Benlysta (belimumab) / GSK - LARVOL DELTA

Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Hospital for Special Surgery, New York | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial primary completion date • Immunology • Scleroderma • Systemic Sclerosis

Therapeutic Approaches for Cutaneous Lupus Erythematosus: a Changing Landscape of Clinical Trials. (PubMed, J Inflamm Res) - "Existing SLE drugs such as belimumab and anifrolumab have shown potential promise as a treatment for CLE, and a Phase III CLE clinical trial for anifrolumab is ongoing. Other emerging therapies such as deucravacitinib, litifilimab, and enpatoran have been successful with skin-related endpoints in Phase II CLE trials...As CLASI has become an accepted primary endpoint for clinical trials, drug development is shifting to prioritize cutaneous outcomes and to use endpoints that measure skin-specific effects. This targeted approach represents a fundamental change that may ultimately increase FDA-approved therapies specifically for CLE and expand treatment options for patients with CLE."

Journal • Review • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

FROM VISION TO REALITY: EVALUATING SAFETY OF THE FIRST IN HOUSE IMPLEMENTED CD19 CAR-T IN UNITED ARAB EMIRATES FOR SLE PATIENTS (EBMT 2026) - "Biologic B-cell–targeted therapies such as rituximab and BAFF (BlyS) inhibitor therapy such as belimumab have advanced disease control by reducing autoantibody production and modulating immune activation...After rigorous quality control—including sterility, immunophenotyping, and vector copy number—patients received lymphodepletion with fludarabine (25 mg/m² for three days) and cyclophosphamide (1,000 mg/m² for one day)...Treatment demonstrated a favorable safety profile: two patients developed grade <3 cytokine release syndrome resolving after a single tocilizumab dose, and no grade ≥4 CRS or ICANS occurred...Two patients experienced CMV reactivation, managed successfully with oral valganciclovir. UAE's locally produced CD19 CAR-T therapy for SLE shows feasibility, safety, and powerful efficacy, inspiring a bold new era of accessible cellular treatments transforming autoimmune care worldwide for patients."

CAR T-Cell Therapy • Clinical • IO biomarker • Autoimmune Hemolytic Anemia • Cardiovascular • Glomerulonephritis • Hematological Disorders • Hemophilia • Hemophilia A • Immune Thrombocytopenic Purpura • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rare Diseases • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura • Thrombosis

FROM VISION TO REALITY: EVALUATING SAFETY OF THE FIRST IN HOUSE IMPLEMENTED CD19 CAR-T IN UNITED ARAB EMIRATES FOR SLE PATIENTS (EBMT 2026) - "Biologic B-cell–targeted therapies such as rituximab and BAFF (BlyS) inhibitor therapy such as belimumab have advanced disease control by reducing autoantibody production and modulating immune activation...After rigorous quality control—including sterility, immunophenotyping, and vector copy number—patients received lymphodepletion with fludarabine (25 mg/m² for three days) and cyclophosphamide (1,000 mg/m² for one day)...Treatment demonstrated a favorable safety profile: two patients developed grade <3 cytokine release syndrome resolving after a single tocilizumab dose, and no grade ≥4 CRS or ICANS occurred...Two patients experienced CMV reactivation, managed successfully with oral valganciclovir. UAE's locally produced CD19 CAR-T therapy for SLE shows feasibility, safety, and powerful efficacy, inspiring a bold new era of accessible cellular treatments transforming autoimmune care worldwide for patients."

CAR T-Cell Therapy • Clinical • IO biomarker • Autoimmune Hemolytic Anemia • Cardiovascular • Glomerulonephritis • Hematological Disorders • Hemophilia • Hemophilia A • Immune Thrombocytopenic Purpura • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rare Diseases • Rheumatology • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura • Thrombosis

