Abstract
Biomarkers are of high and further increasing importance in medicine, particularly in the realm of 'personalized medicine'. They are valuable for predicting prognosis and dose selection. Moreover they may be helpful in detecting therapeutic and adverse responses, and in patient stratification based on efficacy or safety prediction. Thus, biomarkers are essential tools for the selection of appropriate patients for treatment with certain drugs and enable personalized medicine, i.e. 'providing the right treatment to the right patient, at the right dose at the right time'. Currently there are six drugs approved for dermatological indications with recommended or mandatory biomarker testing, most of them for the therapy of melanoma and human immunodeficiency virus infection. In contrast to the few fully validated biomarkers, many exploratory biomarkers and biomarker candidates have potential application. Prognostic biomarkers are of particular significance for malignant conditions. Similarly, diagnostic biomarkers are important in autoimmune diseases. Disease severity biomarkers are helpful tools in the treatment of inflammatory skin diseases. Identification, qualification, and implementation of the different kinds of biomarkers, however, are challenging and frequently necessitate collaborative efforts. This is particularly true for stratification biomarkers that require a companion diagnostic marker that are co-developed with a certain drug. In this article, general definitions and requirements of biomarkers as well as the impact of biomarkers in dermatology are reviewed and opportunities and challenges are discussed.
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