Lemtrada (alemtuzumab) / Sanofi, Bayer - LARVOL DELTA

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

Exacerbation of Orbitopathy After Total Thyroidectomy in Alemtuzumab-Induced Graves' Disease: A Case Report (ESPE-ESE 2025) - "Treatment with thiamazole and propranolol was initiated with partial symptom improvement...Due to only partial improvement, treatment with Tocilizumab has been proposed and is scheduled to begin soon... A patient with severe, difficult-to-control hyperthyroidism and moderate-to-severe inactive orbitopathy underwent total thyroidectomy. Despite this, orbitopathy exacerbation occurred post-surgery, requiring specific treatment. This case highlights a rare complication and raises the question of whether corticosteroid prophylaxis should be considered after surgery in high-risk patients."

Case report • Clinical • CNS Disorders • Dry Eye Disease • Endocrine Disorders • Grave’s Disease • Inflammation • Multiple Sclerosis • Ophthalmology • Pain • Thyroid Eye Disease

Post-alemtuzumab thyroid autoimmunity remitting after commencement of ocrelizumab in patients with multiple sclerosis (ESPE-ESE 2025) - "Objective: Immune reconstitution therapies (IRT), which include antibody-based cell-depleting therapies targeting CD52+ (alemtuzumab) or CD20+ (rituximab, ocrelizumab) leukocytes, are approved for the treatment of multiple sclerosis. These cases highlight the possibility of remission of post alemtuzumab thyroid autoimmunity, especially GD, after ocrelizumab treatment with avoidance of further medical or surgical treatment."

Clinical • CNS Disorders • Endocrine Disorders • Grave’s Disease • Multiple Sclerosis • CD20 • CD52

Ofatumumab Associated Legionella Pneumonia in a Young Multiple Sclerosis Patient (ATS 2025) - "Treatment with ceftriaxone and azithromycin was initiated. Overnight, he developed a high fever to 40.3 Celsius and treatment was broadened to piperacillin-tazobactam...He was treated with levofloxacin for a five-day course with improvement and discharged breathing room air...While some biologics are associated with Legionellosis such as alemtuzumab, this is less common among anti-CD20 therapies like rituximab...Serogroup 1 accounts for 50 to 80 % of Legionella infections and 8% of patients with Legionnaire's disease excrete no antigen in their urine. This first report demonstrates that in patients immunosuppressed with anti-CD20 therapies presenting with pneumonia, Legionellosis must be considered until definitively ruled out by bronchoscopy, even when urine antigen testing is negative."

Clinical • CNS Disorders • Cough • Infectious Disease • Multiple Sclerosis • Musculoskeletal Pain • Pain • Pneumococcal Infections • Pneumonia • Respiratory Diseases

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

Alemtuzumab-Induced Thyroid Eye Disease: Case Series (ENDO 2025) - "Both patients were treated with lubricant eye drops, selenium, and intravenous methylprednisolone, with one requiring Mycophenolate Mofetil (MMF) and Azathioprine as second-line agents before achieving remission. As the use of Alemtuzumab in managing MS increases, the incidence of Al-TED is likely to rise. Al-TED can develop several years after treatment, necessitating a high index of suspicion for timely diagnosis, particularly in cases of mild disease. The potential for significant morbidity in moderate to severe TED underscores the importance of early recognition and appropriate treatment.*."

Clinical • CNS Disorders • Endocrine Disorders • Grave’s Disease • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • CD52

COMBAT-MS: COMparison Between All immunoTherapies for Multiple Sclerosis. (clinicaltrials.gov) - P=N/A | N=3526 | Completed | Sponsor: Karolinska Institutet | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

Effectiveness of Autologous Hematopoietic Stem Cell Transplantation versus Alemtuzumab and Ocrelizumab in Relapsing Multiple Sclerosis: A Single Center Cohort Study. (PubMed, Ann Neurol) - "AHSCT was followed by greater prevention of relapses compared with ATZ and OCR, and suppressed more profoundly MRI activity than ATZ, but similarly to OCR, albeit with shorter follow up. The risk of accumulating disability was similar among the treated groups. Studies with larger sample sizes and longer follow up may enable confirmation of these findings or detection of any additional differential effects. ANN NEUROL 2025."

