EMD Serono to Showcase New Data at ACTRIMS-ECTRIMS MSVirtual2020 Meeting, Furthering Innovation in Multiple Sclerosis
ROCKLAND, Mass, Sept. 3, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced today it will present data on its approved and investigational multiple sclerosis (MS) treatments at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting. The Company will present 54 abstracts at the meeting, taking place virtually from September 11-13, 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 on the efficacy profile of evobrutinib, an investigational, oral, highly selective Bruton's Tyrosine Kinase inhibitor (BTKi), through 108 weeks of treatment in the Phase II open-label extension (OLE) in adult patients with relapsing multiple sclerosis (RMS). 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, Global Head of Research & Development for EMD Serono. "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:
-- Efficacy results from the Phase IV MAGNIFY-MS study and its impact on a
reduction in mean combined unique active (CUA) lesion count in the first
six months of MAVENCLAD(®) treatment for highly active RMS
-- New data evaluating cumulative relapse incidence over five years in
patients enrolled in the MAVENCLAD(®) CLARITY and CLARITY Extension
trials
-- 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 September 25, 2020
-- Results from a post hoc analysis from the CLARITY Extension and the
impact of MAVENCLAD(®) on the prevalence of disability improvement over
five years, as measured by the Expanded Disability Status Scale (EDSS)
-- Results from the MAGNIFY and CLARIFY studies regarding 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 September 25, 2020
-- Updated post-approval safety data of MAVENCLAD(®) in the treatment of
MS, including respiratory viral infections and findings that the safety
profile was 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
Key evobrutinib data include:
-- Efficacy results of the Phase II OLE in patients treated with
evobrutinib 75 mg BID (twice a day) as measured by annualized relapse
rate from Week 48 to Week 108
-- Safety results from the >=60 week Phase II OLE
-- Preclinical data demonstrating evobrutinib's potential to reduce CNS
compartmentalized inflammation thought to drive the progression of
disability seen in MS
Additional EMD Serono 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 (September 12, 2020,
14:30-15:30 EDT; recording available after the event)
-- Two product theatres on demand throughout the congress starting from
September 11, 2020, 11:45 EDT
-- "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
Following the conclusion of MSVirtual2020, EMD Serono will be hosting "Mastering the Neuroscience of Unconscious Bias," the inaugural virtual event for the company`s I'M IN initiative, a diversity, equity and inclusion effort started in February 2019. I'M IN is a US-based initiative started by the 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 EMD Serono abstracts accepted for presentation at ACTRIMS-ECTRIMS 2020:
MAVENCLAD(R) (cladribine) tablets Presentations
---
Title
Authors
Presentation ID
Presentation Details
--- ---
Reduced Grey Matter
Battaglini M,
P0231
Session: ePoster
Atrophy in Patients With Sormani M P,
Relapsing Multiple Luchetti L, Gentile
Date: September 11-
Sclerosis Treated With G, Cortese R, 13, 2020
Cladribine Tablets
Alexandri N, De
Time: Available from
