Methods for identifying and monitoring patients at risk for systemic inflammatory conditions, methods for selecting treatments for these patients and apparatus for use in these methods

Abstract

Methods of identifying, monitoring and matching patients with appropriate treatments who are at risk for developing a systemic inflammatory condition prior to development of signs and symptoms using a systemic mediator-associated physiologic test profile are provided.

1 . A method for predicting levels of inflammatory mediators in the treatment of systemic inflammatory conditions comprising: 
 a) measuring baseline parameters of a patient;    b) generating a systemic mediator-associated response test profile for the patient, said profile comprising one or more of the baseline parameters measured in step a);    c) comparing the baseline parameters of the patient profile with the same patient parameters of established control profiles from patients diagnosed with a systemic inflammatory disease; and    d) predicting levels of circulating inflammatory mediators based upon the comparison in step c).    
     
     
         2 . The method of  claim 1 , wherein the baseline parameters include one or more demographic variables, physiologic variables, clinical laboratory parameters, endotoxin levels, eicosanoid levels, or cytokine levels.  
     
     
         3 . The method of  claim 1 , further comprising selecting a treatment for the patient based upon the predicted levels of circulating inflammatory mediators.  
     
     
         4 . A method for analyzing clinical trial results for a new therapeutic agent comprising 
 a) measuring baseline parameters of a patient in a clinical trial receiving a new therapeutic agent;    b) measuring baseline parameters of a patient in the clinical trial receiving a placebo;    c) measuring outcome of the clinical trial for the patients of steps a) and b);    d) generating, with one or more of the measured parameters, a systemic mediator-associated response test profile for the patients of steps a) and b); and    e) predicting, based upon the patient profiles, what the response of each patient to the new therapeutic agent would have been prior to commencing the clinical trial thereby analyzing the clinical trial results of the new therapeutic agent.