Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab - LARVOL DELTA

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

TRENDS IN THE USE AND SWITCHING OF DISEASE MODIFYING THERAPIES WITH MULTIPLE SCLEROSIS: A SINGLE-CENTER EXPERIENCE (WCN 2025) - "DMT switching occurred in cases of relapse or progression, with ofatumumab or fingolimod selected as escalation therapies... There is a growing trend toward the early initiation of high-efficacy DMTs. However, some patients achieve long-term stability with moderate-efficacy therapies. In patients with favorable prognostic profiles, moderate-efficacy DMTs may remain a viable and adherence-friendly treatment option."

Clinical • 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

OFATUMUMAB: A REAL WORLD STUDY (WCN 2025) - "Ofatumumab was well-tolerated, with no moderate or severe adverse events. After one year, significant reductions in ARR and Gd+ lesions were observed, supporting its efficacy and safety in treating relapsing multiple sclerosis."

Clinical • Real-world • Real-world evidence • CNS Disorders

NEW TREATMENTS OF MULTIPLE SCLEROSIS (WCN 2025) - "This teaching course will provide a comprehensive overview of the latest advancements in MS treatment, including B-cell depleting therapies (e.g., ocrelizumab), cladribine, Bruton's tyrosine kinase (BTK) inhibitors, and sphingosine-1-phosphate (S1P) receptor modulators, with a focus on their mechanisms, clinical applications, emerging indications, and safety considerations...BTK inhibitors (e.g., evobrutinib, tolebrutinib), currently in phase III trials, target both peripheral and CNS-resident immune cells, showing promise for progressive MS. S1P receptor modulators (e.g., fingolimod, siponimod) regulate lymphocyte trafficking and are approved for RMS and secondary progressive MS (SPMS)...Additionally, this course will explore smoldering MS pathology, including chronic active lesions and neurodegeneration, and discuss whether emerging therapies, particularly BTK inhibitors, can address progression beyond relapse suppression. Through case discussions and trial data,..."

CNS Disorders

Bipolar disorder and multiple sclerosis in pregnancy: the complexity of integrated psychiatric management (ECNP 2025) - "Managing Bipolar Disorder and Multiple Sclerosis during pregnancy and postpartum requires delicate balancing of maternal mental health, neuroimmunological stability, and fetal safety. The case further highlights the limitations of standard treatment algorithms in the face of comorbid neuropsychiatric disease and reproductive planning."

Bipolar Disorder • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry • Sleep Disorder • PRL

When Systems Collide: A Unique Case of Ogilvie Syndrome With Endocrine and Neurologic Comorbidities (ACG 2025) - "Beyond getting his monthly Kesimpta (Ofatumumab, Novartis Pharmaceuticals, Basel, Switzerland) injection in the prior week, he had no new medications, no recent illnesses, operations, no sick contacts, and no changes in diet prior to the worsening abdominal pain...This could explain why an additional dose of neostigmine was required. Nevertheless, this is a great example of how ACPO can develop "when systems collide."Figure: Figure 1: KUB on Day of AdmissionFigure: Figure 2: KUB two days after Neostigmine"

Clinical • Cardiovascular • CNS Disorders • Diabetes • Endocrine Disorders • Gastrointestinal Disorder • Inflammatory Bowel Disease • Metabolic Disorders • Multiple Sclerosis • Rare Diseases • Type 2 Diabetes Mellitus

Concomitant treatment of secukinumab and ofatumumab in a psoriasis patient with multiple sclerosis. (PubMed, Ital J Dermatol Venerol) - No abstract available

Journal • CNS Disorders • Dermatology • Immunology • Multiple Sclerosis • Psoriasis

