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

Document Type

Article

Publication Title

Journal of the American Society of Nephrology

Abstract

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 $1 atacicept dose. Over 96 weeks, safety data demonstrated that atacicept was generally well tolerated. There were also sustained reductions (mean6SEM) in Gd-IgA1 (266%62%), percentage of participants with hematuria (275%; 95% confidence intervals, 287 to 259; in participants with baseline hematuria), and UPCR (252%65%). The mean annualized slope of eGFR was 20.660.5 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. Clinical Trial registry name and registration number: Atacicept in Subjects with IgA Nephropathy (ORIGIN 2), NCT04716231.

First Page

679

Last Page

687

DOI

10.1681/ASN.0000000541

Publication Date

4-1-2025

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