Introduction: The efficacy of telitacicept treatment in reducing proteinuria in patients with IgA nephropathy (IgAN) was indicated in a phase II clinical trial with small sample size. In this study, we conducted a large multicenter retrospective study to explore the efficacy and safety of telitacicept in patients with IgAN. Methods: This study recruited patients with IgAN from 19 sites from China who were treated with telitacicept and had been followed up at least once or with side effect reported, since April 1, 2021, to April 1, 2023. The primary outcomes of the study were the changing in proteinuria and eGFR over time. Results: A cohort of 97 patients with IgAN who were treated with telitacicept were recruited, with a median follow-up duration of 3 months. The median baseline proteinuria was 2.3 [1.3, 3.9] g/day and eGFR was 45.0 [26.8, 73.7] mL/min/1.73 m2. There was a significant reduction of proteinuria at 2, 4, 6 months when compared with baseline (2.3 [1.5, 4.1] vs. 1.5 [0.8, 2.3] g/day; 2.3 [1.1, 3.7] vs. 1.1 [0.6, 1.9] g/day; 2.1 [1.0, 2.7] vs. 0.9 [0.5, 1.7] g/day, all p values <0.01). The level of eGFR were comparable between at the baseline and 2, 4, 6 months of follow-up time (41.5 [29.7, 72.0] vs. 42.5 [28.8, 73.3] mL/min/1.73 m2; 41.0 [26.8, 67.7] vs. 44.7 [31.0, 67.8] mL/min/1.73 m2; 33.7 [24.0, 58.5] vs. 32.6 [27.8, 57.5] mL/min/1.73 m2, all p values >0.26). Telitacicept was well tolerated in the patients. Conclusions: This study indicates that telitacicept alone or on top of steroids therapy can significantly and safely reduce proteinuria in patients with IgAN. The long-term kidney protection still needs to be confirmed in large phase III trial.

1.
Kidney Disease: Improving Global Outcomes (KDIGO) Glomerulonephritis Work Group
.
KDIGO clinical practice guideline for glomerulonephritis
.
Kidney Int
.
2021
;
100
(
45
):
153
4
.
2.
Wu
MY
,
Chen
CS
,
Yiang
GT
,
Cheng
PW
,
Chen
YL
,
Chiu
HC
, et al
.
The emerging role of pathogenesis of IgA nephropathy
.
J Clin Med
.
2018
;
7
(
8
):
225
.
3.
Zhao
N
,
Hou
P
,
Lv
J
,
Moldoveanu
Z
,
Li
Y
,
Kiryluk
K
, et al
.
The level of galactose-deficient IgA1 in the sera of patients with IgA nephropathy is associated with disease progression
.
Kidney Int
.
2012
;
82
(
7
):
790
6
.
4.
Samy
E
,
Wax
S
,
Huard
B
,
Hess
H
,
Schneider
P
.
Targeting BAFF and APRIL in systemic lupus erythematosus and other antibody-associated diseases
.
Int Rev Immunol
.
2017
;
36
(
1
):
3
19
.
5.
Cancro
MP
,
D'Cruz
DP
,
Khamashta
MA
.
The role of B Lymphocyte Stimulator (BLyS) in systemic lupus erythematosus
.
J Clin Invest
.
2009
;
119
(
5
):
1066
73
.
6.
Shi
F
,
Xue
R
,
Zhou
X
,
Shen
P
,
Wang
S
,
Yang
Y
.
Telitacicept as a BLyS/APRIL dual inhibitor for autoimmune disease
.
Immunopharmacol Immunotoxicol
.
2021
;
43
(
6
):
666
73
.
7.
Dhillon
S
.
Telitacicept: first approval
.
Drugs
.
2021
;
81
(
14
):
1671
5
.
8.
Lv
J
,
Liu
L
,
Hao
C
,
Li
G
,
Fu
P
,
Xing
G
, et al
.
Randomized phase 2 trial of telitacicept in patients with IgA nephropathy with persistent proteinuria
.
Kidney Int Rep
.
2023
;
8
(
3
):
499
506
.
9.
Levey
AS
,
Stevens
LA
,
Schmid
CH
,
Zhang
YL
,
Castro
AF
3rd
,
Feldman
HI
, et al
.
A new equation to estimate glomerular filtration rate [published correction appears in Ann Intern Med. 2011 Sep 20;155(6):408]
.
Ann Intern Med
.
2009
;
150
(
9
):
604
12
.
10.
Methven
S
,
Traynor
JP
,
Hair
MD
,
St J O'Reilly
D
,
Deighan
CJ
,
MacGregor
MS
.
Stratifying risk in chronic kidney disease: an observational study of UK guidelines for measuring total proteinuria and albuminuria
.
QJM
.
2011
;
104
(
8
):
663
70
.
11.
Methven
S
,
MacGregor
MS
.
Empiricism or rationalism: how should we measure proteinuria
.
Ann Clin Biochem
.
2013
;
50
(
Pt 4
):
296
300
.
12.
Xin
G
,
Shi
W
,
Xu
LX
,
Su
Y
,
Yan
LJ
,
Li
KS
.
Serum BAFF is elevated in patients with IgA nephropathy and associated with clinical and histopathological features
.
J Nephrol
.
2013
;
26
(
4
):
683
90
.
13.
Li
W
,
Peng
X
,
Liu
Y
,
Liu
H
,
Liu
F
,
He
L
, et al
.
TLR9 and BAFF: their expression in patients with IgA nephropathy
.
Mol Med Rep
.
2014
;
10
(
3
):
1469
74
.
14.
Zhai
YL
,
Zhu
L
,
Shi
SF
,
Liu
LJ
,
Lv
JC
,
Zhang
H
.
Increased APRIL expression induces IgA1 aberrant glycosylation in IgA nephropathy
.
Medicine
.
2016
;
95
(
11
):
e3099
.
15.
Makita
Y
,
Suzuki
H
,
Kano
T
,
Takahata
A
,
Julian
BA
,
Novak
J
, et al
.
TLR9 activation induces aberrant IgA glycosylation via APRIL- and IL-6-mediated pathways in IgA nephropathy
.
Kidney Int
.
2020
;
97
(
2
):
340
9
.
16.
Chen
R
,
Fu
R
,
Lin
Z
,
Huang
C
,
Huang
W
.
The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study
.
Lupus
.
2023
;
32
(
1
):
94
100
.
17.
Zheng
N
,
Wang
D
,
Ming
H
,
Zhang
H
,
Yu
X
.
BAFF promotes proliferation of human mesangial cells through interaction with BAFF-R
.
BMC Nephrol
.
2015
;
16
:
72
.
You do not currently have access to this content.