Benlysta (belimumab) / GSK - LARVOL DELTA

Management of Refractory Lupus Nephritis Based on New Guideline: Glomerular and Tubulointerstitial Disorders (KSN 2025) - "Promising options include obinutuzumab, anifrolumab, belimumab, and voclosporin. In this lecture, we will review the key updates in the 2024 KDIGO lupus nephritis guidelines and examine the clinical evidence supporting these changes. We will also explore real-world cases of refractory lupus nephritis and discuss practical examples of how the aforementioned therapies are being applied in clinical practice."

Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Lupus nephritis association with idiopathic CD4 + T lymphocytopenia: a case report of a young man with recalcitrant warts. (PubMed, BMC Nephrol) - "This particular case emphasizes the significance of taking into account the potential presence of underlying immunodeficiency in patients with recalcitrant warts and formulating appropriate treatment strategies. Such patients necessitate meticulous and continuous follow-up by both the dermatology and immunology specialties to vigilantly monitor the emergence of other diseases associated with ICL. Belimumab has manifested outstanding efficacy and safety profiles in SLE patients with compromised immune function."

Journal • Dermatology • Fatigue • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Oncology • Renal Disease • Systemic Lupus Erythematosus • CD4

Incorporating patient perspectives in the design of BEconneCTD-ILD: a belimumab phase 3 trial in CTD-ILD (ERS 2025) - No abstract available

Clinical • P3 data • Interstitial Lung Disease

Does Belimumab Modify the Natural History of SLE? A Propensity Scorematched, Real- World, Basket Study (clinicaltrials.gov) - P=N/A | N=684 | Recruiting | Sponsor: Biomedical Research Foundation, Academy of Athens

New trial • Pan tumor • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Comparative Study of the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus Involving Multiple Units, Based on Previous Data. (clinicaltrials.gov) - P=N/A | N=180 | Active, not recruiting | Sponsor: Yipeng Liu

New trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Real-world effectiveness of belimumab and anifrolumab in systemic lupus erythematosus: comparable trends in disease activity and glucocorticoid reduction. (PubMed, Immunol Med) - "Infection was the most common adverse event (belimumab: 31%, anifrolumab: 41%). Our findings suggest both treatments provide similar effectiveness, with belimumab offering potential benefits in CH50 levels, treatment continuity, and infection risk."

Journal • Real-world evidence • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Placental and breast milk transfer of belimumab in three patients with systemic lupus erythematosus treated through pregnancy. (PubMed, Mod Rheumatol Case Rep) - "Continuation of belimumab throughout pregnancy may be an option to control refractory disease activity and lead to successful outcomes in pregnancies complicated by systemic lupus erythematosus. However, careful monitoring during pregnancy and post-natal follow-up is essential to ensure safety because belimumab can be transferred to the placenta, detected in the neonatal peripheral blood, and affect the neonatal lymphocyte subset counts at birth."

Journal • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Obstetrics • Systemic Lupus Erythematosus • Thrombocytopenia

Development of siRNA Based Therapeutics for Fabry Disease Using Patient Derived Kidney Organoid System: Gene Therapy / RNA Therapy (KSN 2025) - "Key changes include expanded options for initial therapy, such as belimumab-based combinations and calcineurin inhibitor regimens, updated definitions of treatment response, and glucocorticoid-sparing strategies. The guidelines also recommend a prolonged duration of maintenance immunosuppression for at least 36 months and introduce new approaches for managing refractory disease, including the use of novel biologic agents like rituximab...Importantly, the guidelines adopt a more patient-centered approach, aiming to improve long-term renal outcomes while balancing efficacy and safety. This lecture will offer a focused and practical summary of the KDIGO 2024 recommendations, providing clinicians with clear guidance to optimize lupus nephritis management in daily practice."

Clinical • Gene therapy • Fabry Disease • Gene Therapies • Genetic Disorders • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pediatrics • Renal Disease • Systemic Lupus Erythematosus

GN: Advances in Lupus Nephritis Management: Insights from the KDIGO 2024 Guidelines (KSN 2025) - "Key changes include expanded options for initial therapy, such as belimumab-based combinations and calcineurin inhibitor regimens, updated definitions of treatment response, and glucocorticoid-sparing strategies. The guidelines also recommend a prolonged duration of maintenance immunosuppression for at least 36 months and introduce new approaches for managing refractory disease, including the use of novel biologic agents like rituximab...Importantly, the guidelines adopt a more patient-centered approach, aiming to improve long-term renal outcomes while balancing efficacy and safety. This lecture will offer a focused and practical summary of the KDIGO 2024 recommendations, providing clinicians with clear guidance to optimize lupus nephritis management in daily practice."

Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pediatrics

Stratifying patients by TNFSF13B genotype revealed increased flare and renal flare risk, but a greater benefit from belimumab: a potential biomarker for personalized treatment in systemic lupus erythematosus. (PubMed, J Autoimmun) - "Pending further validation, BAFF-var may serve as a predictive and prognostic biomarker for personalized treatment in SLE."

Biomarker • Journal • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • TNFSF13B

Belimumab-driven reductions in retinal microvascular density assessed by optical coherence tomography angiography: insights from systemic lupus erythematosus patients. (PubMed, Front Immunol) - "Belimumab treatment (≥8 times) and hydroxychloroquine use (>5 years) were independently associated with lower DCP-VD, particularly in parafoveal areas. Long-term Belimumab and HCQ treatments were associated with decreased retinal VD. Regular retinal health monitoring was recommended to prevent microvascular complications in SLE patients undergoing prolonged treatment."

Journal • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rheumatology • Systemic Lupus Erythematosus • IL10

Dual benefit of belimumab in post-transplant lupus nephritis: Glucocorticoid withdrawal and extrarenal disease control. (PubMed, Lupus) - "however, there is little information in the literature regarding the use of belimumab in kidney transplant patients and its potential interaction with other immunosuppressive therapies.MethodsThis report presents three clinical cases of renal transplant recipients with LN who received belimumab following transplantation to manage their systemic disease The aim of this case report was to evaluate the efficacy and safety of belimumab administration in renal transplant patients.ResultsBelimumab successfully discontinued or reduced the dose of glucocorticoids, resolved the clinical manifestations of SLE and maintained stable renal function throughout follow-up.ConclusionThese cases highlight belimumab's potential as an effective and safe therapeutic option in managing extrarenal SLE symptoms and reducing glucocorticoid dependence in kidney transplant recipients. Although limited data exists, these findings align with previous evidence supporting belimumab's safety..."

Journal • Chronic Kidney Disease • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • Transplantation

Incidence and prevalence of systemic lupus erythematosus across Italian referral centers and its clinical burden in terms of disease severity, treatment and hospitalization: The ESCULAPIO study. (PubMed, Eur J Intern Med) - "This study provides insights into epidemiological, clinical, and therapeutic features of SLE across referral centers highlighting significant regional disparities and emphasizing the need to increasingly align with EULAR recommendations even in highly qualified centers."

Journal • Immunology • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Systemic Lupus Erythematosus

SEVERE LUPUS PNEUMONITIS: DIAGNOSTIC CHALLENGES AND ROLE OF BELIMUMAB (CHEST 2025) - No abstract available

Immunology • Inflammation • Inflammatory Arthritis • Lupus • Pneumonia

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 role of B cell-activating factor system in autoimmune diseases: mechanisms, disease implications, and therapeutic advances. (PubMed, Front Immunol) - "Emerging strategies, such as sequential therapy with rituximab followed by belimumab, show promise in treating refractory autoimmune diseases such as BP and PV by counteracting the post-depletion BAFF surge. Despite progress, mechanistic gaps in BAFF-mediated crosstalk between innate and adaptive immunity, as well as interspecies-specific pathogenesis warrant further investigation using humanized disease models and single-cell transcriptomic profiling. This review underscores the therapeutic potential of BAFF system modulation while advocating for disease-specific clinical trials to optimize precision-therapeutic targeting in autoimmune diseases."

Journal • Review • Alopecia • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology • Inflammatory Arthritis • Lupus • Pemphigus Vulgaris • Sjogren's Syndrome • Systemic Lupus Erythematosus

Application of Bayesian statistics to support approval of intravenous belimumab in children with systemic lupus erythematosus in the United States. (PubMed, Lupus) - P2 | "These results were further supported by the secondary efficacy endpoints, PK and safety.ConclusionThis approach contributed to FDA's decision to approve belimumab as the first treatment for cSLE. If pre-specified, such an approach may help expedite future clinical development in pediatric rheumatic diseases, and address some of the challenges with conducting trials for rare diseases."

