Biomarkers in systemic lupus erythematosus (original) (raw)
Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001, 69:89–95. Summary of National Institute of Health consensus meeting on biomarkers.
Rolan P: The contribution of clinical pharmacology surrogates and models to drug development—a critical appraisal. Br J Clin Pharmacol 1997, 44:219- 225. ArticlePubMedCAS Google Scholar
Lesko LJ, Atkinson AJ, Jr.: Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. Annu Rev Pharmacol Toxicol 2001, 41:347- 366. ArticlePubMedCAS Google Scholar
Fleming TR, DeMets DL: Surrogate end points in clinical trials: are we being misled?Ann Intern Med 1996, 125:605- 613. PubMedCAS Google Scholar
Wagner JA: Overview of biomarkers and surrogate endpoints in drug development. Dis Markers 2002, 18:41–46. PubMedCAS Google Scholar
Ward MM, Marx AS, Barry NN: Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. J Rheumatol 2000, 27:664- 670. PubMedCAS Google Scholar
Illei GG, Tackey E, Lapteva L, Lipsky PE: Biomarkers in systemic lupus erythematosus I. General overview of biomarkers and their applicability. Arthritis Rheum 2004, 50:1709- 1720. General overview of biomarkers, surrogate endpoints, and their validation and the applicability of this process to SLE. Detailed review of markers of disease susceptibility and organ involvement in lupus. ArticlePubMedCAS Google Scholar
Illei GG, Lapteva L, Tackey E, Lipsky PE: Biomarkers in systemic lupus eythematosus II. Markers of disease activity. Arthritis Rheum 2004, 50:2048- 2065. Detailed summary of the published literature on biomarkers of disease activity in lupus. ArticlePubMedCAS Google Scholar
Kelly JA, Moser KL, Harley JB: The genetics of systemic lupus erythematosus: putting the pieces together. Genes Immun 2002, 3(Suppl 1):S71- S85. ArticlePubMedCAS Google Scholar
Karassa FB, Trikalinos TA, Ioannidis JP: Role of the fcgamma receptor IIa polymorphism in susceptibility to systemic lupus erythematosus and lupus nephritis: a meta-analysis. Arthritis Rheum 2002, 46:1563- 1571. This meta-analysis of 25 comparisons from 17 studies concludes that the Fcγ RIIa-R/H131 polymorphism represents a significant risk factor for SLE but has no clear effect on susceptibility for lupus nephritis. ArticlePubMedCAS Google Scholar
Karassa FB, Trikalinos TA, Ioannidis JP: The Fc gamma RIIIAF158 allele is a risk factor for the development of lupus nephritis: a meta-analysis. Kidney Int 2003, 63:1475- 1482. This meta-analysis of 16 comparisons from 11 studies concludes that the Fcγ RIIIA-V/F158 polymorphism has a significant impact on the development of lupus nephritis. ArticlePubMedCAS Google Scholar
Edberg JC, Langefeld CD, Wu J, et al.: Genetic linkage and association of Fcgamma receptor IIIA (CD16A) on chromosome 1q23 with human systemic lupus erythematosus. Arthritis Rheum 2002, 46:2132- 2140. This study demonstrated linkage and association of Fcγ RIIIA with SLE with family-based and case-control-based analysis in two large cohorts. ArticlePubMedCAS Google Scholar
Kyogoku C, Dijstelbloem HM, Tsuchiya N, et al.: Fcgamma receptor gene polymorphisms in Japanese patients with systemic lupus erythematosus: contribution of FCGR2B to genetic susceptibility. Arthritis Rheum 2002, 46:1242–1254. ArticlePubMedCAS Google Scholar
Manger K, Repp R, Jansen M, et al.: Fcgamma receptor IIa, IIIa, and IIIb polymorphisms in German patients with systemic lupus erythematosus: association with clinical symptoms. Ann Rheum Dis 2002, 61:786- 792. ArticlePubMedCAS Google Scholar
Garred P, Voss A, Madsen HO, Junker P: Association of mannose- binding lectin gene variation with disease severity and infections in a population-based cohort of systemic lupus erythematosus patients. Genes Immun 2001, 2:442- 450. ArticlePubMedCAS Google Scholar
Prokunina L, Castillejo-Lopez C, Oberg F, et al.: A regulatory polymorphism in PDCD1 is associated with susceptibility to systemic lupus erythematosus in humans. Nat Genet 2002, 32:666- 669. One intronic single-nucleotide polymorphism in the PDCD1 gene showed a strong association with the development of SLE in Europeans and Mexicans but not in blacks in a cohort of 2510 individuals. The associated allele of this single nucleotide polymorphism alters a binding site for the runt-related transcription factor 1 that could lead to aberrant regulation of PDCD1, contributing to the disregulated self-tolerance and to the chronic lymphocyte hyperactivity characteristic of SLE. ArticlePubMedCAS Google Scholar