SUCCESSFUL TREATMENT OF LUPUS NEPHRITIS BY SWITCHING FROM BELIMUMAB TO TELITACICEPT: A CASE ANALYSIS (ISN-WCN 2026) - "She was treated orally with methylprednisolone, mycophenolate mofetil, and hydroxychloroquine...After discharge, she was prescribed oral prednisone acetate 6 tablets/day, which gradually reduced to 2 tablets/day after 6 months; combined with cyclophosphamide 0.8g/month (cumulative dose 4.8g); combined with telitacicept 160mg/week; and irbesartan 150mg, once daily.Results January 2025: C3: 0.71 g/L, C4: 0.11 g/L; 24-hour urine protein quantification: 1738.8 mg/24h; serum creatinine: 71 μmol/L, eGFR: 83.56 mL/min.March 2025: C3: 0.71 g/L, C4: 0.12 g/L; 24-hour urine protein quantification: 1112.8 mg/24h; serum creatinine: 70 μmol/L, eGFR: 84.41 mL/min.April 2025: C3: 0.97 g/L, C4: 0.17 g/L; 24-hour urine protein quantification: 560 mg/24h; serum creatinine: 70 μmol/L, eGFR: 84.41 mL/min; anti-dsDNA antibody: 59.67 IU/mL; ANA (titer): 1:320.June 2025: 24-hour urine protein quantification: 324 mg/24h; serum creatinine: 79 μmol/L, eGFR: 82.98 mL/min.No significant adverse..."

Clinical • Alopecia • Fibrosis • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

PHASE 1 STUDY EVALUATING HYDROGEL-FORMULATED UC-MSCS ADMINISTERED SUBCUTANEOUSLY IN ADDITION TO STANDARD OF CARE AS A TREATMENT FOR LUPUS NEPHRITIS (ISN-WCN 2026) - P1 | "Lupus treatment relies on the use of glucocorticoids and conventional immunosuppressants (e.g. methotrexate, azathioprine, or mycophenolate mofetil) and targeted therapies (e.g. belimumab, anifrolumab, or voclosporin) to control disease activity and prevent relapse...Secondary endpoints include changes from baseline in SLE activity scores, patient-reported QoL measurements and prednisone administrationResults As of Oct...Investigation of the safety and clinical utility of SC-administered hf-UC-MSCs as a treatment for lupus and LN is ongoing. Further conclusions to be based on data collected through Jan., 2026"

Late-breaking abstract • P1 data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

TELITACICEPT VERSUS BELIMUMAB IN PROLIFERATIVE LUPUS NEPHRITIS (ISN-WCN 2026) - "Additionally, both groups showed improvements in clinical parameters, but no significant difference was noted at 24 weeks.Conclusion Telitacicept may lead to earlier renal and immunologic remission in patients with proliferative LN than belimumab, potentially reducing the need for glucocorticoids and immunosuppressants. Further validation in larger studies is needed."

Chronic Kidney Disease • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

OVERLAP OF PROPYLTHIOURACIL-INDUCED LUPUS NEPHRITIS AND ANCA-ASSOCIATED VASCULITIS: DIAGNOSTIC SIGNIFICANCE OF MEDULLARY VASCULITIS (ISN-WCN 2026) - "Immunosuppressive therapy with prednisolone, mycophenolate mofetil, hydroxychloroquine, and belimumab led to improved renal function and urinary findings.Conclusion This case presents an overlap between PTU-induced LN and ANCA-associated vasculitis. In the presence of overlapping serological features, histopathological findings, particularly immune complex deposition and medullary vasculitis, provide important diagnostic clues for differentiating between the two conditions. Recognizing these features may aid the differential diagnosis, management, and prognosis of PTU-induced nephritis."

ANCA Vasculitis • Chronic Kidney Disease • Endocrine Disorders • Glomerulonephritis • Grave’s Disease • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Vasculitis • MPO

C3 GLOMERULOPATHY WITH AUTOIMMUNE-LIKE FEATURES: A 12-YEAR COURSE AND RATIONALE FOR IPTACOPAN THERAPY (ISN-WCN 2026) - "Methotrexate was changed to mycophenolate mofetil (MMF) in year 4 (age 17) for relapsing arthralgia and proteinuria...Hydroxychloroquine (HCQ) was administered at year 7 (age 20) for skin and joint manifestations...During years 10-11 (ages 23-24), baricitinib was introduced after belimumab withdrawal but was discontinued at year 12 (age 25) owing to limited efficacy and infection risk...Despite multi-agent immunosuppression, the patient remained steroid-dependent, indicating complement-driven disease activity. Iptacopan, an oral factor B inhibitor, offers a rational steroid-sparing option for complement-driven C3G activation unresponsive to conventional therapy."