Real-world efficacy and safety of Ofatumumab for the treatment of highly active Multiple Sclerosis: the San Raffaele Hospital single-center experience (ECTRIMS 2025) - "According to our experience, OFA is mainly prescribed to young, naïve/early-switchers patients with short disease duration and low disability. Our real-world data suggest it is effective, safe and well tolerated. Longer FU and larger cohorts are needed for confirmation."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Hematological Disorders • Hepatology • Infectious Disease • Liver Failure • Multiple Sclerosis • Neutropenia

AGNOS: A Phase 4 Study of Ofatumumab in Treatment-Naïve Participants with Very Early Relapsing-Remitting Multiple Sclerosis Compared with Healthy Controls (ECTRIMS 2025) - "Darin T Okuda has received personal compensation for consulting and advisory services from Biogen Inc., Cortechs.AI, Eisai, EMD Serono, Genentech, Genzyme/Sanofi, Immunic Therapeutics, Moderna, Octave Bioscience, Pfizer, and Zenas BioPharma along with research support from Alexion and Novartis... This pre-planned analysis confirms the efficacy of OMB in participants with very early, recently diagnosed, treatment-naïve RRMS in the AGNOS study, with over 80% of participants achieving NEDA-3 from months 6 to18. Functional performance and imaging outcomes in OMB-treated participants appeared broadly similar to those observed in healthy controls up to 18 months. Safety findings were consistent with prior reports."

Clinical • Late-breaking abstract • P4 data • CNS Disorders • Fatigue • Infectious Disease • Multiple Sclerosis • Musculoskeletal Pain • Novel Coronavirus Disease

Immunoglobulin G Levels in Ofatumumab-Treated Participants With Episodes of Low Immunoglobulin M: An Analysis of 7-Year Data From the ALITHIOS Extension Study (ECTRIMS 2025) - "IgG levels remained stable for up to 7 years of OMB treatment in plwRMS whose IgM level dropped 10% below LLN and was similar irrespective of whether treatment was interrupted/discontinued. Disclousure of interest: Heinz Wiendl receives research support from Deutsche Forschungsgemeinschaft (DFG), Deutsche Myasthenie Gesellschaft e.V., Europeenzyme, Idorsia, Immunic, Immunovant, INmune Bio_Syneos Health, Kohlhammer, LTS, Lundbean Union, Alexion, Amicus Therapeutics Inc., Argenx, Biogen, CSL Behring, F. Hoffmann-La Roche, Genzyme, Merck, Novartis, Roche, UCB Biopharma as well as speaker and/or consultancy fee from Alexion, Argenx, Argobio, AOCN, AstraZeneca, BGP Products Operations GmbH, Biogen, Bristol Myers Squibb, CEMCAT, Dianthus, EMD Serono Research &Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, EPG Health/Medthority, Fondazione Cariplo, Gck, Merck, MS at the Limits, Muna Therapeutics, Myrobalan Therapeutics, Neurodiem, NMSS,..."

Late-breaking abstract • CNS Disorders • Multiple Sclerosis

Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation (MS-PEKOS) (ECTRIMS 2025) - P | "Interim data from the MS-PEKOS study suggest a lower frequency of local IRRs among patients newly treated with OMB vs OCR SC and provide valuable real-world evidence to help patients with MS and their HCPs select the optimal anti-CD20 therapy. Disclousure of interest: Ming-Hui Tai, Brandon Brown, D'Andra Parker, and Abhijit Gadkari are employees of and stockholders in Novartis Pharmaceuticals Corporation. Helen Chen, Sophie Jacobovitz, and Aaron Cortright are employees of IQVIA, a consultancy company that received funds from Novartis for the conduct of the current study."

Clinical • Late-breaking abstract • CNS Disorders • Multiple Sclerosis • Pruritus

Maternal and neonatal outcomes of natalizumab and anti-CD20 monoclonal antibody exposure during pregnancy and lactation in Multiple Sclerosis (ECTRIMS 2025) - "Introduction: Disease-modifying therapies (DMTs), including natalizumab (NTZ) and anti-CD20 monoclonal antibodies (ocrelizumab, ofatumumab, rituximab), are increasingly prescribed in women with multiple sclerosis (MS) of childbearing age... Continued NTZ therapy during pregnancy and lactation appears effective in maintaining maternal disease stability and is associated with favorable long-term child outcomes. Limited evidence from four anti-CD20-exposed cases suggests reassuring neonatal safety, particularly when used during breastfeeding. Further prospective studies with larger samples are needed to confirm these preliminary findings and support clinical decision-making."