Stefano N 9am ET on September
11, 2020
Presenter: Marco
Battaglini
--- ---
Reduction in CUA MRI
De Stefano N,
P0382
Session: ePoster
Lesions in the First 6 Barkhof F,
Months of Cladribine Montalban X,
Date: September 11-
Tablets Treatment for Achiron A, Derfuss 13, 2020
Highly Active Relapsing T, Chan A,
Multiple Sclerosis: Hodgkinson S, Prat
Time: Available from
MAGNIFY-MS Study A, Leocani L. 9am ET on September
Schmierer K, 11, 2020
Sellebjerg F,
Vermersch P,
Presenter: Nicola De
Wiendl H, Keller B, Stefano
Roy S
--- ---
Durable Efficacy of
Giovannoni G,
P0202
Session: ePoster
Cladribine Tablets: Rammohan K, Leist
Cumulative Relapse T, Coyle P K, Keller
Date: September 11-
Incidence Over 5 years B, Jack D, Alexandri 13, 2020
in CLARITY and N
CLARITY Extension
Time: Available from
9am ET on September
11, 2020
Presenter: Gavin
Giovannoni
--- ---
Disability Improvement
Sormani M P,
P0201
Session: ePoster
in Relapsing-remitting Signori A
Multiple Sclerosis Giovannoni G,
Date: September 11-
Patients Receiving Alexandri N 13, 2020
Cladribine Tablets,
Evaluated by Expanded
Time: Available from
Disability Status Scale 9am ET on September
11, 2020
Presenter: Maria Pia
Sormani
--- ---
Updated Post-Approval
Giovannoni G,
P0415
Session: ePoster
Safety of Cladribine Berger J, Leist T,
Tablets in the Jack D, Galazka A,
Date: September 11-
Treatment of Multiple Nolting A, Damian 13, 2020
Sclerosis, With D
Particular Reference to
Time: Available from
Respiratory Viral Infections 9am ET on September
11, 2020
Presenter: Gavin
Giovannoni
--- ---
Clinical Outcomes in
Karan R, Roy S,
LB1151
Session: Latebreaker
Patients With COVID-19 Alexandri N ePoster
Infection During Phase
IV Studies of Cladribine
Date: September 25-
Tablets for Treatment of 26, 2020
Multiple Sclerosis
Time: Available from
9am ET on September
25, 2020
Presenter: Radmila
Karan
--- ---
Treatment Satisfaction
Brochet B,
P1066
Session: ePoster
in Patients With Highly- Hupperts R,
active Relapsing Langdon D, Solari
Date: September 11-
Multiple Sclerosis A, Piehl F, 13, 2020
Treated With Cladribine Lechner-Scott J,
Tablets: CLARIFY-MS Montalban X,
Time: Available from
Study Interim Analysis Selmaj K, Valis M, 9am ET on September
Rejdak K, Havrdova 11, 2020
EK, Patti F,
Alexandri N, Nolting
Presenter: Bruno
A, Keller B Brochet
--- ---
Initial Findings From a
Sabidó, M, Batech
P0470
Session: ePoster
Dynamic Cohort Study M, Foch C, Boutmy
of Patients With Multiple E, Verpillat P
Date: September 11-
Sclerosis: A Proactive 13, 2020
Approach for Safety and
Comparative
Time: Available from
Effectiveness 9am ET on September
11, 2020
Presenter: Meritxell
Sabidó
--- ---
Characteristics of
Zeng F, Harty G,
P0846
Session: ePoster
Relapsing Multiple Wong SL, Maslova
Sclerosis Patients E, Schade R, Row B
Date: September 11-
Treated With Cladribine 13, 2020
Tablets in Five European
Countries: Multi-year
Time: Available from
Chart Review 9am ET on September
11, 2020
Presenter: Feng Zeng
--- ---
Characterization of
Zeng F, Harty G,
P0847
Session: ePoster
Relapsing Multiple Wong SL, Uebler S,
Sclerosis Patients Maslova E, Schade
Date: September 11-
Treated With Cladribine R, Row B, 13, 2020
Tablets in Germany Ellenberger D,
Since Marketing Stahmann A
Time: Available from
Authorization 9am ET on September
11, 2020
Presenter: Feng Zeng
--- ---
CLASSIC-MS: Long-
Giovannoni G, Leist
LB1229
Session: Latebreaker
