EMD Serono to Showcase Scientific Leadership at ECTRIMS 2019 with New Data Across Multiple Sclerosis Medicines
ROCKLAND, Mass., Aug. 28, 2019 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that it will present data on its approved and investigational multiple sclerosis (MS) treatments at the 35(th) Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS). During ECTRIMS, taking place from September 11-13, 2019, in Stockholm, Sweden, EMD Serono will present 39 abstracts, including new long-term safety and efficacy data on MAVENCLAD(®) (cladribine) tablets and new long-term efficacy data for interferon beta (IFN ) therapies, including Rebif(®) (interferon beta-1a). Data will also be presented further elucidating the proposed mechanism of action for investigational therapy evobrutinib, the first oral, highly selective Bruton's Tyrosine Kinase (BTK) inhibitor to demonstrate clinical proof of concept in relapsing multiple sclerosis (RMS).
"The new data we will be sharing at ECTRIMS touch on several important topics for the scientific community, including long-term safety and efficacy data for MAVENCLAD, long-term efficacy data for interferon beta therapies, including Rebif, and data further elucidating evobrutinib's proposed unique mechanism of action and its potential as a novel therapeutic approach in MS," said Luciano Rossetti, Head of Global R&D for EMD Serono. "These data reinforce the important role of our currently-available treatments and offer further insights on our investigational treatment, as we continue our unwavering commitment to address the needs of the MS community."
Key MAVENCLAD data include:
-- A post hoc analysis evaluating five-year disease stability in patients
enrolled in the CLARITY and CLARITY EXTENSION trials
-- Results from an exploratory analysis of real-world data from an Italian
MS registry assessing time-to-treatment change after MAVENCLAD, which
examined efficacy of MAVENCLAD on relapse rate and disability
progression at five years after starting treatment
-- Results from up to 10 years of follow-up from the PREMIERE safety
registry, which further support the long-term benefit-risk profile of
MAVENCLAD
-- New data further illustrating how MAVENCLAD is thought to preferentially
target key immune cells involved with MS and its potential qualitative
effect on the immune system
Key Rebif data include:
-- Results using a new post hoc exploratory statistical methodology, which
examined changes in disability status over time using eight years of
data from the PRISMS study
Key evobrutinib data include:
-- Three analyses that investigate the potential role of evobrutinib, the
first oral, highly selective BTK inhibitor to demonstrate clinical proof
of concept in RMS, in inhibiting pathogenic B-cells and promoting myelin
repair
Additional EMD Serono activities at ECTRIMS 2019:
-- Panel discussion and networking event on September 11 bringing together
Patient Advocacy Groups, people living with MS and multi-disciplinary
experts to have a conversation about family planning with MS (6:00 -
7:30 PM, Epicenter, Stockholm)
-- Daily "Meet the Expert" sessions at EMD Serono booth B40 where different
MS experts will share insights from clinical practice with MAVENCLAD,
explore family planning for patients with MS and the company`s ongoing
commitment to MS research and development through the Grant for Multiple
Sclerosis Innovation (GMSI)
-- Satellite symposium events on September 11 (12:30 - 1:30 PM, Hall A
Stockholmsmässan) and September 12 (6:15 - 7:15 PM, Hall A
Stockholmsmässan) covering key learnings on managing disease
progression in MS, including monitoring methods, recent advancements in
MS immune targeting and the importance of innovative registry studies
-- #MSInsideOut Experience, including the MS House and virtual reality
(VR), at EMD Serono booth B40 that will immerse visitors into a
day-in-the-life of an MS patient, educating them on symptoms of MS and
how they affect the human body in different settings
Below is a selection of abstracts that have been accepted for presentation at ECTRIMS 2019:
MAVENCLAD(R) (cladribine) tablets Presentations
---
Title Authors
Abstract No. Presentation Date/Time/Session
/ Poster No.