Journal • Bone Marrow Transplantation • CNS Disorders • Multiple Sclerosis • Transplantation

Baló's concentric sclerosis successfully treated with alemtuzumab: Long-term follow-up. (PubMed, Mult Scler) - "The only extant case report of alemtuzumab in BCS described a lack of clinical response in a patient who had previously not responded to corticosteroids, plasmapheresis and cyclophosphamide. The authors speculated that alemtuzumab may have been effective if started earlier in the disease process. We present the outcomes of a patient with BCS who responded clinically and radiologically to alemtuzumab over a 6-year follow-up."

Journal • CNS Disorders • Multiple Sclerosis

Equine Anti-Thymocyte Globulin and Alemtuzumab Are Associated with the Highest Survival Among Common Induction Therapies in U.S. Lung Transplant Recipients (ISHLT 2025) - "Rabbit ATG was not associated with better survival (HR=1.10 [0.99-1.21], p=0.06; MS=5.9 [2.1-12.1] y; n=1114) than no induction. While rejection / respiratory failure-related deaths were lowest with alemtuzumab (HR=0.75 [0.63-0.90], p=0.002), cancer-related deaths were increased (HR=1.39 [1.08-1.78], p=0.009), versus no induction.Conclusion Using Equine ATG or alemtuzumab as induction therapy may increase survival in lung transplant recipients, largely mediated by reduced rejection-related deaths. Use of these agents, particularly Equine ATG as it seems most favorable overall, should be considered as an alternative to basiliximab."

Clinical • Oncology • Respiratory Diseases • Transplantation

Serum Proteomics Analysis of Lung Transplant Patients Receiving Different Induction Therapies (ISHLT 2025) - "Additionally, the upregulation of immunoglobulins and MCAM in the ATG group suggests a more pro-inflammatory state. The downregulation of fibulin-1 and fetuin-B, elevated in lung diseases, was notable in alemtuzumab over time and in alemtuzumab versus no-induction therapy, suggesting potential benefits for graft survival compared to no-induction therapy, possibly ATG as well."

Clinical • Immune Modulation • Immunology • Melanoma • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Transplantation • APOA1 • FBLN1 • ICAM1 • IGH • MCAM

Treatment and Prognosis for Marburg Multiple Sclerosis: A Systematic Review of Case Reports (P9-1.009). (PubMed, Neurology) - "Treatment included intravenous steroids (100%), plasmapheresis (67%), and cyclophosphamide (61%), followed by maintenance therapies such as ocrelizumab, rituximab, or alemtuzumab. Mr. Uwishema has nothing to disclose."

Journal • Review • CNS Disorders • Multiple Sclerosis

CHALLENGING PCI IN THE SETTING OF ITP AND CLOPIDOGREL ALLERGY - Mina Fattah Khudhair (ACC 2025) - "The patient had previously been treated with alemtuzumab, a therapy for multiple sclerosis that was found to be associated with an increased risk of ITP. Early identification and treatment of ITP, along with initiating a P2Y12 inhibitor that has a safer skin-related adverse reactions profile than clopidogrel, played a crucial role in expediting the process of stent placement in a patient with coronary artery disease, ultimately protecting the myocardium from further ischemic damage."

Allergy • Cardiovascular • CNS Disorders • Coronary Artery Disease • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Multiple Sclerosis • Pain • Thrombocytopenia • Thrombocytopenic Purpura

Therapeutic Advances in Pediatric Multiple Sclerosis. (PubMed, Children (Basel)) - "In this narrative review, we will discuss therapeutic advancements in pediatric multiple sclerosis, including the seminal trials of PARADIGMS, which evaluated fingolimod use in pediatric MS patients, CONNECT (dimethyl fumarate), TERIKIDS (teriflunomide), OPERETTA I (ocrelizumab), and LEMKIDS (alemtuzumab). We will also review the safety and efficacy of different monoclonal antibodies that are commonly prescribed for multiple sclerosis. We will then examine induction versus escalation treatment strategies and conclude with discussions on treatment considerations in POMS patients."