term Efficacy and Real- T, Aydemir A, ePoster
World Treatment Verdun Di Cantogno
Patterns for Patients E, on behalf of the
Date: September 25-
Receiving Cladribine CLASSIC-MS 26, 2020
Tablets - Interim Data Steering Committee
with 8-14 Years Follow-up
Time: Available from
9am ET September 25,
2020
Presenter: Thomas
Leist
--- ---
Age-related Efficacy of
Freedman M, Pardo
P0284
Session: ePoster
Cladribine Tablets in G, De Stefano N,
Patients With Relapsing- Aldridge J, Hyvert
Date: September 11-
remitting MS in the Y, Galazka A, 13, 2020
CLARITY Extension Lemieux C
Study
Time: Available from
9am ET on September
11, 2020
Presenter: Mark
Freedman
--- ---
Cladribine Tablets in
Miravelle A, Katz J,
P0310
Session: ePoster
Patients with RRMS and Robertson D,
Active SPMS After Hayward B, Walsh
Date: September 11-
Suboptimal Response to JS, Harlow DE, 13, 2020
Prior DMD (MASTER-2 Lebson LA, Sloane
and CLICK-MS): Initial JA, Bass AD, Fox EJ
Time: Available from
Baseline Demographics 9am ET on September
11, 2020
Presenter: Augusto
Miravelle
--- ---
Treatment-emergent
Oh J, Walker B,
P0411
Session: ePoster
Adverse Events Giovannoni G, Jack
Occurring Early in the D, Dangond F,
Date: September 11-
Treatment Course of Nolting A, Aldridge 13, 2020
Cladribine Tablets in J, Lebson L, Leist
two Phase 3 Trials in TP
Time: Available from
Multiple Sclerosis 9am ET on September
11, 2020
Presenter: Jiwon Oh
--- ---
Identification and
Cisternas MG,
P0967
Session: ePoster
Characterization of Rajagopalan D,
Adherence Trajectory Leszko M, Andrade
Date: September 11-
Subgroups in Patients K, Phillips AL 13, 2020
With MS Initiating
Once- or Twice-daily
Time: Available from
Oral Disease-modifying 9am ET on September
Drugs 11, 2020
Presenter: Amy
Phillips
--- ---
Real-world Patient-level
Kozma CM, Roberts
P1052
Session: ePoster
Costs of Administering NL, Phillips AL
Infusion Disease-
Date: September 11-
modifying Drugs: A US 13, 2020
Retrospective Claims
Database Analysis
Time: Available from
9am ET on September
11, 2020
Presenter: Chris
Kozma
--- ---
Value-added Benefits of
Morgan K, Vernon
P1069
Session: ePoster
a Nurse/Pharmacy-led K, Ayer M
Service for Patients
Date: September 11-
With Multiple Sclerosis 13, 2020
Treated Over 2 Years
With Cladribine Tablets
Time: Available from
in the UK 9am ET on September
11, 2020
Presenter: Kate Morgan
--- ---
Demonstrating the
Morgan K, Joseph
P1015
Session: ePoster
Value of a Patient B, Williams V, Kelly
Support Program for M
Date: September 11-
Multiple Sclerosis 13, 2020
Patients Prescribed
Cladribine Tablets in
Time: Available from
Ireland at the end of 9am ET on September
Year 1 11, 2020
Presenter: Kate
Morgan
--- ---
Low Discontinuation
Oh J, Giacomini P,
P0880
Session: ePoster
Rate and Side-effect Devonshire V, Clift
Burden After Switching F, Lemieux C,
Date: September 11-
to Cladribine Tablets: Sabido M, Allignol 13, 2020
Canadian Experience A, Freedman M
from the adveva(R)
Time: Available from
Patient Support 9am ET on September
Program 11, 2020
Presenter: Jiwon Oh
--- ---
Cladribine Tablets
Piasecka-
P0040
Session: ePoster
Versus Other Disease- Stryczy?ska K,
modifying Therapies in Rolka M, Kaczy?ski
Date: September 11-
Achieving Disability ?, Górecka M, 13, 2020
Improvement in Wójcik R, Adamek
Relapsing-remitting I, Kaczor MP,
Time: Available from
Multiple Sclerosis Rejdak K 9am ET on September
Patients - Network 11, 2020
Meta-analysis
Presenter: K.
