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

Use of B-Cell Depleting Therapy in Advanced Age Multiple Sclerosis Patients Aged 70 Years and Older: A Single-Institution Experience (ACTRIMS Forum 2026) - "We evaluated safety and clinical outcomes for MS patients who are age 70 years or older on B-cell depleting therapy. This is a retrospective study of patients at a single comprehensive MS center with a confirmed diagnosis of multiple sclerosis (ICD-10 code G35) who are at or above the age of 70 years and undergoing treatment with Ocrelizumab, Ofatumumab, or Ublituximab. We identified a total of 47 patients (61.7% women) with MS at or above the age of 70 years at our center who were being treated with a B-cell depleting therapy... Treatment with B-cell therapy was generally well tolerated in older MS patients at or above 70 years old. While the annualized infection rate was increased after initiating B-cell therapy, severe infections requiring hospitalization remained uncommon and hypogammaglobinemia did not correlate with infection risk. These findings suggest that B-cell-depleting therapies can be used safely in carefully selected older adults with MS, though infection..."

Clinical • Metastases • CNS Disorders • Infectious Disease • Multiple Sclerosis

Real-world Effectiveness and Safety Outcomes of Ofatumumab as First-line Treatment in Early RMS (ACTRIMS Forum 2026) - "Background & Objectives: Ofatumumab demonstrated superior efficacy and comparable safety versus teriflunomide in Phase 3 ASCLEPIOS I/II overall relapsing multiple sclerosis (RMS) population and in various subgroups...This prospective, multicenter non-interventional study (NIS) evaluates ofatumumab, interferon beta 1 (IFN) or glatiramer acetate (GA) in treatment-naive people living with RMS (pwRMS) without highly active disease in routine care in Germany... This interim analysis of real-world data on ofatumumab use in treatment-naive pwRMS without highly active disease aligns with findings from pivotal clinical trials and supports the favorable benefit-risk profile of ofatumumab as a first-line therapy. By combining clinical outcomes with patient-reported measures, the study offers deeper insights into the RMS population treated with various self-administered first-line therapies. These findings contribute to a more comprehensive understanding of RMS management in..."

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

Pregnancy and Infant Outcomes in Women With Relapsing Multiple Sclerosis Following Exposure to Ofatumumab: Latest Evidence From the PRIM Study (ACTRIMS Forum 2026) - "As the number of cases collected via the PRIM program grows, findings suggest that prevalence estimates for pregnancy outcomes, as well as major and minor malformations, following maternal ofatumumab administration during pregnancy or up to 180 days prior to LMP are in line with expected background rates in the general population."

Clinical • CNS Disorders • Genetic Disorders • Multiple Sclerosis

Real-World Infusion Experience with Ublituximab in ENABLE: the First Phase 4 Observational Study for Patients with Relapsing Multiple Sclerosis Initiating Ublituximab (ACTRIMS Forum 2026) - P | "In Phase 3 studies (ULTIMATE I and II) ublituximab demonstrated significant reduction in MS disease activity versus teriflunomide...About 32% were treatment-naïve at the start of ENABLE and 28% transitioned to ublituximab from a B-cell therapy- ocrelizumab, ofatumumab or rituximab, followed by 19% from natalizumab...Premedication included corticosteroids (methylprednisolone, 88.5% of patients), antipyretic (paracetamol, 79.8%), and antihistamines (diphenhydramine, 77.6%; cetirizine, 12.8%)... ENABLE patients experienced lower IRRs at the first dose compared to ULTIMATE. IRRs continued to decrease at subsequent doses, and infusions were completed within the specified time. Overall, ublituximab infusions were well-tolerated in this real-world observational study."

Clinical • Observational data • P4 data • Real-world • Real-world evidence • CNS Disorders • Dermatology • Multiple Sclerosis • Pruritus

Neutropenia in the Setting of B-cell Depleting Therapies for Demyelinating Diseases (ACTRIMS Forum 2026) - "Episodes of neutropenia occurred with ocrelizumab (n=24), rituximab (n=8), ofatumumab (n=9) and ublituximab (n=1)... In our experience, patients who had asymptomatic cyclic or presumed “benign” neutropenia tolerated B-cell depletion well, whereas neutropenia as an adverse drug effect, associated with sepsis/fever, prompted medication switches. Neutropenia did not always spontaneously reverse and in some people, neutropenia appeared to be a class effect of B-cell depleting therapies, possibly reflecting presence of an inherent susceptibility."

