Mavenclad (cladribine) / EMD Serono - LARVOL DELTA

Summary of Research: Blood Biomarker Dynamics in People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Results of the 2-Year MAGNIFY-MS Study. (PubMed, Neurol Ther) - "The safety profile was consistent with previous studies. These findings provide evidence of CladT rebalancing the immune system towards a more homeostatic and less pathogenic state."

Biomarker • Journal • CNS Disorders • Multiple Sclerosis • NEFL

Critical role of persistence and adherence in multiple sclerosis treatment: the value of cladribine. (PubMed, Eur J Hosp Pharm) - No abstract available

Journal • CNS Disorders • Multiple Sclerosis

Cladribine effects on emotional awareness and reasoning: The CLEAR study. (PubMed, Mult Scler Relat Disord) - "These results provide the first evidence that RRMS patients receiving cladribine (Cladribine) exhibit stasis in an important area of neurocognitive function relative to healthy controls."

Journal • CNS Disorders • Multiple Sclerosis

Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS) (clinicaltrials.gov) - P3 | N=100 | Active, not recruiting | Sponsor: Haukeland University Hospital | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2026 ➔ Mar 2028 | Trial primary completion date: Mar 2024 ➔ Nov 2026

Enrollment closed • Trial completion date • Trial primary completion date • Bone Marrow Transplantation • CNS Disorders • Multiple Sclerosis • Transplantation

Pregnancy and Infant Outcomes in Multiple Sclerosis: Findings From the Global MAPLE-MS Pharmacovigilance Program. (PubMed, Neurol Neuroimmunol Neuroinflamm) - "Results are limited by the small number of pregnancies with known outcomes. Of pregnancies with known outcomes, the majority resulted in live births, with low frequencies of elective terminations and stillbirths reported. Since 2017, a single MCA (atrial septal defect) has been reported to the global patients' safety database. The results align with published estimates from the general population and MS patient cohorts."

Adverse events • Journal • CNS Disorders • Multiple Sclerosis

Safety and Efficacy of Cladribine in Patients Discontinuing Fingolimod Due to Elevated Transaminase Levels: The FinClad Study. (PubMed, Mult Scler Relat Disord) - "Cladribine emerges as a safe and effective option for pwMS discontinuing fingolimod due to hepatotoxicity concerns. To optimize treatment outcomes, implementing shorter washout periods alongside close monitoring is essential to prevent disease reactivation."

Clinical • Journal • CNS Disorders • Multiple Sclerosis

Cladribine tablets in the new multiple sclerosis era. (PubMed, Ther Adv Neurol Disord) - "Furthermore, emerging biomarkers are discussed as potential tools for predicting individual responses to therapy, thereby enabling more personalized treatment strategies. This review also provides valuable insights into the positive impact of CladT on quality of life measures, long-term outcomes and safety profile, all of which support the use of CladT in the evolving landscape of MS management."

Journal • Review • CNS Disorders • Immune Modulation • Immunology • Infectious Disease • Inflammation • Multiple Sclerosis • NEFL

CLOCK-MS: Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis (clinicaltrials.gov) - P4 | N=47 | Completed | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Completed

Biomarker • Trial completion • CNS Disorders • Multiple Sclerosis

Treatments for cancer and multiple sclerosis accepted for use on NHS (STV) - "The SMC has also has accepted Cladribine, also known as Mavenclad, for the treatment of relapsing-remitting multiple sclerosis in adults who have signs of active disease either through clinical signs or evidence of inflammation on scans....Cladribine as a short course of oral tablets may be a more manageable treatment option for patients with active relapsing-remitting multiple sclerosis."

Reimbursement • Multiple Sclerosis

The Italian Multiple Sclerosis Register Experience With Cladribine: Impact on Relapses, PIRA, and Treatment Sequencing Strategies Evaluation. (PubMed, Neurol Neuroimmunol Neuroinflamm) - "For patients with RMS, both naïve and switchers, as well as younger and older patients, cladribine is an effective treatment in reducing relapses and PIRA. Different therapeutic strategies after cladribine are currently reported."

Journal • Retrospective data • CNS Disorders • Multiple Sclerosis

Cost-Consequences of Cladribine Tablets for the Treatment of Highly Active Relapsing-Remitting Multiple Sclerosis in Italy. (PubMed, Neurol Ther) - "Cladribine tablets are associated with a benefit in terms of prolonging the non-relapsing phase in patients with HA-RRMS, as well as substantial direct cost savings in comparison with all other DMTs. Our analysis suggests that adopting cladribine tablets for HA-RRMS enables clinical benefits over a 4-year time horizon and savings for Italian society."

