Tai'ai (telitacicept) / Rongchang Pharma, Vor Biopharma - LARVOL DELTA

Long-term Telitacicept Treatment for Primary IgA nephropathy: Analysis of Five Cases (ERA 2025) - "Based on the treatment experience of five patients with IgAN at our center, telitacicept has demonstrated good efficacy. Long-term telitacicept therapy is particularly effective in slowing the disease progression in IgAN. Drug combination during telitacicept treatment, n Glucocorticoid/immunosuppressor 3 RAASi 5 SGLT2 inhibitors 1 Continuous variables are expressed as median and interquartile range (IQR)."

Clinical • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Renal Disease • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Efficacy and safety of low-dose Telitacicept in patients with primary IgA nephropathy: a retrospective cohort study (ERA 2025) - "Telitacicept was partially used with the supplement of hydroxychloroquine or IS agents (but without corticosteroids) in different doses. This study indicates that low-dose Telitacicept alone or assisted with IS therapy can significantly and safely reduce proteinuria and protect eGFR in patients with IgAN. Additionally, Telitacicept showed superior kidney protection efficacy compared with IS agents during the 4-month follow-up."

Retrospective data • Glomerulonephritis • IgA Nephropathy • Immunology • Renal Disease

Long-term efficacy and safety of successful pregnancy in a patient with IgA nephropathy treated with telitacicept (ERA 2025) - "The outpatient physician prescribed the maximum tolerated dose of the renin-angiotensin-aldosterone system (RAAS) inhibitor valsartan (150 mg orally once daily)...She received her last dose of telitacicept on June 17, 2022; at the same time, the prednisone acetate was also discontinued.However, the patient became pregnant 3 months after stopping the medication...Considering the patient's need for breastfeeding, we administered hydroxychloroquine 200mg/dose twice daily oral maintenance therapy... This report describes the efficacy of telitacicept in patients with IgAN and explores its value in women of childbearing age, suggesting effective and safe treatment options for women who wish to conceive."

Clinical • Chronic Kidney Disease • Glomerulonephritis • Gynecology • IgA Nephropathy • Infectious Disease • Lupus Nephritis • Obstetrics • Renal Disease

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

Efficacy and safety of Telitacicept treatment for proliferative sclerosis IgA nephropathy: A real-world retrospective study (ERA 2025) - "In the tradition group, 35 patients received treatment with corticosteroids and/or other immunosuppressive agents (cyclophosphamide or mycophenolate mofetil, etc). In patients with proliferative sclerosis IgAN (Lee's grades IV - V), treatment with telitacicept resulted in a clinically significant reduction in proteinuria while maintaining stable eGFR without any severe AEs, compared to traditional immunosuppressive therapies. Our study suggested that telitacicept may be a novel treatment option for proliferative sclerosis IgAN.Figure: Fig. A: the mean change rate in 24h-proteinuria from baseline (%) beteween the two treatment groups."

Real-world • Real-world evidence • Retrospective data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Pneumonia • Renal Disease • Respiratory Diseases

Response to telitacicept in optic neuritis associated with Sjogren's syndrome: a case report and literature review. (PubMed, J Neurol) - "SS-associated ON is uncommon and easily misdiagnosed. Conventional therapies for ON cannot control recurrence. Telitacicept might represent a promising choice to treat SS-associated ON."

Journal • Review • CNS Disorders • Dry Eye Disease • Immunology • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Rare Diseases • Sjogren's Syndrome • Xerostomia

Dual BLyS/APRIL targeted therapy with telitacicept in rituximab-refractory SLE-associated neuromyelitis optica spectrum disorder: a case report. (PubMed, Front Immunol) - "The therapeutic regimen was subsequently modified to incorporate subcutaneous telitacicept (160 mg weekly) in combination with glucocorticoid taper protocol and hydroxychloroquine. To our knowledge, this represents the third documented case validating the therapeutic efficacy of telitacicept in NMOSD. Our findings suggest that telitacicept may serve as a disease-modifying therapy for SLE patients with AQP4-IgG-seropositive NMOSD."

Journal • Cardiovascular • CNS Disorders • Dermatology • Immunology • Inflammatory Arthritis • Lupus • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Rare Diseases • Systemic Lupus Erythematosus • Urticaria

A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome (clinicaltrials.gov) - P3 | N=381 | Completed | Sponsor: RemeGen Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2028 ➔ May 2025 | Trial primary completion date: Dec 2027 ➔ Oct 2024

Trial completion • Trial completion date • Trial primary completion date • Immunology • Sjogren's Syndrome

Efficacy and safety of telitacicept in patients with class III- V lupus nephritis: a real-world retrospective cohort study (ERA 2025) - "This real-event study confirmed that the addition of telitacicept to standard therapy significantly boosted clinical remission rates and improved prognosis in patients with LN. It also found that for baseline use of telitacicept only in combination with MMF (with or without hormones), 24hUTP less than 3 g, lower BMI and higher eGFR levels were more likely to achieve CRR. In addition, for patients achieving CRR, we advocate dose reduction of telitacicept after 6 months of treatment."

