Biological markers for evaluating therapeutic treatment of inflammatory and autoimmune disorders

Abstract

Novel biological markers indicative of the action of an anti-inflammatory or immunosuppressive drug can be used to evaluate drug efficacy and compare local and systemic drug effects. They can also aid in comparison of different drugs, doses, and delivery routes. The biological markers include cell populations, cell surface antigen expression levels, and soluble factor concentrations. Measurement values of the novel biomarkers were shown to change significantly in allergic, atopic asthmatic, and healthy subjects after administration of prednisone.

Description

FIELD OF THE INVENTION The present invention relates generally to treatment of disease in humans and other mammals. More particularly, it relates to biological markers such as cell populations, cell surface antigen expression levels, and soluble factor concentrations that are indicative of the efficacy of treatment of atopic asthma and other inflammatory disorders. BACKGROUND OF THE INVENTION Prednisone is a corticosteroid used to treat a wide variety of inflammatory disorders, including asthma, atopy, arthritis, multiple sclerosis, ulcerative colitis, and Crohn's disease. While a comprehensive understanding of the action of prednisone and other glucocorticoids (a class of corticosteroids) is lacking, the drugs are known to have broad-ranging anti-inflammatory and immunosuppressive effects, including inhibition of pro-inflammatory mediators and activation of anti-inflammatory mediators. They affect the growth, differentiation, and function of monocytes and lymphocytes; the distrib...

AI Technical Summary

Benefits of technology

The present invention addresses these needs by providing novel biological markers (biomarkers) indicative of anti-inflammatory or immunosuppressive action of a drug in a subject. These novel biomarkers can be used to assess the anti-inflammatory action of a drug, detect systemic versus local effects of an anti-inflammatory drug, and better understand the mechanism of action of glucocorticoids such as prednisone. The information obtained can aid in selection of an appropriate glucocorticoid, dose, and administration route. Additionally, the information provided by the present invention can help in designing next generation drugs that have strong anti-inflammatory effects but fewer or less significant side effects than existing glucocorticoids.

Problems solved by technology

In addition, because of their broad-ranging systemic effects, prednisone and other glucocorticoids have a large number of side effects, some of them quite serious, which restrict their applicability in many patients, particularly for long-term use.

However, while many studies examine IgE levels and related factors, there are few data available with respect to other measurements in vivo, such as cell surface marker expression on granulocytes and lymphocytes, or soluble factors in serum.

In addition, accurate but simple methods for evaluating drug efficacy are lacking.

One of the problems in elucidating both drug action and disease pathogenesis is that appropriate tools are lacking to measure a broad range of applicable immunological components in vivo from a large number of subjects.

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