Abstract

In recent years, the interest and research towards assessing disease related biomarkers has greatly accelerated in the field of inflammatory diseases. The potential clinical benefits of evaluating disease-specific biomarkers includes a rapid and accurate disease diagnosis, prediction of clinical end point in early stages of clinical trials, which would speed up drug development.  Psoriasis is a chronic inflammatory immune mediated skin disease characterized by hyperproliferation of epidermal keratinocytes and infiltration of immune cells. One of the key drivers reported to be involved in pathogenesis and maintenance of psoriasis is Th17/IL-17 producing cells. The IL17 pathway is central to other chronic inflammatory diseases such as arthritis, atopic dermatitis, multiple sclerosis, Lupus, Uveitis etc. One of the major challenge in assessing biomarkers is marker assessment methods such as the reliability and reproducibility of the assay. Depending on method used for analyzing samples, there are set of validation criteria including: assay range, specificity, sensitivity, selectivity, cross-reactivity, parallelism, dilution linearity, analyte stability, accuracy and precision.  Biomarker data generated using skin biopsy samples of psoriasis patients across different clinical trials demonstrated that first 4 weeks of treatment can be used to accurately predict (>80% AUC) clinical end-point efficacy. So, systematic evaluation and implementation of the design strategies are essential to accelerate the clinical validation of biomarker-guided therapy, thereby taking us a step closer to the goal of personalized medicine.