Piasecka-Stryczynska
--- ---
MS Disease-modifying
Ziemssen T, 566
Session: ePoster
Therapy Sequencing - Penner IK, Wagner
Natalizumab to T, Huebschen M,
Date: September 11-
Cladribine Tablets - Mueller B, Buescher 13, 2020
Experience in 46 T, Richter J,
Patients Posevitz-Fejfar A
Time: Available from
9am ET on September
11, 2020
Presenter: Tjalf
Ziemssen
--- ---
Switching disease
Saiz A, Aguera E,
P0401
Session: ePoster
modifying treatment in Moral E, Brieva L,
relapsing multiple Rodriguez-
Date: September 11-
sclerosis: Delphi Antiguedad A, 13, 2020
consensus of the Casanova-Estruch
Demyelinating Group of B, Jordi R, Meca-
Time: Available from
the Spanish Society of Lallana V, Garcia- 9am ET on September
Neurology Merino JA, Costa- 11, 2020
Frossard L, Arnal-
Garice C, Landete
Presenter: Luis Brieva
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
Penner IK, Pul R,
P0849
Session: ePoster
Tablets - evaluation of Kallmann BA, Raji
Quality of Life) Study: A, Richter J,
Date: September 11-
Evaluating QoL 12 Wagner T, Mueller 13, 2020
Months After Treatment B, Buescher T,
Initiation with Cladribine Posevitz-Fejfar A
Time: Available from
Tablets 9am ET on September
11, 2020
Presenter: Iris-
Katharina Penner
--- ---
Effects of Cladribine on
Eixarch H, Calvo-
P0330
Session: ePoster
Proliferation, Survival Barreiro L, Fissolo
and Cytokine Release of N, Boschert U,
Date: September 11-
Human Astrocytes Comabella M, 13, 2020
Montalban X,
Espejo C
Time: Available from
9am ET on September
11, 2020
Presenter: Herena
Eixarch
--- ---
Real-world Experience
Butzkueven H,
P0907
Session: ePoster
With Cladribine in the Spelman T, Verdun
MSBase Registry di Cantogno E,
Date: September 11-
Fabris J, Zeng F, G 13, 2020
Harty
Time: Available from
9am ET on September
11, 2020
Presenter: Helmut
Butzkueven
--- ---
2-
Aybar F, Marcora S,
P0270
Session: ePoster
Chlorodeoxyadenosine Eugenia Samman
(Cladribine) M, Perez MJ,
Date: September 11-
Preferentially Inhibits Pasquini JM, 13, 2020
the Biological Activity of Correale J
Microglia Cells
Time: Available from
9am ET on September
11, 2020
Presenter: Jorge
Correale
--- ---
Cladribine to Halt
Lieberman D,
P0196
Session: ePoster
Deterioration in People Mangat H, Allen-
With Advanced Multiple Philby K, Baker D,
Date: September 11-
Sclerosis (ChariotMS) Barkhof F, 13, 2020
Chandran S,
Chapman C,
Time: Available from
Chataway J, Ford H, 9am ET on September
Giovannoni G, 11, 2020
Hobart J, Hooper R,
Hussain T, Walker
Presenter: David
N, Macmanus D, Lieberman
Mihaylova B, Pavitt
S
--- ---
Predicting Long-term
Sharmin S, Bovis F,
P0131
Session: ePoster
Sustained Disability Sormani MP,
Progression in Multiple Butzkueven H,
Date: September 11-
Sclerosis: Application in Kalincik T and the 13, 2020
the CLARITY Trial MSBase study
group
Time: Available from
9am ET on September
11, 2020
Presenter: S Sharmin
--- ---
A Clinical Data
Forsberg L,
P0276
Session: ePoster
Summary for Cladribine Kagström S, Hillert
Patients Treated at least J, Nilsson P, Dahle
Date: September 11-
12 Months - A Swedish C, Svenningsson A, 13, 2020
Nationwide Study of the Lycke J, Landtblom
Long-Term AM, Burman J,
Time: Available from
Effectiveness and Safety Martin C, 9am ET on September
of Cladribine (IMSE 10) Sundström P, 11, 2020
Gunnarsson M,
Piehl F, Olsson T
Presenter: L Forsberg
--- ---
Impact of Cladribine
Raji A, Winkler G
P0586
Session: ePoster
Tablets on Brain Volume
Protection in Highly
Date: September 11-
Active MS 13, 2020
Time: Available from
9am ET on September
11, 2020
Presenter: A Raji
--- ---
Early Real-World Safety,
Bain J, Jones A,
P0319
Session: ePoster
Tolerability, and Efficacy Overholt S,