Real-world • Real-world evidence • Retrospective data • Anemia • Glomerulonephritis • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Telitacicept Therapy in Recurrent IgA Nephropathy Post-Kidney Transplantation: A Case Series and Literature Review (ERA 2025) - "This study reports three distinct cases of recurrent IgAN post-KT, exploring the efficacy and safety of telitacicept combined with cyclophosphamide-methylprednisolone pulse therapy. Telitacicept demonstrates efficacy in inhibiting B cell maturation and suppressing the release of Gd-IgA1 and anti-Gd-IgA1 antibodies, thereby preventing immune complex deposition in the renal mesangium. When combined with pulse therapy, telitacicept shows promising results in treating recurrent IgAN post-KT, significantly reducing proteinuria and hematuria, improving graft function, and exhibiting an excellent safety profile. This study underscores the importance of early diagnosis and proactive management of recurrent IgAN post-KT."

Clinical • Review • Glomerulonephritis • Hepatology • IgA Nephropathy • Infectious Disease • Inflammation • Liver Failure • Renal Disease • Transplantation • CD68 • MRC1

Prospective analysis of B cell subset dynamics following telitacicept treatment in systemic lupus erythematosus. (PubMed, Arthritis Res Ther) - P4 | "Combining telitacicept with standard therapy induced significant changes in B cell subsets and clinical markers in SLE patients. The reduction in naive and transitional B cells, along with the restoration of Breg cell, suggests a potential positive influence on immunoregulatory capacity."

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

The successful use of Telitacicept in IIMs-associated ILD patients: a case series (EULAR 2025) - "Six patients with severe ILD and PaO2/FiO2 less than 300 were treated with glucocorticoid (GCs), Rituximab (RTX) (327 mg/m2/week for four weeks) followed by Telitacicept (160 mg/week), whereas four patients received treatment with GCs and Telitacicept (160 mg/week)...One patient received additional treatment with Nintedanib for pulmonary fibrosis due to insufficient improvement in lung function... Telitacicept demonstrates substantial clinical efficacy in treatment of IIMs-associated ILD, exhibiting a low rate of infections and a favorable safety profile."

Clinical • Immunology • Infectious Disease • Interstitial Lung Disease • Musculoskeletal Pain • Myositis • Pain • IFIH1

Real-World Study on the Effectiveness and Safety of Telitacicept in Treating IgA Nephropathy (ERA 2025) - "Preliminary data indicate that short-course Telitacicept therapy significantly reduced proteinuria levels in individuals with IgAN, a finding of clinical relevance. However, validation through multicenter, prospective trials with extended follow-up periods is imperative to establish therapeutic efficacy and safety."

Clinical • Real-world • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Renal Disease

Two Case Reports of Telitacicept Treatment in Primary IgAN with Low eGFR (ERA 2025) - "Based on our center's treatment experience of two IgAN patients with low eGFR, telitacicept demonstrated good efficacy, filling a gap in IgAN treatment."

Case report • Clinical • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Efficacy and safety of telitacicept in IgA nephropathy: real-world study outcomes. (PubMed, Clin Kidney J) - "Our study confirms that telitacicept has a definite proteinuria-lowering effect in IgAN. Extending the treatment duration from 6 months to 9-12 months further enhances its ability to reduce proteinuria."

Journal • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

Efficacy Evaluation of Telitacicept in IgA Nephropathy: a real-world study (ERA 2025) - "In this analysis of a small single-center cohort, Telitacicept demonstrated significant efficacy in reducing proteinuria and preserve renal function in patients with IgAN over both short-term (3- month) and long-term (≥6-month) treatment periods. Additionally, it exhibited an excellent safety profile, with no treatment-related adverse events observed. These findings support the further investigation and clinical application of Telitacicept in the management of IgAN."

