DARMSTADT, Germany -
Four-year data show nearly 9 in 10 RMS patients remained free from progression independent of relapse activity (PIRA)
Results highlight the potential of MAVENCLAD to reduce neurodegeneration and neuroinflammation beyond established clinical efficacy outcomes in RMS
Evidence suggests that MAVENCLAD effectiveness could be driven by peripheral and central effects without requiring continuous immunosuppression
(BUSINESS WIRE)--Not intended for UK-, US- or Canada-based media
Merck, a leading science and technology company, today announced the presentation of over 30 abstracts from its multiple sclerosis (MS) portfolio. New four-year data from two large Phase 4 studies highlight the long-term efficacy, favorable disability outcomes and durable impact of MAVENCLAD® (cladribine tablets) in people living with relapsing multiple sclerosis (RMS). These findings are to be presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held September 24-26 in Barcelona.
“As the only high-efficacy short-course oral treatment, MAVENCLAD has demonstrated sustained benefits across a variety of outcomes—extending beyond relapses and MRI—without requiring continuous immunosuppression,” said Alex Kulla, Senior Vice President & Global Head of the Neurology & Immunology Medical Unit for the Healthcare business of Merck. “With over two decades of clinical experience and substantial real-world data, MAVENCLAD has been utilized to treat more than 130,000 individuals, amounting to over 360,000 patient-years of exposure. The comprehensive data presented at ECTRIMS 2025 reinforces its role in delivering durable, effective care for individuals with RMS—supporting them from early diagnosis through later stages of life.”
Key MAVENCLAD data:
An integrated analysis of four-year data from CLARIFY-MS (n=482) and MAGNIFY-MS (n=270), including their extension studies, showed low rates of disability accumulation and progression independent of relapse activity (PIRA) in patients treated with MAVENCLAD, especially those who initiated treatment in the early stages of their disease.
At Year 4, 83.4% of patients were free from confirmed disability progression (CDP) and 89.2% were free from PIRA.
15.4% experienced confirmed disability improvement (CDI).
Patients aged ≤40 experienced lower rates of PIRA compared to those over 40 (7.6% vs. 15.4%, respectively).
The analysis demonstrated that MAVENCLAD provided durable efficacy after short-course treatment, with long-term control over both inflammatory and non-inflammatory components of MS-related disability.
Data from MAGNIFY-MS showed MAVENCLAD reduced serum and cerebrospinal fluid (CSF) biomarkers of neuroinflammation, suggesting a broader central nervous system (CNS) benefit.
At Year 2, reductions were observed in key biomarkers, including serum glial fibrillary acidic protein (GFAP), immunoglobulin G (IgG) index, and C-X-C motif chemokine ligand 13 (CXCL-13) levels.
Brain imaging data from MAGNIFY-MS indicated that the brain atrophy rate in MAVENCLAD-treated patients was comparable to that observed in the healthy population, reinforcing the importance of brain volume (BV) preservation as a therapeutic goal in MS.
From Years 2 to 4, annualized percent BV change remained below 0.4%, across all subgroups.
Patients with low brain atrophy rates at Year 4 had markedly lower annualized relapse rate (ARR) (0.04 ±0.12 vs. 0.16 ±0.26) and less clinical deterioration compared to those with annualized percentage BV change exceeding -0.4%.
Additional MAVENCLAD presentations:
Poster Presentation Title: Treatment Continuation With Cladribine Tablets Beyond Year 4: Analysis of Longitudinal Prescription Data From Germany
Lead Author: David Kormann, Real World Data Analytics, IQVIA Commercial GmbH & Co. OHG, Frankfurt, Germany
Poster Presentation Title: Treatment continuation with cladribine tablets (CladT) beyond year 4– second interim analysis of the CLIP-5 study
Lead Author: Catharina Korsukewitz, University Hospital Muenster, Muenster, Germany
Poster Presentation Title: Incidence Rate of Malignancies in People with Multiple Sclerosis Newly Initiating Cladribine Tablets or Fingolimod: Second Interim Results from CLARION
Lead Author: Anna Glaser, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Poster Presentation Title: Clinical Outcomes of Cladribine Tablets in Aging (≥50 years) Patients with Relapsing Multiple Sclerosis in a Real-World Setting: Insights From the ‘Aging’ Study
Lead Author: Joshua Katz, Elliot Lewis Center for Multiple Sclerosis Care, Wellesley, MA, United States
Below is the full list of MAVENCLAD abstracts accepted for presentation at ECTRIMS 2025:
The Effect of Cladribine Tablets on Brain Volume over 4 Years in the MAGNIFY-MS Extension Study
Barkhof F, Schmierer K, Vermersch P, et al.
Poster: P687
Session: Poster Session 2
Date: September 25, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Barkhof F
Impact of Cladribine Tablets on GFAP Levels and Intrathecal Biomarkers in RMS: Results from the MAGNIFY-MS Study
Wiendl H, Derfuss T, Sponton L, et al.
