University of Pittsburgh

Allegheny-Singer Research Institute

Other

Nationwide Children's Hospital

Joseph M Ahearn

Susan M Manzi

Chau-Ching Liu

Jeannine Navratil

Ariella M Rosengard

C Yung Yu

Cell-bound complement activation product (CB-CAP) profiling is combined with determination of C4 gene copy number as biomarkers for lupus and/or pre-lupus diagnosis and monitoring.

Methods and systems using C4 gene copy number and cell-bound complement activation products for identification of lupus and pre-lupus

Methods, systems, and kits useful for determining whether a subject is likely to benefit from therapy with an antibody are provided. In particular aspects, cell-bound complement activation products (CB-CAPs) associated with B lymphocytes may serve as diagnostic biomarkers.

Cell-bound complement activation product assays as companion diagnostics for antibody-based drugs

Cell-bound complement activation product (CB-CAP) profiling and scoring serve as diagnostic biomarkers for patients to determine whether a patient who has not met at least four American College of Rheumatology (or similar e.g. SLICC) criteria for a definite Lupus diagnosis should be classified as exhibiting a pre-existing condition that this document refers to as pre-Lupus. This document also describes methods for determining whether a patient who has been determined to exhibit pre-Lupus has progressed to exhibiting definite Lupus.

Cell-bound complement activation products as diagnostic biomarkers for pre-lupus

Provided are methods, systems, and kits for diagnosing or monitoring systemic lupus erythematosus in an individual. In particular aspects, in a blood sample containing white blood cells from the individual, autoantibodies deposited on or contacting with the surface of a T lymphocyte in the sample are quantitated.

Anti-lymphocyte autoantibodies as diagnostic biomarkers

Cell-bound complement activation product (CB-CAP) profiling and scoring serve as diagnostic biomarkers for patients to determine whether a patient who has not met at least four American College of Rheumatology (or similar e.g. SLICC) criteria for a definite Lupus diagnosis should be classified as exhibiting a pre-existing condition that this document refers to as pre-Lupus.

A method for identifying or monitoring SLE in an individual is provided. The method includes quantitating complement component C4d on the surfaces of platelets and comparing the amounts of C4d to reference levels of C4d on platelets of individuals without SLE and/or on platelets of the individual obtained at a different time. Kits for use in the above-described methods are provided along with computer readable media tangibly embodying executable instructions to perform the methods.

Identification and monitoring of systemic lupus erythematosus

This invention relates to the diagnosis and/or monitoring of patients with inflammatory diseases or conditions, e.g., immunologic, hematologic, vascular, or infectious diseases or conditions, by determining levels of complement pathway components on erythrocytes. Methods of diagnosing vascular diseases or conditions by determining levels of complement pathway components on platelets are also disclosed.

Monitoring immunologic, hematologic and inflammatory diseases

The invention is related to methods of diagnosing inflammatory diseases or conditions by determining levels of components of the complement pathway on the surface of white blood cells.

Diagnosing and monitoring inflammatory diseases by measuring complement components on white blood cells

Methods for diagnosing and monitoring systemic lupus erythematosus (SLE) or scleroderma by determining, in a blood sample from the individual being diagnosed or monitored, complement component C4d deposited on surfaces of red blood cells in the sample, and optionally also determining complement receptor CR1 deposited on the red blood cell surfaces. For diagnosis this is compared with the quantity of C4d (and optionally CR1) present on red blood cells of normal individuals. For monitoring it is compared with a value in a sample or samples previously obtained from the individual patient. The comparison may be made with individual values for C4d and CR1 and/or with a ratio of the two found in normal individuals.

Diagnosis and monitoring of systemic lupus erythematosus and of scleroderma

This invention relates to the diagnosis and/or monitoring of patients with inflammatory diseases or conditions, including systemic lupus erythematosus, particularly for diagnosis of the acute stage of the disease, including methods and kits for carrying out this activity. This disclosure presents the surprising discovery that levels of complement pathway components on reticulocytes can be used to diagnose, monitor, or predict the occurrence of acute episodes of chronic inflammatory diseases or conditions.

Real time method of detecting acute inflammatory conditions

The invention provides a complement inhibitor derived from variola, called smallpox inhibitor of complement enzymes (SPICE) and SPICE-related proteins, such as fusion proteins. These proteins are useful in the treatment of complement-mediated conditions, such as hyperacutc rejection of xenografts.

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Sewickley, PA, United States of America

Joseph M Ahearn