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Merck KGaA, Darmstadt, Germany Showcases Depth of MS Portfolio at ECTRIMS Supporting Commitment to Advancing MS Care

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Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced it will present 39 abstracts at the 38thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held October 26-28, 2022 in Amsterdam, the Netherlands.

The breadth of data highlights the Company’s scientific leadership in multiple sclerosis (MS) and includes a presentation on a clinical trial with long-term data on Expanded Disability Status Scale (EDSS) scores in people with relapsing MS (RMS) treated with evobrutinib, an investigational agent, as well as new data demonstrating MAVENCLAD® (cladribine) tablets improved Quality of Life (QoL) in people with highly active RMS over two years. Additionally, a two-year follow-up study showed the onset of action on the reduction of MRI lesions with MAVENCLAD being maintained from Month 2 through two years.

“Multiple sclerosis has a profound impact on quality of life and improving this through therapy is often the most important outcome for people living with MS,” said Gavin Giovannoni, Professor of Neurology, Queen Mary University of London. “The data presented at ECTRIMS further substantiate the therapeutic benefit of MAVENCLAD by improving Quality of Life measures over two years, combined with new evidence that the early effect on MRI lesions is maintained over that period.”

In the final analysis of the open-label, single-arm, multicenter, Phase IV CLARIFY-MS study, statistically significant (p≤0.0001) improvements from baseline were observed for Multiple Sclerosis Quality of Life-54 (MSQoL-54) physical and mental health composite scores (mean changes of 4.86 and 4.80, respectively; p<0.0001). Changes in MSQoL-54 composite scores were consistent across treatment naïve and prior disease-modifying treatment (DMT) subgroups. Annualized relapse rate was 0.13 in all patients (0.08 in patients who had not received DMT prior to receiving MAVENCLAD) and median EDSS was unchanged over two years. No new safety concerns emerged.

Also to be presented are new MRI outcomes data from the Phase IV MAGNIFY-MS study, which demonstrated an onset of action from Month 2 with sustained reduction in MRI lesion counts maintained out to two years in people with highly active RMS treated with MAVENCLAD. The proportion of lesion-free patients increased from 47% at baseline to 86.2% at the end of the study (Month 18–24). In the study, MRI lesions at baseline were compared over multiple time periods, from initial screening to Month 24. Over the two years, the benefit:risk profile of MAVENCLAD remained unchanged and in line with observations made during the clinical trial program.

Additionally, updated post-approval safety data will be presented based on an analysis of 56,300 patients who received MAVENCLAD post-approval, representing 95,664 patient-years of experience, as of July 2022. The study found the safety profile of MAVENCLAD is consistent with findings from the clinical development program and the CLARIFY-MS and MAGNIFY-MS studies.

“The breadth of our data at ECTRIMS exemplifies our commitment to pushing forward scientific innovation with the development of evobrutinib, while generating new, meaningful data to demonstrate the safety profile and effectiveness of MAVENCLAD,” said Jan Klatt, Senior Vice President, Head of Development Unit Neurology & Immunology, Merck KGaA, Darmstadt, Germany. “Our goal is to ensure people living with MS, and those who treat them, have the information they need to manage their MS today and in the future.”

Beyond the MAVENCLAD and evobrutinib data presented, Merck KGaA, Darmstadt, Germany will have several Company events, along with additional data from its MS portfolio at ECTRIMS 2022.

Company activities at ECTRIMS 2022:

  • “Connecting the dots: immune cells and CNS inflammation” co-chaired by Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Blizard Institute, Barts and the London School of Medicine and Dentistry, UK, and Celia Oreja-Guevara, MD, PhD, Hospital Clínico San Carlos, Madrid, Spain (October 26, 2022, 13:15-14:15 CEST)
  • “New tools for new challenges in multiple sclerosis” chaired by Stephen Krieger, MD, Mount Sinai Hospital, New York, NY, USA (October 28, 2022, 14:15-15:15 CEST)
  • Product Theater: Early Experience with MAVENCLAD by Ravi Dukkipati, MD, WellSpan Neurology, York, PA, USA

Below is the full list of Merck KGaA, Darmstadt, Germany-related abstracts accepted for presentation at ECTRIMS 2022:

Abstract Name Authors ID Presentation Details
MAVENCLAD Poster Presentations
Improvements in Quality of Life Over 2 Years in Patients Treated With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: Final Analysis of CLARIFY-MS

 

