Lemtrada (alemtuzumab) / Sanofi, Bayer - LARVOL DELTA

Towards practical management of the Marburg variant of multiple sclerosis. (PubMed, Mult Scler Relat Disord) - "While no single regimen was uniformly effective, our three-group analysis suggests a stepwise strategy: steroids ± plasma exchange alone were often insufficient; adding a cytotoxic agent with dual B- and T-cell activity (cyclophosphamide or mitoxantrone) was associated with more frequent improvement; and the highest proportion of improvement occurred when dual-arm cytotoxic therapy was combined with a B-cell-directed/lymphocyte-depleting agent."

Journal • CNS Disorders • Multiple Sclerosis • Pediatrics

Graves' orbitopathy following Alemtuzumab treatment for multiple sclerosis: a systematic review and real-world insights. (PubMed, Thyroid Res) - No abstract available

Journal • Real-world evidence • Review • CNS Disorders • Endocrine Disorders • Immunology • Multiple Sclerosis • Ophthalmology • Thyroid Eye Disease

Recent Advances in Interventions Targeting Remyelination and a Systematic Review of Remyelinating Effects of Approved Disease-Modifying Treatments for Multiple Sclerosis. (PubMed, Eur J Neurol) - "Future proof-of-concept clinical trials investigating remyelinating agents in MS should consider combining outcome measures into composite endpoints. Furthermore, research efforts should be dedicated to novel biomarkers to assess repair mechanisms in MS."

Journal • Review • CNS Disorders • Multiple Sclerosis • Solid Tumor

MIGRA-MS: A case series on chronic migraine and multiple sclerosis (EHF-EHC 2025) - "Prior treatments included interferons and glatiramer acetate; current therapies consisted of ocrelizumab, natalizumab, alemtuzumab, teriflunomide, or dimethyl fumarate...All received a median of three classic preventives (amitriptyline in all cases) and onabotulinumtoxinA (PREEMPT, 155 IU) with only one responder; two patients received an extended dose (195 IU) without benefit and later CGRP monoclonal antibodies (galcanezumab, erenumab, eptinezumab) with no response, and atogepant with only transient or partial benefit...In this case series of relapsing–remitting MS with chronic resistant migraine, response to onabotulinumtoxinA and anti-CGRP therapies was limited, with no drug interactions or adverse effects observed. An individualized approach and further studies are needed to assess emerging treatments in this subgroup."

Clinical • CNS Disorders • Migraine • Multiple Sclerosis • Pain

Alemtuzumab in relapsing-remitting multiple sclerosis in clinical practice: Annual NEDA-3 follow-up for up to 4 years. (PubMed, Farm Hosp) - "Alemtuzumab has proven to be effective, over 4 years, in clinical practice in patients with RRMS according to the different parameters of the NEDA-3 concept."

Journal • CNS Disorders • Multiple Sclerosis

LemKids: A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT (clinicaltrials.gov) - P3 | N=16 | Terminated | Sponsor: Genzyme, a Sanofi Company | Active, not recruiting ➔ Terminated; Enrolment formally closed earlier than planned due to recruitment challenges.

Trial termination • CNS Disorders • Multiple Sclerosis • Pediatrics

Safety of disease-modifying therapies in multiple sclerosis: real-world data from the Austrian MS Treatment Registry (AMSTR). (PubMed, J Neurol) - "The safety data from the AMSTR do not reveal any new safety issues, particularly regarding neoplasms and infections. Hence, people with MS as well as their treating neurologists are reassured to continue treatment with DMT, as the benefit-risk profile of DMT could be reaffirmed."

Journal • Real-world evidence • Basal Cell Carcinoma • CNS Disorders • Endocrine Disorders • Infectious Disease • Multiple Sclerosis • Non-melanoma Skin Cancer • Oncology

Long-term effectiveness and cost-effectiveness of testing for alemtuzumab antidrug antibodies to guide treatment in multiple sclerosis: a modelling study. (PubMed, Eur J Health Econ) - "Cost-effectiveness of anti-drug antibody testing was sensitive to anti-drug antibody development risk, their impact on drug efficacy, and costs of disease-modifying therapies (DMTs). Anti-drug antibody testing to inform MS treatment switching could improve clinical outcomes, but its cost-effectiveness depends on anti-drug antibody risk, its impact on drug efficacy, and costs of DMTs."

