Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria

Lv, Jicheng; Liu, Lijun; Hao, Chuan‐Ming; Li, Guisen; Fu, Ping; Xing, Guolan; Zheng, Hao; Chen, Nan; Wang, Caili; Luo, Ping; Xie, Deqiong; Zuo, Li; Li, Rongshan; Mao, Yonghui; Dong, Shaoshao; Zhang, Pengfei; Zheng, Huixiao; Wang, Yue; Qin, Wei; Wang, Wenxiang; Li, Lin; Jiao, Wenjuan; Fang, Jianmin; Zhang, Hong

doi:10.1016/j.ekir.2022.12.014

Cited by 56 publications

(36 citation statements)

References 32 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Moreover, the eGFR remained stable over time, and AEs were similar in all groups. The results confirmed that telitacicept treatment led to a clinically meaningful reduction in proteinuria in patients with IgAN 37 …”

Section: Treatment Of Igansupporting

confidence: 71%

“…The results confirmed that telitacicept treatment led to a clinically meaningful reduction in proteinuria in patients with IgAN. 37 Atacicept is a fusion protein consisting of the extracellular ligand-binding domain of the TACI receptor and the Fc portion of human IgG. It binds to and inhibits BLyS and APRIL simultaneously, resulting in a reduction in B cell numbers and the disruption of B cell maturation, differentiation, and effector functions.…”

Section: Blys-or April-targeting Antibodiesmentioning

confidence: 99%

“…[30][31][32][33][34] Telitacicept, atacicept, BION-1301, and narsoplimab are mainly indicated for progressive IgAN, with persistent urine protein >0.5 g/day and an eGFR >30 mL/min/1.73 m² based on a background of standard ACEI or ARB treatment. [37][38][39][40] Meanwhile, eculizumab is primarily used for IgAN with aHUS and crescentic IgAN. 40,41 5 | CONCLUSION IgAN is the most common primary glomerular disease, primarily driven by a mechanism associated with the "four-hit hypothesis."…”

Section: Appropriate Patient Population For the Use Of Biologic Agent...mentioning

confidence: 99%

“…However, RTX and OFA have a broader range of suitable patients, including those with MCD‐like IgAN with steroid dependence or relapse, progressive IgAN, crescentic IgAN, IgAN with membranous nephropathy, and IgAN recurrence after kidney transplantation 30–34 . Telitacicept, atacicept, BION‐1301, and narsoplimab are mainly indicated for progressive IgAN, with persistent urine protein >0.5 g/day and an eGFR >30 mL/min/1.73 m² based on a background of standard ACEI or ARB treatment 37–40 . Meanwhile, eculizumab is primarily used for IgAN with aHUS and crescentic IgAN 40,41 …”

Section: Appropriate Patient Population For the Use Of Biologic Agent...mentioning

confidence: 99%

See 3 more Smart Citations

Advances in the treatment of IgA nephropathy with biological agents

Zhuang,

Lu,

2023

Chronic Diseases and Translational Medicine

View full text Add to dashboard Cite

Immunoglobulin A nephropathy (IgAN) is the most common primary glomerular disease, and the “four‐hit” theory represents its currently accepted pathogenic mechanism. Mucosal immunity triggered by infections in the respiratory tract, intestines, or other areas leads to antigen presentation, T cell stimulation, B cell maturation, and the production of IgA‐producing plasma cells. The proteins B‐lymphocyte stimulator (BLyS) and a proliferation‐inducing ligand (APRIL) are involved in this process, and alternative complement and lectin pathway activation are also part of the pathogenic mechanism. Kidney Disease Improving Global Outcomes guidelines indicate that a specific effective treatment for IgAN is lacking, with renin–angiotensin–aldosterone system inhibitors being the primary therapy. Recent research shows that biological agents can significantly reduce proteinuria, stabilize the estimated glomerular filtration rate, and reverse some pathological changes, such as endocapillary proliferation and crescent formation. There are four main categories of biological agents used to treat IgA nephropathy, specifically anti‐CD20 monoclonal antibodies, anti‐BLyS or APRIL monoclonal antibodies, monoclonal antibodies targeting both BLyS and APRIL (telitacicept and atacicept), and monoclonal antibodies inhibiting complement system activation (narsoplimab and eculizumab). However, further research on the dosages, treatment duration, long‐term efficacy, and safety of these biological agents is required.