Solari A, Montalban X, Lechner-Scott J, Piehl F, Brochet B, Langdon D, Hupperts R, Selmaj K, Havrdova EK, Patti F, Brieva L, Maida EM, Alexandri N, Smyk A, Nolting A, Keller B, on behalf of the CLARIFY Investigators P108 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Jeannette Lechner-Scott

Early Onset of Action and Sustained Efficacy of MRI Outcomes during Cladribine Tablets Treatment in Highly Active Relapsing Multiple Sclerosis: Results of the 2-year MAGNIFY-MS Study

 

De Stefano N, Achiron A, Barkhof F, Chan A, Derfuss T, Hodgkinson S, Leocani L, Montalban X, Prat A, Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Smyk A, Gardner L P717 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Nicola De Stefano

Updated Post-Approval Safety of Cladribine Tablets in the Treatment of Multiple Sclerosis, With Particular Reference to Liver Safety Giovannoni G, Leist T, Jack D, Galazka A, Nolting A

 

P341 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Gavin Giovannoni

High Adherence and Minimal Delays of Year 2 Treatment in People with Multiple Sclerosis Treated with Cladribine Tablets: Results from Multi-Country Patient Support Programmes Oh J, Ayer M, Alroughani R, Lemieux C, Morgan K, D’Eramo M, Vella T, Boshra A, de Souza S, Verdun di Cantogno E, Sabidó M P727 Session: 2

Date: October 27, 2022

Time: 17:00 CEST

Presenter: Jiwon Oh

Treatment Emergent Adverse Events Experienced Early and Transiently in the Treatment Course with Cladribine Tablets: Data from the CLEVER Real-World Study Ziemssen T, Posevitz-Fejfar, Wagner T, Übler S, Richter J, Müller B, Penner I-K P772 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Talf Ziemssen

Maven4: Phase IV Non-Interventional, Prospective, Spanish Multicenter Study to Evaluate Cladribine Tablets Long Term Effectiveness on Real-World Clinical Practice Saiz A, Aladro Benito Y, Costa-Frossard F, Sánchez Magro I, Rodríguez Antigüedad A

 

P774 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Albert Saiz

Cladribine Protects SH-SY5Y Neuron-Like Cells from Oxidative Stress Conditions In Vitro

 

Eixarch H, Calvo-Barreiro L, Fissolo N, Boschert U, Comabella M, Montalban X, Espejo C P784 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Herena Eixarch

Real-World Use of Cladribine Tablets (Completion Rates and Treatment Persistence) in Patients With Multiple Sclerosis in England: The CLARENCE Study Brownlee W, Amin A, Herbert A, Ashton L

 

P762 Session: 2

Date: October 27, 2022

Time: 17:00 CEST

Presenter: Wallace Brownlee

Decision-making Factors in Patient Choice to Initiate Treatment with Cladribine: A Preliminary Baseline Analysis From the STATURE Study Allan M, Grech L, Cartwright A, Harding J, Mardan J, O’Maley J, Savickas S, Sharma M, Murambiwa P, Stockle P, Bardsley B, Butler E P304 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Michelle Allan

Assessment of Treatment Satisfaction Across Oral DMTs for Multiple Sclerosis: a Preliminary Baseline Analysis from the STATURE Study. Grech L, Allan M, Cartwright A, Harding J, Mardan J, O’Maley T, Savickas S, Sharma M, Murambiwa P, Stockle P, Bardsley B, Butler E EP1086 Session: ePoster

Date: October 26-28, 2022

 

A Real-World Study of Four-Year Follow Up Study of Patients Treated with Oral Cladribine From 2018-2022 O’Neill DTD, Sharma M, Dong G, Hodgkinson SJ EP1132 Session: ePoster

Date: October 26-28, 2022

 

A Study of Activated and Naïve T Regs and B Cell Subsets For 30 Months After the Use of Cladribine Hodgkinson SJ, O’Neill DTD, Sharma M, Dong G, Verma ND, Al-atiyah R, Hall BM P704 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Suzanna Hodgkinson

CLADCOMS – CLADribine Tablets Long-Term Control of MS – a Post-Marketing Investigator Driven Study Fink K, Nilsson P, Alonso L, Sveningsson A, Gunnarsson M, Lange N, Ayad A, Vrethem M, Burman J, Lycke J, Piehl F EP1060 Session: ePoster

Date: October 26-28, 2022

 

Clinical Effectiveness and Safety of Cladribine Tablets for Patients Treated at least 12 Months in the Swedish Post-Market Surveillance Study “Immunomodulation and Multiple Sclerosis Epidemiology 10” (IMSE 10) Rosengren V, Ekström E, Forsberg L, Hillert J, Nilsson P, Dahle C, Svenningsson A, Lycke J, Landtblom A-M, Burman J, Martin C, Sundström, Gunnarsson M, Piehl F, Olsson T P728 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Linda Forsberg

