Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial.
Average rating
Cast your vote
You can rate an item by clicking the amount of stars they wish to award to this item.
When enough users have cast their vote on this item, the average rating will also be shown.
Star rating
Your vote was cast
Thank you for your feedback
Thank you for your feedback
Author
Ginzler, Ellen MWax, Stephen
Rajeswaran, Anand
Copt, Samuel
Hillson, Jan
Ramos, Eleanor
Singer, Nora G
Journal title
Arthritis research & therapyDate Published
2012-02-07Publication Volume
14Publication Issue
1Publication Begin page
R33
Metadata
Show full item recordAbstract
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).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.
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.
Future studies are needed to characterize the safety, efficacy, and pharmacodynamic response of atacicept in LN patients.
ClinicalTrials.gov: NCT00573157.
Citation
Ginzler EM, Wax S, Rajeswaran A, Copt S, Hillson J, Ramos E, Singer NG. Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. Arthritis Res Ther. 2012 Feb 7;14(1):R33. doi: 10.1186/ar3738. PMID: 22325903; PMCID: PMC3392829.DOI
10.1186/ar3738ae974a485f413a2113503eed53cd6c53
10.1186/ar3738
Scopus Count
Collections
The following license files are associated with this item:
- Creative Commons
Except where otherwise noted, this item's license is described as Attribution-NonCommercial-NoDerivatives 4.0 International
Related articles
- Efficacy of mycophenolate mofetil in adolescent patients with lupus nephritis: evidence from a two-phase, prospective randomized trial.
- Authors: Sundel R, Solomons N, Lisk L, Aspreva Lupus Management Study (ALMS) Group
- Issue date: 2012 Nov
- Serum immunoglobulin G level in patients with lupus nephritis and the effect of treatment with corticosteroids and mycophenolate mofetil.
- Authors: Yap DY, Yung S, Ma MK, Mok MM, Kwan LP, Chan GC, Chan TM
- Issue date: 2014 Jun
- Reduced B lymphocyte and immunoglobulin levels after atacicept treatment in patients with systemic lupus erythematosus: results of a multicenter, phase Ib, double-blind, placebo-controlled, dose-escalating trial.
- Authors: Dall'Era M, Chakravarty E, Wallace D, Genovese M, Weisman M, Kavanaugh A, Kalunian K, Dhar P, Vincent E, Pena-Rossi C, Wofsy D
- Issue date: 2007 Dec
- Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.
- Authors: Rovin BH, Teng YKO, Ginzler EM, Arriens C, Caster DJ, Romero-Diaz J, Gibson K, Kaplan J, Lisk L, Navarra S, Parikh SV, Randhawa S, Solomons N, Huizinga RB
- Issue date: 2021 May 29
- Efficacy and safety of ocrelizumab in active proliferative lupus nephritis: results from a randomized, double-blind, phase III study.
- Authors: Mysler EF, Spindler AJ, Guzman R, Bijl M, Jayne D, Furie RA, Houssiau FA, Drappa J, Close D, Maciuca R, Rao K, Shahdad S, Brunetta P
- Issue date: 2013 Sep