Clinical • Real-world • Real-world evidence • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Immunology • Infectious Disease • Renal Disease • Respiratory Diseases

Exploring Telitacicept for Neurological Autoimmune Disorders: A Case Study on Morvan Syndrome. (PubMed, Am J Case Rep) - "After thorough discussion of alternative options, including intravenous immunoglobulin, plasma exchange, and rituximab, the patient opted for subcutaneous telitacicept at a dose of 160 mg weekly. No infections or other adverse effects were reported during the treatment period. CONCLUSIONS This report has highlighted the approach to diagnosing Morvan syndrome, which can present with peripheral nerve hyperexcitability, and supports the role of immunomodulatory therapy, including telitacicept."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Dermatology • Immunology • Infectious Disease • Neuralgia • Pain • Psychiatry • Sleep Disorder

Telitacicept followed by Rituximab in highly active SLE:two successful cases (ERA 2025) - "First-line treatments for SLE typically include mycophenolate mofetil or cyclophosphamide combined with glucocorticoids (GC). Telitacicept followed by rituximab can effectively relieve the condition of patients with highly active SLE."

Clinical • Glomerulonephritis • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Musculoskeletal Diseases • Musculoskeletal Pain • Nephrology • Orthopedics • Pain • Peripheral Neuropathic Pain • Pulmonary Disease • Systemic Lupus Erythematosus • CD20

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

BCMA-CD19 dual-targeting CAR-T cell for the treatment of refractory thrombocytopenia associated with autoimmune diseases (EULAR 2025) - "Following the lymphodepleting therapy of cyclophosphamide 500mg/m 2 /day, patients were dosed with 0.5-1.0×10 6 CAR-T cells/kg body weight...All patients previously exposed to high dose steroids, Hydroxychloroquine, immunosuppressive drugs (Cyclosporine, Mycophenolate mofetil, Tacrolimus), Intravenous immunoglobulin (IVIg), biological agents (rituximab, telitacicept, beliuzumab) and thrombopoietin receptor agonists...Tocilizumab was administered in 2 patients... Preliminary data from the first 4 patients suggested favorable profiles on safety and efficacy with our novel BCMA-CD19 dual-targeting CAR-T therapy. Remarkable short-interval resolution of thrombocytopenia to date (all patients by day 14 post-cCAR) is encouraging. No severe toxicity has been observed to date."

CAR T-Cell Therapy • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Neutropenia • Rheumatology • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura

A comparison of the effectiveness of corticosteroids or telitacicept management alone in patients with IgA nephropathy: a retrospective observational study (ERA 2025) - "The experimental group was administered subcutaneous injections of telitacicept (160 mg/week), either in combination with or without methylprednisolone/prednisone (0.3-0.5 mg/kg) and/or mycophenolate mofetil (≤1.0 g/d). These findings suggest that both therapeutic regimens are effective for proteinuria reduction, with comparable safety. The corticosteroids group demonstrated superior renal function preservation, while the telitacicept group showed a marginally higher late-phase efficacy trend. The follow-up period of this study is relatively short, indicating a need for longer-term and larger-scale clinical studies to validate long-term outcomes."

Observational data • Retrospective data • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Renal Disease

Long-term efficacy and safety of telitacicept in the treatment of IgAN (ERA 2025) - "Telitacicept could be an effective and safe treatment for high-risk progression IgAN patients."

Clinical • Glomerulonephritis • IgA Nephropathy

Clinical Efficacy and Safety of Telitacicept in the Treatment of Renal Involvement in Primary Sjögren's Syndrome: A Report of 4 Cases (ERA 2025) - "Membranous nephropathy is the most common type of glomerular involvement in pSS. The expression of B cell stimulatory factors BLyS/APRIL was detected in renal specimens of patients with pSS complicated by renal involvement. This clinical observation confirms the efficacy and safety of Telitacicept in treating renal involvement in pSS."

Clinical • Dry Eye Disease • Glomerulonephritis • Immunology • Ophthalmology • Renal Disease • Sjogren's Syndrome • Xerostomia

Efficacy and Safety of Telitacicept in IgA Nephropathy: A Preliminary Report of the Large Single-center Observational Study (ERA 2025) - "Telitacicept can reduce the dose of corticosteroids and is no inferior to corticosteroid therapy in IgAN, the long-term kidney protection still needs to be confirmed."

Clinical • Observational data • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Immunology • Lupus Nephritis • Renal Disease

THE PATHOGENESIS OF TRANSMEMBRANE ACTIVATOR, CALCIUM MODULATOR AND CYCLOPHILIN LIGAND INTERACTOR (TACI) IN PRIMARY SJOGREN'S SYNDROME AND ITS INTRICATE REGULATION OF B CELLS (EULAR 2025) - "Telitacicept reduced B cell proliferation, increased transmembrane TACI expression on B cells, and lowered IgG levels. B cell impairment, especially in Breg subsets, is linked to low TACI expression, which is associated with reduced hsa-miR-30b-5p, activating the TGF-β/Hippo pathway through SMAD1/Id2, contributing to pSS pathogenesis."

IO biomarker • Immunology • Sjogren's Syndrome • CD24 • IL10 • MIR30B • TGFB1