Journal • CNS Disorders • Immunology • Multiple Sclerosis

Real-world evidence from Türkiye on cancer risk and treatment exposure in multiple sclerosis: A histopathology-verified, registry-based study. (PubMed, Mult Scler Relat Disord) - "This study demonstrated that Multiple sclerosis does not appear to increase the risk of cancer compared to the general population and none of the MS treatments, except for azathioprine, were associated with an increased risk of cancer."

HEOR • Journal • Real-world evidence • Breast Cancer • CNS Disorders • Multiple Sclerosis • Oncology • Solid Tumor

Personalized therapy in multiple sclerosis: an Italian Delphi consensus. (PubMed, J Neurol) - "This research highlights best practices and provides a roadmap for improving patient outcomes through tailored, well-communicated therapeutic strategies."

Journal • CNS Disorders • Multiple Sclerosis

Comparative effectiveness of rituximab and cladribine in relapsing-remitting multiple sclerosis: A target trial emulation. (PubMed, Mult Scler) - "These findings suggest that rituximab has superior effectiveness compared to cladribine during a median follow-up of 4.5 years."

HEOR • Journal • CNS Disorders • Multiple Sclerosis

Assessment of Real-World Adverse Events Associated with Ozanimod in Relapsing Remitting Multiple Sclerosis (RRMS) (ISPOR 2025) - "AE reports and patient outcomes were extracted for all instances where DMTs (ozanimod, dimethyl fumarate, monomethyl fumarate, diroximel fumarate, fingolimod, ponesimod, siponimod, teriflunomide, cladribine, alemtuzumab, natalizumab, ocrelizumab, ublituximab, and ofatumumab) were the ‘primary suspect’ for the AE... Based on this descriptive analysis of the FAERS data, ozanimod has a lower proportion of AEs linked to serious outcomes than the other DMTs. Ozanimod generally had a larger share of the ten labeled AEs compared with the other DMTs; however, these labeled AEs made up a small percentage of all the AEs reported for ozanimod and the other DMTs."

Adverse events • Clinical • Real-world • Real-world evidence • Back Pain • Cardiovascular • CNS Disorders • Hypertension • Hypotension • Infectious Disease • Multiple Sclerosis • Musculoskeletal Pain • Pain • Respiratory Diseases

Role of Immune Reconstitution Therapy with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in Older Patients. (PubMed, Neurol Ther) - "Switching to CladT is a rational option for reducing the dual burdens of continuous treatment (including side effects associated with continuous immunosuppression with some DMTs) and monitoring for older people with RMS. This includes possible use as an "exit therapy", beyond which some patients may not need pharmacological therapy for their RMS in the future."

Journal • Review • CNS Disorders • Inflammation • Multiple Sclerosis

Dual MEK and BRAF Inhibition in Neonate With Refractory Multi-System Langerhans Cell Histiocytosis (ASPHO 2025) - "Objectives: To report treatment response to combination dabrafenib and trametinib and highlight ocular complications in a very young infant with refractory MS, RO+BRAFV600+ LCH, refractory to first line treatment with vinblastine and prednisone (as per LCH III), Vemurafenib (monotherapy), and cladribine (single course)...Although there was radiographic improvement, patient was switched to vemurafenib that month because of persistent liver dysfunction and profound edema, requiring continual repletion with albumin and diuresis with furosemide... We present the youngest patient with refractory multi-system LCH treated on dual MEK and BRAF inhibitor therapy published in the literature."

Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Langerhans Cell Histiocytosis • Liver Failure • Ocular Inflammation • Oncology • Ophthalmology • Solid Tumor • Uveitis • CD1a

The case for targeting latent and lytic Epstein-Barr virus infection in multiple sclerosis. (PubMed, Brain) - "B-cell depleting therapies have been shown to have anti-EBV activity; additionally new strategies to target intrathecal B-cells, plasmablasts and plasma cells are being explored including high-dose anti-CD20 therapy, cladribine, proteasome inhibitors, BTK inhibitors, CNS-penetrant anti-CD20/CD19 monoclonal antibodies and CD19-targeted CAR T-cells. Innovative trial designs for proof-of-concept studies to test EBV antivirals and immunotherapies in MS are needed to catalyse a wave of drug development targeting EBV as a therapeutic strategy to prevent or treat MS."

