Application of Biomarkers to Clinical Trials in Systemic Sclerosis

被引:0
作者
Robert Lafyatis
机构
[1] Boston University School of Medicine,
来源
Current Rheumatology Reports | 2012年 / 14卷
关键词
Scleroderma; Systemic sclerosis; Surrogate outcomes; Subtypes; Biomarkers; Clinical trial; Disease status;
D O I
暂无
中图分类号
学科分类号
摘要
Important clinical advances in the treatment of systemic sclerosis have been made, yet fibrotic disease remains largely untreatable. Optimal design of clinical trials to test new therapeutics for fibrotic disease features has suffered from dual difficulties in patient selection and patient evaluation. Patient selection for entry into trials for treatment of interstitial lung disease and/or skin fibrosis is challenged by the natural history of the disease, which stabilizes in some patients while relentlessly progressing in others, and our lack of good clinical markers to distinguish between these trajectories. Patient evaluation is made difficult, particularly in skin disease, by the inherent difficulty in quantifying the extent of disease. Biomarkers hold the potential to solve many of these problems as surrogate outcome measures and as markers for disease progression. Identified biomarkers may have the potential to graduate to surrogate outcome singly or, more likely, in combination. Predictive biomarkers are still largely unknown.
引用
收藏
页码:47 / 55
页数:8
相关论文
共 314 条
  • [1] Katz R(2004)Biomarkers and surrogate markers: an FDA perspective NeuroRx 1 189-195
  • [2] Hesselstrand R(2008)COMP: a candidate molecule in the pathogenesis of systemic sclerosis with a potential as a disease marker Ann Rheum Dis 67 1242-1248
  • [3] Kassner A(2010)Osteopontin in the development of systemic sclerosis–relation to disease activity and organ manifestation Rheumatology (Oxford) 49 1989-1991
  • [4] Heinegard D(2002)Increased circulating concentrations of the counteradhesive proteins SPARC and thrombospondin-1 in systemic sclerosis (scleroderma). Relationship to platelet and endothelial cell activation J Rheumatol 29 2565-2570
  • [5] Saxne T(2010)A four-gene biomarker predicts skin disease in patients with diffuse cutaneous systemic sclerosis Arthritis Rheum 62 580-588
  • [6] Lorenzen JM(2005)Elevated matrix metalloproteinase-9 in patients with systemic sclerosis Arthritis Res Ther 7 R71-R79
  • [7] Kramer R(1994)Serum concentration of procollagen type I carboxyterminal propeptide in systemic sclerosis Arch Dermatol Res 286 77-80
  • [8] Meier M(1998)Circulating type I collagen degradation products: a new serum marker for clinical severity in patients with scleroderma? Br J Dermatol 139 1020-1025
  • [9] Werfel T(1988)Serum and urinary aminoterminal type III procollagen peptide in progressive systemic sclerosis: relationship to sclerodermal involvement, serum hyaluronan and urinary collagen metabolites J Rheumatol 15 460-467
  • [10] Wichmann K(2005)Increased levels of amino terminal propeptide of type III procollagen are an unfavourable predictor of survival in systemic sclerosis Clin Exp Rheumatol 23 165-172