--- ---
Reduction of risk of
Vermersch P,
A-1026-0005-
Session Title: Poster
secondary progressive Giovannoni G, 00522 Session 1
multiple sclerosis within Soelberg-Sorensen P,
two years of treatment Rammohan K, Cook S,
Session Date:
with Cladribine Tablets: Keller B, Roy S 09.11.2019
An analysis of the
CLARITY study
Presenting Time:
5:15-7:15 PM
--- ---
Long-term disease stability assessed Giovannoni G, Comi G,
by the Expanded Disability Status Rammohan K,
Scale in patients treated with Rieckmann P,
Cladribine Tablets in the CLARITY and Vermersch P, Dangond
CLARITY Extension studies F, Keller B, Jack D
A-1026-0033-00521
ePoster
--- ---
The CLARITY Study: Efficacy Outcomes Vermersch P, Rammohan
Among Patients Who Received Disease- K, Damian D, Jack D,
Modifying Therapies Prior to Treatment Harty G, Wong S L
with Cladribine Tablets
A-1026-0031-01868
Session Title:
Poster Session 1
Session Date:
09.11.2019
Presenting Time:
5:15-7:15 PM
--- ---
Updated safety of cladribine tablets in Cook S, Giovannoni G,
the treatment of patients with Leist T, Comi G,
multiple sclerosis: Integrated safety Syed S, Nolting A,
analysis and post-approval data Damian D, Schick R
A-1026-0033-00523
Session Title:
Poster Session 3
Session Date:
09.13.2019
Presenting Time:
12:15-2:15 PM
--- ---
An analysis of the relationship between Cook S, Giovannoni G,
cladribine dose and risk of Leist T, Comi G,
malignancies in patients with multiple Nolting A, Sylvester
sclerosis E, Jack D, Damian D,
Galazka A
A-1026-0033-01927
Session Title:
Poster Session 1
Session Date:
09.11.2019
Presenting Time:
5:15-7:15 PM
--- ---
Long term, registry-based, Butzkueven H,
prospective, post-authorization Korhonen P,
safety study evaluating adverse events
of special interest in patients with
highly active relapsing multiple
sclerosis newly started on oral
cladribine - CLARION
A-1026-0033-00518
ePoster
Hillert J, Trojano M,
Aydemir A,
Magyari M, Khanfir H,
Pinuaga C, Sabidó M,
CLARION Study group
--- ---
Incidence of any malignancies in Magyari M, Foch C, Scientific Session 2: Safety assessment in the
patients treated for multiple Nørgaard M, Boutmy post-approval phase - real world evidence
sclerosis. A Danish registry-based E, Veres K, Sabidó M
cohort
A-1026-0034-01799
Session Date: 09.11.2019
Presenting Time: 3:01-3:13 PM
--- ---
Increase of naïve B cells M2 Giovannoni G, Leist
macrophages and reduction of memory B/ T, Soelberg-
T cells during immune repopulation at Sorensen P,
96 weeks in CLARITY assessed by Immune Kalatskaya I,
cell deconvolution Boschert U,
DeMartino J, Rolfe A
A-1026-0031-00511
Session Title: Poster Session 2
Session Date: 09.12.2019
Presenting Time: 5:15-7:15 PM
--- ---
Long-term effectiveness in patients Patti F, Visconti A,
previously enrolled in the Cladribine Capacchione A,
Tablets pivotal trials: a Real-World Trojano M on behalf
Evidence analysis using data from the of the CLARINET-MS
Italian Multiple Sclerosis Registry study group
(CLARINET-MS)
A-1026-0031-00516
Session Title: Poster Session 1
Session Date: 09.11.2019
Presenting Time: 5:15-7:15 PM
--- ---
Comparative effectiveness of Cladribine Signori A, Saccà F,
tablets vs other drugs in relapsing- Lanzillo R,
remitting multiple sclerosis: an Maniscalco GT,
approach merging randomized controlled Signoriello E,
trial with real life data Repice A, Annovazzi
P, Baroncini D,
Clerico M, Binello
E, Cerqua R,
Mataluni G, Perini
P, Bonavita S,
Lavorgna L, Zarbo
