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Cited by 284

The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.

Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial

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Ginzler, Ellen M, Wax, Stephen, Rajeswaran, Anand, Copt, Samuel, Hillson, Jan, Ramos, Eleanor, Singer, Nora G·2012·Arthritis Research & Therapy

Abstract

Introduction: Atacicept is a soluble, fully human, recombinant fusion protein that inhibits B cell-stimulating factors APRIL (a proliferation-inducing ligand) and BLyS (B-lymphocyte stimulator). The APRIL- LN study aimed to evaluate the efficacy and safety of atacicept in patients with active lupus nephritis (LN), receiving newly initiated corticosteroids (CS) and mycophenolate mofetil (MMF). Methods: This was a randomized, double-blind, placebo-controlled Phase II/III, 52-week study. At screening (Day -14), patients initiated high-dose CS (the lesser of 0.8 mg/kg/day or 60 mg/day prednisone) and MMF (1 g daily, increased by 1 g/day each week to 3 g daily). From Day 1, atacicept (150 mg, subcutaneously, twice weekly for 4 weeks, then weekly) was initiated with MMF along with a tapered dose of CS. Results: The trial was terminated after the enrollment of six patients, due to an unexpected decline in serum immunoglobulin G (IgG) and the occurrence of serious infections. Efficacy was thus not evaluated. By Day 1, serum IgG levels had declined substantially in patients then randomized to atacicept ( n = 4) compared with placebo ( n = 2). Patients receiving atacicept also had more severe proteinuria on Day -14 than those on placebo. Lymphocyte counts were low at screening in all patients. IgG decline continued following initiation (Day 1) of atacicept. Three atacicept-treated patients developed serum IgG below the protocol-defined discontinuation threshold of 3 g/l, two of whom developed serious pneumonia. Conclusions: Future studies are needed to characterize the safety, efficacy, and pharmacodynamic response of atacicept in LN patients. Trial Registration: ClinicalTrials.gov: NCT00573157

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Metadata

Authors
Ginzler, E. M., Wax, S., Rajeswaran, A., Copt, S., Hillson, J., Ramos, E., & Singer, N. G.
Venue
Arthritis Research & Therapy
Published
2012-02-07
Volume
14
Issue
1
Pages
R33-R33
ISSN
1478-6354 (ISSN-L)
OpenAlex
W2161537704
Cited by
284
References
9
FWCI
23.73
Type
journal article
Language
en
Open access
gold

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CoChat. (2026). Citation check: Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. https://app.cochat.ai/papers/10.1186/ar3738
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Ginzler, E. M., Wax, S., Rajeswaran, A., Copt, S., Hillson, J., Ramos, E., & Singer, N. G. (2012). Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. Arthritis Research & Therapy. https://doi.org/10.1186/ar3738

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