CNS Disorders • Hematological Disorders • Immunology • Infectious Disease • Multiple Sclerosis • Neutropenia • Septic Shock

Real-World Effectiveness, Tolerability, and Safety of Ofatumumab in Adults with Multiple Sclerosis over 36 Months (ACTRIMS Forum 2026) - "Most (n=276, 83.9%) had prior disease-modifying therapy (DMT) experience with the most common prior DMTs being ocrelizumab or rituximab (n=105, 38.0%)... In our real-world cohort, OMB was well-tolerated with good treatment persistence. Safety and effectiveness data remained compatible with those from randomized clinical trials. Infection rates increased with increasing time on therapy despite a stable IgG trend that may in part be due to IgM reduction."

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

Cortical Atrophy and Cognitive Outcomes in Relapsing MS Patients Treated With Ofatumumab: a Real-World Longitudinal Study (ACTRIMS Forum 2026) - "In our cohort, treatment with OFA was associated with an improvement in cognitive performance, despite the observation of relatively high rates of brain atrophy and cortical thinning in patients with longer disease duration and older age. Studies with longer follow-up and larger sample sizes are needed to further investigate these results."

Clinical • Longitudinal study • Observational data • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis

Effect of Ofatumumab on NfL and GFAP Levels in Treatment-Naïve Patients With Early Relapsing Multiple Sclerosis: Results From the AGNOS Study (ACTRIMS Forum 2026) - P4 | "The AGNOS study confirms that OMB is effective in reducing biomarkers of neuroaxonal injury in people living with RRMS. Participants with very early, recently diagnosed, treatment-naïve RRMS on OMB and HCs had similar biomarker levels. These findings support OMB as a first-line therapy in early RRMS."

Clinical • CNS Disorders • Multiple Sclerosis • GFAP • NEFL

CNS Inflammatory Lesions in a Patient with Behçet’s Disease: A Case of Neuro-Behçet’s versus Behçet’s Disease with Multiple Sclerosis (ACTRIMS Forum 2026) - "She was started on apremilast, hydroxychloroquine, colchicine, and prednisone... This case highlights the challenge in determining a diagnosis of NBD versus BD with MS. Our patient’s CNS lesions appear more consistent with MS. However, certain factors raise the possibility of a diagnosis of NBD and overlap syndrome: she had a higher degree of disease activity than expected for MS while on high potency B-cell therapy, she had multi-system involvement related to BD as seen in her cardiac and gastroenterological manifestations, and she developed migrainous headaches prior to starting BD treatment which are a common presentation of NBD."

Clinical • CNS Disorders • Dermatology • Migraine • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases • Uveitis • Vasculitis

Preliminary Baseline Characteristics and Early Follow-up in the COAST Study: Anti-CD20 to Ozanimod Sequencing Trial (ACTRIMS Forum 2026) - "For the 23 subjects starting ozanimod, the mean age at enrollment was 55 (range: 38-68) years, and most were women (60.9%), Caucasian (100%), and previously on ocrelizumab (69.6%, 21.7% on rituximab, and 8.7% on ofatumumab)... The COAST study is 23% enrolled with sequencing from B-cell depleting therapies to S1PR ozanimod appearing to maintain efficacy early in this transition. This is a three-year study that is ongoing to better evaluate efficacy and safety of this treatment switch."

CNS Disorders • Infectious Disease • Multiple Sclerosis • Nephrology

Efficacy and Safety of Ofatumumab in Treatment-Naive People With Early RMS and Low Clinical Disease Activity (ACTRIMS Forum 2026) - "Background & Objectives: Ofatumumab (OMB), a fully human anti-CD20 monoclonal antibody approved for self-administration, has demonstrated sustained efficacy and a favorable safety profile compared to teriflunomide (TER) in people living with relapsing multiple sclerosis (plwRMS), including treatment-naive plwRMS... In this subgroup of treatment-naive people with early RMS and low clinical disease activity, the safety profile of OMB was consistent with that of the overall study population, and treatment with OMB was associated with more than two-fold higher odds of remaining free of disease activity in Year 1 and nearly 20-fold in Year 2, compared to TER. Results support first-line use of OMB in plwRMS with low disease activity and reinforce the benefit of early OMB initiation in this population."