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

Serum Neurofilament Light chain as a Marker for Therapeutic Response and Disease Activity in Multiple Sclerosis: A Systematic Review (ECTRIMS 2025) - " Data were extracted from 27 randomized trials and cohort studies reporting sNfL in 14,571 MS patients treated with high-efficacy monoclonal antibodies (ofatumumab, ocrelizumab, natalizumab), oral agents (teriflunomide, fingolimod, dimethyl fumarate), moderate efficacy platform therapy(interferon-beta, glatiramer acetate), and untreated controls... High-efficacy DMTs in MS are associated with greater and more sustained sNfL reductions, paralleling superior clinical and MRI outcomes. These findings support sNfL as a sensitive biomarker for monitoring disease activity and therapeutic response in MS. Disclousure of interest: Jaahnavee Trivedi: nothing to disclose"

Late-breaking abstract • Review • CNS Disorders • Multiple Sclerosis • NEFL

Reduced oligodendrocyte-specific cytotoxicity of peripheral blood leukocytes in patients with Multiple Sclerosis following treatment with ofatumumab (ECTRIMS 2025) - "These findings suggest that B-cell depletion with ofatumumab is associated with changes in the secretory profile of the remaining peripheral leukocyte subsets to be less cytotoxic to OL lineage cells. Disclousure of interest: A.G.M. has no disclosures."

Clinical • Late-breaking abstract • CNS Disorders • Immunology • Multiple Sclerosis • Solid Tumor • CD14 • CD8 • NCAM1

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

Complications of Multiple Sclerosis Disease-Modifying Therapies in the Southeastern United States: Anti-CD20 Therapy is Associated with Higher Rates of Emergency Department Visits due to Infections (ECTRIMS 2025) - "Introduction: The anti-CD20 therapies rituximab (RTX), ocrelizumab (OCR), ofatumumab (OFA), and ublituximab (UTX) are considered highly effective disease modifying therapy (DMT) in relapsing-remitting multiple sclerosis (MS)...Objectives/Aims: To assess rates of emergency department (ED) visits due to infection in people with MS (PwMS) treated with anti-CD20 therapy compared to glatiramer acetate (GA)... This large cohort provides evidence that PwMS treated with anti-CD20 therapy have higher rates of ED visits due to infections compared to GA. Disclousure of interest: Freddy Escobar-Montalegre: nothing to disclose. Ziyad Aboudan: nothing to disclose."

Late-breaking abstract • CNS Disorders • Dermatology • Infectious Disease • Multiple Sclerosis • Nephrology • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Quantifying Adherence to Smartphone-Based Tests Over 96 Weeks in the ARTIOS Study: Monitoring Motor Function, Dexterity, Cognition and Patient-Reported Outcomes in People Living with Relapsing Multiple Sclerosis (ECTRIMS 2025) - "We have collected a large volume of data through smartphone-based active tests and passive monitoring from plwRMS. Our analysis provides insights into the adherence patterns for daily, weekly and fortnightly tests in plwRMS. Further analysis will provide valuable insights into the daily impact of MS on patients' lives, enhancing the understanding of the disease dynamics."

