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Proteinuria is a key treatable target in IgA nephropathy(IgAN). Telitacicept, a novel BLyS/APRIL dual inhibitor, offers a targeted therapeutic strategy. We evaluated the efficacy and safety of add-on telitacicept compared to supportive therapy alone in patients with IgAN.
We conducted a retrospective cohort study of adults with biopsy-proven IgAN(January 2022–June 2024). Patients receiving telitacicept plus supportive therapy (Telitacicept Group, TTG; n=6) were compared to those on supportive therapy alone (Control Group, CTG; n=30). Supportive therapy comprised Renin-Angiotensin System Inhibitors (RASi) with or without SGLT2 inhibitors (SGLT2i). The primary endpoints were: 1) proteinuria remission (≥50% reduction in 24-hour urinary protein excretion [24hUPRO]), and 2) a composite renal function event (≥30% decline in estimated glomerular filtration rate [eGFR]). Secondary endpoints included absolute change in 24hUPRO, annualized eGFR slope, serum IgA changes, and adverse events.
A total of 36 patients were included.Baseline demographics, clinical characteristics, and laboratory parameters were well-balanced between the two groups, as detailed in Table 1, ensuring comparability.
Table 1. Baseline Demographics and Clinical Characteristics
Characteristic
ControlGroup
（CTG）
(n=30)
Telitacicept Group（TTG）
(n=6)
P-Value
Demographics
Age, years
45.5(35.0,52.8)
41.0(32.5,48.3)
0.521
Male,n (%)
16（53.3）
3（50.0）
0.876
BodyMass Index(BMI), kg/m²
24.1(22.3, 26.0)
23.5(21.8, 25.5)
0.634
Comorbidities, n(%)
Arterial Hypertension
25 (83.3)
5(83.3)
0.999
Diabetes Mellitus
8(26.7)
1(16.7)
0.615
Chronic Kidney Disease
(CKD) Stage, n(%)
0.821
Stage1(eGFR≥90)
4(13.3)
Stage2(eGFR60-89)
15(50.0)
2(33.3)
Stage3(eGFR30-59)
10(33.3)
3(50.0)
Stage4(eGFR15-29)
1(3.3)
0(0)
Laboratory Parameters
24h Urinary Protein
(24hUPRO), g/day
1.8(1.2, 2.5)
2.1(1.5, 2.8)
0.443
Estimated GFR (eGFR),
mL/min/1.73m²
68.5(55.3, 85.0)
72.1(58.4, 88.9)
0.678
Serum Creatinine(SCr),
μmol/L
98.5(78.3,125.0)
92.0(75.5,110.5)
0.501
Serum Albumin(ALB),
g/L
38.5(36.1,41.2)
37.8(35.5, 40.5)
0.712
Serum Immunoglobulin A
(IgA),g/L
3.2(2.7, 3.8)
3.4(2.9, 4.0)
0.389
Background Supportive
Therapy,n(%)
<0.001
RASi only
14(46.7)
4(66.7)
RASi+SGLT2i
16(53.3)
1. Data Presentation: Continuous variables are presented as median (interquartile range); categorical variables are presented as number (percentage).
2. Statistical Tests: P-values for continuous variables were calculated using Mann-Whitney U test; P-values for categorical variables were calculated using Chi-square test or Fisher's exact test, as appropriate.
3. Abbreviations:
· CTG: Control Therapy Group
· TTG: Telitacicept Therapy Group
· eGFR: estimated glomerular filtration rate
· RASi: Renin-Angiotensin System Inhibitors
· SGLT2i: Sodium-Glucose Cotransporter-2 Inhibitors
4. Significance Level: A P-value < 0.05 was considered statistically significant.
At 24 weeks, add-on telitacicept led to a significantly greater reduction in proteinuria. The 24hUPRO decreased by 60.9% in the TTG versus 25.4% in the CTG (P < 0.01), and the rate of proteinuria remission was significantly higher (83.3% vs. 33.3%, P < 0.05). The annualized eGFR slope remained stable in both groups, with no significant difference between them. A profound reduction in serum IgA was observed in the TTG (–40.0% from baseline, P < 0.05). The therapy was well-tolerated; the most common adverse events were mild, self-limited injection-site reactions (2/6, 33.3%), with no serious infections or hyperkalemia reported.
In this real-world cohort,adding telitacicept to supportive therapy was associated with a significantly greater reduction in proteinuria and a high rate of proteinuria remission, while maintaining stable renal function. The concomitant decrease in serum IgA confirms its expected mechanism of action. These promising efficacy and safety data support the potential of telitacicept in IgAN management and warrant confirmation in larger, prospective studies.