Journal • Review • CNS Disorders • Multiple Sclerosis • Pediatrics

A Phase 1, Multicenter, Single-Arm, Dose-Escalation Study of BMS-986353 (CC-97540), a CD19-Directed Chimeric Antigen Receptor T Cell Therapy Manufactured Using a Next-Generation Process, Evaluating Safety and Tolerability in Patients With Relapsing or Progressive Forms of Multiple Sclerosis (Breakfree-2) (ACTRIMS Forum 2025) - P1 | "BMS-986353 (CC-97540) is an investigational CAR T cell therapy expressing the CD19-directed CAR used in FDA-approved lisocabtagene maraleucel; the NEX-T® manufacturing process shortens manufacturing time and optimizes phenotypic attributes...Two to 9 days after lymphodepletion (3 days of fludarabine and cyclophosphamide), a single BMS-986353 infusion was administered...One pt was a 33-yr-old male diagnosed with RRMS in 2011 with an Expanded Disability Status Scale (EDSS) score at screening of 3.0, whose previous MS treatments included alemtuzumab, glatiramer acetate, interferon beta-1a, fingolimod, natalizumab, ocrelizumab, ofatumumab, and ublituximab... Treatment with BMS-986353 demonstrated promising initial safety in pts with highly active RRMS, with no ICANS observed and 1 pt with transient low-grade CRS. Trial enrollment is ongoing. Updated safety, pharmacokinetic, and translational data will be presented."

CAR T-Cell Therapy • Clinical • P1 data • CNS Disorders • Hematological Disorders • Infectious Disease • Inflammation • Multiple Sclerosis • Neutropenia • Thrombocytopenia • CD19

Assessment of the impact of reconstitution therapies-cladribine tablets and alemtuzumab-on the atrophy progression among patients with relapse-remitting multiple sclerosis. (PubMed, Front Neurosci) - "The study was limited by the small number of both groups. Therefore, further studies are needed to fully assess the effect of reconstitution therapies on neurodegenerative processes in patients with RRMS."

Journal • CNS Disorders • Multiple Sclerosis

Herpes Zoster Infections With Multiple Sclerosis Disease-Modifying Therapies: A Real-World Pharmacovigilance Study. (PubMed, Neurol Clin Pract) - "We queried the Food and Drug Administration Adverse Event Reporting System (FAERS) and OpenVigil 2.1 for reports of HZ involving immunosuppressive MS DMTs (ocrelizumab [OCR], ofatumumab [OFT], rituximab [RTX], natalizumab [NTZ], alemtuzumab, dimethyl fumarate and diroximel fumarate [DRF], fingolimod [FING], siponimod [SIP], ozanimod [OZ], mitoxantrone [MITO], cladribine [CLAD], and teriflunomide [TERF]) and calculated reporting odds ratios and their 95% CIs...Immunosuppressive MS DMTs are associated with greater HZ reporting in the FAERS. These findings emphasize the importance of pre-DMT HZ vaccination because of avoidable HZ infections."

Adverse events • Journal • Real-world evidence • CNS Disorders • Herpes Zoster • Infectious Disease • Multiple Sclerosis • Varicella Zoster

Rituximab for people with multiple sclerosis. (PubMed, Cochrane Database Syst Rev) - "For preventing relapses in relapsing MS, rituximab as 'first choice' and 'switching' treatment compares favourably with a wide range of approved DMTs. The protective effect of rituximab against disability worsening is uncertain. There is limited information to determine the effect of rituximab on primary progressive MS. There is limited evidence for long-term adverse events of rituximab in people with MS. Evidence for serious adverse events, cancer, and mortality was of very low certainty due to few events. There is an increased risk of serious (hospital-treated) infections with rituximab compared with other DMTs, although the absolute risk is low. High-quality (prospectively registered) NRSIs should be conducted to draw more reliable conclusions about the potential benefits and harms of rituximab in people with MS."

