Biomarker for monitoring development of diseases and assessing the efficacy of therapies

摘要

The invention concerns a method for monitoring the development of a disease in a patient, and for assessing the efficacy of a therapy influencing on the CD73 level or activity in the patient, in particular a cytokine therapy or a statin therapy. CD73 in a tissue fluid drawn from the patient is used as a biomarker. The invention concerns also methods for determining of CD73 protein in a sample drawn from an individual's tissue fluid.

主权项

1. A method of determining a course of treatment of an inflammatory disease in a patient undergoing treatment of the inflammatory disease with an active agent that influences CD73 protein level or activity in the patient, the method comprising:
(a) identifying a patient undergoing treatment of an inflammatory disease with an agent that influences the CD73 protein level or activity in the patient, wherein the inflammatory disease is selected from the group consisting of acute lung injury, acute respiratory distress syndrome, acute pancreatitis, multi-organ failure and systemic inflammatory response syndrome; (b) obtaining a sample of tissue fluid from the patient at a first or earlier point in time; (c) determining the amount of CD73 protein or the activity of the CD73 protein in the sample at the first or earlier point in time; (d) obtaining a sample of tissue fluid from the patient at a second or subsequent point in time; (e) determining the amount of CD73 protein or the activity of the CD73 protein in the sample at the second or subsequent point in time; (f) comparing the amount of the CD73 protein or the activity of the CD73 protein in the sample at the second or subsequent point in time with that of the first or earlier point in time; (g) determining the course of treatment of the patient with an agent that influences the CD73 protein level or activity in the patient from the comparison of the amount of the CD73 protein or the activity of the CD73 protein in the sample by
(g1) continuing the treatment of the patient with an agent that influences the CD73 protein level or activity in the patient if the amount of the CD73 protein or the activity of the CD73 protein is increased at the second or subsequent point of time or(g2) replacing or supplementing the treatment of the patient with an agent that influences the CD73 protein level or activity in the patient by another therapy if the amount of the CD73 protein or the activity of the CD73 protein is not increased at the second or subsequent point in time; (h) repeating steps (d)-(f); and (i) determining the course of treatment of the patient with an agent that influences the CD73 protein level or activity in the patient from the comparison of the amount of the CD73 protein or the activity of the CD73 protein in the sample by
(i1) continuing the treatment of the patient with an agent that influences the CD73 protein level or activity in the patient if the amount of the CD73 protein or the activity of the CD73 protein is increased at the subsequent point of time or(i2) stopping the treatment of the patient with an agent that influences the CD73 protein level or activity in the patient if the amount of the CD73 protein or the activity of the CD73 protein is not increased at the subsequent point in time.