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

Six-year safety and efficacy outcomes with first-line ofatumumab in recently diagnosed treatment-naive patients with relapsing multiple sclerosis. (PubMed, Mult Scler Relat Disord) - "Findings support ofatumumab's highly favourable longer-term benefit-risk profile as first-line therapy for plwRMS."

Journal • CNS Disorders • Infectious Disease • Multiple Sclerosis • Oncology

Selected aspects of epidemiology of multiple sclerosis in Poland: a multicenter pilot study. (PubMed, Neurol Neurochir Pol) - "This study highlights substantial progress in the diagnostic and therapeutic management of MS in Poland over the past 15 years. The widespread implementation of MRI and CSF analysis, alongside significantly improved access to DMTs, has contributed to notably better clinical outcomes. These improvements are reflected in reduced relapse rates, slower disability progression, and a decreased prevalence of secondary progressive MS."

Journal • CNS Disorders • Multiple Sclerosis

Experience with new anti-CD20 monoclonal antibodies for immune-mediated glomerulopathies in a tertiary hospital. (PubMed, Nefrologia (Engl Ed)) - "The indications for the new anti-CD20 therapy were 4 (66%) for refractory disease, 1 (16.7%) recurrent flares, and 1 (16.7%) due to an anaphylactic reaction to rituximab. The new anti-CD20 used were obinutuzumab in 4 (66%) and ofatumumab in 2 patients (33%)...In conclusion, the use of new anti-CD20 therapies for the treatment of immune-mediated glomerular diseases is a safe and effective alternative for its treatment. Further research and clinical trials should be conducted to confirm these positive results."

Journal • Retrospective data • Complement-mediated Rare Disorders • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Lupus Nephritis • Nephrology • Renal Disease

ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients (clinicaltrials.gov) - P=N/A | N=376 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Real-world evidence • CNS Disorders • Multiple Sclerosis

Exploring the wearing-off phenomenon among anti-CD20 therapies in multiple sclerosis. (PubMed, Mult Scler Relat Disord) - "Wearing-off is frequently reported across anti-CD20 therapies, though its subjective nature and lack of biomarkers present challenges for targeted management strategies."

Journal • CNS Disorders • Cognitive Disorders • Fatigue • Mood Disorders • Multiple Sclerosis • Psychiatry

KOSMOS: Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (clinicaltrials.gov) - P=N/A | N=107 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2026 ➔ Mar 2026 | Trial primary completion date: Jun 2026 ➔ Mar 2026

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

Primary large B-cell lymphoma of the central nervous system mimicking inflammatory myelitis at initial presentation. (PubMed, J Clin Exp Hematop) - "Clinicians should maintain a high index of suspicion for central nervous system lymphoma in cases of relapsing myelitis unresponsive to conventional immunotherapy and consider timely biopsy when clinically feasible. Heightened awareness of sentinel lesions may facilitate early recognition and improve outcomes in patients with PCNSL."

Journal • B Cell Lymphoma • CNS Disorders • CNS Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Multiple Sclerosis • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • IL10

Wash-out duration and lymphocyte count in switching from fingolimod to ofatumumab: A case report and literature review. (PubMed, J Neuroimmunol) - "Literature review highlights the complexity of factors influencing rebound, including washout duration, lymphocyte count, and disease control during fingolimod therapy. Evidence suggests that initiating ofatumumab treatment without a prolonged washout period may mitigate rebound risk."

Journal • CNS Disorders • Multiple Sclerosis

STHENOS: Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS (clinicaltrials.gov) - P3 | N=185 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed | Trial completion date: Feb 2026 ➔ Nov 2025

Trial completion • Trial completion date • CNS Disorders • Multiple Sclerosis

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

Effectiveness and safety of ofatumumab in treatment-naive and oral DMT-switched multiple sclerosis patients: a multicenter observational study in China. (PubMed, Mult Scler Relat Disord) - "This real-world study revealed a significant decrease in disease activity and progression among MS patients treated with ofatumumab, both in treatment-naïve and oral DMTs-switched patients, while maintaining a well-tolerated safety profile."