Complement-mediated Rare Disorders • Glomerulonephritis • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Musculoskeletal Pain • Systemic Lupus Erythematosus • Varicella Zoster • CTLA4

INITIAL EXPERIENCE WITH IV BELIMUMAB IN LUPUS NEPHRITIS PATIENTS WITH ACUTE KIDNEY INJURY AND FREQUENT RELAPSES: A CASE SERIES FROM SINGLE TERTIARY UNIVERSITY HOSPITAL (ISN-WCN 2026) - "None developed severe infection or infusion reaction.Conclusion Our experience with belimumab suggests its feasibility, preliminary efficacy and tolerability in treating LN patients with AKI and frequent relapses. Findings from this case series support the role of belimumab as an adjunct in difficult-to-treat lupus nephritis, warranting longer follow-up and multicentre validation."

Clinical • Acute Kidney Injury • Glomerulonephritis • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Varicella Zoster • CD163

LONG-TERM EFFICACY AND SAFETY OF BELIMUMAB ON SYSTEMIC LUPUS ERYTHEMATOSUS IN CHILDREN: A META-ANALYSIS OF REAL- WORLD DATA (ISN-WCN 2026) - "Adverse event rates were 12% (95% CI, 6%–21%) at 6 months and 46% (95% CI, 18%–77%) at 12 months. Compared with standard immunotherapy, belimumab yielded greater SLEDAI reduction (MD, 2.86; 95% CI, 1.48–4.24; p<0.001), fewer adverse events (RR, 0.37; 95% CI, 0.19 – 0.73; p=0.004), and higher LN remission (RR, 1.26; 95% CI, 1.03–1.55; p=0.03) at 6 months, and a lower flare risk at 12 months (RR, 0.44; 95% CI, 0.20–0.88; p=0.02), with no other significant differences at 12 months.Conclusion In pediatric SLE, add-on belimumab improves disease control and safety at 6 months and reduces flare risk at 12 months compared with standard immunotherapy."

Real-world • Retrospective data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Eating during immunotherapy sessions: a cross-sectional study of meal quality in patients with rheumatic diseases undergoing intravenous therapy with immunomodulators. (PubMed, Clin Rheumatol) - "Although many patients consumed breakfast prior to their IV infusion immunotherapy sessions, only a small number chose to bring a snack with them. Breakfast quality appeared to be influenced by the type of immunomodulatory therapy patients were receiving. These findings highlight the need for individualized nutritional care and tailored meal guidance on the days of IV treatment, as nutrition may represent a potentially modifiable factor warranting further investigation in relation to therapeutic response and disease outcomes. Key Points • On intravenous immunotherapy treatment days, patients consumed energy-dense breakfast and meal snacks, with moderate protein and high saturated fat content. • Meal composition was influenced by the type of immunomodulatory therapy. • Individualized nutrition guidance is essential, promoting high-protein, plant-based, fiber-rich, and unsaturated fat-rich meals, to support therapy and disease outcomes."

Journal • Observational data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Systemic Lupus Erythematosus

Evolving management of SARD-ILD : Current challenges and emerging treatment options for rheumatoid-associated interstitial lung diseases (PubMed, Z Rheumatol) - "Promising results from ongoing clinical studies provide new therapeutic perspectives for SARD-ILD and PPF and may significantly improve prognosis and disease burden in the future."

Journal • Review • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatology

Integrative Use of Belimumab and Individualized Traditional Chinese Medicine in Refractory Pediatric Lupus Nephritis: A Case Report. (PubMed, J Inflamm Res) - "A pediatric patient with LN presented with persistent gross hematuria, conventional glucocorticoids immunosuppressants and hydroxychloroquine treatment failed to achieve adequate disease control. No serious adverse effects were observed, and clinical remission was sustained throughout the follow-up period. The combination of belimumab and individualized TCM may safely and effectively control refractory childhood LN, reduce corticosteroid dosage, and sustain remission; however, validation through studies with larger sample sizes is required."

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

Efficacy and safety of belimumab in IgA nephropathy: real-world evidence. (PubMed, Nephrol Dial Transplant) - "Belimumab treatment was associated with higher proteinuria remission rates in patients with IgAN, without an increased incidence of common adverse events. These findings suggest that belimumab may represent a superior therapeutic approach for IgAN in real-world clinical practice."