Poster: P1694
Session: ePoster
Date: September 24-26, 2025
Presenter: Wiendl H
Long-Term Effect of Cladribine Tablets on Disability Progression and Improvement: Insights from Pooled Analyses of CLARIFY-MS and MAGNIFY-MS Studies
Vermersch P, Wiendl H, Leocani L, et al.
Poster: P335
Session: Poster Session 1
Date: September 24, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Vermersch P
Cladribine Tablets Show Low 4-Year PIRA Rates in MS: Insights from Pooled Analyses of CLARIFY-MS and MAGNIFY-MS Studies
Montalban X, De Stefano N, Hodgkinson S, et al.
Poster: P1707
Session: ePoster
Date: September 24-26, 2025
Presenter: Montalban X
Comparing Changes in Brain Tissue Damage Between the Two-year Active Dosing Treatment Period and the Following Two Years Extension Period in Cladribine-treated MS Patients Stratified by MRI Phenotypes
De Stefano N, Sforazzini F, Luchetti L, et al.
Poster: P208
Session: Poster Session 1
Date: September 24, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: De Stefano N
Cladribine Tablets-treated Multiple Sclerosis Patients Show Different Spatio-temporal Patterns of Acute, Chronic and Resolving Brain Inflammatory Activity
Gentile G, Smyk A, Ben-Amor A-F, et al.
Poster: P1450
Session: ePoster
Date: September 24-26, 2025
Presenter: Gentile G
Using Deep Learning on Baseline MRI Data for Highly Accurate Prediction of Cladribine Tablets-treated MS Patients who Improve Physical and Cognitive Disability in 4 Years
Battaglini M, Sforazzini F, Luchetti L, et al.
Poster: P672
Session: Poster Session 2
Date: September 25, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Battaglini M
Incidence Rate of Malignancies in People with Multiple Sclerosis Newly Initiating Cladribine Tablets or Fingolimod: Second Interim Results from CLARION
Glaser A, Ziemssen T, Butzkueven H, et al.
Poster: P856
Session: Poster Session 2
Date: September 25, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Glaser A
Real-world Experience with Cladribine (Mavenclad) in the MSBase Registry 2025
Spelman T, van der Walt A, Ozakbas S, et al.
Poster: P875
Session: Poster Session 2
Date: September 25, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Butzkueven H
Treatment Continuation With Cladribine Tablets Beyond Year 4: Analysis of Longitudinal Prescription Data From Germany
Kormann D, Parekh M, von der Maßen K, et al.
Poster: P1773
Session: ePoster
Date: September 24-26, 2025
Presenter: Kormann D
Real-world Experience with Cladribine Tablets in Older Age Groups in the MSBase Registry
Spelman T, van der Walt A, Havrdova E, et al.
Poster: P1985
Session: ePoster
Date: September 24-26, 2025
Presenter: Butzkueven H
Cladribine Tablets Reduce Pathological Brain Ageing Gap in MS Patients
Leoncini M, Battaglini M, Sforazzini F, et al.
Poster: P432
Session: Poster Session 1
Date: September 24, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Leoncini M
Clinical Outcomes of Cladribine Tablets in Aging (≥50 years) Patients with Relapsing Multiple Sclerosis in a Real-World Setting: Insights From the ‘Aging’ Study
Katz J, Hughes B, Gutierrez A, et al.
Poster: P332
Session: Poster Session 1
Date: September 24, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Katz J
Relationship Between CSF Cellular Populations and MRI Biomarkers of MS Disease Severity: Insights from the CLOCK-MS Study
Samara A, Judge B, Salter A, et al.
Poster: P1471
Session: ePoster
Date: September 24-26, 2025
Presenter: Brier MR
Three-Year Effectiveness and Safety Data for Cladribine Tablets in Patients with Relapsing Multiple Sclerosis after Transitioning from Natalizumab (CLADRINA Study)
Sguigna P, Okai A, Kaplan J, et al.
Poster: P1947
Session: ePoster
Date: September 24-26, 2025
Presenter: Sguigna P
Treatment Continuation with Cladribine Tablets (CladT) Beyond Year 4– Second Interim Analysis of the CLIP-5 Study
Korsukewitz C, Richter N, Klehmet J, et al.
Poster: P1803
Session: ePoster
Date: September 24-26, 2025
Presenter: Korsukewitz C
Long-term Effects of Treatment with Cladribine Tablets on Cognition and Treatment Satisfaction in People with Relapsing Multiple Sclerosis: 4‑year Results from the Noninterventional CLADQoL Study
Penner I-K, Chudecka A, Refik P, et al.
Poster: P1820
Session: ePoster
Date: September 24-26, 2025
Presenter: Penner I-K
48 Month Follow-up of Maven4: a Phase IV Non-interventional, Prospective, Spanish Multicenter Study to Assess the Long Term Effectiveness of Cladribine Tablets in Real-world Clinical Practice
Aladro-Benito Y, Costa-Frossard L, Sánchez Magro MI, et al.
Poster: P346
Session: Poster Session 1
Date: September 24, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Aladro-Benito Y
Design and Baseline Characteristics of the Real-world MAVENAGE Study in Relapsing MS Patients Older and Younger Than 50 Years Treated with Cladribine Tablets
Meca-Lallana JE, Eichau S, Oreja-Guevara C, Meca V, et al.
