Methods for diagnosing systemic lupus erythematosus
AssigneeExagen Inc.
InventorsThierry Dervieux, Cole Harris
Life of this patent
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Abstract
Provided herein are methods of diagnosing and monitoring disease activity and response to treatment in patients having systemic lupus erythematosus using panels of biomarkers, such as at least one biomarker selected from the group consisting of B-lymphocyte-bound C4d, erythrocyte-bound C4d, platelet-bound C4d, and erythrocyte complement receptor type 1, and one further biomarker selected from the group consisting of anti-MCV antibody and anti-nuclear antibody.
Claims19
A method for treating systemic lupus erythematosus in a human subject in need thereof, wherein the human subject is negative for systemic lupus erythematosus based on a level of double-stranded DNA antibody;
- the method comprising:
- (a) measuring a level of erythrocyte-bound complement component C4d (EC4d) marker in a blood sample obtained from the patient;
- (b) measuring a level of B-lymphocyte-bound C4d complement component (BC4d) marker in the blood sample;
- (c) measuring a level of anti-nuclear antibody (ANA) in the blood sample;
- (d) determining a systemic lupus erythematosus risk score comprising the steps of:
- (i) adjusting the level of EC4d by a weighting coefficient to produce a weighted score for EC4d;
- (ii) adjusting the level of BC4d by a weighting coefficient to produce a weighted score for BC4d;
- (iii) adjusting the level of ANA by a weighting coefficient to produce a weighted score for ANA;
- and
- (iv) combining the weighted score for EC4d, BC4d, and ANA to generate the systemic lupus erythematosus risk score
- (e) determining that the human subject has systemic lupus erythematosus based on the systemic lupus erythematosus risk score;
- and
- (f) treating the human subject from step (e) that has systemic lupus erythematosus based on the systemic lupus erythematosus risk score with an effective amount of cyclophosphamide, a corticosteroid, mycophenolate, methotrexate, azathioprine, leflunomide, belimumab, or hydroxychloroquine.
A method for treating systemic lupus erythematosus in a human subject in need thereof, wherein the human subject is negative for systemic lupus erythematosus based on a level of double-stranded DNA antibody;
- the method comprising:
- (a) measuring a level of erythrocyte-bound complement component C4d (EC4d) marker in a blood sample obtained from the patient;
- (b) measuring a level of B-lymphocyte-bound C4d complement component (BC4d) marker in the blood sample;
- (c) measuring a level of anti-nuclear antibody (ANA) in the blood sample;
- (d) determining a systemic lupus erythematosus risk score by adjusting the level of EC4d, the level of BC4d, and the level of ANA by a transformation analysis;
- (e) determining that the human subject has systemic lupus erythematosus based on the systemic lupus erythematosus risk score;
- and
- (f) treating the human subject from step (e) that has systemic lupus erythematosus based on the systemic lupus erythematosus risk score with an effective amount of cyclophosphamide, a corticosteroid, mycophenolate, methotrexate, azathioprine, leflunomide, belimumab, or hydroxychloroquine.
A method for treating systemic lupus erythematosus in a human subject in need thereof, wherein the human subject is negative for systemic lupus erythematosus based on a level of double-stranded DNA antibody;
- the method comprising:
- (a) measuring a level of erythrocyte-bound C4d (EC4d) marker, a level of B-lymphocyte-bound C4d (BC4d) marker, and a level of anti-nuclear antibody (ANA) in a blood sample obtained from the human subject;
- (b) determining that the human subject has systemic lupus erythematosus based on the level of EC4d, the level of BC4d, and the level of ANA;
- and
- (b) administering to the human subject an effective amount of cyclophosphamide, a corticosteroid, mycophenolate, methotrexate, azathioprine, leflunomide, belimumab, or hydroxychloroquine, thereby treating systemic lupus erythematosus.
Dependencies are inferred from the claim text.