Adherence • Clinical • Late-breaking abstract • Patient reported outcomes • CNS Disorders • Multiple Sclerosis

Tumefactive demyelinating lesion during B-cell depletion therapy by ofatumumab. (PubMed, Mult Scler) - "Ten months after initiating subcutaneous ofatumumab following two episodes of transverse myelitis, the patient developed a large tumefactive lesion with closed-ring contrast-enhancement and intralesional microhemorrhages and was diagnosed as having a TDL by brain biopsy. After repeated intravenous methylprednisolone and plasma exchanges, the TDL gradually shrank, although a perilesional hypointense ring remained on susceptibility-weighted images. TDLs can occur even during B-cell depletion therapy; however, the underlying mechanism is not fully elucidated."

Journal • CNS Disorders • Hematological Disorders

Assessing the Efficacy of Ofatumumab After Natalizumab Discontinuation in RRMS Patients: A Multicentric Observational Study (ECTRIMS 2025) - "Early initiation of ofatumumab after natalizumab discontinuation is associated with effective disease control, supporting ofatumumab as a strategy to prevent rebound activity in RRMS patients and reduce the risk of Relapse-associated worsening (RAW)."

Clinical • Observational data • CNS Disorders • Multiple Sclerosis • Rare Diseases

Real-world effectiveness and safety of Ofatumumab in a Relapsing Multiple Sclerosis cohort (ECTRIMS 2025) - "Introduction: Ofatumumab (OFA) is a subcutaneous, fully human anti-CD20 monoclonal antibody approved for the treatment of Relapsing Multiple Sclerosis (RMS)... These findings demonstrate a strong impact of OFA on disease control with a favorable safety profile. Moreover, this real-world study suggests greater effectiveness of OFA when initiated early in the MS treatment algorithm."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Cardiovascular • CNS Disorders • Cutaneous T-cell Lymphoma • Dermatology • Multiple Sclerosis • Mycosis Fungoides • Myocardial Infarction

Ofatumumab Treatment in Patients with Neuromyelitis Optica Spectrum Disorder (ECTRIMS 2025) - "Subcutaneous ofatumumab treatment significantly reduces the relapse risk, limits worsening of disability and reduced AQP4-IgG titers in NMOSD. Moreover, the safety profiles were generally acceptable. Further research is necessary to explore the sustained clinical response of ofatumumab in NMOSD."

Clinical • CNS Disorders • Infectious Disease • Neuromyelitis Optica Spectrum Disorder • Pneumonia • Rare Diseases • Respiratory Diseases

Ocrelizumab vs. Ofatumumab: A Real-World Comparison of 18-Month NEDA-3 Outcomes in Treatment-Naive Multiple Sclerosis Patients (ECTRIMS 2025) - "In this preliminary analysis of a real-world cohort of treatment-naive MS patients, initiation of ofatumumab or ocrelizumab resulted in comparable 18-month NEDA-3 rates after adjusting for baseline differences. This suggests that failure to achieve NEDA-3 at 18 months in this naive cohort is primarily driven by higher baseline disability and longer disease duration, rather than the specific initial anti-CD20 therapy selected. Future analyses will include: (1) extended follow-up (at years 2 and 5) and an increase in the number of participants for robust long-term comparison; (2) propensity score matching to improve group balance; and (3) examination of individual NEDA components to detail effectiveness."

Clinical • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis

Comparative Effectiveness and Safety of Ofatumumab vs Ocrelizumab in Multiple Sclerosis: A Target-Trial Emulation (ECTRIMS 2025) - "This target trial emulation with nationwide patient representation suggests ofatumumab has similar effectiveness compared to ocrelizumab in adults with MS, and potentially greater effectiveness in treatment naive patients. The findings suggest a similar safety profile, but safety outcomes were imprecisely estimated."

Clinical • HEOR • CNS Disorders • Herpes Zoster • Infectious Disease • Multiple Sclerosis • Nephrology • Rare Diseases • Varicella Zoster

Real-World Effectiveness and Safety of Ofatumumab in Multiple Sclerosis: data from a 24-months follow-up study (ECTRIMS 2025) - "This real-world study confirms OFA as an effective and safe therapy, primarily prescribed to patients with low disability and mild frailty."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Infectious Disease • Multiple Sclerosis