Telitacicept for childhood HSPN: A prospective self-controlled study.

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.