IR, Laroni A,
Gutierrez LP, Gioia
SL, Frigeni B,
Barcella V, Frau J,
Cocco E, Fenu G,
Clerici VT, Sartori
A, Rasia S, Cordioli
C, Stromillo ML, Di
Sapio A, Pontecorvo
S, Grasso R, Barone
S, Barrilà C, Russo
CV, Esposito S,
Ippolito D, Landi D,
Visconti A, Sormani
MP
A-1026-0031-00187
Session Title: Poster Session 2
Session Date: 09.12.2019
Presenting Time: 5:15-7:15 PM
--- ---
CD4+ T cells and CD19+ B cells respond Carlini F, Ivaldi F,
differentially to cladribine treatment Boschert U, Visconti
in vitro depending on their activation A, de Rosbo NK,
status. Role of deoxycytidine kinase Uccelli A
P1353
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
Studying the effect of cladribine on Eixarch H, Calvo-
microglia survival, proliferation, Barreiro L, Fissolo
activation and cytokine release N, Boschert U,
Comabella M,
Montalban X, Espejo
C
P610
Session Title: Poster Session 1
Session Date: 09.11.2019
Presenting Time: 5:15-7:15 PM
--- ---
Effects of 2-chlorodeoxyadenosine Aybar F, Perez MJ,
(Cladribine) on Microglial cells and Pasquini JM,
Astrocytes Correale J
P623
Session Title: Poster Session 1
Session Date: 09.11.2019
Presenting Time: 5:15-7:15 PM
--- ---
Understanding the mechanisms of action C. Rodríguez-Mogeda,
of Cladribine in innate immune cells S. Van der Pol, A.J.
in MS Van het Hof, HE. De
Vries
P984
Session Title: Poster Session 2
Session Date: 09.12.2019
Presenting Time: 5:15-7:15 PM
--- ---
Year 1 Performance of adveva(R), a Lyons M, Lott N,
Patient Support Programme for patients Morgan K
taking MAVENCLAD (cladribine tablets)
in UK
A-1026-0037-01914
ePoster
--- ---
Cladribine is not mutagenic to Järvinen E, Tienari
mitochondrial DNA and RNA in leukemic PJ, Battersby BJ
cell lines
P698
Session Title: Poster Session 1
Session Date: 09.11.2019
Presenting Time: 5:15-7:15 PM
--- ---
Cladribine modify functional properties Jørgensen LØ, Hyrlov
of murine microglia KH, Elkjær ML,
Pedersen AE,
Svenningsen AF,
Illes Z
A-1026-0031-01729
Session Title: Poster Session 2
Session Date: 09.12.2019
Presenting Time: 5:15-7:15 PM
--- ---
Safety data from the non- Penner, I-K,
interventional, prospective study Ziemssen T, Nolting
CLEVER (CLadribine Tablets - A, Hübschen M,
EValuation of thERapy satisfaction) Richter J, Schel E,
and CLADQoL (CLADribine Tablets - Wagner T, Mueller B,
evaluation of Quality of Life) Posevitz-Fejfar A
A-1026-0031-01026
Session Title: Poster Session 1
Session Date: 09.11.2019
Presenting Time: 5:15-7:15 PM
--- ---
Non-interventional, prospective study Ziemssen T, Grothe C,
CLEVER (CLadribine Tablets - Reifschneider G,
EValuation of thERapy satisfaction) Morgenbesser T,
Richter J, Schel E,
Wagner T, Müller B,
Posevitz-Fejfar A
A-1026-0031-01164
Session Title: Poster Session 1
Session Date: 09.11.2019
Presenting Time: 5:15-7:15 PM
--- ---
Non-interventional, prospective study Penner, I-K, Raji A,
CLADQoL (CLADribine Tablets - Pul R, Kallmann BA,
evaluation of Quality of Life) Richter J, Schel E,
Wagner T, Müller B,
Posevitz-Fejfar A
A-1026-0031-01120
ePoster
--- ---
Cladribine tablets versus other Bartosik-Psujek H,
disease-modifying oral treatments in Kaczy?ski ?, Górecka
multiple sclerosis (MS) in achieving M, Rolka M, Wójcik
no evidence of radiological and R, Kaczor M P, Zi?ba
clinical disease activity (NEDA) - P
network meta-analysis (NMA)
A-1026-0037-01912
Session Title: Poster Session 2
Session Date: 09.12.2019
Presenting Time: 5:15-7:15 PM
