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
Open accessAbstract
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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Arnett, F. C., Edworthy, S. M., Bloch, D. A., Mcshane, D. J., Fries, J. F., Cooper, N. S., Healey, L. A., Kaplan, S. R., Liang, M. H., Luthra, H. S., et al. (1988) · Arthritis & Rheumatism · doi:10.1002/art.1780310302 · Cited by 19,752
Mycophenolate Mofetil or Intravenous Cyclophosphamide for Lupus Nephritis
Ginzler, E. M., Dooley, M. A., Aranow, C., Kim, M. Y., Buyon, J., Merrill, J. T., Petri, M., Gilkeson, G. S., Wallace, D. J., Weisman, M. H., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa043731 · Cited by 1,128
Self-citationMycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis
Appel, G. B., Contreras, G., Dooley, M. A., Ginzler, E. M., Isenberg, D., Jayne, D., Li, L.-S., Mysler, E., Sa[Combining Acute Accent]nchez-Guerrero, J., Solomons, N., et al. (2009) · Journal of the American Society of Nephrology · doi:10.1681/asn.2008101028 · Cited by 1,118
Self-citationKorbet, S. M. (2010) · Cited by 519
Dall'Era, M., Chakravarty, E., Wallace, D., Genovese, M., Weisman, M., Kavanaugh, A., Kalunian, K., Dhar, P., Vincent, E., Pena‐Rossi, C., et al. (2007) · Arthritis & Rheumatism · doi:10.1002/art.23047 · Cited by 294
Roschke, V., Sosnovtseva, S., Ward, C. D., Hong, J. S., Smith, R., Albert, V., Stohl, W., Baker, K. P., Ullrich, S., Nardelli, B., et al. (2002) · The Journal of Immunology · doi:10.4049/jimmunol.169.8.4314 · Cited by 259
van Vollenhoven, R. F., Kinnman, N., Vincent, E., Wax, S., & Bathon, J. (2011) · Arthritis & Rheumatism · doi:10.1002/art.30372 · Cited by 167
Self-citationGenovese, M. C., Kinnman, N., Bourdonnaye, G. D. L., Rossi, C. P., & Tak, P. P. (2011) · Arthritis & Rheumatism · doi:10.1002/art.30373 · Cited by 123
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Lisnevskaia, L., Murphy, G., & Isenberg, D. (2014) · The Lancet · doi:10.1016/s0140-6736(14)60128-8 · Cited by 752
Hoffman, W., Lakkis, F. G., & Chalasani, G. (2016) · Clinical Journal of the American Society of Nephrology · doi:10.2215/cjn.09430915 · Cited by 482
Targeting B cells and plasma cells in autoimmune diseases
Hofmann, K., Clauder, A.-K., & Manz, R. A. (2018) · Frontiers in Immunology · doi:10.3389/fimmu.2018.00835 · Cited by 294
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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- 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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