of Cladribine Tablets: A Guenette M,
Date: September 11-
Single Center Selchen D, Jiwon 13, 2020
Experience Oh
Time: Available from
9am ET on September
11, 2020
Presenter: J Bain
--- ---
Switching From
O'Neill DTD,
P0399
Session: ePoster
Ocrelizumab to Sharma M,
Cladribine: Real-world Gonzales B,
Date: September 11-
Data Vandenheuvel M, 13, 2020
Tse B, Hodgkinson
SJ
Time: Available from
9am ET on September
11, 2020
Presenter: D O'Neill
--- ---
The Effect of Cladribine
Verma ND, Al-
P0406
Session: ePoster
Upon Naïve and Atiyah R, O'Neill D,
Activated CD4+ T Sharma M, Tran CT,
Date: September 11-
Regulatory Cells in MS Hall BM, 13, 2020
Patients Hodgkinson SJ
Time: Available from
9am ET on September
11, 2020
Presenter: Suzanne
Hodgkinson
--- ---
Rebif(R) (interferon beta-1a) Presentations
---
A Systematic Review
Lopez-Leon S,
P0278
Session: ePoster
and Meta-analyses of Geissbuehler Y,
Pregnancy and Fetal
Date: September 11-
Outcomes in Women
Sabidó M, Turkson, 13, 2020
with Multiple Sclerosis. M, Wahlich C,
IMI2 ConcePTION Morris J
Time: Available from
9am ET on September
11, 2020
Presenter: Meritxell
Sabidó
--- ---
Post-approval Safety of
Freedman M S,
P0370
Session: ePoster
Subcutaneous Guehring H,
Interferon -1a in the Murgasova Z,
Date: September 11-
Treatment of Multiple Jack D 13, 2020
Sclerosis, With
Particular Reference to
Time: Available from
Respiratory Viral 9am ET on September
Infections 11, 2020
Presenter: Mark
Freedman
--- ---
Effect of Neutralizing
Freedman MS,
P0323
Session: ePoster
Antibodies on Holmberg KH, Fluck
Pharmacodynamic M, Hyvert H, Stinchi
Date: September 11-
Biomarkers of S, D'Urso V, 13, 2020
Subcutaneous Dangond F
Interferon -1a in
Time: Available from
REFLEX and REFLEXION 9am ET on September
11, 2020
Presenter: Mark
Freedman
--- ---
Baseline Serum
Kuhle J, Leppert D,
P0032
Session: ePoster
Neurofilament Light Comi G, De Stefano
Chain Levels Predict N, Kappos L,
Date: September 11-
Conversion to McDonald Freedman MS, 13, 2020
2005 MS Within 2 yrs of Issard D, Roy S
a First Clinical
Time: Available from
Demyelinating Event in 9am ET on September
REFLEX 11, 2020
Presenter: Sanjeev
Roy
--- ---
Effect of age on
Sabidó M, Allignol A
P0320
Session: ePoster
Effectiveness and Marhardt K,
Discontinuation of Vermersch P,
Date: September 11-
Subcutaneous Boutmy EF 13, 2020
Interferon beta-1a, and
Healthcare Utilization, in
Time: Available from
Patients With Multiple 9am ET on September
Sclerosis 11, 2020
Presenter: Patrick
Vermersch
--- ---
Comparing Infection-
Bove R, Kozma C,
P0451
Session: ePoster
related Outcomes in Phillips AL, Harlow
Patients with Multiple DE, Lobo C
Date: September 11-
Sclerosis and Matched 13, 2020
Controls Using
Administrative Claims
Time: Available from
Data 9am ET on September
11, 2020
Presenter: Riley Bove
--- ---
Assessment of the
Hemelin F, Marie
P1095
Session: ePoster
Effectiveness of a Claire G, Olivier H,
Cognitive Behavioral Marie B, Frederic B
Date: September 11-
Program for Fatigue 13, 2020
(FACETS +) in 110
French Patients with
Time: Available from
Relapsing Remitting 9am ET on September
Multiple Sclerosis (RR 11, 2020
MS): A randomized,
controlled trial (RCT)
Presenter: Fanny
Hamelin
--- ---
Impact of Interferon-
Tokic M, Thiel S,
P1126
Session: ePoster
beta Exposure During Litvin N, Ciplea A,
Early Pregnancy on Gold R, Hellwig K
Date: September 11-
Relapse Rate 13, 2020
Time: Available from
9am ET on September
11, 2020
Presenter: M Tokic
--- ---
Evobrutinib Presentations
---
Clinical Relapse Rates
Montalban X,
P0197
Session: ePoster
in Relapsing MS Patients Arnold D L, Weber
Treated with the BTK MS, Staikov I,
Date: September 11-
Inhibitor Evobrutinib: Piasecka- 13, 2020
