Application of Biomarkers to Clinical Trials in Sy

Authors: Robert Lafyatis

Publish Date: 2011/11/04

Volume: 14, Issue: 1, Pages: 47-55

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Abstract

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 unknownDr Lafyatis has served as a consultant for Genentech and Regeneron Pharmaceuticals has received grant support from ISDIN Novartis MedImmune and Actelion Pharmaceuticals and has a patent pending fourgene biomarker for skin disease in systemic sclerosis for which no profit has been derived to date

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