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…

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® (cladribine) tablets Presentations

Title

Authors

Presentation ID

Presentation Details

Reduced Grey Matter

Atrophy in Patients With

Relapsing Multiple

Sclerosis Treated With

Cladribine Tablets

Battaglini M,

Sormani M P,

Luchetti L, Gentile

G, Cortese R,

Alexandri N, De

Stefano N

P0231

Session: 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

De Stefano N,

Barkhof F,

Montalban X,

Achiron A, Derfuss

T, Chan A,

Hodgkinson S, Prat

A, Leocani L.

Schmierer K,

Sellebjerg F,

Vermersch P,

Wiendl H, Keller B,

Roy S

P0382

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Nicola De

Stefano

Durable Efficacy of

Cladribine Tablets:

Cumulative Relapse

Incidence Over 5 years

in CLARITY and

CLARITY Extension

Giovannoni G,

Rammohan K, Leist

T, Coyle P K, Keller

B, Jack D, Alexandri

N

P0202

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Gavin

Giovannoni

Disability Improvement

in Relapsing-remitting

Multiple Sclerosis

Patients Receiving

Cladribine Tablets,

Evaluated by Expanded

Disability Status Scale

Sormani M P,

Signori A

Giovannoni G,

Alexandri N

P0201

 

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Maria Pia

Sormani

Updated Post-Approval

Safety of Cladribine

Tablets in the

Treatment of Multiple

Sclerosis, With

Particular Reference to

Respiratory Viral Infections

Giovannoni G,

Berger J, Leist T,

Jack D, Galazka A,

Nolting A, Damian

D

P0415

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Gavin

Giovannoni

Clinical Outcomes in

Patients With COVID-19

Infection During Phase

IV Studies of Cladribine

Tablets for Treatment of

Multiple Sclerosis

Karan R, Roy S,

Alexandri N

LB1151

Session: Latebreaker

ePoster

Date: September 25-

26, 2020

Time: Available from

9am ET on September

25, 2020

Presenter: Radmila

Karan

Treatment Satisfaction

in Patients With Highly-

active Relapsing

Multiple Sclerosis

Treated With Cladribine

Tablets: CLARIFY-MS

Study Interim Analysis

Brochet B,

Hupperts R,

Langdon D, Solari

A, Piehl F, 

Lechner-Scott J,

Montalban X,

Selmaj K, Valis M,

Rejdak K, Havrdova

EK, Patti F, 

Alexandri N, Nolting

A, Keller B

P1066

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020  

Presenter: Bruno

Brochet

Initial Findings From a

Dynamic Cohort Study

of Patients With Multiple

Sclerosis: A Proactive

Approach for Safety and

Comparative

Effectiveness

Sabidó, M, Batech

M, Foch C, Boutmy

E, Verpillat P

P0470

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020  

Presenter: Meritxell

Sabidó

Characteristics of

Relapsing Multiple

Sclerosis Patients

Treated With Cladribine

Tablets in Five European

Countries: Multi-year

Chart Review

Zeng F, Harty G,

Wong SL, Maslova

E, Schade R, Row B

P0846

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Feng Zeng

Characterization of

Relapsing Multiple

Sclerosis Patients

Treated With Cladribine

Tablets in Germany

Since Marketing

Authorization

Zeng F, Harty G,

Wong SL, Uebler S,

Maslova E, Schade

R, Row B,

Ellenberger D,

Stahmann A

P0847

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Feng Zeng

CLASSIC-MS: Long-

term Efficacy and Real-

World Treatment

Patterns for Patients

Receiving Cladribine

Tablets – Interim Data

with 8–14 Years Follow-up

Giovannoni G, Leist

T, Aydemir A,

Verdun Di Cantogno

E, on behalf of the

CLASSIC-MS

Steering Committee

LB1229

Session: Latebreaker

ePoster

Date: September 25-

26, 2020

Time: Available from

9am ET September 25,

2020

Presenter: Thomas

Leist

Age-related Efficacy of

Cladribine Tablets in

Patients With Relapsing-

remitting MS in the

CLARITY Extension

Study

Freedman M, Pardo

G, De Stefano N,

Aldridge J, Hyvert

Y, Galazka A,

Lemieux C

P0284

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Mark

Freedman

Cladribine Tablets in

Patients with RRMS and

Active SPMS After

Suboptimal Response to

Prior DMD (MASTER-2

and CLICK-MS): Initial

Baseline Demographics

Miravelle A, Katz J,

Robertson D,

Hayward B, Walsh

JS, Harlow DE,

Lebson LA, Sloane

JA, Bass AD, Fox EJ

P0310

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Augusto

Miravelle

Treatment-emergent

Adverse Events

Occurring Early in the

Treatment Course of

Cladribine Tablets in

two Phase 3 Trials in

Multiple Sclerosis

Oh J, Walker B,

Giovannoni G, Jack

D, Dangond F,

Nolting A, Aldridge

J, Lebson L, Leist

TP

P0411

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Jiwon Oh

Identification and

Characterization of

Adherence Trajectory

Subgroups in Patients

With MS Initiating

Once- or Twice-daily

Oral Disease-modifying

Drugs

Cisternas MG,

Rajagopalan D,

Leszko M, Andrade

K, Phillips AL

P0967

Session: 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

Kozma CM, Roberts

NL, Phillips AL

P1052

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Chris

Kozma

Value-added Benefits of

a Nurse/Pharmacy-led

Service for Patients

With Multiple Sclerosis

Treated Over 2 Years

With Cladribine Tablets

in the UK

Morgan K, Vernon

K, Ayer M

P1069

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Kate Morgan

Demonstrating the

Value of a Patient

Support Program for

Multiple Sclerosis

Patients Prescribed

Cladribine Tablets in

Ireland at the end of

Year 1

Morgan K, Joseph

B, Williams V, Kelly

M

P1015

Session: 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

P0880

Session: ePoster

Date: September 11-

13, 2020

Time: Available from

9am ET on September

11, 2020

Presenter: Jiwon Oh

Cladribine Tablets

Versus Other Disease-

modifying Therapies in

Achieving Disability

Improvement in

Relapsing-remitting

Multiple Sclerosis

Patients – Network

Meta-analysis

Piasecka-

Stryczyńska K,

Rolka M, Kaczyński

Ł, Górecka M,

Wójcik R, Adamek

I, Kaczor MP,

Rejdak K

P0040

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

P0401

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

P0849

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

P0330

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

P0907

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

P0270

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

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

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

P0276

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

P0586

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

Evobrutinib, a Highly

Selective BTK Inhibitor,

Prevents Antigen-

activation of B Cells and

Ameliorates B Cell–

mediated Experimenta

l Autoimmune

Encephalomyelitis

Torke S, Pretzsch

R, Häusler D,

Grenningloh R,

Boschert U, Brück

W, Weber MS

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

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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SOURCE EMD Serono