Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12385912-B2
Publication Date
2025-08-12
Expiration Date
Abstract
Provided herein are methods for assessing response to inflammatory disease therapy. The methods include placing a subject on a therapeutic regimen and subsequently performing an immunoassay to generate a score based on quantitative data for expression of biomarkers relating to inflammatory biomarkers. The methods further include recommending that the subject either remains on the therapeutic regimen, or is removed from the therapeutic regimen, based on the score.
Core Innovation
The invention relates to a method for treating a subject having an arthritic disorder by administering a therapeutic regimen comprising one or more of DMARD therapy and administration of a therapeutic compound, and then performing an immunoassay on a sample from the subject. The immunoassay generates a score using an interpretation function based on a set of quantitative data that comprises expression data for a set of biomarkers, including CHI3L1, CRP, EGF, IL6, LEP, MMP1, MMP3, RETN, SAA1, TNFRSF1A, VCAM1, and VEGFA.
The score is on a scale of 1-100, with the score being low if the score is <30, moderate if the score is 30-44, and high if the score is >44. The method determines from the score that the subject has a decreased risk of relapse if the subject has a low or moderate score, where relapse is one of TNFi re-initiation, medication escalation, or physician-reported flare.
The method reduces the dose or frequency of the one or more of DMARD therapy and administration of a therapeutic compound when the score is low or moderate. In an additional aspect, the method administers the therapeutic regimen until the subject reaches a clinically low level or remission level of disease activity and includes DMARD therapy and administration of a therapeutic compound, and optionally reversible bariatric surgery.
The same immunoassay scoring framework and thresholds are used to determine decreased risk of relapse for low or moderate scores. When the score is low or moderate, the method reduces the dose or frequency of the DMARD therapy and therapeutic compound, or reverses the bariatric surgery.
Claims Coverage
Two independent claims are provided. Across the independent claims, the inventive features center on biomarker-based immunoassay scoring, interpreting the score to determine decreased relapse risk, and using that determination to reduce or adjust the therapeutic regimen.
Biomarker-based immunoassay score interpretation for relapse risk
Performing an immunoassay on a sample from the subject to generate a score based on a set of quantitative data comprising expression data for a set of biomarkers including CHI3L1, CRP, EGF, IL6, LEP, MMP1, MMP3, RETN, SAA1, TNFRSF1A, VCAM1, and VEGFA, wherein the score is calculated by an interpretation function on a scale of 1-100 with low if <30, moderate if 30-44, and high if >44.
Decreased risk of relapse determination from low/moderate score
Determining from the score that the subject has a decreased risk of relapse if the subject has a low or moderate score, wherein relapse is one of TNFi re-initiation, medication escalation, or physician-reported flare.
Therapy dose or frequency reduction based on low/moderate score
Reducing the dose or frequency of the one or more of DMARD therapy and administration of a therapeutic compound if the score is low or moderate.
Clinically low or remission treatment stage with immunoassay-guided regimen adjustment
Administering a therapeutic regimen to the subject until the subject reaches a clinically low level or remission level of disease activity, wherein the therapeutic regimen comprises one or more of DMARD therapy, reversible bariatric surgery, and administration of a therapeutic compound, followed by performing the immunoassay to generate the score and determining a decreased risk of relapse from a low or moderate score, and then reducing the dose or frequency of DMARD therapy and administration of a therapeutic compound, or reversing the bariatric surgery.
The independent claims cover using an immunoassay-generated 1-100 biomarker score with defined low, moderate, and high thresholds to determine decreased relapse risk and guide reducing DMARD therapy and therapeutic-compound dosing, with an additional regimen-stage aspect that includes reaching clinically low or remission and optionally reversing bariatric surgery when the score is low or moderate.
Stated Advantages
Decreased risk of relapse if the subject has a low or moderate score.
Reduction of the dose or frequency of DMARD therapy and administration of a therapeutic compound when the score is low or moderate.
In the clinically low or remission setting, reversing bariatric surgery if the score is low or moderate.
Documented Applications
No documented applications found
Interested in licensing this patent?