian
Autoimmune Encephalomyelitis
Torke
Expression of Bruton’s Kebir H, Ceja G, Miller P0962 Session: ePoster Date:
Tyrosine Kinase in B MC, Li C, May MJ, Vite CH,
11-13 September 2020
Cell-rich Meningeal Church ME, Grenningloh R,
Time: Available from 9am
Infiltrates in two Models of Boschert U, Alvarez JI
EDT on 11 September 2020
Progressive MS
Presenter: Kebir Hania
T-bet+ B-cell Development in Rijvers L, Melief MJ, van P0403 Session: ePoster Date:
MS: Association with Bruton’s Langelaar J, Wierenga-Wolf
11-13 September 2020
Tyrosine Kinase Activity and AF, Marieke van Ham S,
Time: Available from 9am
Targeting by Evobrutinib Boschert U, Grenningloh R,
EDT 11 September 2020
Smolders J, van Luijn MM
Presenter: Liza Rijvers
The Bruton’s Tyrosine Kinase Kim S, Boschert U P0404 Session: ePoster Date:
Inhibitor Evobrutinib Grenningloh R, Bhargava P
11-13 September 2020
Ameliorates Meningeal
Time: Available from 9am
Inflammation in Experimental
EDT on 11 September 2020
Autoimmune Encephalomyelitis
Presenter: Pavan Bhargava
The Validity and Kamudoni P, Amtmann D, P1062 Session: ePoster Date:
Applicability of the PROMIS Johns J, Cook K, Salem R,
11-13 September 2020
SF v2.1 – Physical Function Salek S, Raab J, Middleton
Time: Available from 9am
(MS) 15a: A new PROMIS® Short R, Repovic P, Alschuler
EDT on 11 September 2020
Form for Assessing Physical KN, von Geldern G, Wundes
Presenter: Paul Kamudoni
Function in Relapsing and A, Henke C
Progressive Multiple
Sclerosis Types
The Interpretation and Kamudoni P, Johns J, Cook P1061 Session: ePoster Date:
Clinical Application of the K, Salem R, Henke C, Salek
11-13 September 2020
PROMIS® SF v1.0 – Fatigue S, Raab J, Middleton R,
Time: Available from 9am
(MS) 8b: A PROMIS Short Form Repovic P, Alschuler KN,
EDT on 11 September 2020
for Assessing Fatigue in von Geldern G,Wundes A,
Presenter: Paul Kamudoni
Relapsing and Progressive Amtmann D
Multiple Sclerosis
General MS Franchise
Identifying Gaps in Schmierer K, Peniuta M, Oh P1100 Session: ePoster Date:
Knowledge, Skills and J, Leist T, Lazure P,
11-13 September 2020
Confidence Among MS Péloquin S
Time: Available from 9am
Specialists to Facilitate
EDT on 11 September 2020
Improved MS Care
Presenter: Klaus
Schmierer
An Investigation Into the Langdon D, Sumelahti M L, P1006 Session: ePoster Date:
Role and Impact That Carers Potra S, Alroughani R, on
11-13 September 2020
Play in Consultations Between behalf of the MS in the
Time: Available from 9am
Healthcare Professionals and 21st Century initiative,
EDT on 11 September 2020
People With MS Verdun Di Cantogno E
Presenter: Dawn Langdon
Characterization of Zuroff LR, Li R, Shinoda P0952 Session: ePoster Date:
Age-related Changes in K, Rezk A, Bar-Or A
11-13 September 2020
Circulating T cells in
Time: Available from 9am
Multiple Sclerosis and Normal
EDT on 11 September 2020
Controls: A Pilot Study
Presenter: LR Zuroff
Treatment and Care Freeman L, Lucas A, Zhou P0176 Session: ePoster Date:
Management, Clinical Outcomes J, Hayward B, Livingston T
11-13 September 2020
and Mobility Impairment in
Time: Available from 9am
People With or Without MS
EDT on 11 September 2020
Aged >=50 Years:
Presenter: Terrie
Observational 6-year Analysis
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.
All Merck Press Releases are distributed by email at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
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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