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