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Telitacicept for childhood HSPN: A prospective self-controlled study
Hanhan Zhang1, Dan Song2, Ke Song1
1Pediatric Nephrology and Purpura Center, Children's Hospital, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, 450000, China.
Insights
Telitacicept (RC18) effectively treats Henoch-Schönlein Purpura Nephritis (HSPN) in children by reducing urine protein and red blood cells. This study confirms its good clinical effects and safety profile for pediatric HSPN management.
Area of Science:
- Pediatric Nephrology
- Immunology
- Rheumatology
Background:
- Henoch-Schönlein Purpura Nephritis (HSPN) is a common vasculitis affecting children, characterized by kidney inflammation.
- Current treatments for HSPN often have limitations, necessitating the exploration of novel therapeutic agents.
- Telitacicept (RC18) is an emerging biologic agent with potential immunomodulatory effects.
Purpose of the Study:
- To evaluate the efficacy and safety of Telitacicept (RC18) in pediatric patients diagnosed with HSPN.
- To assess the impact of Telitacicept on key clinical and laboratory markers of HSPN.
- To explore the potential mechanisms of action of Telitacicept in HSPN treatment.
Main Methods:
- A prospective, self-controlled study involving children with HSPN.
- Treatment with Telitacicept (RC18) administered over a 1-4 month follow-up period.
- Monitoring of 24-hour urine total protein (UTP), urinary red blood cell (RBC) count, renal function, and safety parameters.
Main Results:
- Telitacicept demonstrated a 100% response rate for 24-hour UTP and a 66.7% response rate for urine RBC count.
- Significant reductions in 24-hour UTP and urinary RBC count were observed post-treatment (P<0.01).
- Renal function remained stable, and no serious adverse reactions were reported, though minor biochemical and injection site reactions occurred.
Conclusions:
- Telitacicept (RC18) is effective in reducing proteinuria and hematuria in children with HSPN.
- The treatment shows a favorable safety profile, making it a promising option for pediatric HSPN.
- Preliminary findings suggest Telitacicept may modulate lymphocyte populations and Gd-IgA1 levels in HSPN.
Objectives:
To investigate the efficacy and safety of Telitacicept (RC18) in children with Henoch-Schönlein Purpura Nephritis (HSPN).
Methods:
A prospective self-controlled study enrolled HSPN children from the First Affiliated Hospital of Henan University of Chinese Medicine from December 2023 to January 2025. Clinical and laboratory indices and adverse reactions were recorded during 1-4 months of follow-up. Primary study endpoint was 24 h UTP, and the secondary study endpoints included urinary RBC count, renal function (BUN, UA, Scr, eGFR) and safety. Exploratory analysis included dynamic changes in lymphocytes, BAFF, APRIL and Gd-IgA1.
Results:
Twenty-one patients were enrolled. After Telitacicept treatment, the 24 h UTP response rate was 100%, and urine RBC response rate was 66.7%. Renal function remained stable. Compared with baseline, 24 h UTP values and the reduction rate were significantly decreased at 4 months (P < 0.01), and urinary RBC count was significantly decreased at 3 months (P < 0.01). Exploratory analyses showed that the percentage of CD19 + decreased, while there was no decrease in CD3 + , CD3 + CD4 + , and CD3 + CD8 + cells. Meanwhile, the Gd-IgA1 level trended downward. Safety assessment demonstrated no serious adverse reactions, with abnormalities observed in biochemical parameters (ALT: 4.8%; UA: 19.0%) and injection site reactions (14.3%).
Conclusion:
RC18 effectively reduces urine protein and RBC in HSPN children, with good clinical effects and safety. Key Points • Efficacy and safety study of Telitacicept in the treatment of children with HSPN. • Preliminary exploration on the mechanism of Telitacicept in the treatment of children with HSPN.
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