Arzerra (ofatumumab) / Novartis, Genmab - LARVOL DELTA

Lattice light-sheet microscopy reveals patient specific responses to CD20-directed antibodies in B cell malignancies (ASH 2025) - "IntroductionCD20-targeting monoclonal antibodies (mAbs) are in clinical use and standard of care in the treatment ofhematological malignancies and autoimmune diseases, including rituximab (RTX), obinutuzumab (OBZ)or ofatumumab (OFA)...In a third patient, who was in first relapse10 years after RTX-bendamustine therapy, the highest binding was observed for 2H7 whereas OBZ againshowed the lowest activity...LLS microscopy holds significant potential to support personalization ofimmunotherapies in hematologic malignancies by identifying the most effective mAb for each individualpatient. When integrated with genetic and molecular profiling, LLS microscopy will further contribute to abroader understanding of underlying mechanisms of organism-treatment interactions."

Clinical • Hematological Malignancies • Immunology

Transformed Waldenström macroglobulinemia is associated with poor outcomes and chemorefractory disease (ASH 2025) - "Therapy prior to HT included rituximab (R) (n=4), Ofatumumab (Ofa) alone (n=1), R/Ofa-Benda based (n=12), BTKi (n=10), proteasome inhibitor-based (n=7), FCR (n=2), R-CHOP (n=1), R-Cytoxan(n=1), idealisib (n=1), and venetoclax (n=1)...Treatment for tWMincluded R-CHOP/Pola-R-CHP (70%), dose intense therapies [R-EPOCH, R-CODOX, HyperCVAD, RICE](17%), and 14% received other regimens [R-MPV, R-Cytoxan, R-CEPP]... Our single-center experience recapitulates the poor OS of tWM patients and reinforces theneed for further advances for this vulnerable population. The median time to relapse was less than 12months, suggestive of chemorefractory disease. The presence of CNS involvement significantlyinfluenced PFS."

IO biomarker • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Lymphoplasmacytic Lymphoma • Waldenstrom Macroglobulinemia • ARID1A • CD79B • CDKN2A • CXCR4 • MYD88 • TP53

The addition of inotuzumab ozogamicin to frontline hyper-CVAD and sequential blinatumomab leads to durable survival outcomes in adults with newly diagnosed B-cell acute lymphoblastic leukemia: Four-year follow-up of a phase 2 study (ASH 2025) - "Pts received Hyper-CVAD alternating with high-dosemethotrexate (MTX) and cytarabine (Ara-C) for up to 4 cycles, followed by 4 cycles of blina...Ofatumumab 2000 mg or rituximab 375 mg/m2 wasadministered in pts with CD20>1%...Pts received 12 ITchemotherapies and ursodiol.ResultsAs of July 2025, 75 pts were treated (38 without InO [cohort 1] and 37 with InO [cohort 2])...With death as a competing risk, the 4-year cumulative incidenceof relapse (CIR) rate was 18% for cohort 1 and 8% for cohort 2 (p = 0.177) and 4-year cumulativeincidence of death without relapse rate was 2% and 0% (p = 0.083), respectively.MVA for OS and EFS demonstrates that the administration of InO was the only favorable predictive factorfor OS (no InO HR 12.5; p=0.02) and borderline for EFS (no InO HR 3.15; p=0.06).There were no episodes of veno-occlusive disease.ConclusionFor pts with ND Ph-negative B-ALL, the addition of InO to Hyper-CVAD plus blina leads to promisingsurvival outcomes with the..."

