Abstract for: Individualized Medicine and Biophysical System Dynamics: An Example from Clinical Practice in End Stage Renal Disease

Erythropoietic Stimulating Agents (ESAs), have been used in hemodialysis patients since 1988, largely eliminating the need for transfusions to correct the anemia of chronic renal failure. However, current ESA protocols lead to suboptimal anemia control. Questions about the safety of ESAs and clinically desirable hemoglobin levels remain open, despite a series of clinical trials. Moreover, ESAs are expensive: Medicare reimbursements for ESA’s in 2008 approached two billion dollars. A process improvement project conducted at Mayo Clinic initiated in 2007 revealed that current ESA protocols lead to (undesirable) oscillations in hemoglobin levels. Recognizing the behavior as a system signature, we developed a bio-pharmacokinetic model of erythropoiesis. Using prior data for a specific patient, the model provides parameters for individualized ESA response profiles. Parameter values are then used to design dosing regimens that achieve the desired results. 650 patients are enrolled in this prototype information system. The percentage of patients who achieved target and stable hemoglobin levels has improved by 40%, ESA costs have been reduced by 35%, and anemia management resource requirements have been reduced by more than 50%. Indications that hospitalizations may have been reduced by 25% are currently under study. Commercial development is underway.