--- ---
Cladribine tablets: Observational Miravalle A A, Katz
evaluation of effectiveness, safety, J, Sloane J, Hayward
and patient reported outcomes in B, Walsh J S, Harlow
suboptimally controlled patients D E
previously taking injectable disease-
modifying drugs for relapsing forms of
multiple sclerosis (CLICK-MS)
A-1026-0033-01906
ePoster
--- ---
Risk reduction of EDSS progression in Thrower B, Fox E J,
patients with relapsing multiple Damian D, Lebson L,
sclerosis treated with cladribine Dangond F
tablets in the CLARITY study: post-
hoc analysis including patients who
went on to receive rescue therapy
A-1026-0031-01938
Session Title: Poster Session 1
Session Date: 09.11.2019
Presenting Time: 5:15-7:15 PM
--- ---
In depth analysis of B cells in Marsh-Wakefield F,
multiple sclerosis patients after Juillard P, Ashhurst
treatment with cladribine T, McGuire H, Byrne
SN, Hawke S, Grau GE
P1225
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM.
--- ---
FIMS Study: Exploration of Factors Bardsley B, Cinc E,
which Influence treatment decisions of Heriot E, Lazarus K-
patients with Multiple Sclerosis J, McMurtrie M,
Haynes J, Coleman E,
Macdonell R
P676
Session Title: Poster Session 1
Session Date: 09.11.2019
Presenting Time: 5:15-7:15 PM
--- ---
Markers of premature immunosenescence Clénet ML, Daigneault
in the peripheral blood of multiple A, Laurent C, Jamann
sclerosis subjects vs. healthy H, Mamane V,
controls Ouedraogo O, Carmena
Moratalla A,
Duquette P, Rousseau
MC, Arbour N and
Larochelle C
A-1026-0029-01320
Session Title: Poster Session 1
Session Date: 09.11.2019
Presenting Time: 5:15-7:15 PM
--- ---
MAVENCLAD(R) (cladribine) tablets Late-Breaker Presentation
---
Cladribine decreases CD95 expressing Kap Y, Boschert U,
CD4+ and CD8+ cells in lymphoid organs t'Hart B
in naïve marmosets (Callithrix
jacchus)
A-1026-0000-02694
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
Rebif(R) (interferon beta-1a) Presentations
---
Effect of Interferon -1a Treatment on Kuhle J, Leppert D,
Serum Neurofilament Light Chain Levels Comi G, De Stefano
in Patients with a First Clinical N, Kappos L,
Demyelinating Event in the REFLEX Freedman MS, Roy S,
trial Issard D
A-1026-0035-00622
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
Pharmacodynamic biomarkers of Freedman MS, Wojcik
interferon -1a: Assessment in J, D'Antonio M,
patients receiving long-term Hyvert Y, Stinchi S,
treatment with subcutaneous interferon D'Urso V, Dangond F
-1a in REFLEX and REFLEXION
A-1026-0033-00634
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
Efficacy of subcutaneous interferon Freedman MS, Kappos
-1a in patients with a first clinical L, Comi G, De
demyelinating event: the REbif Stefano N, Roy S,
FLEXible dosing in early multiple Issard D
sclerosis (REFLEX) study - outcomes in
patients stratified by the 2017
McDonald criteria
A-1026-0031-00626
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
Post-hoc Analysis to Evaluate the Freedman MS, Brod S,
Effects of Subcutaneous Interferon - Wray S, Singer B,
1a in Subgroups of Patients from the Dangond F, Issard D,
PRISMS Study with Early Onset vs Late Harlow D, Jack D
Onset Disease
A-1026-0031-00628
ePoster
--- ---
Assessing the duration of EDSS Signori A, Bovis F,
improvement after a therapy start: a Carmisciano L,
new statistical approach applied to Alexandri N, Sormani
the long term extension of the PRISMS M P
study
A-1026-0035-00443