Poster: P1649
Session: ePoster
Date: September 24-26, 2025
Presenter: Meca-Lallana JE
Retrospective Analysis of Multiple Sclerosis Patients Who Initiated Oral Cladribine 5-8 Years Ago – Data from a German Cladribine Cohort
Woitschach L, Cepek L, Kowarik M, et al.
Poster: P357
Session: Poster Session 1
Date: September 24, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Ernst M
Clinical Effectiveness of Cladribine Tablets for PwMS Switching from Natalizumab, AntiCD20 Treatment or “Other”; Data from the Swedish Post-market Surveillance Study “Immunomodulation and Multiple Sclerosis Epidemiology 10” (IMSE 10)
Forsberg L, Larsson V, Hillert J, et al.
Poster: P1762
Session: ePoster
Date: September 24-26, 2025
Presenter: Forsberg L
Clinical Effectiveness and Safety of Cladribine Tablets for PwMS Treated at Least 36 Months in the Swedish Post-market Surveillance Study “Immunomodulation and Multiple Sclerosis Epidemiology 10” (IMSE 10)
Forsberg L, Larsson V, Hillert J, et al.
Poster: P344
Session: Poster Session 1
Date: September 24, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Forsberg L
Clinical Effectiveness of Cladribine Tablets for Patients Below or Above 50 Years of Age at Treatment Start in the Swedish Post-market Surveillance Study "Immunomodulation and Multiple Sclerosis Epidemiology 10" (IMSE 10)
Larsson V, Forsberg L, Hillert J, et al.
Poster: P861
Session: Poster Session 2
Date: September 25, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Larsson V
CLADCOMS - CLADribine Tablets Long-term Control of MS – a Post-Marketing Investigator Driven Study
Larsson V, Forsberg L, Nilsson P, et al.
Poster: P865
Session: Poster Session 2
Date: September 25, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Larsson V
Clinical Effectiveness of Cladribine Tablets for Patients with Few vs Many Treatments Prior CladT Initiation in the CLADCOMS Study -CLADribine Tablets Long-term Control Of MS – a Post-marketing Investigator Driven Study
Larsson V, Forsberg L, Nilsson P, et al.
Poster: P1804
Session: ePoster
Date: September 24-26, 2025
Presenter: Larsson V
Recurrent Effects on the Clonal Composition of Peripheral B Cells in MS Patients During the Second Year of Cladribine Treatment
Tieck MP, Vasilenko N, Stadelmaier J, et al.
Poster: P813
Session: Poster Session 2
Date: September 25, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Tieck MP
Preliminary Data of Paramagnetic Rim Lesion Dynamic at 7 Tesla Magnetic Resonance Imaging in Cladribine Tablets-Treated People with Multiple Sclerosis
Dal-Bianco A, Hametner S, Grabner G, et al.
Poster: P216
Session: Poster Session 1
Date: September 24, 2025
Time: 07:30-09:30 am PDT/10:30 am-12:30 pm EDT
Presenter: Dal-Bianco A
Baseline and Early Safety Data Following Full Recruitment of ChariotMS, the First DMT trial for People with Advanced MS (EDSS 6.5-8.5)
Schmierer K, Mattoscio M, De Angelis F, et al.
Poster: P1633
Session: ePoster
Date: September 24-26, 2025
Presenter: Schmierer K
Breaking Inflammatory Cycles: Cladribine Targets Pathogenic B Cell Subsets in Multiple Sclerosis
Pirronello M, Picozza M, Corbisiero S, et al.
Poster: P1374
Session: ePoster
Date: September 24-26, 2025
Presenter: Battistini L
Circulating MicroRNAs as Potential Biomarkers for Treatment Response in Cladribine-Treated Multiple Sclerosis Patients
Vigiser I, Zeevi Y, Piura Y, Kolb H, Golan M, Karni A, Regev K
Poster: P762
Session: ePoster
Date: September 24-26, 2025
Presenter: Vigiser I
Integrin β1 Demarks Circulating Precursors of Brain-residing Antibody-secreting Cells in People with MS
Kuiper K, Bogers L, Rip J, et al.
Oral presentation: O123
Session: Scientific Session 14: Antibody-mediated pathology
Date: September 26, 2025
Time: 12:26-12:33 am PDT/03:26-03:33 am EDT
Presenter: Smolders J
Early Lymphocyte Reduction as a Potential Marker of Cladribine Efficacy
Celius E, et al.
Poster: P2028
Session: ePoster
Date: September 24-26, 2025
Presenter: Celius E
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.
More than 130,000 patients have been treated with MAVENCLAD since its launch in 2019. MAVENCLAD has been approved in over 80 countries, including the European Union (EU), Canada, Australia and Switzerland, for various relapsing MS indications. Visit www.MAVENCLAD.com for more information.
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 2.9 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.
Merck in Neurology and Immunology
Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company’s current MS portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine tablets). Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck’s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE) and generalized myasthenia gravis (gMG).
About Merck
Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck generated sales of € 21.2 billion in 65 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.
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