Journal • Observational data • CNS Disorders • Multiple Sclerosis

Multiple sclerosis-associated uveitis successfully controlled with ofatumumab. (PubMed, J Ophthalmic Inflamm Infect) - "While the benefits of ofatumumab have been well reported in MS, this is the first case report to describe the successful treatment of MS-associated uveitis with ofatumumab. Ofatumumab may prove to be an effective therapeutic option for these patients, with the additional benefit of self-administration. Further studies would be beneficial to identify the patients who would most benefit from this treatment."

Journal • CNS Disorders • Inflammation • Macular Edema • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Uveitis • Vasculitis

Optimizing Therapeutic Strategies for Multiple Sclerosis in Italy: A Budget Impact Analysis (ISPOR-EU 2025) - "A more efficient allocation of available therapies could reduce the economic burden on the healthcare system and improve patient access to effective treatments."

HEOR • CNS Disorders • Multiple Sclerosis

Workforce and Environmental Impact of Home-Based vs. Hospital-Based Administration of Second-Line MS Therapies in the Netherlands: A Comparative Analysis of Personnel Time and Carbon Footprint (ISPOR-EU 2025) - "This analysis examines the workforce burden and environmental impact of administering second-line disease-modifying treatments (DMTs) for relapsing-remitting multiple sclerosis (RRMS) in the Netherlands, comparing personnel time requirements and the estimated carbon footprint across different routes and settings. Data were drawn from the MICRO-MARS study involving patients treated with hospital-based intravenous ocrelizumab or natalizumab, or home-based oral cladribine or subcutaneous ofatumumab... Home-based DMT administration requires less workforce input and produces lower CO₂e emissions per administration than hospital-based administration. On an annual basis, the workforce advantage remains, but the CO₂e benefit may be offset when accounting for differences in treatment frequency."

Clinical • CNS Disorders • Multiple Sclerosis

Microcosting Analysis of Oral, Subcutaneous, and Intravenous Second-line Multiple Sclerosis Treatments Administered at Home or in Hospital (ISPOR-EU 2025) - "Patients received either nurse-administered ocrelizumab or natalizumab intravenously (IV) at the hospital, or self-administered cladribine (oral) or ofatumumab (subcutaneous; SC) at home... Home-based administration of RRMS treatments (oral or SC) was associated with lower healthcare and non-healthcare costs compared to hospital-based IV therapies. Including overhead costs would likely widen this difference further. Administration costs should be considered alongside drug costs in cost-effectiveness analyses of RRMS therapies, as they may influence comparative value assessments."

Clinical • HEOR • CNS Disorders • Multiple Sclerosis

Discrete Event Simulation and Treatment Sequencing Cost-Effectiveness Model in Second-Line Highly Active Relapse Remitting Multiple Sclerosis for a NICE Multiple Technology Appraisal (ISPOR-EU 2025) - "OBJECTIVES: We undertook a Multiple Technology Assessment (MTA) for the UK National Institute for Health and Care Excellence (NICE) assessing the cost-effectiveness of natalizumab as second line treatment for Highly Active Relapsing Remitting Multiple Sclerosis (HARRMS) in comparison to cladribine, ofatumumab, ocrelizumab and ublituximab... This was the first NICE MTA to use a DES model built in R and it was found to be robust for decision making. In HARRMS, natalizumab biosimilar was found to have greater INMB than originator but cladribine had greatest INMB. The 95% CrI were wide and decision uncertainty, driven by treatment effects, was high."

