Arzerra (ofatumumab) / Novartis, Genmab - LARVOL DELTA

NCI-2018-01198: Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Cell Lymphoma • Burkitt Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • BCL2

Anti-Rituximab Antibodies Occurrence and Clinical Outcomes in Patients With Primary Membranous Nephropathy. (PubMed, Kidney Int Rep) - "The development of ARAs represents one of the most important prognostic factors in pMN, being significantly associated with a reduced remission rate and a higher relapse rate after rituximab therapy. Alternative therapies with obinutuzumab or ofatumumab should be considered for these patients."

Clinical • Clinical data • Journal • Glomerulonephritis • Nephrology • Renal Disease

Successful sequential treatment with ofatumumab followed by efgartigimod for refractory autoimmune encephalitis with dual anti-NMDAR and anti-GFAP antibody positivity: first case report. (PubMed, Front Immunol) - "OFA induced rapid B-cell depletion, while efgartigimod effectively cleared pathogenic IgG, demonstrating synergistic efficacy. Comparative analysis with literature cases highlighted the superiority of this sequential approach in balancing efficacy and safety."

Journal • CNS Disorders • Immunology • Oncology • Ovarian Cancer

Case Report: Treatment of delayed tremor episodes in a patient with DPPX antibody encephalitis. (PubMed, Front Immunol) - "Steroid therapy was restarted in combination with eculizumab, which was later switched to ofatumumab treatment. The prodromal symptoms of Anti-DPPX encephalitis are easily misdiagnosed as infectious diseases due to the heterogeneity of its clinical manifestations. Early identification of the antibody and initiation of immunotherapy can improve the prognosis."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy • Immunology • Infectious Disease • Inflammation • Movement Disorders • Pain • Psychiatry

Adherence to HBV Screening and Reactivation Prevention Protocols in Patients Receiving Anti-CD20 Treatment (ACG 2025) - "Use of prophylaxis in individuals with +sAg or -sAg/+cAb with tenofovir or entecavir was also assessed. A total of 803 patients received anti-CD20 infusions (rituximab=531, ocrelizumab=223, obituzumab=49, ofatumumab=2), 24% (n=189) of whom did not undergo appropriate sAg and cAb testing before initiation (Figure). The majority of those missing testing (88%; n=166) lacked cAb tests. Patients prescribed ocrelizumab were most likely to have incomplete HBV testing (Figure)."

Adherence • Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Failure • Rheumatology

Ofatumumab for the Treatment of Anti-Neurofascin 155 Autoimmune Nodopathy: A Case Series. (PubMed, Brain Behav) - "Our research findings suggested that ofatumumab holds significant potential for treating anti-NF155 AN."

Journal • Ataxia • Immunology • Movement Disorders • Pain

Case Report: Clinical features and management of anti-mGluR1 encephalitis: case illustration and review of the literature. (PubMed, Front Integr Neurosci) - "We present a case of anti-mGluR1 encephalitis successfully treated with ofatumumab...Therefore, patients suspected of having this encephalitis should be tested for the presence of anti-mGluR1 antibodies in serum and cerebrospinal fluid. Notably, the first-line immunotherapy may be a critical factor influencing clinical outcomes."

Journal • Ataxia • CNS Disorders • Immunology • Movement Disorders

Nodular Lymphocyte-Predominant Hodgkin Lymphoma: Update on Biology and Treatment (ICML 2025) - P2 | "A single-center analysis included 27 NLPB/HL patients treated with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) either alone or followed by consolidation RT...A different analysis investigated 20 patients who had treatment with BR (bendamustine, rituximab)...At 26 months, the 2-year PFS estimate among 28 patients with relapsed NLPB/HL treated with eight weekly doses of ofatumumab was 80%...Novel approaches that might play a role in the future treatment of NLPB/HL include chimeric antigen receptor T-cell therapy and bispecific antibodies. A study investigating the CD20xCD3 bispecific antibody mosunetuzumab in NLPB/HL (NCT05886036) is currently open for recruitment in North America [55]."

IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Nodular Lymphocyte Predominant Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Histiocyte Rich Large B Cell Lymphoma • BCL6 • CARD11 • CD163 • CD4 • CD79A • CD8 • DUSP2 • IGH • IRF4 • JAK2 • JUNB • MME • NOTCH2 • PAX5 • PD-1 • PD-L1 • SOCS1 • STAT6 • TET2 • TNFRSF8

CLINICAL IMPACT OF ANTI-RITUXIMAB ANTIBODIES IN SMALL VESSEL VASCULITIS: A MULTICENTRIC RETROSPECTIVE STUDY (EULAR 2025) - "Following ARA detection, 78% (25/32) required a therapeutic switch, with obinutuzumab being the most frequently used alternative (50%), followed by cyclophosphamide, belimumab, and ofatumumab (9% each). This study provides the first comprehensive characterization of ARAs in small vessel vasculitis, highlighting their association with loss of RTX efficacy and persistent B-cell activity. Our findings suggest that ARAs negatively impact disease control, but switching to an alternative anti-CD20 agent may effectively restore B-cell depletion and induce remission. Future analyses will compare ARA-positive and ARA-negative patients to identify risk factors for ARA development and refine treatment strategies."

Retrospective data • ANCA Vasculitis • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Lupus Nephritis • Musculoskeletal Pain • Nephrology • Pain • Renal Disease • Rheumatoid Arthritis • Rheumatology • Septic Shock • Sjogren's Syndrome • Vasculitis • CRP

THE PROGNOSTIC ROLE OF NEUTROPHIL-TO-LYMPHOCYTE RATIO (NLR) IN WALDENSTRÖM MACROGLOBULINEMIA: AN INDEPENDENT PROGNOSTIC MARKER (EHA 2025) - "However, the response rate to Immunotherapy (Rituximab or ofatumumab) was less among those with high NLR, combined complete response (CR) and very good partial response (VGPR) was 77 % vs 84%, P<0.005. Our study identifies NLR as a simple, cost-effective, and independent prognostic marker in WM. High NLR at diagnosis is associated with worse mOS, higher bone marrow infiltration, increased risk of transformation to DLBCL, and inferior response to immunotherapy. These findings support the role of systemic inflammation in WM progression."

Biomarker • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Lymphoplasmacytic Lymphoma • Monoclonal Gammopathy • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

Anti-drug antibodies are common in Membranous Nephropathy and affect response to rituximab: a multicenter study (ERA 2025) - "In accordance with literature data, our study confirmed that: (1) up to 50% of patients with pMN treated with rituximab develop ADA; (2) ADA are associated with a higher relapse rate in patients with pMN. Furthermore, for the first time we demonstrated that (3) ADA are significantly associated with a reduced remission rate in patients with pMN, making these antibodies one of the most important prognostic factors; (4) standardized monitoring of ADA at both 9th- and 12th-month following rituximab infusion, in addition to the monitoring of ADA prior to rituximab re-administration, would allow the identification of about 90% of ADA positive patients. In this subgroup of patients, alternative therapies with obinutuzumab or ofatumumab should be considered."

Clinical • Glomerulonephritis • Immunology • Renal Disease

Long-term outcomes of patients with Primary FSGS treated with Rituximab (ERA 2025) - "2/5 were re-treated with RTX, 2/5 were treated with steroids and maintenance RTX/ofatumumab, 1/5 was treated with tacrolimus and maintenance ofatumumab. The long-term data from this study suggests that RTX may be effective for achieving and maintaining remission in patients with difficult to treat primary FSGS with a favourable long-term safety profile. Sustained B cell depletion with maintenance RTX dosing was required to achieve a response (at median time of 9.2 months). Response was associated with improved long-term outcomes, but patients do relapse."

Clinical • Diabetes • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Immunology • Infectious Disease

Beyond BCL2 (B cell lymphoma) and BTK (Bruton tyrosine kinase) inhibitors: novel agents and resistance mechanisms for chronic lymphocytic leukemia. (PubMed, Discov Oncol) - "CLL has demonstrated acquired resistance to BTK inhibitors and BCL2 inhibitors, necessitating the development and evaluating of treatment options beyond their use. Cancer immunotherapies such as bispecific antibodies and chimeric T cell therapies present with viable therapies for CLL. Novel agents have also been developed that enhance the cytotoxic effect of T cells. Future studies may focus on the developing treatments that overcome the acquired resistance that results when treatment with standard of care targeted therapies ibrutinib and venetoclax."

IO biomarker • Journal • Review • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

Interventions for idiopathic steroid-resistant nephrotic syndrome in children. (PubMed, Cochrane Database Syst Rev) - "Calcineurin inhibitors may increase the likelihood of complete or partial remission compared with placebo/no treatment or cyclophosphamide. For other regimens, it remains unclear whether the interventions alter outcomes because the certainty of the evidence is low. Further adequately powered, well-designed RCTs are needed to evaluate other regimens for children with idiopathic SRNS. Since SRNS represents a spectrum of diseases, future studies should enrol children from better-defined groups of people with SRNS."