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
Effectiveness of subcutaneous Rollot F, Foch C,
interferon beta-1a 22/44 g versus Laplaud D, Boutmy E,
teriflunomide in newly treated Marhardt K, Sabido S
patients with multiple sclerosis. A
study in a French nationwide cohort of
Multiple Sclerosis: Observatoire
Francais de la sclérose en plaques
(OFSEP)
A-1026-0034-00636
Session Title: Poster Session 2
Session Date: 09.12.2019
Presenting Time: 5:15-7:15 PM
--- ---
Prevalence of infant outcomes at birth Vattulainen P,
after exposure to interferon beta Burkill S,
prior to or during pregnancy: A Geissbuehler Y,
register-based cohort study in Sabidó M, Popescu C,
Finland and Sweden among women with MS Adamo A, Myhr K-M,
Montgomery S,
Korhonen P, the
European Interferon
Beta Pregnancy Study
Group and the Nordic
MS Pregnancy &
Interferon Beta
study group
A-1026-0009-01725
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
Systematic mapping of the global Bharadia T,
educational offerings for multiple Kesselring J, Boyko
sclerosis patients on the topic of A, Sumelahti M-L on
disease progression behalf of the MS in
the 21st Century
initiative, and
Alexandri N
A-1026-0005-01837
Session Title: Poster Session 2
Session Date: 09.12.2019
Presenting Time: 5:15-7:15 PM
--- ---
Family planning decisions in people Lavorgna L, Worton H,
with multiple sclerosis S Russell, Jack D
A-1026-0009-00639
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
Evobrutinib (Bruton's Tyrosine Kinase Inhibitor) Presentations
---
Bruton's tyrosine kinase (BTK) Aigrot M S, Martin E,
inhibition promotes myelin repair in Grenningloh R,
two different models of demyelination Stankoff B, Lubetzki
C, Boschert U, Zalc
B
A-1026-0025-01553
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
Inhibition of Bruton's Tyrosine Kinase Torke S, Häusler D,
Selectively Prevents Antigen- Grenningloh R,
Activation of B cells and Ameliorates Boschert U, Brück W
B cell-Mediated Experimental and Weber M S
Autoimmune Encephalomyelitis
A-1026-0031-01785
Session Title: Poster Session 2
Session Date: 09.12.2019
Presenting Time: 5:15-7:15 PM
--- ---
Effect of evobrutinib, a Bruton's Montalban X, Shaw J,
tyrosine kinase inhibitor, on immune Syed S, Dangond F,
cell and immunoglobulin levels over 48 Martin E C,
weeks in a phase 2 study in relapsing Grenningloh R, Weber
multiple sclerosis MS, on behalf of the
Evobrutinib Phase 2
Study Group
A-1026-0031-01645
Session Title: Poster Session 3
Session Date: 09.13.2019
Presenting Time: 12:15-2:15 PM
--- ---
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 over 60 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.
-- 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.
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. The efficacy and safety of Rebif in controlled clinical trials beyond 2-years has not been established.
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.
There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Please see the full Prescribing Information for additional information: http://www.emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version=
About Evobrutinib
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). 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 1,300 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com
Your Contact
alice.mcgrail@emdserono.com
Phone: +1 781 738 8791
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