Adjusted multi-biomarker disease activity score for inflammatory disease assessment
Inventors
HWANG, Ching Chang • Chernoff, David • Gutin, Alexander • Flake, Darl • Lanchbury, Jerry • Eastman, Paul Scott • Sasso, Eric
Assignees
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Publication Number
US-12392785-B2
Publication Date
2025-08-19
Expiration Date
Abstract
Provided herein are methods for assessing response to inflammatory disease therapy. The methods include performing immunoassays to generate scores based on quantitative data for expression of biomarkers relating to inflammatory biomarkers to assess disease activity in inflammatory diseases, e.g., rheumatoid arthritis. Also provided are methods of adjusting disease activity scores to account for variables that can influence such scores.
Core Innovation
The invention relates to a method for assessing a subject for treatment for rheumatoid arthritis disease activity. The method obtains a blood sample and performs an immunoassay to measure protein expression values of at least six protein markers, the at least six markers comprising CHI3L1, IL6, LEP, MMP1, MMP3, and SAA1.
The method generates a multi-biomarker disease activity (MBDA) score by weighting the determined expression of each protein marker with a predefined coefficient and combining the weighted expression. The method then calculates a disease activity score according to a formula that adjusts the MBDA score using age, male (sex), and leptin, with values stated to be within a 95% Confidence Interval.
The invention further determines that the subject has a disease activity score of 45 to 100 and a high level of rheumatoid arthritis disease activity, and administers a DMARD or biologic DMARD therapy to the subject having the disease activity score in that range. Dependent embodiments refine the protein marker panel by using additional protein markers, and embodiments may specify CRP as one additional protein marker or provide an expanded marker list for calculating the disease activity score.
Claims Coverage
The partial content includes one independent claim describing a blood-based immunoassay approach with an age/sex/leptin-adjusted disease activity score. The independent claim includes four inventive features: obtaining a blood sample and measuring a specified minimum protein marker set, generating an MBDA score using predefined coefficients, computing an adjusted disease activity score with an explicit age/sex/leptin formula, and linking the resulting score range to high rheumatoid arthritis disease activity and therapy selection.
Blood-based immunoassay of specified protein markers
Obtaining a blood sample and performing an immunoassay to measure protein expression values of at least six protein markers, the at least six markers comprising CHI3L1, IL6, LEP, MMP1, MMP3, and SAA1.
Coefficient-weighted MBDA multi-biomarker score generation
Generating a multi-biomarker disease activity (MBDA) score by weighting the determined expression of each protein marker with a predefined coefficient and combining the weighted expression.
Age/sex/leptin-adjusted disease activity score calculation
Calculating a disease activity score according to a formula that adjusts the MBDA score using age, male (sex), and leptin, with values stated to be within a 95% Confidence Interval.
Therapy selection based on high disease activity score range
Determining that the subject has a disease activity score of 45 to 100 and a high level of rheumatoid arthritis disease activity, and administering a DMARD or biologic DMARD therapy to the subject having the disease activity score in that range.
Across the independent claim, the inventive core is an immunoassay-based MBDA score using a predefined-coefficient weighting of a specified marker set, followed by computation of an age/sex/leptin-adjusted disease activity score. The resulting score is used to identify high rheumatoid arthritis disease activity (45 to 100) and to administer DMARD or biologic DMARD therapy.
Stated Advantages
Enables determination of high rheumatoid arthritis disease activity using an age/sex/leptin-adjusted disease activity score.
Supports administering DMARD or biologic DMARD therapy to subjects identified as having a disease activity score of 45 to 100 and a high level of rheumatoid arthritis disease activity.
Documented Applications
Assessing a subject for treatment for rheumatoid arthritis disease activity.
Identifying subjects with high rheumatoid arthritis disease activity based on a disease activity score of 45 to 100 and administering a DMARD or biologic DMARD therapy accordingly.
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