Clinical • CNS Disorders • Multiple Sclerosis • NEFL

Efficacy of Ofatumumab in People With Relapsing Multiple Sclerosis and Breakthrough Disease on Oral Therapies: A Subgroup Analysis of ARTIOS in Hispanic/Latino and Not Hispanic/Latino Participants (ACTRIMS Forum 2026) - "In the ARTIOS study, OMB treatment showed similar and strong disease control in both Hispanic/Latino and Not Hispanic/Latino subpopulations of plwRMS who previously experienced suboptimal responses to fingolimod or fumarate-based therapies."

Clinical • CNS Disorders • Multiple Sclerosis

Efficacy and Safety of Ofatumumab in Chinese Participants With Relapsing Multiple Sclerosis: Results From a 12-Month, Prospective, Open-Label, Multicenter Study (ACTRIMS Forum 2026) - P4 | "Additional endpoints included gadolinium-enhancing (Gd+) T1 lesions, new or enlarging T2 (neT2) lesions, changes in T2 lesion volume, 3-month confirmed disability progression (3mCDP), and safety (NCT05199571). Of 115 participants screened, 99 received ofatumumab (20 mg SC), of whom 95 (96.0%) completed the treatment period... Ofatumumab provided clinical meaningful benefits in Chinese patients with RMS and was well tolerated. The efficacy and safety profile were generally consistent with the phase 3 ASCLEPIOS I/II trial results."

Clinical • CNS Disorders • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Respiratory Diseases

Efficacy of Ofatumumab Versus Teriflunomide Based on MRI-Verified Relapses: A Post-hoc Analysis from ASCLEPIOS I/II (ACTRIMS Forum 2026) - "In this analysis, the reduction in ARR with OMB compared to TER based on MRI-verified relapses was greater than the ARR difference reported in the pivotal ASCLEPIOS I/II trials. This suggests that MRI-verified relapses may serve as a more specific composite endpoint that more accurately reflects disease activity and enhances the ability to detect treatment differences in ARR. Conversely, unverified relapses (which may include pseudo-relapses) may potentially be a marker of impending disability worsening."

Clinical • Retrospective data • CNS Disorders • Multiple Sclerosis

Findings from the OLIKOS Study: B-Cell Concentrations in Patients with Relapsing Multiple Sclerosis Switching from Intravenous Anti-CD20 Therapies to Ofatumumab (ACTRIMS Forum 2026) - P3 | "Ocrelizumab (OCR) and rituximab (RTX) are typically administered intravenously (IV) every 6 months, whereas ofatumumab (OMB) is administered subcutaneously (SC) via autoinjector pen once per month... After switching to OMB, B-cell concentrations were below LLN across all subgroups and all time points (Months 6 and 12). This suggests a more stable pharmacodynamic effect with OMB treatment, leading to a more consistent and sustained effect on B-cell concentration which may be due to the more frequent dosing (once per month) of OMB compared to OCR/RTX (every 6 months)."

Clinical • CNS Disorders • Multiple Sclerosis

Using the Octave® MSDA Test to Identify Differences in Disease Activity and Panel Biomarkers Between Natalizumab and Anti-CD20 Therapies (ACTRIMS Forum 2026) - "This analysis compares overall disease activity score and individual biomarkers in patients on natalizumab versus anti-CD20 (ocrelizumab, ublituximab, ofatumumab, rituximab). A retrospective analysis characterized longitudinal changes in Octave® MSDA scores for patients on anti-CD20 therapies or natalizumab... Median DA scores were low for both treatment groups, with anti-CD20 patients showing lower scores than natalizumab, suggesting suppression of biomarker-based disease activity. These findings highlight distinct immunological effects of different MOAs and support the utility of the MSDA test in monitoring DMT-specific real-world biological signatures. Additional research is required to further validate these findings in order to guide individualized care for MS patients."

Biomarker • CNS Disorders • Multiple Sclerosis • CXCL13 • IL12B • SERPINA9 • TNFSF13B

Real world predictors of hypogammaglobulinemia and serious infections in patients receiving ocrelizumab or ofatumumab for the treatment of multiple sclerosis: The REPLACE-MS study. (PubMed, Mult Scler) - "Age over 50, Caucasian race, time on therapy 3 or more years were risk factors for HGG."