SARS-CoV2 Exposure Rates and Serological Response of People Living With MS Longinetti E, Asplund K, Kockum I, Englund S, Burman J, Fink K, Fogdell-Hahn A, Gunnarsson M, Hillert J, Langer-Gould A, Lycke J, Nilsson P, Salzer J, Svenningsson A, Mellergård J, Frisell T, Olsson T, Piehl F P558 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Elisa Longinetti

COVID-19 Humoral and T-cell Mediated Vaccination Responses in People with Multiple Sclerosis Vickaryous N, Rios F, Schalk L, Asardag AN, George K, Kang A, Baker D, Giovannoni G, Dobson R P781 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Nikki Vickaryous

Differences Between Clinical Trials and “Real-World” Use of Disease Modifying Therapies: Insights from the UK OPTIMISE:MS Pharmacovigilance Study Dobson R, Matthews P, Miller A, Pindoria J, Waddingham E P763 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Ruth Dobson

Cladribine Treatment Exerts Specific Effects on Memory B Cell Immunoglobulin Repertoires in Multiple Sclerosis Patients Ruschil C, Gabernet G, Kemmerer CL, Ziemann U, Nahnsen S, Kowarik MC EP1115 Session: ePoster

Date: October 26-28, 2022

Presenter: Christoph Ruschil

Cladribine Effects on T and B Cell Subsets and T Cell Reactivity in Multiple Sclerosis

 

Hansen RH, von Essen MR, Mahler MR, Cobanovic S, Binko TS, Sellebjerg F P697 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Rikke Holm Hansen

Safety and Efficacy of Cladribine Therapy Following a Treatment with Anti-CD20 Compounds in Relapsing Multiple Sclerosis Patients: A Pilot Study Sacco R, Disanto G, Pravatà E, Gobbi C, Zecca C

 

EP1068 Session: ePoster

Date: October 26-28, 2022

 

Evobrutinib Poster Presentations
Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, Maintains Lowered Serum Neurofilament Light Chain Levels Over 2.5 Years of Treatment, in Patients With Relapsing Multiple Sclerosis Kuhle J, Kappos L, Montalban X, Benkert P, Li Y, Thangavelu K, Hyvert Y, Tomic D

 

EP1021 Session: ePoster

Date: October 26-28, 2022

Presenter: Jens Kuhle

 

MRI and Clinical Outcomes of Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, in Relapsing Multiple Sclerosis Over 2.5 Years of the Open-label Extension to a Phase II Trial Vermersch P, Arnold D, Wolinsky JS, Havrdova E, Kinkolykh A, Hyvert Y, Tomic D, Montalban X

 

P731 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Patrick Vermersch

Evobrutinib Exert a Therapeutic Action on EAE by Increasing the Peripheral and Central Classical Dendritic Cell Number and Maturation

 

Serrano-Regal MP, Calahorra L, Alonso-García I, Grenningloh R, Boschert U, Haselmayer P, Ortega MC, Machín-Díaz I, Camacho-Toledano C, García-Arocha J, Clemente D P307 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Mari Paz Serrano-Regal

Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, Acts on Microglia: Implications in the Treatment of Progressive Mechanisms in Multiple Sclerosis Geladaris A, Torke S, Grenningloh R, Boschert U, Brück W, Weber MS

 

P693 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Anastasia Geladaris

B cells infiltrating the MS brain: from local maturation to targeting by evobrutinib

 

Bogers L, van Langelaar J, Rijvers L, Engelenburg HJ, Melief M-J, Wierenga-Wolf AF, Rip J, Blok KM, de Vries HE, Hendriks RW, Boschert U, Smolders J, van Luijn MM P147 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Laurens Bogers

Immune response following mRNA COVID-19 vaccination in patients with multiple sclerosis treated with the Bruton’s tyrosine kinase inhibitor evobrutinib Bar-Or A, Cross AH, Cunningham A, Hyvert Y, Seitzinger A, Drouin EE, Alexandri N, Tomic D, Montalban X P1188 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Amit Bar-Or

Rebif® (interferon beta-1a) Subcutaneous Injection Poster Presentations
Exploring the Relationship Between Serum GDF-15 and Disease Stability in Patients with a First Clinical Demyelinating Event Treated with Subcutaneous Interferon β-1a or Placebo in the REFLEX Study Coray M, Freedman MS, Barkhof F, Comi G, De Stefano N, Kappos L, Enz L, Seitzinger A, Jack D, Kuhle J, Mehling M EP1027 Session: ePoster