HEOR • Journal • CNS Disorders • Multiple Sclerosis

Clinical and Economic Impact of Early Treatment in Relapsing Remitting Multiple Sclerosis With High-Efficacy Disease-Modifying Therapy in Mexico (ISPOR-EU 2025) - "OBJECTIVES: To estimate the clinical and economic impact of early use of high efficacy disease modifying therapies (DMTs) for relapsing remitting multiple sclerosis (RRMS), by comparing four treatment strategies currently used in Mexico: (1) no DMT (symptomatic treatment), (2) moderate efficacy DMTs (interferons, glatiramer acetate, teriflunomide, dimethyl fumarate), (3) escalation (starting with moderate efficacy DMTs and switching to high efficacy DMTs after five years: cladribine, fingolimod, alemtuzumab, ocrelizumab, natalizumab, ofatumumab), and (4) early initiation with high efficacy DMTs. A cost consequence analysis was conducted using a Markov model with four health states: mild disability (EDSS <4), moderate disability (EDSS 4, 5.5), severe disability (EDSS ≥6), and death... Early initiation with high-efficacy DMTs represents the most favorable strategy in terms of clinical outcomes and costs, maximizing life years gained and significantly improving..."

Clinical • HEOR • CNS Disorders • Multiple Sclerosis

Cytomegalovirus Infection in a Multiple Sclerosis Patient on Dimethyl Fumarate. (PubMed, Case Rep Neurol Med) - "CMV infection has been reported in MS patients treated with alemtuzumab, rituximab, and ocrelizumab, but its occurrence in patients receiving dimethyl fumarate (DMF) is less studied...It may be beneficial with routinely test with viral panel with patients with progression in MS. Further studies are needed to clarify the risk of CMV infection in DMF-treated MS patients."

Journal • CNS Disorders • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Herpes Simplex • Immune Modulation • Immunology • Infectious Disease • Inflammation • Multiple Sclerosis • Varicella Zoster

MS Fatigue Post High-Efficacy Treatment. (PubMed, Eur J Neurol) - "MS-related fatigue levels, especially in its physical aspect, decrease after the initiation of HET. This finding reinforced the role of neuroinflammation in driving fatigue and highlighted the need for domain-specific research and treatment strategies."

Clinical • Journal • Review • CNS Disorders • Fatigue • Inflammation • Multiple Sclerosis

Assessment of brain atrophy as a promising marker of radiological activity in patients with relapsing-remitting multiple sclerosis. (PubMed, Front Neurosci) - "Clinical and MRI data from RRMS patients treated with cladribine tablets (CLAD) and alemtuzumab (ALEM) were retrospectively analyzed at 4 time points (pretreatment and 3 years of follow-up). The results of the presented study suggested an association of increased brain atrophy with radiological activity rather than with relapsing disease activity. However, further studies with larger numbers of patients are needed to verify these associations more precisely."

Journal • CNS Disorders • Multiple Sclerosis

Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple Sclerosis (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Brigham and Women's Hospital | N=10 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • CNS Disorders • Multiple Sclerosis

Lymphocyte Dynamics and the Emergence of Secondary Autoimmunity Following Immune Reconstitution Therapies in Multiple Sclerosis. (PubMed, Neurol Neuroimmunol Neuroinflamm) - "A low BL CD4+ Trte:CD8+ Temra ratio, accompanied by a sharp relative increase during follow-up, was associated with SAD development. While no definitive associations were found between BL lymphocyte subpopulations and disease activity, a lower CD8+ T-cell count may suggest an increased risk."

