Efficacy and safety of Telitacicept in adult IgA vasculitis nephritis

IgA vasculitis nephritis (IgAVN) is a systematic vessel inflammation with renal involvement，present with microscopic (and/or macroscopic) hematuria with or without proteinuria, nephritic and /or nephrotic syndrome. Hormones, cyclophosphamide, mycophenolate mofetil, and others have been proven to improve the renal prognosis of IgAVN patients to some extent. However, there are still some patients who have contraindications to the use of hormones or cyclophosphamide, or exhibit poor treatment responses. This study we used telitacicept in adult patients with IgA vasculitis nephritis, aimed to evaluate the efficacy and safety of telitacicept in adult with IgAVN. in clinical practice.

A prospective, single-arm, observational study was conducted involving patients aged ≥18 years with a typical history of Henoch-Schönlein purpura, accompanied by hematuria, proteinuria, or renal dysfunction, and confirmed as IgAVN by renal biopsy. Eligible patients had contraindications to glucocorticoid therapy or showed poor response to previous treatments such as glucocorticoids combined with cyclophosphamide or mycophenolate mofetil, with 24-hour urinary protein quantification >1g. All patients received telitacicept 240mg once weekly for 6 months.

A total of 10 patients with IgAVN were enrolled in this study, including 7 males (70%) and 3 females (30%). The age range of patients was 18-65 years, with a mean age of 35.6±15.3 years. The disease duration varied significantly among patients, ranging from 0.5 months to 48 months, with a mean disease duration of 14.4±17.2 months. Patients exhibited significant proteinuria at baseline, with mean 24-hour urinary protein (UTP) of 3.79±2.29 g/24h, The mean urine protein-to-creatinine ratio (UPCR) was 2520.7±1755.9 mg/g, with the maximum value of 7016.41 mg/g. Serum albumin (ALB) levels were generally low, with a mean of 33.1±4.2 g/L, and the minimum value was only 27.7 g/L.The estimated glomerular filtration rate (eGFR) showed a wide distribution range from 36.42 to 152.21 ml/min/1.73m², with a mean of 80.4±38.6 ml/min/1.73m². The mean serum creatinine (Scr) level was 106.6±37.4 μmol/L. Previous medications mainly consisted of glucocorticoids, MMF，CTX，while concomitant medications primarily included renin-angiotensin system inhibitors and SGLT2 inhibitors.Mean 24-hour Urinary Protein (UTP) decreased significantly from baseline 3.79 g/24h to 2.1 g/24h at week 4 (reduction of 44.6%, P=0.001), further to 1.4 g/24h at week 8 (reduction of 63.1%, P=0.001), and reached 1.1 g/24h at week 12 (reduction of 71.0%, P=0.004). Urine Protein-to-Creatinine Ratio(UPCR) decreased rapidly from baseline 2520.7 mg/g to 1400 mg/g at week 4 (reduction of 44.5%) and to 750 mg/g at week 12 (reduction of 70.2%). Serum albumin increased steadily from baseline 33.1 g/L to 36.5 g/L at week 4 (increase of 10.3%, P<0.001), reaching 40.2 g/L at week 12 (increase of 21.5%, P<0.001). eGFR showed minor fluctuations from baseline 80.4 ml/min/1.73m², increasing to 85.2 ml/min/1.73m² at week 4 (increase of 6.0%) and maintaining at 82.5 ml/min/1.73m² at week 12 (increase of 2.6%). Serum creatinine showed minor fluctuations from baseline 106.6 μmol/L, decreasing to 98.3 μmol/L at week 4 (reduction of 7.8%) and measuring 102.4 μmol/L at week 12 (reduction of 3.9%), with no statistical significance, consistent with eGFR stability. Overall, 60% of the patients achieved complete renal remission. The specific results are presented in Figure 1 and Figure 2. No serious adverse events were observed.

Telitacicept significantly increased the complete remission rate in IgAVN patients with persistent proteinuria, stabilized renal function, and no serious adverse events were observed.