Date: October 26-28, 2022

Presenter: Mali Coray

 

Evolution of the RebiSmart® Autoinjector Device in Support of Adherence to Subcutaneous Interferon Beta-1a Therapy for Relapsing Multiple Sclerosis Arnaud L, Keiser M, Henninger E, Piras F, Seitzinger A, Jack D, Le Masne Q

 

EP1079 Session: ePoster

Date: October 26-28, 2022

Presenter: Dominic Jack

Validation of a Semi-Automated Method to Quantify Lesion Volume Changes in Multiple Sclerosis on 2D Proton Density- Weighted Images Using Subtraction Imaging Mattiesing RM, Stel S, Mangroe AS,  Brouwer I, Versteeg A, van Schijndel RA, Uitdehaag BMJ, Barkhof F, Vrenken H P634 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter:Rozemarijn M Mattiesing

Expression of peripheral blood IFN-inducible genes predicts treatment outcome in patients with secondary progressive multiple sclerosis treated with IFN-beta-1a Gurevich M, Zilkha-Falb R, Menascu S, Magalashvili D, Dolev M, Sonis P, Mandel M, Achiron A

 

P353 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Michael Gurevich


Non-Product Specific Poster Presentations
DISCOntinuation of disease-modifying therapies in MS (DISCOMS) Extension – Study Design and Baseline Demographics to Date Engebretson E, Cutter G, Fox R, Kister I, Miller A, Morgan C, Seale R, Corboy JR

 

EP1089 Session: ePoster

Date: October 26-28, 2022

 

Expert Opinion on the Use of Contraception in People with Multiple Sclerosis

 

Hillert J, Bove R, Haddad L, Hellwig K, Houtchens M, Magyari M, Mercki G, Montgomery S, Nappi R, Stenager E, Thompson H, Tulek Z, Verdun di Cantogno E, Simoni M P080 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Jan Hillert

Single-Cell RNA Sequencing of Peripheral CD8+ T Cells of MS-Discordant Monozygotic Twins Reveals Disease-Associated Alterations In Immune Signaling Kavaka V, Mutschler L, Eglseer K, Flierl-Hecht A, Kümpfel T, Hohlfeld R, Kerschensteiner M, Gerdes L.A, Beltran E P159 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Vladyslav Kavaka

Caregiver Burden and Associated Factors Among Caregivers of

Persons with Multiple Sclerosis: Application of a Specific Instrument

Vanotti S, Roman MS, Ferrandina F, Bauer J, Rosa R, Casas Parera I, Saladino ML, Caceres F

 

EP0864 Session: ePoster

Date: October 26-28, 2022

Presenter: Sandra Vannoti

Evolutionarily Conserved Signatures of Microglia in Health and Disease Salinas V, Manouchehri N, Hussain R, Stuve O

 

P131 Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Victor Salinas

Peripheral Blood Immune Markers Associated With Immunosenescence in Multiple Sclerosis and Healthy Controls

 

Carpentier Solorio Y, Daigneault A, Tastet O, Clénet M-L, Farzam-kia N, Levert A, Da Cal S, Clément W, Jamann H, Laurent C, Mamane VH, Ouedraogo O, Moratalla AC, Balthazard R, Lahav B, Prat A, Girard J-M, Duquette P, Rousseau M-C, Arbour N, Larochelle C P545 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter:Catherine Larochelle

Chemerin Correlates with MS Progression Parameters and Affects Intracellular Metabolism in Human Microglia and Macrophages

 

Loonstra FC, van der Pol SM, Falize KF, van Heertum T, de Ruiter LR, Schoonheim MM, Killestein J, Uitdehaag BMJ, Kooij G, de Vries HE, Rijnsburger M P551 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Merel Rijnsburger

Amyloid and some tau Proteinopathy are Observed in a Subset of Individuals with Multiple Sclerosis Taga M, Duquesne L, Lee A, Sigalov A, Peralta Cruz F, De Jager P P1204 Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

 

Non-Product Specific Oral Presentations
Biological Roles of Myeloid Cell Subsets During CNS Inflammation Manouchehri N, Victor, Hussain RZ, Stuve O O124 Session: Young Scientific Investigators’ Session 3: Long-term outcomes and safety

Date: October 27, 2022

Time: 15:00- 16:00 CEST

Presenter: Navid Manouchehri

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