Clinical • Cost effectiveness • HEOR • CNS Disorders • Multiple Sclerosis

Cost Savings From Patient Preference-Based Allocation of High-Efficacy Therapies for MS: Evidence From Switzerland (ISPOR-EU 2025) - "Based on estimated real-world HET utilization (66% ocrelizumab i.v., 21% ofatumumab, 9% natalizumab i.v., 4% natalizumab s.c.) and 7,067 patients, treatment-related HET-costs reached EUR 149 million... This CMA shows that pen-at-home administration - favored by most patients - can offer substantial cost savings compared to more resource-intensive regimens. These findings suggest that educating patients about administration options may support preference-aligned treatment choices and improve resource efficiency."

Clinical • HEOR • 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

Assessing the Socioeconomic Value of Ocrelizumab Subcutaneous for Treating Relapsing Multiple Sclerosis in the Evolving Treatment Landscape in the United Kingdom (ISPOR-EU 2025) - "Indirect costs included productivity losses to patients (due to short term absence, long term absence and early retirement) and informal care. The socioeconomic value of ocrelizumab subcutaneous versus ublituximab and ofatumumab was approximately £188 million and £44 million, respectively... The results presented show that reducing MS progression can result in patients going back to work and requiring less informal care. This analysis highlights the importance of considering the societal perspective when assessing the benefit of anti-CD20 medicines in RMS to the wider society."

CNS Disorders • Multiple Sclerosis

CALGB-50904: Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=135 | Completed | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2026 ➔ Sep 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • CD4

IgE-mediated allergic reactions to ocrelizumab in multiple sclerosis: A retrospective cohort study. (PubMed, Mult Scler Relat Disord) - "IgE-mediated allergic reactions to ocrelizumab are uncommon but important to recognize. IDT with immediate reading is useful for diagnosis. A history of allergy may help identify high-risk patients. Ofatumumab is a safe alternative in confirmed cases."

Journal • Retrospective data • Allergy • CNS Disorders • Immunology • Multiple Sclerosis

Multiple sclerosis pathophysiology: a comprehensive review of genetic, environmental, and immunological drivers. (PubMed, Inflammopharmacology) - "Therapeutically, modern disease-modifying therapies (interferon-β, glatiramer acetate, oral S1P modulators, fumarates, teriflunomide, cladribine, natalizumab, anti-CD20 monoclonals including ocrelizumab, ofatumumab, and ublituximab) reduce relapse rates and MRI activity yet do not consistently prevent disability progression-particularly in non-active progressive MS. Acute relapses are treated with high-dose corticosteroids; plasma exchange is reserved for steroid-refractory attacks. These realities motivate mechanism-informed strategies that pair sustained immune control with CNS-intrinsic neuroprotection and remyelination."

Journal • Review • CNS Disorders • Epstein-Barr Virus Infections • Immunology • Infectious Disease • Inflammation • Multiple Sclerosis • HLA-DRB1 • IFNB1

Switch from intravenous anti-CD20 therapy to subcutaneous ofatumumab in patients with relapsing MS: results from the OLIKOS study. (PubMed, J Neurol) - P3 | "The findings indicate efficacy and safety are maintained following a switch from IV anti-CD20 to SC ofatumumab with improved treatment satisfaction."

Clinical • Journal • CNS Disorders • Multiple Sclerosis

Financial Performance First Nine Months of 2025 (GlobeNewswire) - "Revenue was $2,662 million for the first nine months of 2025 compared to $2,198 million for the first nine months of 2024. The increase of $464 million, or 21%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and higher EPKINLY net product sales."

Commercial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Multiple Myeloma • Multiple Sclerosis

Ad hoc announcement pursuant to Art. 53 LR (Novartis Press Release) - "Q3 net sales grew +7% (cc, +8% USD) and core operating income grew +7% (cc, +6% USD)...Sales growth was driven by continued strong execution on priority brands including Kisqali (+68% cc), Kesimpta (+44% cc), Pluvicto (+45% cc) and Scemblix (+95% cc); Core operating income margin1 was stable (cc) at 39.3% despite increasing generic impact"

Commercial • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Glioblastoma • Hematological Malignancies • Melanoma • Multiple Sclerosis • Neuroendocrine Tumor • Ovarian Cancer • Prostate Cancer • Sarcoma