Journal • CNS Disorders • Epstein-Barr Virus Infections • Infectious Disease • Multiple Sclerosis • Oncology

Multiple Sclerosis Disease-Modifying Treatment Algorithms: 2025 Positioning of the Portuguese Multiple Sclerosis Study Group. (PubMed, Acta Med Port) - "Recent advances in MS treatment include the development and approval of several new disease-modifying therapies (DMTs) such as ocrelizumab, cladribine, siponimod, and others, thus expanding options for relapsing-remitting MS (RRMS). This document provides evidence- and clinical practice-based recommendations to optimize decision-making during MS management in Portuguese centers. The experts aim to prompt the urgent revision of national MS treatment frameworks, incorporating the latest advancements in MS research and international guidelines, to reduce the socio-economic burden on the national healthcare system and improve the long-term health outcomes of MS patients."

Journal • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • Pediatrics

The relationship between cladribine and reduced regional grey matter volume loss in people with relapsing-remitting multiple sclerosis. (PubMed, Mult Scler) - No abstract available

Journal • CNS Disorders • Multiple Sclerosis

Cost-effectiveness of ofatumumab for the treatment of relapsing forms of multiple sclerosis in the United Arab Emirates. (PubMed, Ther Adv Neurol Disord) - "Base-case results indicated that ofatumumab was dominant over ocrelizumab, dimethyl fumarate, fingolimod, and natalizumab intravenous; was more cost-effective compared with teriflunomide, fingolimod (generic), glatiramer acetate, interferons, and best supportive care; and resulted in an incremental cost-effectiveness ratio of AED 713,068 per QALY versus cladribine. Sensitivity analyses were in line with the results of the base-case analysis. From the UAE payer's perspective, ofatumumab could be a cost-effective treatment alternative for patients with RMS."

HEOR • Journal • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis

Evaluation of the Efficacy, Safety, and Adherence to Oral Drug Therapy in Patients with Relapsing-Remitting Multiple Sclerosis. (PubMed, Medicina (Kaunas)) - " The study population included 131 patients on teriflunomide (TFN), 53 on dimethyl fumarate (DMF), 37 on fingolimod (FTY), and 65 on cladribine (CLAD)... Over four years, second-line patients had greater ARR reduction, fewer MRI lesions, and higher EDSS from year two. DMF showed the lowest adherence, mainly due to patient forgetfulness, while lymphopenia occurred most frequently with FTY."

Journal • Retrospective data • CNS Disorders • Multiple Sclerosis

Impact of High-Efficacy Therapies for Multiple Sclerosis on B Cells. (PubMed, Cells) - "The aim of this review is to provide an overview of the mechanisms of action of high-efficacy therapies for MS, with a focus on their impact on B cells and how this contributes to the drugs' efficacy and safety profiles. Anti-CD20 monoclonal antibodies, Alemtuzumab, Cladribine and sequestering therapies encompassing Natalizumab and S1P receptors modulators will be discussed and emerging therapies, including Bruton's Tyrosine Kinase inhibitors, will be presented."

Journal • Review • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis

NICE recommends cladribine for treating active relapsing forms of multiple sclerosis (Pharm J) - "The National Institute for Health and Care Excellence (NICE) has expanded access to cladribine (Mavenclad; Merck) for adults with active relapsing-remitting multiple sclerosis (MS), if they would otherwise be offered highly effective disease-modifying drugs....The technology appraisal guidance, published on 15 April 2025, said that cladribine can be offered to people with MS as an alternative to Ocrevus (ocrelizumab; Roche Products) or Kesimpta (ofatumumab; Novartis) on the NHS....According to NICE’s evaluation committee, clinical trial evidence from the CLARITY and CLARITY-EXT trials shows that cladribine reduces relapses and increases the time until disability progresses compared with placebo."

NICE • Multiple Sclerosis

Serological screening and Vaccine Update in a cohort of Multiple Sclerosis Patients as a strategy to prevent infection reactivation during immunosuppressant therapy. (PubMed, Mult Scler Relat Disord) - "MS patients using immunosuppressant therapy may be susceptible to vaccine-preventable infectious diseases. The study demonstrates the feasibility of vaccine updates, and infectious diseases specialists can contribute assessing infection risks and providing individualized vaccines recommmendations."

Journal • CNS Disorders • Cytomegalovirus Infection • Hepatitis B • Hepatology • Herpes Zoster • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Multiple Sclerosis • Mumps • Novel Coronavirus Disease • Pertussis • Pneumococcal Infections • Respiratory Diseases • Rubella • Tetanus • Varicella Zoster