Clinical • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Hepatology • Leukemia • CD20 • CD22 • CRLF2 • KMT2A

Hyper-CVAD versus hyper-CVAD plus blinatumomab for adult patients with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia: A propensity score analysis (ASH 2025) - P2 | "We,therefore, conducted a propensity matched analysis comparing the outcomes of pts with ND Ph-negative(-) B-ALL who received HCVAD vs. HCVAD and sequential blina.MethodsPts with ND Ph- B-ALL 18-60 years who received HCVAD with/without an anti-CD20 antibody(rituximab/ofatumumab) (NCT01363128) or HCVAD and sequential blina with/without inotuzumab(NCT02877303) were included...The duration of maintenance was reducedfrom 30 cycles of POMP (6-mercaptopurine, vincristine, methotrexate, prednisone) to 12 cycles with 1course of blina every third course for a total of 3 courses of blina...For matched Ph-like, the 3- and 5-year EFS rates were 63% and 50% vs. 83% and83% for HCVAD vs. HCVAD/blina, respectively (p=0.271), with 3- and 5-year OS rates of 63% vs. 100%respectively (p=0.099).MVA identified age (EFS HR 1.02 p=0.003 OS HR 1.024 p=0.013), smoking (EFS HR 1.8 p=0.003 OS HR 1.8p=0.01), BMI (EFS HR 1.06 p<0.001 OS HR 1.04 p=0.017), ECOG (EFS HR 2.1 p=0.01), KMT2Ar (EFS..."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • KMT2A

A Randomized, Double-Blind, Placebo-Controlled Study/ Ofatumumab Add-On Therapy in Patients with Treatment-Resistant Depression（OFA-TRD Trial） (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: Beijing An Ding Hospital, Capital Medical University; Beijing An Ding Hospital, Capital Medical University

New P4 trial • CNS Disorders • Depression • Mood Disorders • 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

Impact and risk factors of anti-rituximab antibodies in small-vessel vasculitis: a multicenter retrospective study (ACR Convergence 2025) - "After ARA detection, 27 patients (75%) required a change in therapy, with obinutuzumab being the most common alternative (50%), while others received cyclophosphamide, belimumab or ofatumumab. In conclusion, ARA detection is associated with younger age, Sjogren's syndrome and infusion-related reactions in cryolgobulinemia vasculitis, and with microscopic polyangiitis, renal involvement, and mononeuritis multiplex in AAV, with the RTX regimen of 1 gram on days 1 and 15 being associated with ARA detection in both vasculitis. Monitoring and switching to obinutuzumab may improve outcomes."

Retrospective data • ANCA Vasculitis • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus Nephritis • Nephrology • Rheumatoid Arthritis • Rheumatology • Sjogren's Syndrome • Vasculitis

Ofatumumab for the management of refractory pemphigus vulgaris: A case series. (PubMed, JAAD Int) - No abstract available

Journal • Dermatology • Immunology • Pemphigus Vulgaris

Treatment and prognosis of failure of first-line immunotherapy or recurrent autoimmune encephalitis patients with ofatumumab-a fully human anti-CD20 mAb. (PubMed, Front Neurol) - "However, this study is retrospective, and the clinical sample size is small, which may be biased. In the follow-up study, we will further expand the scale of case collection to further prove the efficacy and prognosis of OFA in treating AE patients."

Journal • Review • CNS Disorders • Epilepsy • Immunology • Psychiatry • CD20

Effectiveness of Anti-CD20 B cells depleting therapy versus conventional treatment in severe Anti-N-methyl-d-aspartate receptor encephalitis: A real-world multi-center prospective cohort study. (PubMed, Neurotherapeutics) - "We aim to evaluate the efficacy of B cell depletion therapy (BCDT) via CD20 antibodies versus conventional first-line immunotherapy only (intravenous methylprednisolone for 5 days, 0.4 ​g/kg intravenous immunoglobulin for 5 days, and ≥4 consecutive plasma exchange treatments, non-BCDT group) in treatment of severe NMDARE in the real-world setting. We calculated the probability of relapse-free as ofatumumab and rituximab reduced risk of disease relapses compared to non-BCDT (ofatumumab vs. non-BCDT: HR, 0.193; 95 ​% CI, 0.062-0.6; p ​= ​0.007; rituximab vs. non-BCDT: HR, 0.265; 95 ​% CI, 0.089-0.787; p ​= ​0.029). Therefore, we suggest that BCDT effectively promoted neurological recovery, and reduced relapse risk with favorable safety, while ofatumumab demonstrated superior efficacy in controlling early disease severity."