Journal • Immunology • Inflammatory Arthritis • Lupus • Pediatrics • Rare Diseases • Rheumatology • Systemic Lupus Erythematosus

Comparing Efficacy and Safety of Telitacicept and Belimumab in Lupus Nephritis: A Retrospective Multicenter Cohort Study. (clinicaltrials.gov) - P=N/A | N=56 | Active, not recruiting | Sponsor: Yipeng Liu

New trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

FDA approves Benlysta (belimumab) Autoinjector for children with active lupus nephritis (Businesswire) - "GSK plc...announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy. With this approval, GSK is expanding choices for belimumab treatment, offering pediatric lupus nephritis patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home."

FDA approval • Lupus Nephritis

Efficacy and safety of telitacicept in patients with systemic lupus erythematosus complicated with immune thrombocytopenia: a retrospective study (EULAR 2025) - "The previous treatments of the 22 patients included: corticosteroids (n=21), cyclosporine (n=6), tacrolimus (n=4), mycophenolate mofetil (n=5), methotrexate (n=2), cyclophosphamide (n=5), belimumab (n=3), and hydroxychloroquine (n=13). Telitacicept shows promising clinical results in the treatment of SLE patients with thrombocytopenia. Further prospective studies are needed to verify these findings in a larger patient population."

Retrospective data • Hematological Disorders • Herpes Zoster • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Respiratory Diseases • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura • Varicella Zoster

Allogenic CD19 CAR NK Cell Therapy in Refractory Systemic Lupus Erythematosus-A Case Series Study (EULAR 2025) - P1 | "All subjects received one 3 doses treatment cycle consisted of 3 doses after conditioning chemotherapy with fludarabine (25 mg/m²) and cyclophosphamide (300 mg/m²) intravenously on days –5 to –3...Patients had received at least two standard systemic therapies, including 18 (75%) of 24 patients treated with biological agents (Belimumab and Telitacicept), and 1 who underwent plasmapheresis... This study supports that Allogeneic CAR-NK cell therapy is a potent option for autoimmune diseases treatment and indicates that such a therapy might address limitations of currently autologous CAR-T cell therapy, including manufacturing scale and time, access, safety and cost."

Clinical • Late-breaking abstract • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Oncology • Systemic Lupus Erythematosus

Benlysta - opinion on variation to marketing authorisation (European Medicines Agency) - "On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Benlysta. The marketing authorisation holder for this medicinal product is GlaxoSmithKline (Ireland) Limited....Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy."

CHMP • Systemic Lupus Erythematosus

Clinical Outcomes of Patients with SLE Treated with Belimumab, Without Versus With Prior Immunosuppressant Use: a US Claims Database Study. (PubMed, Rheumatol Ther) - "In this large, retrospective, real-word study using IPTW adjustment, initiating belimumab without prior IS use was associated with OGC-sparing benefits and reduced incidence and severity of SLE flares."

Clinical data • Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

INFECTION RISK IN RHEUMATOLOGY PATIENTS RECEIVING INTRAVENOUS IMMUNOSUPPRESIVE TREATMENT: A SINGLE CENTER ONE-YEAR OBSERVATIONAL STUDY (EULAR 2025) - " All patients receiving IV immunosuppressive treatment with cyclophosphamide, rituximab, infliximab, belimumab, tocilizumab, abatacept for 8-month period in our department were included. Infections are seen in the vast majority of rheumatology patients under IV immunosuppressive treatment and the risk for serious infections should be assessed for every patient based on significant commorbidities, treatment agent, cosrticosteroids, IgG levels. Proper education and preventative measures could have a significant impact in lowering the risk for infection."

Clinical • Observational data • ANCA Vasculitis • Ankylosing Spondylitis • Cardiovascular • Chronic Kidney Disease • Diabetes • Giant Cell Arteritis • Hypertension • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Metabolic Disorders • Myositis • Nephrology • Psoriasis • Psoriatic Arthritis • Pulmonary Disease • Rare Diseases • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Seronegative Spondyloarthropathies • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Belimumab to Aid Pre-Transplant Immunological Risk-Stratification by Uncovering Broader HLA-Specific Memory B-Cell Profiles. (PubMed, HLA) - "HLA-specific memory B-cell profiles were assessed before and after treatment, revealing significantly broader HLA-specific memory B-cell profiles after belimumab in addition to a significant increase of HLA-antibody MFI in the eluate of stimulated memory B-cells. This strategy may pave the way for a new paradigm in pretransplant immunological risk-stratification, allowing improved assessment of HLA-specific memory B-cell profiles, which could potentially limit the risk of memory responses."

Journal • Antibody-mediated Rejection • Nephrology • Transplantation