Journal • Bone Marrow Transplantation • CNS Disorders • Immunology • Multiple Sclerosis • Transplantation • CD4 • CD8

Incidence of Alemtuzumab-Induced Thyroid-Associated Orbitopathy: A Systematic Review and Meta-Analysis. (PubMed, Ophthalmic Plast Reconstr Surg) - "The incidence of AI-TAO is 6% which is less common than the estimated incidence of 20% to 30% of alemtuzumab-induced thyroid dysfunction. This finding emphasizes the need for patient counseling, baseline ophthalmic examination, and interdisciplinary follow-up for early detection and management of AI-TAO."

Journal • Retrospective data • CNS Disorders • Dry Eye Disease • Endocrine Disorders • Grave’s Disease • Multiple Sclerosis • Ophthalmology • Pain • Thyroid Eye Disease • CD52

The effect of disease-modifying therapies on brain volume loss and disability accumulation in multiple sclerosis: a systematic review and network meta-analysis. (PubMed, Lancet Reg Health Eur) - "Eight DMTs significantly reduced BVL compared to placebo, including ponesimod (ROM = 0.52; 95%-CI: 0.35-0.77), ofatumumab (ROM = 0.58; 95%-CI: 0.40-0.83), alemtuzumab (ROM = 0.63; 95%-CI: 0.49-0.83), teriflunomide (ROM = 0.71; 95%-CI: 0.52-0.97), ozanimod (ROM = 0.74; 95%-CI: 0.56-0.98), natalizumab (ROM = 0.77; 95%-CI: 0.61-0.96), siponimod (ROM = 0.77; 95%-CI: 0.60-0.98), and fingolimod (ROM = 0.83; 95%-CI: 0.71-0.96)...These findings support BVL as a meaningful treatment target in MS. None."

Journal • Retrospective data • CNS Disorders • Multiple Sclerosis

NATALIZUMAB-INDUCED IMMUNE THROMBOCYTOPENIA IN RELAPSING-REMITTING MULTIPLE SCLEROSIS (WCN 2025) - "Treatment was switched to ocrelizumab, resulting in platelet recovery and favorable clinical outcomes. The co-occurrence of ITP and MS primarily manifests as drug-induced thrombocytopenia, notably with alemtuzumab (2.2%). This case highlights a rare adverse effect of natalizumab. The pathogenesis of drug-induced thrombocytopenia remains unclear, but the temporal association suggests a causal relationship."

CNS Disorders

COST-EFFECTIVENESS ANALYSIS OF HIGH-EFFICACY DRUGS USED IN THE TREATMENT OF MULTIPLE SCLEROSIS IN A LARGE HEALTH INSURANCE PROVIDER IN BRAZIL (WCN 2025) - "This study aims to assess the cost-effectiveness of cladribine for highly active relapsing-remitting MS (RRMS) within a large health insurance provider in southern Brazil, covering a population of 645,291 lives. A cost-effectiveness analysis was conducted using updated relapse rate as the effectiveness outcome, comparing cladribine with other high-efficacy treatments (alemtuzumab, natalizumab, ofatumumab, and ocrelizumab)... From a payer's perspective, cladribine represents a cost-effective alternative to high-efficacy treatments for RRMS within the Brazilian private healthcare system, with lower short-term economic impact. Further budget impact analyses are warranted to support final decision-making."

Clinical • Cost effectiveness • HEOR • Reimbursement • US reimbursement • CNS Disorders

MULTIPLE SCLEROSIS: A REAL-WORLD DATA ANALYSIS IN A PRIVATE HEALTH INSURANCE PROVIDER IN BRAZIL (WCN 2025) - "At the time of analysis, 90 (45.23%) were on natalizumab, 78 (39.20%) on ocrelizumab, 20 (10.05%) on ofatumumab, 5 (2.51%) on glatiramer acetate, 4 (2.01%) on cladribine, and 2 (1.01%) on alemtuzumab... Patients, predominantly women, experienced a sixfold reduction in MS-related hospitalizations with high-efficacy DMTs. However, hospitalization costs remained unchanged in the short term."

Clinical • Real-world • Real-world evidence • Reimbursement • US reimbursement • CNS Disorders

Lymphocyte dynamics following alemtuzumab, autologous hematopoietic stem cell transplantation, and cladribine tablets: associations with secondary autoimmunity and disease recurrence (ECTRIMS 2025) - "Low BL CD4+ Trte:CD8+ Temra ratio, accompanied by a sharp relative increase during follow-up, was associated with the development of SAD. While no definitive associations were found between BL lymphocyte subpopulations and disease activity, a lower CD8+ T cell count may suggest an increased risk, requiring further investigation."

Bone Marrow Transplantation • Transplantation • CD4 • CD8

Elevated Procalcitonin and C-reactive Protein After Alemtuzumab Infusion: Sepsis or Pseudosepsis? (ECTRIMS 2025) - "Alemtuzumab-induced cytokine release can cause marked elevations in CRP and PCT, mimicking sepsis in the absence of infection. Recognizing pseudosepsis is crucial to avoid unnecessary antimicrobial treatments and improve patient safety during infusion monitoring."

CNS Disorders • Dermatology • Immunology • Infectious Disease • Inflammation • Multiple Sclerosis • Septic Shock • Systemic Inflammatory Response Syndrome • Urticaria • CD52 • CRP

Breaking the assumption: Disease-modifying therapy efficacy and relapse severity in relapsing-remitting multiple sclerosis. (PubMed, Mult Scler Relat Disord) - "These findings indicate that, among the DMTs analyzed (both moderate- and high-efficacy), the level of preventive efficacy does not substantially modify relapse severity or recovery once a relapse occurs."

Journal • CNS Disorders • Multiple Sclerosis

Amygdala volume changes as a potential marker of multiple sclerosis progression - about the relationship between the atrophy pattern, Expanded Disability Status Scale (EDSS) and progression independent of relapse activity (PIRA) (ECTRIMS 2025) - "Objectives/Aims: The study aimed to assess the correlation of disability measured by the Expanded Disability Status Scale (EDSS) and progression independent of relapse activity (PIRA) with volumetric changes in patients with RRMS treated with cladribine tablets (CLAD) and alemtuzumab (ALEM). The study showed association of EDSS progression with an increase in amygdala (and to a lesser extent pallidum) volume in RRMS patients during a 3-years follow-up. Conversely, progression of disability measured by EDSS was associated with a decrease in the thalamus volume. Interestingly, an increase in amygdala volume was observed in patients with PIRA-related progression compared to patients with relapse-associated worsening."

CNS Disorders • Multiple Sclerosis

COVID-19 immunity in Multiple Sclerosis: results from a real-world longitudinal study (ECTRIMS 2025) - " We conducted a cohort study (n=235) including PwMS (n=205; Ocrelizumab, Alemtuzumab, Natalizumab, Fingolimod, Tecfidera, Interferon, no-DMT HV; n=30 each). Data support role of boosters and maintenance of complementary mechanisms of serological and cellular COVID-19 immunity in PwMS. Though the number are small, status of immunity is clearly and consistently demonstrated in DMT groups. Disclousure of interest: This Investigator Initiated (IIT) study has been funded by grant from Biogen Idec Limited."

Clinical • Late-breaking abstract • Longitudinal study • Observational data • Real-world • Real-world evidence • CNS Disorders • Immunology • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Respiratory Diseases

Experience of Using Natalizumab After Failed High Efficacy Disease Modifying Therapies (ECTRIMS 2025) - " Thirty-one patients who transitioned to natalizumab after prior HE-DMT failure were included: 21 from B-cell depleting agents (ocrelizumab, ofatumumab, rituximab) and 10 from immune reconstitution therapies (alemtuzumab, cladribine)... Natalizumab can be an effective and well-tolerated treatment option for patients with MS who require a switch from other HE-DMTs, particularly B-cell or immune reconstitution therapies. Our data support its use as a viable next-line agent, offering sustained disease control without additional safety signals. These findings highlight the value of individualized, mechanism-based sequencing to optimize long-term outcomes in MS care."

Clinical • Late-breaking abstract • CNS Disorders • Infectious Disease • Multiple Sclerosis