show abstract

Section: Treatment Of Igansupporting

confidence: 71%

Section: Blys-or April-targeting Antibodiesmentioning

confidence: 99%

Section: Appropriate Patient Population For the Use Of Biologic Agent...mentioning

confidence: 99%

Section: Appropriate Patient Population For the Use Of Biologic Agent...mentioning

confidence: 99%

See 2 more Smart Citations

Advances in the treatment of IgA nephropathy with biological agents

Zhuang,

Lu,

2023

Chronic Diseases and Translational Medicine

View full text Add to dashboard Cite

show abstract

“…In a Chinese phase II trial (NCT 04291781), 44 patients with IgAN received two different dosages of telitacicept, another recombinant TACI fusion protein [35]. After 6 months, proteinuria was reduced by about 50% with high-dose telitacicept.…”

Section: B-cell-targeting Agentsmentioning

confidence: 99%

Novel agents for treating IgA nephropathy

Kunter

Seikrit

Floege

2023

Current Opinion in Nephrology &Amp; Hypertension

View full text Add to dashboard Cite

Purpose of reviewIn the past, the treatment of IgA nephropathy (IgAN), which is the most common glomerulonephritis worldwide, mostly relied on blockade of the renin–angiotensin system as a central component of so-called supportive therapy as well as on high-dose systemic corticosteroid therapy.Recent findingsThe supportive treatment arm has been expanded by the addition of sodium-glucose cotransporter-2 inhibitors, hydroxychloroquine, and, most recently, endothelin A receptor blockers. Treatment with high-dose systemic corticosteroids has become more controversial, with some studies observing no benefit and others documenting the protection of kidney function. However, all recent studies on systemic corticosteroids consistently found significant toxicity. An important novel approach to IgAN, therefore, is therapy with a targeted release formulation of budesonide with preferential release in the distal small intestine, given the mounting evidence for a gut–kidney axis in the pathophysiology of IgAN. In addition, emerging new therapeutic options include a variety of complement inhibitors as well as agents targeting B-cell proliferation and differentiation.SummaryIn recent years, IgAN has become the focus of a considerable number of clinical studies that will significantly advance the development of new therapy strategies.

show abstract

Single‐dose telitacicept therapy for refractory idiopathic membranous nephropathy: A case series

Sun,

Chen,

Zhang

2024

Clinical Case Reports

View full text Add to dashboard Cite

Key Clinical MessageWe report three cases of IMN from our center, where patients received a single dose of telitacicept after showing no response to conventional treatments. Although one case did not respond, the other two cases achieved complete or partial remission of proteinuria. These cases illustrates the telitacicept may offer new hope for the treatment of IMN.AbstractDespite the variety of treatment options available, effective therapies for refractory membranous nephropathy remain lacking. Recently, some reports have suggested that telitacicept is a new therapeutic option. However, only a few published studies have documented the use of telitacicept for treating idiopathic membranous nephropathy (IMN). We present three cases of IMN from our center, where patients received a single dose of telitacicept after showing no response to conventional treatments, including glucocorticoids, tacrolimus, mycophenolate mofetil, cyclophosphamide, cyclosporine, and rituximab. Although one case did not respond, the other two cases achieved complete or partial remission of proteinuria. Thus, telitacicept may offer new hope for the treatment of refractory membranous nephropathy.

show abstract

Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria

Cited by 56 publications

References 32 publications

Advances in the treatment of IgA nephropathy with biological agents

Advances in the treatment of IgA nephropathy with biological agents

Novel agents for treating IgA nephropathy

Single‐dose telitacicept therapy for refractory idiopathic membranous nephropathy: A case series

Contact Info

Product

Resources

About