Long-Term Results from an Open-Label Extension Study of Atacicept for the Treatment of IgA Nephropathy

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F25%3A10488703" target="_blank" >RIV/00064165:_____/25:10488703 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/25:10488703

Result on the web

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=.1L4IeFZ5x" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=.1L4IeFZ5x</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1681/ASN.0000000541" target="_blank" >10.1681/ASN.0000000541</a>

Result language

angličtina

Original language name

Long-Term Results from an Open-Label Extension Study of Atacicept for the Treatment of IgA Nephropathy

Original language description

Background: B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) play key roles in the pathogenesis of IgA nephropathy. Atacicept is a novel fully humanized fusion protein, self-administered at home by subcutaneous injection, that binds and inhibits BAFF and APRIL. By inhibiting BAFF and APRIL, atacicept targets the underlying B-cell-mediated pathogenesis driving disease progression. This study evaluated the long-term efficacy and safety of atacicept in patients with IgA nephropathy over 96 weeks. Methods: Participants with IgA nephropathy who received atacicept (25, 75, or 150 mg) or placebo in a 36-week phase 2b, randomized, blinded trial were enrolled in an open-label extension study and received atacicept 150 mg for an additional 60 weeks. Key efficacy outcomes were changes in galactose-deficient IgA1 (Gd-IgA1), percentage of participants with hematuria, urine protein-creatinine ratio (UPCR), and eGFR over 96 weeks. Long-term safety data were also evaluated. Results: There were 113 participants (67 [59%] male; 46 [41%] female) who ranged in age from 18 to 67 years who received &gt;=1 atacicept dose. Over 96 weeks, safety data demonstrated that atacicept was generally well tolerated. There were also sustained reductions (mean+-SEM) in Gd-IgA1 (-66%+-2%), percentage of participants with hematuria (-75%; 95% confidence intervals, -87 to -59; in participants with baseline hematuria), and UPCR (-52%+-5%). The mean annualized slope of eGFR was -0.6+-0.5 ml/min per 1.73 m2 through 96 weeks. Conclusions: Atacicept was well tolerated over the duration of the study. Atacicept treatment reduced Gd-IgA1, hematuria, and UPCR with stabilization of eGFR through 96 weeks.

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30217 - Urology and nephrology

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of the American Society of Nephrology

ISSN

1046-6673

e-ISSN

1533-3450

Volume of the periodical

36

Issue of the periodical within the volume

4

Country of publishing house

US - UNITED STATES

Number of pages

9

Pages from-to

679-687

UT code for WoS article

001342121200001

EID of the result in the Scopus database

2-s2.0-85207939353