Aim <p>Given the limitations of current Immunoglobulin A nephropathy (IgAN) therapies, this study sought to evaluate the short-term efficacy and safety of the novel agent Telitacicept, a dual inhibitor of B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), in a real-world clinical setting.</p> Methods <p>This study employed a single-center, retrospective, self-controlled before–after design. Twelve patients with primary IgAN on stable background therapy comprising angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEI/ARB) and a sodium–glucose cotransporter 2 inhibitor (SGLT2i) received add-on Telitacicept treatment for 6&#xa0;months. Data on 24-h urinary protein excretion (24hUP) and estimated glomerular filtration rate (eGFR) were collected at baseline, 3&#xa0;months, and 6&#xa0;months. Urinary red blood cell count and safety-related indicators were collected at baseline and 6&#xa0;months. Efficacy and safety were assessed by comparing intra-individual data across these time points.</p> Results <p>After Telitacicept treatment, 24hUP decreased at 3 and 6&#xa0;months with statistical significance (<i>p</i> = 0.016, 0.004, respectively). The median 24hUP decreased from 1.13&#xa0;g/24&#xa0;h (IQR 0.62–2.24) at baseline to 0.52&#xa0;g/24&#xa0;h (IQR 0.26–1.33) at 3&#xa0;months and was maintained at 0.51&#xa0;g/24&#xa0;h (IQR 0.15–1.07) at 6&#xa0;months, yielding a clinical remission rate of 75.0%. Concurrently, the median eGFR increased from 61.09&#xa0;mL/min/1.73&#xa0;m<sup>2</sup> at baseline to 77.44&#xa0;mL/min/1.73m<sup>2</sup> at 6&#xa0;months, with statistical significance (<i>p</i> = 0.008), and 83.3% of patients showed renal function improvement. The median urinary red blood cell count decreased from 159.00 cells/μL to 15.00 cells/μL with statistical significance (<i>p</i> = 0.005), and 70.0% of patients with baseline hematuria achieved hematuria remission. The incidence of adverse events was low (4 cases), and all were mild. Non-high-density lipoprotein cholesterol (non-HDL-C) levels decreased, with statistical significance (<i>p</i> = 0.028), while other cardiovascular risk indicators remained stable.</p> Conclusion <p>Add-on Telitacicept to standard supportive care may reduce proteinuria, improve renal function, and promote hematuria remission in patients with primary IgAN, with a favorable safety profile.</p>

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Observation on the short-term efficacy of telitacicept in the treatment of primary IgA nephropathy

  • Xiaoling Gu,
  • Chun Xu,
  • Yuqing Hu,
  • Liyun Chen,
  • Meng Liang

摘要

Aim

Given the limitations of current Immunoglobulin A nephropathy (IgAN) therapies, this study sought to evaluate the short-term efficacy and safety of the novel agent Telitacicept, a dual inhibitor of B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), in a real-world clinical setting.

Methods

This study employed a single-center, retrospective, self-controlled before–after design. Twelve patients with primary IgAN on stable background therapy comprising angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEI/ARB) and a sodium–glucose cotransporter 2 inhibitor (SGLT2i) received add-on Telitacicept treatment for 6 months. Data on 24-h urinary protein excretion (24hUP) and estimated glomerular filtration rate (eGFR) were collected at baseline, 3 months, and 6 months. Urinary red blood cell count and safety-related indicators were collected at baseline and 6 months. Efficacy and safety were assessed by comparing intra-individual data across these time points.

Results

After Telitacicept treatment, 24hUP decreased at 3 and 6 months with statistical significance (p = 0.016, 0.004, respectively). The median 24hUP decreased from 1.13 g/24 h (IQR 0.62–2.24) at baseline to 0.52 g/24 h (IQR 0.26–1.33) at 3 months and was maintained at 0.51 g/24 h (IQR 0.15–1.07) at 6 months, yielding a clinical remission rate of 75.0%. Concurrently, the median eGFR increased from 61.09 mL/min/1.73 m2 at baseline to 77.44 mL/min/1.73m2 at 6 months, with statistical significance (p = 0.008), and 83.3% of patients showed renal function improvement. The median urinary red blood cell count decreased from 159.00 cells/μL to 15.00 cells/μL with statistical significance (p = 0.005), and 70.0% of patients with baseline hematuria achieved hematuria remission. The incidence of adverse events was low (4 cases), and all were mild. Non-high-density lipoprotein cholesterol (non-HDL-C) levels decreased, with statistical significance (p = 0.028), while other cardiovascular risk indicators remained stable.

Conclusion

Add-on Telitacicept to standard supportive care may reduce proteinuria, improve renal function, and promote hematuria remission in patients with primary IgAN, with a favorable safety profile.