Short-term changes in clinical parameters associated with telitacicept in pediatric IgA nephropathy: a single-center self-controlled observational study.

BACKGROUND

Progressive IgA nephropathy (IgAN) in childhood presents challenges for treatment. Telitacicept has shown significant benefits in adult IgAN patients, warranting investigation into its potential efficacy in the pediatric population. This study was designed to evaluate the changes in clinical parameters before and after telitacicept treatment in children with IgA nephropathy (IgAN).

METHODS

A single-center, self-controlled before-and-after study was conducted. Children received subcutaneous injections of telitacicept once weekly, in addition to ongoing background therapy (including renin-angiotensin system inhibitors, sodium-glucose cotransporter 2 inhibitors, glucocorticoids, and/or other immunosuppressants). The primary clinical parameter was the change in 24-hour urinary protein (24-h UP) from baseline. Secondary clinical parameters included changes in serum albumin (ALB), immunoglobulins, CD19+ B-cell count, estimated glomerular filtration rate (eGFR), and immunosuppressant dosage. Adverse events were recorded.

RESULTS

Eleven children were included. The 24-h UP level began a non-significant decline at week 4 (P > 0.05) but continued to significantly decrease at weeks 12 and 24 (P < 0.05), whereas serum ALB levels tended to increase concurrently. Serum levels of IgG, IgA, and IgM exhibited a decreasing trend over time (P < 0.001). Compared with baseline, the reductions in all three immunoglobulin subtypes reached statistical significance at week 24 (P < 0.01), with IgA and IgM showing more pronounced decreases. The CD19+ B-cell count was significantly reduced at week 24 (P = 0.001). The eGFR remained stable throughout the treatment period (P > 0.05). The glucocorticoid dosage tended to decrease during follow-up (P < 0.05). Adverse events were mild, primarily upper respiratory tract infections (4 episodes) and local injection site reactions (1 episode), with no serious adverse events reported.

CONCLUSION

In children with IgAN, telitacicept was associated with reduced proteinuria, facilitated immunosuppressant tapering, and demonstrated a favorable safety profile, while preserving renal function.