Journal • Real-world evidence • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Immunology

Real-world Evaluation of the Efficacy and Safety of Ofatumumab as a Second-line Therapy in Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (ECTRIMS 2025) - "Ofatumumab showed favorable efficacy in reducing relapse rate and disability in patients with refractory MOGAD. However, careful and continuous safety monitoring remains essential during treatment."

Clinical • HEOR • Real-world • Real-world evidence • CNS Disorders • Solid Tumor

Clinical Presentation and Long-Term Outcomes in Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease: A Multicenter Retrospective Study in Greece (ECTRIMS 2025) - "At data collection, immunosuppressive prophylaxis included azathioprine (n=5), mycophenolate mofetil (n=3), rituximab (n=6), ofatumumab (n=1), and low-dose prednisolone (n=5). This cohort highlights the clinical variability of MOGAD. Despite favorable clinical outcomes to the acute treatment regimen, relapses were common, supporting the need for individualized long-term management strategies."

Retrospective data • CNS Disorders • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Optic Neuritis • Solid Tumor

Efficacy and Safety of Ofatumumab in the Treatment of NMOSD: A Multi-Center Prospective Study (ECTRIMS 2025) - "Introduction: B-cell-depleting therapies such as rituximab and inebilizumab are first-line maintenance treatments of neuromyelitis optica spectrum disorder (NMOSD)...We enrolled AQP4-IgG-positive NMOSD patients initiating or switching maintenance immunotherapy to ofatumumab or mycophenolate mofetil (MMF), with at least 72 weeks of follow-up... Ofatumumab demonstrates superior efficacy over MMF in reducing relapse risk among NMOSD patients. These promising results position ofatumumab as a valuable therapeutic option, particularly for MMF-refractory patients."

Clinical • CNS Disorders • Cytomegalovirus Infection • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Telitacicept as a novel B cell-targeted therapy in autoimmune encephalitis: a case report. (PubMed, Front Immunol) - "(2) An anti-leucine-rich glioma inactivated 1 (LGI1) antibody patient resisted corticosteroids, intravenous immunoglobulin, and ofatumumab treatment. (3) A newly diagnosed, anti-LGI1 antibody and anti-contactin-associated protein 2 (CASPR2) antibody dual-positive patient required sequential therapy to consolidate the remission and facilitate prednisone tapering...Our case series evaluates the use of telitacicept in AE patients with varied antibody subtypes, particularly for patients with relapsed or refractory disease, intolerance to CD20-targeted agents, or steroid-related complications. Moreover, telitacicept may serve as an effective sequential therapy to sustain remission and reduce long-term steroid dependency."

Journal • Brain Cancer • CNS Disorders • Gastroenterology • Glioma • Immunology • Inflammation • Oncology • Psychiatry • Solid Tumor • CNTN

A Case of Severe Bilateral Optic Neuritis and a Tumefactive Demyelinating Lesion in Pregnancy. (PubMed, Intern Med) - "Although her bilateral optic neuritis improved with intravenous methylprednisolone, plasma exchange, and intravenous immunoglobulin, the TDL lesion expanded, and the accompanying symptoms worsened. Following a shared decision-making process, the patient received ofatumumab (OFA) after repeated steroid pulse therapy. Subsequently, the lesion enlargement stopped and there was no exacerbation of the symptoms. This case demonstrates the challenges and management of a rare condition involving co-occurrence of severe bilateral optic neuritis and a TDL during pregnancy."

Journal • Ocular Inflammation • Ophthalmology • Optic Neuritis

An engineered IgM antibody targeting CD20 has enhanced complement-dependent cytotoxicity compared to an IgG. (PubMed, Exp Hematol) - "Complement-dependent cytotoxicity (CDC) is one of the main mechanisms of action for approved therapeutic anti-CD20 IgG antibodies, including rituximab, ofatumumab and ocrelizumab, in the treatment of B cell lymphoma patients. An IgM antibody was more effective and efficient at killing tumor cells with low antigen density, in low levels of complement, and in the presence of high complement inhibitor expression. These preclinical studies demonstrate the potential of an anti-CD20 IgM-based therapeutic antibody having superior CDC activity compared to a traditional IgG antibody."

Journal • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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

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