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

Hypogammaglobulinemia in patients with multiple sclerosis receiving disease modifying therapies: disproportionality analysis using the EudraVigilance database. (PubMed, Expert Opin Drug Saf) - "The study highlights the importance of monitoring for the occurrence of hypogammaglobulinemia and infections in patients receiving ocrelizumab, ofatumumab and rituximab for MS. These ADRs can be extremely serious and highlight the need for ongoing research to optimize their safety profiles."

Journal • CNS Disorders • Immunology • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Respiratory Diseases

Comparison of B-cell Depletion and Natalizumab for Treatment of Multiple Sclerosis: A Semi-supervised Causal Analysis (P8-1.008). (PubMed, Neurology) - "B-cell depleting (BCD) agents (ocrelizumab, ofatumumab, rituximab) and natalizumab (NTZ) are both higher efficacy disease-modifying therapies (DMTs) for multiple sclerosis (MS)...The institution of Dr. Xia has received research support from Genentech/Roche."

Clinical • Journal • CNS Disorders • Multiple Sclerosis

Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab Treatment (clinicaltrials.gov) - P=N/A | N=40 | Active, not recruiting | Sponsor: University of Southern California | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

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

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

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

The Evolution of Anti-CD20 Treatment for Multiple Sclerosis: Optimization of Antibody Characteristics and Function. (PubMed, CNS Drugs) - "Initial apparent success with rituximab in MS and neuromyelitis optica spurred development of the anti-CD20 monoclonal antibody (mAb) therapies ocrelizumab, ofatumumab, and ublituximab as well as the anti-CD19 mAb inebilizumab...Glycoengineering of the mAbs ublituximab and inebilizumab enhances ADCC and can overcome the reduced responses to mAb-mediated B-cell depletion associated with certain genetic polymorphisms. Other strategies for therapeutic targeting of CD20, including brain shuttle antibodies (e.g., RO7121932), bispecific antibodies, chimeric antigen receptor T-cell therapies, and antibody-drug conjugates, are in active clinical development and may be future treatment approaches in MS and other B-cell-mediated autoimmune diseases."

Journal • Review • CNS Disorders • Hematological Disorders • Hematological Malignancies • Immunology • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Oncology • Rare Diseases

Subcutaneous ofatumumab in recurrent focal segmental glomerulosclerosis after kidney transplantation. (PubMed, Clin Kidney J) - "Treatment typically involves plasmapheresis, with adjunctive rituximab therapy, achieving partial or complete remission in up to 57% of patients. There were no severe adverse effects of the combined protocol. We propose a combination treatment of subcutaneous ofatumumab and intensive plasmapheresis, with CD19 and CD20 levels monitored regularly, might be safe and effective in rFSGS in KT patients."

Journal • Acute Kidney Injury • Allergy • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Pediatrics • Transplantation • CD20

Effects of Anti-CD20 Antibody Therapy on Immune Cell Dynamics in Relapsing-Remitting Multiple Sclerosis. (PubMed, Cells) - "Our interim data add weight to the argumentation that the exhaustion/activation markers, notably TIGIT, may be relevant to the pathogenesis of MS. In addition, we identify a potentially interesting increase in the expression of CD5+ on B cells. Finally, we identified a population of double-negative T cells (KLRG1+HLADR+, in particular) that is associated with MS activity and decreased with CD20 depletion."

IO biomarker • Journal • CNS Disorders • Multiple Sclerosis • CD4 • CD5 • CD8 • CTLA4 • HAVCR2 • KLRG1 • PD-1 • TIGIT

Idiosyncratic Drug-induced Neutropenia Secondary to Ofatumumab Exposure in Multiple Sclerosis: A Case Report and Analysis of Food and Drug Administration Adverse Event Reporting System (P8-1.012). (PubMed, Neurology) - "Three anti-CD20 mAbs (ocrelizumab, ofatumumab, and ublituximab) are currently approved by the Food and Drug Administration (FDA) for MS treatment...Dr. Hooshmand has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapeutics ."

Adverse events • Journal • Agranulocytosis • CNS Disorders • Dental Disorders • Febrile Neutropenia • Granulocytopenia • Hematological Disorders • Infectious Disease • Multiple Sclerosis • Neutropenia • Pain • Septic Shock

Cost-Effectiveness Analysis of Ofatumumab versus Teriflunomide for Relapsing-Remitting Multiple Sclerosis: A 10-Year Markov Model. (PubMed, Clinicoecon Outcomes Res) - "This cost-effectiveness analysis demonstrates that ofatumumab is a cost-effective treatment for RRMS in Saudi Arabia, with an ICER below the WTP. Policymakers should consider including ofatumumab in national formularies and prioritize its use in early-stage RRMS to maximize patient benefit and cost-effectiveness."

HEOR • Journal • CNS Disorders • Multiple Sclerosis

Reconstitution of CXCR3+ CCR6+ Th17.1-Like T Cells in Response to Ofatumumab Therapy in Patients With Multiple Sclerosis. (PubMed, Ann Clin Transl Neurol) - P=N/A | "These findings suggest that ofatumumab impacts interactions among pathogenic B cells, T cells, and myeloid cells, with Th17.1 cells emerging as a potential direct target within T cells. Persistent and regular infusions of ofatumumab appear necessary to sustain clinical efficacy."

IO biomarker • Journal • CNS Disorders • Multiple Sclerosis • CCR6 • CD4 • CD8 • CTLA4 • CXCR3 • FOXP3

WOE of Anti-CD20 Therapies (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Feb 2025 ➔ Dec 2025 | Trial primary completion date: Feb 2025 ➔ Dec 2025

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

ARTIOS: An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab (clinicaltrials.gov) - P3 | N=562 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed | Trial primary completion date: Apr 2025 ➔ Oct 2024

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

Cost-Effectiveness of Ofatumumab for the Management of Multiple Sclerosis from the Perspective of Saudi Healthcare Payers: A 10-Year Markov Cohort Study (ISPOR 2025) - "Compared to teriflunomide, ofatumumab is more cost-effective for the management of RRMS from the perspective of Saudi payers. Additional research should investigate the long-term cost-effectiveness of ofatumumab for a period exceeding ten years."

Cost effectiveness • HEOR • CNS Disorders • Multiple Sclerosis

Case Report: Efficacy of ofatumumab in refractory anti-NMDAR encephalitis: case series and literature review. (PubMed, Front Immunol) - "However, their symptoms were effectively controlled following subcutaneous administration of ofatumumab...Thirteen patients achieved full recovery. These findings suggest that CD20 monoclonal antibodies, particularly ofatumumab, may offer a promising treatment option for anti-NMDAR encephalitis."

Journal • Review • CNS Disorders • Epilepsy • Immunology • Psychiatry

Novartis to present new data at AAN, including seven-year disability outcomes and safety analysis of Kesimpta in people with relapsing multiple sclerosis (Novartis Press Release) - "Novartis will present data from studies across its neuroscience portfolio, including seven-year disability outcomes and safety data from the ALITHIOS open-label extension trial of Kesimpta® (ofatumumab) in people with relapsing multiple sclerosis (RMS), at the American Academy of Neurology (AAN) 2025 Annual Meeting in San Diego from April 5-9, 2025. Additional data on Kesimpta and pipeline assets including remibrutinib and iptacopan will also be highlighted."

Clinical data • Multiple Sclerosis

Recurrent late-onset neutropenia after ofatumumab treatment in a case of multiple sclerosis. (PubMed, Neurol Res Pract) - "This case highlights the necessity of identifying patients at risk and monitoring white blood cell counts regularly for up to 6 months after initial neutropenia."

Journal • CNS Disorders • Dermatology • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Sclerosis • Neutropenia • Oncology • ASXL1 • BCORL1

Study on changes in serum immunoglobulin concentration in multiple sclerosis patients after administration of Ofatumumab (JSNE 2025) - No abstract available

Clinical • CNS Disorders • Multiple Sclerosis

Three cases of multiple sclerosis presenting with palmoplantar pustulosis while receiving ofatumumab (JSNE 2025) - No abstract available

Clinical • CNS Disorders • Immunology • Multiple Sclerosis • Psoriasis

Study of 10 patients with atypical multiple sclerosis using ofatumumab (JSNE 2025) - No abstract available

Clinical • CNS Disorders • Multiple Sclerosis

Immune response to influenza vaccine in patients with relapsing multiple sclerosis treated with ofatumumab: Results from an open-label, multicenter, phase 4 study. (PubMed, Mult Scler Relat Disord) - P4 | "Some OMB-treated patients with RMS were able to mount an immune response following inactivated influenza vaccination. Patients who were vaccinated before OMB initiation generally had a better immune response than those vaccinated after OMB initiation. No T-cell analyses were performed."

Journal • P4 data • CNS Disorders • Infectious Disease • Influenza • Multiple Sclerosis • Respiratory Diseases

Ofatumumab-exposed breastfeeding in multiple sclerosis patients. (PubMed, Mult Scler) - "Ofatumumab-exposed breastfeeding did not adversely affect infants' health or development. Despite higher RIDs using the more appropriate method 2, the risk of substantial antibody absorption by infants appears to be low."

Journal • Observational data • CNS Disorders • Developmental Disorders • Infectious Disease • Multiple Sclerosis

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

Ofatumumab Associated Legionella Pneumonia in a Young Multiple Sclerosis Patient (ATS 2025) - No abstract available

Clinical • CNS Disorders • Infectious Disease • Multiple Sclerosis • Pneumonia • Respiratory Diseases

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

Effect of Treatment on Steroidome in Women with Multiple Sclerosis. (PubMed, Int J Mol Sci) - "Anti-CD20 monoclonal antibodies (mAb), such as ofatumumab and ocrelizumab; inhibitors of the sphingosine-1-phosphate receptor (S1PRI); and IFNβ-1a decreased circulating 17-hydroxy-pregnanes and shifted the CYP17A1 functioning from the hydroxylase- toward the lyase step. Decreased conjugated/unconjugated steroid ratios were found after treatment with anti-MS drugs, especially for glatiramer acetate and anti-CD20 mAb...Anti-CD20 mAb reduced the functioning of enzymes catalyzing the synthesis of immunomodulatory 7α/β and 16α-hydroxy-androgens, which may affect the severity of MS. The above findings may be important concerning the alterations in bioactive steroids, such as cortisol; active androgens and estrogens; and neuroactive, neuroprotective, and immunomodulatory steroids in terms of optimization of anti-MS treatment."

Journal • CNS Disorders • Multiple Sclerosis • CYP17A1 • IFNB1