Clinical • Journal • Review • Cardiovascular • Dermatology • Glomerulonephritis • Hypertension • Infectious Disease • Nephrology • Pediatrics • Renal Disease • Transplantation

Real-world data of 535 Japanese patients using ofatumumab (JSNE 2025) - "Co-sponsored by: Novartis Pharma K.K."

Clinical • Real-world • Real-world evidence

Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL (clinicaltrials.gov) - P2 | N=45 | Completed | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Sep 2024

Trial completion • Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD20 • CD5

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

Obinutuzumab and Ofatumumab are More Effective Than Rituximab in the Treatment of Membranous Nephropathy Patients With Anti-Rituximab Antibodies. (PubMed, Kidney Int Rep) - "Obinutuzumab and ofatumumab are more effective than rituximab in treating patients with membranous nephropathy with anti-rituximab antibodies. Anti-rituximab antibodies should be systematically monitored, to determine appropriate treatment."

Clinical • Journal • Glomerulonephritis • Nephrology • Renal Disease

A randomized, controlled, multicenter, open-label clinical trial of the efficacy and safety of B cell depletion followed by daratumumab in the treatment of autoimmune encephalitis (ChiCTR) - P3 | N=200 | Not yet recruiting | Sponsor: the First People's Hospital of Changzhou; the First People's Hospital of Changzhou

New P3 trial • CNS Disorders • Immunology

Ofatumumab for the treatment of COVID-19-associated autoimmune encephalitis: A case report. (PubMed, J Neuroimmunol) - "Nevertheless, his clinical symptoms and cranial MRI abnormalities markedly improved following the administration of Ofatumumab. Administering Ofatumumab early in COVID-19-related autoimmune encephalitis may benefit patients more."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Epilepsy • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

RADIA: Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: The First People's Hospital of Changzhou | Active, not recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Immunology

CDSCO Panel Approves Updated Package Insert For Novartis' Ofatumumab Injection (Medical Dialogues) - "The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the proposal presented by the drug major Novartis for update in package insert for the drug product Ofatumumab solution for injection in pre-filled syringe of 20 mg/0.4 mL with changes in sections of contraindications, warnings and precautions, patient counseling information and instructions for use....This came after the firm presented the proposal for an update in the package insert for the drug product Ofatumumab solution for injection in a pre-filled syringe of 20 mg/0.4 mL based on the U.S. pack insert dated 12 April 2024 with changes in Sections of Contraindications, Warning and Precaution, Patient Counseling Information, and Instructions for Use."

Commercial • Multiple Sclerosis

Enhancing complement activation by therapeutic anti-tumor antibodies: Mechanisms, strategies, and engineering approaches. (PubMed, Semin Immunol) - "At the same time, preclinical and clinical studies on antibodies such as rituximab, ofatumumab, and daratumumab have provided evidence for the role of complement in therapeutic success, encouraging strategies to further enhance its activity. Finally, we highlight the potential of complement-dependent cellular cytotoxicity (CDCC) and complement-dependent cellular phagocytosis (CDCP) as effector mechanisms that warrant deeper investigation. By integrating advances in antibody and complement biology with insights from efforts to enhance complement activation in therapeutic antibodies, this review aims to provide a comprehensive framework of antibody design and engineering strategies that optimize complement activity for improved anti-tumor efficacy."

Journal • Review • Infectious Disease • Oncology

RADIA: Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis (clinicaltrials.gov) - P3 | N=200 | Active, not recruiting | Sponsor: The First People's Hospital of Changzhou

New P3 trial • CNS Disorders • Immunology

Real-world-data on Ofatumumab as First-line Treatment in Early RMS (AIOLOS study) (AAN 2025) - "Objective:The non-interventional study (NIS) AIOLOS evaluates ofatumumab, interferon β1 (IFN-β1) or glatiramer acetate (GA) in treatment-naïve RMS patients who do not meet the highly-active disease criteria in daily clinical routine in Germany.Background:Ofatumumab, a fully human monoclonal aCD20 antibody, showed superior efficacy and comparable safety versus teriflunomide in the Phase 3 ASCLEPIOS I/II overall population and in various subgroups, including recently diagnosed treatment-naive and in non-highly active participants...This interim analysis on real-world use of ofatumumab in treatment-naive RMS patients who do not meet the highly-active disease criteria is in line with data from the pivotal ofatumumab trials and confirms the favorable benefit-risk profile of ofatumumab as first-line treatment. The data provide insights into the RMS patient population treated with different self-administered first-line therapies."

Clinical • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis • IFNB1