HEOR • Journal • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus

Anifrolumab in Refractory Oral Manifestations in Systemic Lupus Erythematosus: A Case Report and Literature Review. (PubMed, Biologics) - "We report the case of a 39-year-old woman with SLE who developed severe, refractory tongue ulcers and glossodynia persisting for three years, unresponsive to hydroxychloroquine (HCQ), azathioprine (AZA), colchicine, methotrexate (MTX), and glucocorticoids (GC). Belimumab was discontinued due to gastrointestinal intolerance and lack of efficacy on oral lesions...While conventional immunosuppressants such as azathioprine, methotrexate, and mycophenolate mofetil remain options, their efficacy for isolated oral lesions is limited...The key learning point is that refractory tongue involvement may represent a dominant and treatment-resistant manifestation of SLE, yet it can respond to targeted biologic therapy such as anifrolumab and our report adds to this growing body of evidence. Prospective comparative studies and registry analyses are required to define anifrolumab's effectiveness specifically for refractory oral manifestations and to compare outcomes with other..."

Journal • Immunology • Inflammatory Arthritis • Lupus • Rheumatology • Systemic Lupus Erythematosus

Obinutuzumab or Belimumab ? (ERA 2026) - No abstract available

Immunology • Lupus • Lupus Nephritis

Daratumumab and belimumab for patients with neutralising anti-interferon-γ autoantibodies mediated adult-onset immunodeficiency: a case series (ESCMID Global 2026) - No abstract available

Clinical • IFNG

Belimumab in SLE (clinicaltrialsregister.eu) - P4 | N=15 | Recruiting | Sponsor: Amsterdam UMC Stichting | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Systematic Review and Model-Based Meta-Analysis of Targeted Drugs for Systemic Sclerosis. (PubMed, Pharmaceutics) - "Guselkumab, an anti-IL-23 antibody, showed the greatest effect on mRSS, followed by tofacitinib, inebilizumab, and baricitinib. For FVC, B-cell-targeted therapies, with belimumab and rituximab, demonstrated the highest efficacy, while tocilizumab and nintedanib had more moderate effects. Time to 50% maximal response was approximately 27.5 weeks, indicating a 6.3-month period for half treatment response development. This model-based meta-analysis provides a broad comparison of targeted therapies in SSc, highlighting distinct efficacy patterns for skin versus lung involvement and offering hypothesis-generating insights that may support treatment selection and the design of future clinical trials."

Journal • Retrospective data • Review • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis • IL23A

BE-MOBILYZED: BElimumab to MOBIlise memory B-cells from secondary LYmhoid organs to improve memory B-cell HLA-specificity profiling to support delisting for transplant access in highly-sensitiZED. (clinicaltrialsregister.eu) - P1/2 | N=25 | Recruiting | Sponsor: Academisch Ziekenhuis Leiden | Not yet recruiting ➔ Recruiting

Enrollment open • Antibody-mediated Rejection • Transplantation

The immune landscape of systemic sclerosis: from pathogenic mechanisms to precision therapeutic breakthroughs. (PubMed, Front Immunol) - "Emerging therapies targeting the IL-6 receptor (tocilizumab), B cells (rituximab, belimumab, CAR-T), the JAK-STAT pathway (tofacitinib, baricitinib), and T-cell co-stimulation (abatacept) have shown potential to improve disease progression in clinical studies. However, heterogeneity in treatment response, difficulty in reversing fibrosis, and the lack of biomarkers remain current challenges. Future efforts require integrating multi-omics and artificial intelligence technologies to build dynamic predictive models, promoting multi-target combination and individualized therapies, ultimately aiming for early intervention and long-term remission in SSc."

IO biomarker • Journal • Review • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis • IL6

Baseline Serum IgA2 anti-dsDNA as a theragnostic biomarker for low disease activity with belimumab after rituximab therapy in systemic lupus erythematosus (EULAR 2026) - No abstract available

Biomarker • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

The use of belimumab in systemic lupus erythematosus in real life setting: analysis of drug discontinuation and flares from a multicentric, nationwide Italian cohort (BeRLiSS-JS 2.0) (EULAR 2026) - No abstract available

Clinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Targeting B cells in Autoimmune Hepatitis: Clinical experience with Rituximab and Belimumab (EASL 2026) - No abstract available

Clinical • Autoimmune Hepatitis • Hepatitis C • Hepatology • Immunology • Inflammation