Journal • Real-world evidence • CNS Disorders • Infectious Disease • Multiple Sclerosis

AGNOS Study Results Demonstrate Ofatumumab’s Impact on Neurofilament Light, GFAP (NeurologyLive) - "In the analysis, mean serum GFAP levels in the ofatumumab group decreased from 23.17 pg/mL at baseline to 20.36 pg/mL at month 6 and remained stable at 20.57 and 21.22 pg/mL at months 12 and 18, respectively. In healthy controls, sGFAP concentrations were lower and relatively unchanged over time, measuring 15.35 pg/mL at baseline and ranging from 14.51 to 15.25 pg/mL through month 18."

P4 data • Multiple Sclerosis

Multiple Sclerosis With Migraine and Pyoderma Gangrenosum Treated With Ofatumumab and Erenumab. (PubMed, Cureus) - "She experienced persistent migraines despite valproic acid and sumatriptan use. After the administration of intravenous methylprednisolone (IVMP), ofatumumab treatment was introduced; erenumab was later initiated to manage migraines...The combination therapy demonstrated effectiveness without exacerbating the patient's underlying dermatological condition. This case suggests that combining ofatumumab and erenumab is a viable therapeutic option for patients with MS and comorbid migraine and pyoderma gangrenosum, offering effective disease control with an acceptable safety profile."

Journal • CNS Disorders • Migraine • Multiple Sclerosis • Pain • Pyoderma Gangrenosum

Net sales grew +8% (cc1, +8% USD) with core operating income up +14% (cc, +12% USD) (GlobeNewswire) - "Sales growth driven by continued strong performance from priority brands including...Kesimpta (+36% cc)...Cosentyx (+8% cc)...Kesimpta (USD 1 228 million, +27% cc) sales grew across all regions driven by increased demand and strong access...Cosentyx (USD 1 807 million, +11% cc) sales grew across all regions, driven by volume, with continued demand for recent launches (including HS and IV in the US) and steady performance in core indications (PsO, PsA, AS and nr-AxSpA)...Leqvio (USD 335 million, +46% cc) continued steady growth across all regions...Fabhalta (USD 155 million, +167% cc) sales grew, reflecting continued launch execution in PNH as well as renal indications IgAN and C3G."

Sales • Ankylosing Spondylitis • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia • Hidradenitis Suppurativa • Multiple Sclerosis • Paroxysmal Nocturnal Hemoglobinuria • Psoriasis • Psoriatic Arthritis

Ofatumumab Versus Intravenous Ocrelizumab after Sphingosine-1-Phosphate Receptor Modulators in Patients with Relapsing-Remitting Multiple Sclerosis: A Real-World Inverse Probability of Treatment Weighting Multicenter Study. (PubMed, CNS Drugs) - "In S1PRM-exposed RRMS, OFA was associated with reduced relapse risk, disability accumulation, EDSS worsening, and MRI activity compared with OCR, with overall good tolerability and safety."

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

Industry Therapeutic Update from Novartis Pharmaceuticals: Switch to KESIMPTA® (ofatumumab): Bridging clinical data and real-world experiences with Gabriel Pardo, MD, FAAN and Zenovia, a real patient (AAN 2026) - "Sponsored by Novartis Pharmaceuticals. Learning Objectives Explore how clinical data and real-world experience inform decision-making around a switch to KESIMPTA."

Clinical data • Real-world • Real-world evidence

Industry Therapeutic Update from Novartis Pharmaceuticals: Switch to KESIMPTA® (ofatumumab): Bridging clinical data and real-world experiences with Gabriel Pardo, MD, FAAN and Zenovia, a real patient (AAN 2026) - "Sponsored by Novartis Pharmaceuticals."

Clinical data • Real-world • Real-world evidence

Real-world evidence of clinical outcomes and adherence to ofatumumab in the UK and the impact of a patients support programme: A retrospective, non-interventional cohort study. (PubMed, Mult Scler Relat Disord) - "This study provides evidence of good adherence for RMS patients using ofatumumab. Further, there is evidence of clinical effectiveness based on reduction in ARR post-ofatumumab initiation, as well as tolerability and a favourable safety profile. The results of this study support the continued use of ofatumumab in providing effective RMS disease management in the UK NHS."

Clinical data • HEOR • Journal • Real-world evidence • Retrospective data • CNS Disorders • Multiple Sclerosis

9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis (clinicaltrials.gov) - P3 | N=10 | Completed | Sponsor: Brigham and Women's Hospital | Recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis