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

Developing anti-CD20 molecules and B cell depletion in multiple sclerosis (PubMed, Ideggyogy Sz) - "Since then, three anti-CD20 monoclonal antibodies - ocrelizumab, ofatumumab, and ublituximab - have been developed and approved for MS treatment, whereas rituximab, the first monoclonal antibody shown to be effective, remains an off-label therapy in this indication...Fc engineering can enhance ADCC and partially overcome the functional consequences of FcγRIIIa polymorphisms. This article reviews the structure and mechanisms of action of immunoglobulins and anti-CD20 antibodies; outlines the development of antibody humanization and Fc engineering to enhance efficacy and tolerability; presents clinical data from ublituximab treatment; and discusses additional strategies for achieving effective B-cell depletion."

Journal • Review • CNS Disorders • Multiple Sclerosis

Ocular toxicity associated with anti-CD20 monoclonal antibodies: A pharmacovigilance analysis using the FAERS database. (PubMed, Mult Scler Relat Disord) - "Anti-CD20 antibodies require careful ocular monitoring, particularly in multiple sclerosis patients. The elevated blepharospasm risks with ofatumumab and dyschromatopsia with rituximab highlights potential CNS-and optic pathway-related effects that warrant further study to improve MS treatment safety."

Adverse events • Journal • CNS Disorders • Hematological Malignancies • Immunology • Infectious Disease • Multiple Sclerosis • Ocular Infections • Oncology • Ophthalmology • ROR1

Real World Data of Laboratory Changes and Immunophenotyping in Patients with Multiple Sclerosis Treated with Ofatumumab-Single Center Experience. (PubMed, Biomedicines) - "These findings suggest that routine laboratory monitoring is sufficient for most patients, while immunophenotyping may be reserved for selected clinical scenarios. Further prospective studies integrating clinical and radiological outcomes are needed to better define the clinical relevance of these immunological findings."

Journal • Real-world evidence • CNS Disorders • Infectious Disease • Multiple Sclerosis • CD4 • CD8

Steroid-Resistant Focal Segmental Glomerulosclerosis with Alport-like Glomerular Basement Membrane Lesions Due to a MYO1E Mutation: A Pediatric Case Report. (PubMed, Int J Mol Sci) - "Glucocorticoids induced no remission; sequential calcineurin inhibition (cyclosporine, then tacrolimus) and a single dose of ofatumumab yielded only transient, partial reductions in proteinuria...Supportive therapy with ramipril was continued. At last follow-up (January 2025), renal function was normal (serum creatinine 0.5 mg/dL; creatinine clearance 122 mL/min) with stable sub-nephrotic proteinuria (0.52 g/day; 16 mg/m2 per hour) and normotension. This case broadens clinicopathologic recognition of MYO1E-associated nephropathy and highlights the teaching point that Alport-like GBM changes are not pathognomonic for type IV collagen disorders but may signal defects in podocyte cytoskeletal anchoring."

Journal • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Pediatrics • Renal Disease • Rheumatology

Psoriasis under B-cell depleting therapies in multiple sclerosis: a retrospective multicenter analysis. (PubMed, Ther Adv Neurol Disord) - "B-cell depleting therapies (BCDT), including ocrelizumab, ofatumumab, and ublituximab, are highly effective disease-modifying therapies for multiple sclerosis (MS)...Topical therapies were effective in most cases, but a change of MS treatment or initiation of psoriasis-specific immunotherapies, including the interleukin-17A-antibody secukinumab, was required in four patients...While most cases are manageable with standard psoriasis treatments, severe cases may necessitate therapy adjustments. The potential immunological interplay between MS and psoriasis treatment warrants further investigation."

Journal • Retrospective data • CNS Disorders • Dermatology • Immunology • Multiple Sclerosis • Psoriasis • IL17A

EAFToS: Characterizing the Use of Ofatumumab in a Real World Setting (clinicaltrials.gov) - P=N/A | N=103 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Real-world evidence • Trial completion • CNS Disorders • Multiple Sclerosis

Obinutuzumab use in rituximab-allergic glomerulonephritis patients: experience from Imperial College Healthcare NHS Trust (UKKW 2026) - "A total of 27 patients received obinutuzumab. All patients had a documented allergy to rituximab, predominantly presenting as Type III serum sickness; approximately 15% experienced Type I angioedema. The underlying indications included systemic lupus erythematosus (SLE n=15), ANCA-associated vasculitis (AAV, n=3), membranous nephropathy (MN, n=3), minimal change disease (MCD, n=3), focal segmental glomerulosclerosis (FSGS, n=2) and anti-glomerular basement membrane disease (anti- GBM, n=1)."

Clinical • ANCA Vasculitis • Cardiovascular • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • Vasculitis

SOCIETAL IMPACT ASSESSMENT OF OFATUMUMAB IN RELAPSING-REMITTING MULTIPLE SCLEROSIS: A 5-PILLAR ANALYSIS FROM A SOCIETAL PERSPECTIVE (ISPOR 2026) - "OWSA identified EDSS gain (amplitude: 5.4M MAD), I-O multiplier, and relapse cost as most influential parameters. Ofatumumab demonstrates substantial societal value in Morocco, with over one-third of pharmaceutical investment recovered through productivity preservation, healthcare savings, and economic spillovers. This framework provides comprehensive assessment complementing traditional cost-effectiveness analyses for market access decisions in emerging markets"

CNS Disorders • Multiple Sclerosis

Comparative Efficacy of 35 Disease-modifying Therapies in Relapsing-remitting MS: A Network Meta-analysis Identifying Top Performers for Relapse, MRI Activity, and Disability Progression (AAN 2026) - "At 6 months, SC IFNbeta-1b (RR 0.14) and SC Ofatumumab (RR 0.33) were associated with the lowest disability progression... Alemtuzumab and the Ocrelizumab formulations were highly effective for relapse prevention, while Ponesimod + DMF and Natalizumab formulations reduced MRI lesions. Mitoxantrone was associated with long-term prevention of disability progression."

Retrospective data • CNS Disorders • Multiple Sclerosis

From Brain to Bone Marrow: Concurrent Use of Bruton's Tyrosine Kinase Inhibition and Anti-CD20 Therapy in Relapsing Multiple Sclerosis With Chronic Lymphocytic Leukemia (AAN 2026) - "Natalizumab was maintained until CLL progression with associated dermatologic symptoms prompted transition to acalabrutinib plus subcutaneous ofatumumab. This case underscores the therapeutic complexity of managing concurrent RMS and CLL. It suggests that B-cell–directed therapies, BTKi and anti-CD20, can be used in combination. A crucial consideration is the need to overlap immunotherapies when transitioning from an immune-trafficking agent in the setting of high lymphocyte counts, to reduce the risk of rebound disease."

Chronic Lymphocytic Leukemia • CNS Disorders • Hematological Malignancies • Immunology • Leukemia • Multiple Sclerosis

Appendicitis and multiple sclerosis disease-modifying therapies: a disproportionality analysis of the FDA adverse event reporting system. (PubMed, Mult Scler Relat Disord) - "Patient counseling on early appendicitis warning signs and indications for urgent evaluation may be warranted for people with MS on DMTs."

Adverse events • Journal • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Multiple Sclerosis

Cladribine for the Treatment of Relapsing Multiple Sclerosis: The Northern Ireland Experience (AAN 2026) - "Subsequently, patients commenced ofatumumab (n=6), ocrelizumab (n=4), and natalizumab (n=1)... This study evaluated the Northern Ireland experience of cladribine use in patients with active RMS. Of those treated with cladribine, one quarter had a relapse with MRI activity, and following this received another highly effective DMT. The limitations of this observational study include a small sample size and relatively short median duration of follow up of 6 years, but highlight the importance of real-world data."

CNS Disorders • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Optic Neuritis

Multimodal MRI Assessment of neuroprotective effects of Ofatumumab on brain structure, function, and clinical correlates in Relapsing Multiple Sclerosis. (PubMed, Front Neurol) - "In contrast, the NTG displayed gray matter atrophy. These preliminary findings suggest that OFA treatment may preserve brain structure and function in RMS, with potential neuroprotective effects mediated, through thalamocortical network modulation and white matter restoration."

Journal • CNS Disorders • Inflammation • Mood Disorders • Multiple Sclerosis • Psychiatry

BUDGET IMPACT ANALYSIS OF OFATUMUMAB FOR RELAPSING-REMITTING MULTIPLE SCLEROSIS IN MOROCCO: A PROBABILISTIC MULTI-SCENARIO ASSESSMENT FROM THE PUBLIC PAYER PERSPECTIVE (ISPOR 2026) - "Ofatumumab introduction generates predictable, modest budget impact with quantified uncertainty bounds. Relapse-related savings offset 15.1% of incremental drug expenditure. PSA and scenario analyses demonstrate model robustness, providing transparent evidence for formulary decision-making in resource-constrained settings"

HEOR • CNS Disorders • Multiple Sclerosis

COST-EFFECTIVENESS ANALYSIS OF UBLITUXIMAB FOR THE TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS (ISPOR 2026) - "In Model 2, ublituximab was compared with ofatumumab using weighted ARR for teriflunomide, as both treatments were evaluated against the same active comparator in phase III clinical trials... Results from Models 1 and 2 highlight the sensitivity of cost-effectiveness outcomes to comparator selection and indirect comparison methodology, underscoring the importance of robust comparative effectiveness evidence when evaluating high-efficacy DMTs for RRMS."

Cost effectiveness • HEOR • CNS Disorders • Multiple Sclerosis

ECONOMIC VALUE OF RELAPSE RATE REDUCTION WITH OFATUMUMAB VERSUS COMPARATOR DISEASE-MODIFYING THERAPIES IN RELAPSING MULTIPLE SCLEROSIS: A FIVE-YEAR BUDGET IMPACT ANALYSIS WITH CLINICAL OUTCOME OFFSETS (ISPOR 2026) - "Comparator ARRs from phase III trials and literature: ofatumumab 0.11 (ASCLEPIOS I/II, Hauser NEJM 2020); interferon β-1a IM 0.61; interferon β-1a SC 0.86; teriflunomide 0.37; fingolimod 0.18; natalizumab 0.25; rituximab 0.20... Ofatumumab's superior ARR profile (0.11, lowest in class) generates substantial clinical value through relapse avoidance, translating into quantifiable cost offsets that reduce net budget impact by approximately one-quarter. These findings support value-based pricing negotiations incorporating ARR-driven outcomes"

Clinical • Clinical data • HEOR • CNS Disorders • Multiple Sclerosis • IFNB1

Novel option for maintaining remission of relapsing aPLA2R membranous nephropathy (NKF-SCM 2026) - "INTRODUCTION Rituximab has become first-line therapy for anti-phospholipase A2 receptor antibody membranous nephropathy (aPLA2R-MN) due to efficacy and safety compared with cyclophosphamide–steroid regimens and calcineurin inhibitors...We previously reported remission of rituximab-intolerant aPLA2R-MN using intravenous (IV) ofatumumab; here we describe sustained remission with chronic subcutaneous ofatumumab...He later developed neuropathy attributed to rituximab, possibly related to prior chemotherapy, so cyclosporine was used in a 2020 relapse (aPLA2R 110.5 RU/mL), but treatment was unsuccessful...CONCLUSION While intravenous formulations may be limited by infusion reactions, the subcutaneous version—FDA-approved in 2020 for relapsing multiple sclerosis—offers a well-tolerated alternative. Further studies are needed to define its role as primary, rescue, or maintenance therapy in aPLA2R-MN."

Clinical • CNS Disorders • Diabetes • Glomerulonephritis • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Lymphoma • Metabolic Disorders • Multiple Sclerosis • Nephrology • Renal Disease

What Happens When Older MS Patients Stop Their Anti-CD20? A Two-center Retrospective Study (AAN 2026) - "Stopped anti-CD20 therapies were ocrelizumab (n=37), rituximab (n=14), and ofatumumab (n=1)... In our retrospective study, long-term cessation of anti-CD20 therapy in this older, clinically stable MS population was associated with lasting disease quiescence and functional stability on over 90% of patients, challenging the need for continuous immunosuppression with anti-CD20 in this patient subset."

Retrospective data • Infectious Disease • Multiple Sclerosis

Ofatumumab Treatment Up to Eight Years Shows a Favorable and Consistent Safety Profile in People Living With Relapsing Multiple Sclerosis (AAN 2026) - "Objective: To analyze the long-term safety profile of ofatumumab for up to 8 years (data cutoff: 25 September 2025) in people living with relapsing multiple sclerosis (plwRMS), including those recently diagnosed (≤3 years) and treatment-naive (RDTN).Background: Ofatumumab, a fully human anti-CD20 monoclonal antibody, demonstrated superior efficacy versus teriflunomide in the phase 3 ASCLEPIOS I/II trials in plwRMS... The 8-year results will provide further insights into the long-term safety of ofatumumab in plwRMS including RDTN plwRMS, supporting informed clinical decision-making."

Clinical • CNS Disorders • Infectious Disease • Multiple Sclerosis

Real-world Tolerability, Safety, and Effectiveness of Ofatumumab in Adults With Multiple Sclerosis Over 36 Months (AAN 2026) - " A total of 329 PwMS (mean [SD] age 44.2 [10.2] years; 76% female; 78% White; mean disease duration 12.1 [9.0] years) initiated OMB; 276 (83.9%) had prior disease-modifying therapy (DMT) exposure, most commonly ocrelizumab/rituximab (32%)... OMB was well-tolerated with robust persistence and effectiveness over 36 months. Safety was compatible with randomized clinical trial results. Infection rates rose with increasing treatment duration despite stable IgG, possibly due to IgM reduction."

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

Treatment Patterns, Medication Adherence, and Insurance Barriers in African American Women with Multiple Sclerosis (AAN 2026) - " The most common MS therapies used in this cohort were Ocrevus (42.05%), Tysabri (12.3%), and Kesimpta (12.31%). Treatment patterns in African American women living with MS reflect the range of available therapies, but access barriers related to cost and insurance coverage significantly affect medication adherence. Strategies to address these barriers, such as improved insurance coverage, financial assistance programs, and enhanced patient education, are needed to improve treatment outcomes and reduce disparities in this population."

Adherence • Clinical • Reimbursement • US reimbursement • CNS Disorders • Multiple Sclerosis

Comparative Effectiveness of Alternative versus Standard Anti-CD20 Dosing in Multiple Sclerosis: A Systematic Review and Meta-analysis (AAN 2026) - "These comprised 14 on ocrelizumab, 6 on rituximab, one mixed and one on ofatumumab... Alternative dosing strategies of anti-CD20 monoclonal antibodies appear to provide disease control comparable to standard regimens. Extended interval dosing didnot increase the risk of relapse, MRI activity, disability progression, or NEDA-3 loss. Dose reduction showed similarly stable outcomes, though current evidence remains limited."

HEOR • Retrospective data • Review • 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 (AAN 2026) - "Pregnancy outcomes 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

Beyond B-cells: Neutropenia in the Setting of B-cell Depleting Therapies for Demyelinating Diseases (AAN 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

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