Results of an Open- Stryczynska K,
Label Extension Martin E C, Mandel
Time: Available from
to Phase II Study M, Ona V, Dangond 9am ET on September
F, Wolinsky JS 11, 2020
Presenter: Fernando
Dengond
--- ---
Safety of the Bruton's
Montalban, X
P0235
Session: ePoster
Tyrosine Kinase Arnold D L, Weber
Inhibitor Evobrutinib in M S, Staikov I,
Date: September 11-
Relapsing Multiple Piasecka- 13, 2020
Sclerosis During an Stryczynska K,
Open-label Extension to Martin E C, Mandel
Time: Available from
a Phase II Study M, Ona V, Zima Y, 9am ET on September
Dengond F, Tomic 11, 2020
D, Wolinsky JS
Presenter: Fernando
Dengond
--- ---
Effect Of Evobrutinib,
Montalban X, Shaw
P0070
Session: ePoster
a BTK Inhibitor, on J, Dangond F,
Immune Cell and Martin EC,
Date: September 11-
Immunoglobulin Levels Grenningloh R, Ying 13, 2020
in Relapsing MS: An Li, Weber MS
Open-Label Extension to
Time: Available from
a Phase II Study 9am ET on September
11, 2020
Presenter: Jamie
Shaw
--- ---
Evobrutinib, a Highly
Torke S, Pretzsch
P0334
Session: ePoster
Selective BTK Inhibitor, R, Häusler D,
Prevents Antigen- Grenningloh R,
Date: September 11-
activation of B Cells and Boschert U, Brück 13, 2020
Ameliorates B Cell- W, Weber MS
mediated Experimenta
Time: Available from
l Autoimmune 9am ET on September
Encephalomyelitis 11, 2020
Presenter: Sebastian
Torke
--- ---
Expression of Bruton's
Kebir H, Ceja G,
P0962
Session: ePoster
Tyrosine Kinase in B Miller MC, Li C, May
Cell-rich Meningeal MJ, Vite CH, Church
Date: September 11-
Infiltrates in two Models ME, Grenningloh R, 13, 2020
of Progressive MS Boschert U, Alvarez
JI
Time: Available from
9am ET on September
11, 2020
Presenter: Kebir
Hania
--- ---
T-bet+ B-cell
Rijvers L, Melief MJ,
P0403
Session: ePoster
Development in MS: van Langelaar J,
Association with Wierenga-Wolf AF,
Date: September 11-
Bruton's Tyrosine Marieke van Ham 13, 2020
Kinase Activity and S, Boschert U,
Targeting by Grenningloh R,
Time: Available from
Evobrutinib Smolders J, van 9am ET on September
Luijn MM 11, 2020
Presenter: Liza
Rijvers
--- ---
The Bruton's Tyrosine
Kim S, Boschert U
P0404
Session: ePoster
Kinase Inhibitor Grenningloh R,
Evobrutinib Ameliorates Bhargava P
Date: September 11-
Meningeal Inflammation 13, 2020
in Experimental
Autoimmune
Time: Available from
Encephalomyelitis 9am ET on September
11, 2020
Presenter: Pavan
Bhargava
--- ---
The Validity and
Kamudoni P,
P1062
Session: ePoster
Applicability of the Amtmann D, Johns
PROMIS SF v2.1 - J, Cook K, Salem R,
Date: September 11-
Physical Function (MS) Salek S, Raab J, 13, 2020
15a: A new PROMIS(R) Middleton R,
Short Form for Repovic P, Alschuler
Time: Available from
Assessing Physical KN, von Geldern G, 9am ET on September
Function in Relapsing Wundes A, Henke C 11, 2020
and Progressive Multiple
Sclerosis Types
Presenter: Paul
Kamudoni
--- ---
The Interpretation and
Kamudoni P, Johns
P1061
Session: ePoster
Clinical Application of J, Cook K, Salem R,
the PROMIS(R) SF v1.0 - Henke C, Salek S,
Date: September 11-
Fatigue (MS) 8b: A Raab J, Middleton 13, 2020
PROMIS Short Form for R, Repovic P,
Assessing Fatigue in Alschuler KN, von
Time: Available from
Relapsing and Geldern G,Wundes 9am ET on September
Progressive Multiple A, Amtmann D 11, 2020
Sclerosis
Presenter: Paul
Kamudoni
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General MS Franchise
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Identifying Gaps in
Schmierer K,
P1100
Session: ePoster
Knowledge, Skills and Peniuta M, Oh J,
Confidence Among MS Leist T, Lazure P,
Date: September 11-
Specialists to Facilitate Péloquin S 13, 2020
Improved MS Care
Time: Available from
9am ET on September
11, 2020
Presenter: Klaus
Schmierer
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An Investigation Into
Langdon D,
P1006
Session: ePoster
the Role and Impact Sumelahti M L,
That Carers Play in Potra S, Alroughani
Date: September 11-
Consultations Between R, on behalf of the 13, 2020
Healthcare Professionals MS in the 21st
and People With MS Century initiative,
Time: Available from
Verdun Di Cantogno 9am ET on September
E 11, 2020
Presenter: Dawn
Langdon
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Characterization of Age-
Zuroff LR, Li R,
P0952
Session: ePoster
related Changes in Shinoda K, Rezk A,
Circulating T cells in Bar-Or A
Date: September 11-
Multiple Sclerosis and 13, 2020
Normal Controls: A Pilot
Study
Time: Available from
9am ET on September
11, 2020
Presenter: LR Zuroff
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Treatment and Care
Freeman L, Lucas
P0176
Session: ePoster
Management, Clinical A, Zhou J, Hayward
Outcomes and Mobility B, Livingston T
Date: September 11-
Impairment in People 13, 2020
With or Without MS
Aged >=50 Years:
Time: Available from
Observational 6-year 9am ET on
Analysis September 11, 2020
Presenter: Terrie
Livingston
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About MAVENCLAD(®)
MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the first and only short-course oral therapy for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). Patients should follow healthcare provider instructions including cancer screening, contraception and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose-dependent reduction in lymphocyte counts followed by recovery.
Because cladribine is cytotoxic, special handling and disposal instructions should be followed.
MAVENCLAD has been approved in 79 countries, including the European Union (EU), Canada, Australia and Switzerland, for various relapsing MS indications. Visit www.MAVENCLAD.com for more information.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
-- Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD
is contraindicated in patients with current malignancy; evaluate the
benefits and risks of the use of MAVENCLAD on an individual patient
basis for patients with prior or increased risk of malignancy.
-- MAVENCLAD is contraindicated for use in pregnant women and in women and
men of reproductive potential who do not plan to use effective
contraception because of the potential for fetal harm.
CONTRAINDICATIONS
-- Current malignancy.
-- Pregnancy, and women and men of reproductive potential who do not plan
to use effective contraception during MAVENCLAD dosing and for 6 m after
the last dose in each treatment course.
-- Human immunodeficiency virus (HIV).
-- Active chronic infections (e.g., hepatitis or tuberculosis).
-- History of hypersensitivity to cladribine.
-- Breastfeeding while taking MAVENCLAD and for 10 days after the last
dose.
DOSING CONSIDERATIONS: After the completion of 2 treatment courses, do not administer additional MAVENCLAD during the next 2 years. The risk of malignancy with reinitiating MAVENCLAD more than 2 years after completion of 2 treatment courses has not been studied.
ADDITIONAL WARNINGS AND PRECAUTIONS
-- Lymphopenia: In clinical studies, 87% of MAVENCLAD-treated patients
experienced lymphopenia. Concomitant use of MAVENCLAD with hematotoxic
drugs may increase the risk of adverse reactions because of the additive
hematological effects. Monitor lymphocyte counts before and during
treatment, periodically thereafter, and when clinically indicated.
-- Infections: Infections occurred in 49% of MAVENCLAD-treated patients
compared to 44% of patients treated with placebo in clinical studies.
The most frequent serious infections included herpes zoster and
pyelonephritis. Single fatal cases of tuberculosis and fulminant
hepatitis B were reported in the clinical program. Administer
live-attenuated or live vaccines at least 4 to 6 weeks prior to starting
MAVENCLAD. Screen patients for latent infections; consider delaying
treatment until infection is fully controlled. Vaccinate patients
antibody-negative to varicella zoster virus prior to treatment. Monitor
for infections. Administer anti-herpes prophylaxis in patients with
lymphocyte counts less than 200 cells per microliter. In patients
treated with parenteral cladribine for oncologic indications, cases of
progressive multifocal leukoencephalopathy (PML) have been reported. No
case of PML has been reported in clinical studies of cladribine in
patients with MS.
-- Hematologic Toxicity: Mild to moderate decreases in neutrophil counts,
hemoglobin levels, and platelet counts were observed. Severe decreases
in neutrophil counts were observed in 3.6% of MAVENCLAD-treated
patients, compared to 2.8% of placebo patients. Obtain complete blood
count (CBC) with differential including lymphocyte count before and
during treatment, periodically thereafter, and when clinically
indicated.
-- Risk of Graft-versus-Host Disease With Blood Transfusions: Irradiation
of cellular blood components is recommended.
-- Liver Injury: Obtain liver function tests prior to treatment.
Discontinue MAVENCLAD if significant injury is suspected.
-- Hypersensitivity: In clinical studies, 11% of MAVENCLAD-treated patients
had hypersensitivity reactions, compared to 7% of placebo patients.
Serious hypersensitivity reactions occurred in 0.5% of MAVENCLAD-treated
patients, compared to 0.1% of placebo patients. If a hypersensitivity
reaction is suspected, discontinue treatment. Do not use MAVENCLAD in
patients with a history of hypersensitivity to cladribine.
-- Cardiac Failure: In clinical studies, one MAVENCLAD-treated patient
experienced life-threatening acute cardiac failure with myocarditis,
which improved after approximately one week. Cases of cardiac failure
have also been reported with parenteral cladribine used for treatment
indications other than multiple sclerosis.
Adverse Reactions: The most common adverse reactions with an incidence of >20% for MAVENCLAD are upper respiratory tract infection, headache, and lymphopenia.
Drug Interactions/Concomitant Medication: Concomitant use of MAVENCLAD with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Avoid concomitant use of certain antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD.
Please see the full Prescribing Information, including boxed WARNING for additional information.
About Rebif® (interferon beta-1a)
Rebif (interferon beta-1a) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is used to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.
IMPORTANT SAFETY INFORMATION:
Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.
Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif.
Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury. Monitor liver function tests and patients for signs and symptoms of hepatic injury. Consider discontinuing Rebif if hepatic injury occurs.
Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs.
In controlled clinical trials, injection site reactions occurred more frequently in Rebif-treated patients than in placebo-treated and Avonex-treated patients. Injection site reactions including injection site pain, erythema, edema, cellulitis, abscess, and necrosis have been reported in the postmarketing setting. Do not administer Rebif into affected area until fully healed; if multiple lesions occur, discontinue Rebif until skin lesions are healed.
Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients. Patients should be monitored for symptoms or signs of decreased blood counts. Monitoring of complete blood and differential white blood cell counts is also recommended.
Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy. Discontinue Rebif if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.
Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been temporally associated with the use of beta interferons, including Rebif, in clinical trials and in postmarketing reports.
The most common side effects with Rebif are injection-site disorders, headaches, influenza-like symptoms, abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities.
Epidemiological data do not suggest a clear relationship between interferon beta use and major congenital malformations, but interferon beta may cause fetal harm based on animal studies. Data from a large human population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent.
Please see the full Prescribing Information for additional information: https://www.emdserono.com/us-en/pi/rebif-pi.pdf
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.
EMD Serono, Inc. and Multiple Sclerosis
For more than 20 years, EMD Serono has been relentlessly focused on understanding the journey people living with MS face in order to create a meaningful, positive experience for them and the broader MS community. However, there is still much that is unknown about this complex and unpredictable disease. EMD Serono is digging deeper to advance the science.
About EMD Serono, Inc.
EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com.
Your Contact
emma.silva@emdserono.com
1-781-206-1951
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