Clinical • Journal • Review • CNS Disorders • Infectious Disease • Multiple Sclerosis • Oncology • Respiratory Diseases

Comorbidities of hypothyroidism. (PubMed, Curr Med Res Opin) - "Hypothyroidism may arise as a comorbidity of some other conditions, e.g. following the application of targeted cancer therapies or alemtuzumab for multiple sclerosis. Other common treatments, including metformin, glucocorticoids or proton pump inhibitors among others, may alter levels of thyrotropin, thus impacting on the monitoring of thyroid dysfunction and the diagnosis of thyroid dysfunction. Ensuring good control of hypothyroidism is a necessary first step in managing any patient with hypothyroidism. Then, physicians should be aware of the possibility of other comorbid conditions that must be addressed to achieve an optimal patient outcome."

Journal • Review • Cardiovascular • CNS Disorders • Depression • Dyslipidemia • Endocrine Disorders • Fatigue • Hypertension • Immunology • Mood Disorders • Multiple Sclerosis • Oncology • Psychiatry

Treatment and Prognosis for Marburg Multiple Sclerosis: A Systematic Review of Case Reports (AAN 2025) - "Marburg variant MS, primarily affecting young women, demonstrates clinical and radiological improvement with aggressive treatment, though early mortality underscores the need for prompt intervention"

Case report • Clinical • Review • CNS Disorders • Multiple Sclerosis

The Evolving Management of Multiple Sclerosis During Pregnancy: Experience from an Irish Multiple Sclerosis Centre (AAN 2025) - "At conception, 6 patients (17%) were not receiving DMT, 10 (28%) on platform injectables, 4 (11%) on dimethyl fumarate (DMF), 7 (20%) on Natalizumab, 4 (11%) on Ocrelizumab, 3 (0.8%) had recent courses of cladribine. One received alemtuzumab 7-years pre-conception.Four pregnancies were unplanned; 2 between courses of cladribine, one had received ocrelizumab when unknowingly four-weeks pregnant and one reported a pregnancy during the work-up for DMF. Three patients discontinued fingolimod prior to planned conception; with one switching to natalizumab without any post-fingolimod relapse, another to copaxone with a steroid-bridge and one proceeding without DMT...This data supports the current use of DMTs to the point of conception and during pregnancy where appropriate, and may be protective against disease activity during pregnancy and post-partum."

CNS Disorders • Multiple Sclerosis

Lymphocyte Reconstitution Patterns in People with MS Being Treated with Rituximab After Alemtuzumab to Reduce the Frequency of Autoimmune Adverse Events in the RAMBLE Trial (AAN 2025) - "We have demonstrated that administration of rituximab following alemtuzumab slows the rate of B cell repopulation. This trial is ongoing."

Adverse events • CNS Disorders • Immunology • Multiple Sclerosis • CD4 • CD8

Comparing the efficacy of divozilimab and second-line treatments for relapsing-remitting multiple sclerosis in the Russian Federation: a systematic review and network meta-analysis (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "Systematic literature review and network meta-analysis revealed statistically significant superiority of divozilimab over cladribine and fingolimod and absence of statistically significant differences with alemtuzumab, ocrelizumab, ofatumumab and natalizumab in the annual relapse rate during 2 years of treatment."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

SS5. Industry Supported Satellite Symposium 5 - A New Era in NMOSD Treatment: Optimizing Therapeutic Transitions and Reducing Patient Burden (ACTRIMS Forum 2025) - "In some cases, this results in the initiation of disease-modifying therapies for MS, such as interferon beta, fingolimod, and alemtuzumab, which can significantly worsen NMOSD symptoms. Evaluate clinical trial data for current and emerging therapies in the management of NMOSD. Implement evidence-based approaches to modify treatment in patients with NMOSD based on treatment response."

Clinical • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

TREAT-MS: Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (clinicaltrials.gov) - P=N/A | N=900 | Active, not recruiting | Sponsor: Johns Hopkins University | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis