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This chapter reviews the mechanism of action of cladribine, summarizes data from clinical trials in patients with multiple sclerosis (MS), and provides guidance on the management of these patients in clinical practice. The study of parenteral cladribine showed encouraging results, which lead to the development of an oral tablet formulation. Cladribine is rapidly absorbed with Cmax within 30- 50 minutes after oral administration. CLARITY, a 96-week, placebo-controlled Phase 3 study of cladribine tablets as an annual short-course oral monotherapy in RRMS, was recently completed and the principal results published. Benefit of doses of cladribine over placebo was demonstrated for a variety of clinical and imaging end-points. The most common adverse events in the patients were lymphopenia, headache, nasopharyngitis, and upper respiratory tract infections (URTI). The outcomes observed during the CLARITY study were associated with a reduced consumption of health care resources and a decreased need for medical and societal support.
This chapter lists the factors that differentiate pharmacogenomics from conventional biomarker research on a strategic, operational, and technical level. The "-omics" technologies and conventional methods are mutually complementary approaches in the search for biomarkers. The genetic component of multiple sclerosis (MS) risk has been the focus of study for a long time, and beyond the classic association with the MHC locus, seven genome-wide association studies (GWAS) reported in recent years have helped identify other candidate genes, such as the IL-7 and IL-2 receptors. Compared with DNA- and RNA-based analyses, proteomics and metabolomics are less advanced techniques. The requirements for establishing a comprehensive and integrated matrix of genotype/phenotype interaction are: development of technologies for proteomics and metabolomics to the same level as genotyping and trancriptomics, development of bioinformatic tools, and development of longitudinally studied cohorts characterized using standardized, high-quality clinical and paraclinical methods.
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