Pharmacogenomic Strategies in Clinical Care

Information on variability in the target and the PK/PD behavior for a therapeutic protein will promote development of drugs with the highest value for patients. Such information may guide the decision of which drug to prescribe as first choice for a given patient. As the literature on Pgx studies of protein therapeutics matures, it is likely that certain genotypes will be associated with responses in several indications, as has been noted for FCGR3A genotype and Fc-containing drugs. The ideal situation would allow physicians to use Pgx data from multiple genotypes and multiple potential treatment options within a given indication to aid in decisions about care. This would require well-controlled studies that differentiate between prognostic markers and markers that predict specific treatment responses (136). The information for multiple treatments will not become available all at once. Nonetheless, all stakeholders, including industry, academics, regulatory agencies, payers, and patients, should promote the generation of this data.

Ultimately, one could envision that several markers will define subsets of patients within an indication, and information on the best treatment for a given patient subset will be available to physicians and patients. Patient subsets would be defined by a predominant molecular pathology that indicates certain target pathways for therapeutic intervention. In this scenario, the treatment options targeting multiple pathways could be selected on the basis of results of diagnostic assays. This is similar to the current practice of customized care in oncology settings. A large research effort will be required in the coming decades to define novel therapeutic targets and to characterize responsive patient subsets. Our hope is that Pgx strategies can help to shift the treatment paradigm for most indications, resulting in improved patient responses, earlier treatment with effective medications, and lower incidence of drug-related adverse events.

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