Tjernstrom F, Hellmer G, Nived O, et al.: Synergetic effect between interleukin-1 receptor antagonist allele (IL1RN*2) and MHC class II (DR17,DQ2) in determining susceptibility to systemic lupus erythematosus. Lupus 1999, 8:103- 108. ArticlePubMedCAS Google Scholar
Huang CM, Wu MC, Wu JY, Tsai FJ: Interleukin-1 receptor antagonist gene polymorphism in chinese patients with systemic lupus erythematosus. Clin Rheumatol 2002, 21:255- 257. ArticlePubMed Google Scholar
Tanaka Y, Nakashima H, Hisano C, et al.: Association of the interferon-gamma receptor variant (Val14Met) with systemic lupus erythematosus. Immunogenetics 1999, 49:266- 271. ArticlePubMedCAS Google Scholar
Nakashima H, Inoue H, Akahoshi M, et al.: The combination of polymorphisms within interferon-gamma receptor 1 and receptor 2 associated with the risk of systemic lupus erythematosus. FEBS Lett 1999, 453:187–190. ArticlePubMedCAS Google Scholar
Mehrian R, Quismorio FP, Jr., Strassmann G, et al.: Synergistic effect between IL-10 and bcl-2 genotypes in determining susceptibility to systemic lupus erythematosus. Arthritis Rheum 1998, 41:596- 602. ArticlePubMedCAS Google Scholar
Arbuckle MR, McClain MT, Rubertone MV, et al.: Development of autoantibodies before the clinical onset of systemic lupus erythematosus. N Engl J Med 2003, 349:1526- 1533. This study demonstrates that autoantibodies appear years before clinical symptoms and seem to follow an ordered temporal sequence. ArticlePubMedCAS Google Scholar
Arbuckle MR, James JA, Kohlhase KF, et al.: Development of antidsDNA autoantibodies prior to clinical diagnosis of systemic lupus erythematosus. Scand J Immunol 2001, 54:211- 219. ArticlePubMedCAS Google Scholar
Spronk PE, Bootsma H, Kallenberg CG: Anti-DNA antibodies as early predictor for disease exacerbations in SLE. Guideline for treatment? Clin Rev Allergy Immunol 1998, 16:211- 218. CAS Google Scholar
Bootsma H, Spronk P, Derksen R, et al.: Prevention of relapses in systemic lupus erythematosus. Lancet 1995, 345:1595- 1599. ArticlePubMedCAS Google Scholar
Esdaile JM, Joseph L, Abrahamowicz M, Li Y, et al.: Routine immunologic tests in systemic lupus erythematosus: is there a need for more studies?J Rheumatol 1996, 23:1891- 1896. PubMedCAS Google Scholar
Esdaile JM, Abrahamowicz M, Joseph L, et al.: Laboratory tests as predictors of disease exacerbations in systemic lupus erythematosus. Why some tests fail. Arthritis Rheum 1996, 39:370- 378. ArticlePubMedCAS Google Scholar
Bootsma H, Spronk PE, ter Borg EJ, et al.: The predictive value of fluctuations in IgM and IgG class anti-dsDNA antibodies for relapses in systemic lupus erythematosus. A prospective long-term observation. Ann Rheum Dis 1997, 56:661- 666. ArticlePubMedCAS Google Scholar
Kallenberg CG, Bootsma H, Spronk PE, et al.: Laboratory tests as predictors of flares in systemic lupus erythematosus: comment on the article by Esdaile et al. Arthritis Rheum 1997, 40:393- 394. ArticlePubMedCAS Google Scholar
Swaak AJ, Smeenk RJ: Following the disease course in systemic lupus erythematosus: are serologic variables of any use?J Rheumatol 1996, 23:1842- 1844. PubMedCAS Google Scholar
Zonana-Nacach A, Sanchez L, Camargo-Coronel A, et al.: Laboratory abnormalities and systemic lupus erythematosus flare: comment on the article by Esdaile et al. Arthritis Rheum 1997, 40:2092- 2093. ArticlePubMedCAS Google Scholar
Ho A, Magder LS, Barr SG, Petri M: Decreases in anti-doublestranded DNA levels are associated with concurrent flares in patients with systemic lupus erythematosus. Arthritis Rheum 2001, 44:2342- 2349. ArticlePubMedCAS Google Scholar
Ahearn J, Liu C-C, Navratil J, et al.: Erythrocyte C4D and CR1 as biomarkers for SLE [abstract]. Paper presented at the 7th International Congress of SLE and Related Conditions. New York, NY, May 9- 13, 2004.
Baechler EC, Batliwalla FM, Karypis G, et al.: Interferon-inducible gene expression signature in peripheral blood cells of patients with severe lupus. Proc Natl Acad Sci U S A 2003, 100:2610- 2615. Compared with healthy controls, half of the lupus patients studied by RNA microarray showed dysregulated expression of genes in the IFN pathway. Furthermore, this IFN gene expression "signature" served as a marker for more severe disease involving the kidneys, hematopoetic cells, and/or the central nervous system. ArticlePubMedCAS Google Scholar
Bennett L, Palucka AK, Arce E, et al.: Interferon and granulopoiesis signatures in systemic lupus erythematosus blood. J Exp Med 2003, 197:711- 723. Using oligonucleotide microarrays, active SLE could be distinguished by overexpression of granulopoiesis-related and IFN-induced genes. High dose glucocorticoids, shut down the interferon signature, further supporting the role of this cytokine in SLE. The expression of 10 genes correlated with disease activity. The most striking correlation was found with the formyl peptide receptor-like 1 protein that mediates chemotactic activities of defensins. Therefore, while the IFN signature confirms the central role of this cytokine in SLE, microarray analysis of blood cells reveals that immature granulocytes may be involved in SLE pathogenesis. ArticlePubMedCAS Google Scholar
Kim T, Kanayama Y, Negoro N, et al.: Serum levels of interferons in patients with systemic lupus erythematosus. Clin Exp Immunol 1987, 70:562- 569. PubMedCAS Google Scholar
Bengtsson AA, Sturfelt G, Truedsson L, et al.: Activation of type I interferon system in systemic lupus erythematosus correlates with disease activity but not with antiretroviral antibodies. Lupus 2000, 9:664–671. ArticlePubMedCAS Google Scholar
Blanco P, Palucka AK, Gill M, Pascual V, Banchereau J: Induction of dendritic cell differentiation by IFN-alpha in systemic lupus erythematosus. Science 2001, 294:1540- 1543. Serum from SLE patients induced normal monocytes to differentiate into dendritic cells capable of capturing antigens from dying cells and present them to CD4-positive T cells. The capacity of SLE patients’ serum to induce dendritic cell differentiation correlated with disease activity and depended on the actions of IFN-α. ArticlePubMedCAS Google Scholar
Laut J, Senitzer D, Petrucci R, et al.: Soluble interleukin-2 receptor levels in lupus nephritis. Clin Nephrol 1992, 38:179- 184. PubMedCAS Google Scholar
ter Borg EJ, Horst G, Limburg PC, Kallenberg CG: Changes in plasma levels of interleukin-2 receptor in relation to disease exacerbations and levels of anti-dsDNA and complement in systemic lupus erythematosus. Clin Exp Immunol 1990, 82:21- 26. ArticlePubMed Google Scholar
Swaak AJ, Hintzen RQ, Huysen V, et al.: Serum levels of soluble forms of T cell activation antigens CD27 and CD25 in systemic lupus erythematosus in relation with lymphocytes count and disease course. Clin Rheumatol 1995, 14:293- 300. ArticlePubMedCAS Google Scholar
Davas EM, Tsirogianni A, Kappou I, et al.: Serum IL-6, TNFalpha, p55 srTNFalpha, p75srTNFalpha, srIL-2alpha levels and disease activity in systemic lupus erythematosus. Clin Rheumatol 1999, 18:17- 22. ArticlePubMedCAS Google Scholar
Dejica D: Serum soluble IL-2 receptor as a marker of lymphocyte activation in some autoimmune diseases. Effect of immunosuppressive therapy. Roum Arch Microbiol Immunol 2001, 60:183- 201. PubMedCAS Google Scholar
Spronk PE, ter Borg EJ, Huitema MG, et al.: Changes in levels of soluble T-cell activation markers, sIL-2R, sCD4 and sCD8, in relation to disease exacerbations in patients with systemic lupus erythematosus: a prospective study. Ann Rheum Dis 1994, 53:235- 239. ArticlePubMedCAS Google Scholar
Gabay C, Cakir N, Moral F, et al.: Circulating levels of tumor necrosis factor soluble receptors in systemic lupus erythematosus are significantly higher than in other rheumatic diseases and correlate with disease activity. J Rheumatol 1997, 24:303- 308. PubMedCAS Google Scholar
Aderka D, Wysenbeek A, Engelmann H, et al.: Correlation between serum levels of soluble tumor necrosis factor receptor and disease activity in systemic lupus erythematosus. Arthritis Rheum 1993, 36:1111- 1120. ArticlePubMedCAS Google Scholar
Aringer M, Feierl E, Steiner G, et al.: Increased bioactive TNF in human systemic lupus erythematosus: associations with cell death. Lupus 2002, 11:102- 108. ArticlePubMedCAS Google Scholar
Ho CY, Wong CK, Li EK, et al.: Elevated plasma concentrations of nitric oxide, soluble thrombomodulin and soluble vascular cell adhesion molecule-1 in patients with systemic lupus erythematosus. Rheumatology (Oxford) 2003, 42:117- 122. ArticleCAS Google Scholar
Horak P, Scudla V, Hermanovo Z, et al.: Clinical utility of selected disease activity markers in patients with systemic lupus erythematosus. Clin Rheumatol 2001, 20:337- 344. ArticlePubMedCAS Google Scholar
Ikeda Y, Fujimoto T, Ameno M, et al.: Relationship between lupus nephritis activity and the serum level of soluble VCAM- 1. Lupus 1998, 7:347- 354. ArticlePubMedCAS Google Scholar
Janssen BA, Luqmani RA, Gordon C, et al.: Correlation of blood levels of soluble vascular cell adhesion molecule-1 with disease activity in systemic lupus erythematosus and vasculitis. Br J Rheumatol 1994, 33:1112–1116. ArticlePubMedCAS Google Scholar
Spronk PE, Bootsma H, Huitema MG, et al.: Levels of soluble VCAM-1, soluble ICAM-1, and soluble E-selectin during disease exacerbations in patients with systemic lupus erythematosus (SLE); a long term prospective study. Clin Exp Immunol 1994, 97:439- 444. ArticlePubMedCAS Google Scholar
Tesar V, Masek Z, Rychlik I, et al.: Cytokines and adhesion molecules in renal vasculitis and lupus nephritis. Nephrol Dial Transplant 1998, 13:1662- 1667. ArticlePubMedCAS Google Scholar
Kaplanski G, Cacoub P, Farnarier C, et al.: Increased soluble vascular cell adhesion molecule 1 concentrations in patients with primary or systemic lupus erythematosus-related antiphospholipid syndrome: correlations with the severity of thrombosis. Arthritis Rheum 2000, 43:55- 64. ArticlePubMedCAS Google Scholar
Boehme MW, Nawroth PP, Kling E, et al.: Serum thrombomodulin. A novel marker of disease activity in systemic lupus erythematosus. Arthritis Rheum 1994, 37:572- 577. ArticlePubMedCAS Google Scholar
Frijns R, Fijnheer R, Schiel A, et al.: Persistent increase in plasma thrombomodulin in patients with a history of lupus nephritis: endothelial cell activation markers. J Rheumatol 2001, 28:514- 519. PubMedCAS Google Scholar
Kotajima L, Aotsuka S, Sato T: Clinical significance of serum thrombomodulin levels in patients with systemic rheumatic diseases. Clin Exp Rheumatol 1997, 15:59- 65. PubMedCAS Google Scholar
Jacobi AM, Odendahl M, Reiter K, et al.: Correlation between circulating CD27high plasma cells and disease activity in patients with systemic lupus erythematosus. Arthritis Rheum 2003, 48:1332- 1342. The number and frequency of CD27high plasma cells significantly correlated with SLE disease activity indices and with the titer of antidsDNA antibodies. B cell abnormalities provided predictive values for nonactive and active disease of 78.0% and 78.9%, respectively. ArticlePubMed Google Scholar