IP Library › Granted Patent US 12,385,912
Granted Patent B2
US 12,385,912 · App. 17/202,081 · Granted Aug 12, 2025

Methods of treatment of arthritic disorders

Inventor: Eric Sasso (South San Francisco, CA)
Assignee: LABORATORY CORPORATION OF AMERICA HOLDINGS
G01N33/564C07K16/241G16B20/00G01N2800/102G01N2800/52G01N2800/60
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Quick Facts
Patent No.
US 12,385,912
App. No.
17/202,081
Granted
Aug 12, 2025
Kind
B2
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.

Claims (34)

1. A method for treating a subject having an arthritic disorder, the method comprising:

a) administering a therapeutic regimen to the subject comprising one or more of DMARD therapy and administration of a therapeutic compound;

b) performing an immunoassay on a sample from the subject to generate a score based on a set of quantitative data, wherein the set of quantitative data comprises expression data for a set of biomarkers comprising chitinase 3-like 1 (cartilage glycoprotein-39) (CHI3L1); C-reactive protein, pentraxin-related (CRP); epidermal growth factor (beta-urogastrone) (EGF); interleukin 6 (interferon, beta 2) (IL6); leptin (LEP); matrix metallopeptidase 1 (interstitial collagenase) (MMP1); matrix metallopeptidase 3 (stromelysin 1, progelatinase) (MMP3); resistin (RETN); serum amyloid A1 (SAA1); tumor necrosis factor receptor superfamily, member 1A (TNFRSF1A); vascular cell adhesion molecule 1 (VCAM1); and, vascular endothelial growth factor A (VEGFA), wherein the score is calculated by an interpretation function, wherein the score is on a scale of 1-100, wherein the score is low if the score is <30, wherein the score is moderate if the score is 30-44, and wherein the score is high if the score is >44;

c) 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 tumor necrosis factor alpha inhibition (TNFi) re-initiation, medication escalation, or physician-reported flare; and

d) 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.

2. The method of claim 1 , wherein performance of the immunoassay comprises:

obtaining the sample, wherein the sample comprises the protein markers;

contacting the sample with a plurality of distinct reagents;

generating a plurality of distinct complexes between the reagents and markers; and

detecting the complexes to generate the data.

3. The method of claim 1 , wherein the immunoassay comprises a multiplex assay.

4. The method of claim 1 , wherein the therapeutic regimen prevents radiographic progression.

5. The method of claim 1 , wherein the arthritic disorder is rheumatoid arthritis.

6. The method of claim 1 , wherein the arthritic disorder is early rheumatoid arthritis.

7. The method of claim 1 , wherein the score is predictive of a clinical assessment of patients having the arthritic disorder.

8. The method of claim 1 , wherein the score is predictive of a clinical assessment comprising one of a DAS, a DAS28, a DAS28-CRP, a DAS28-ESR, a Sharp score, a tender joint count (TJC), and a swollen joint count (SJC).

9. The method of claim 1 , wherein the therapeutic compound is selected from MTX, azathioprine (AZA), bucillamine (BUC), chloroquine (CQ), ciclosporin, doxycycline (DOXY), hydroxychloroquine (HCQ), intramuscular gold (IM gold), leflunomide (LEF), levofloxacin (LEV), sulfasalazine (SSZ), certolizumab, apremilast, folinic acid, D-pencillamine, gold auranofin, gold aurothioglucose, gold thiomalate, cyclophosphamide, chlorambucil, infliximab, adalimumab, etanercept, golimumab, anakinra, abatacept, rituximab, and tocilizumab.

10. A method for treating a subject having an arthritic disorder, the method comprising:

a) administering a therapeutic regimen to the subject until the subject reaches a clinically low level or remission level of disease activity, the therapeutic regimen comprising one or more of DMARD therapy, reversible bariatric surgery, and administration of a therapeutic compound;

b) performing an immunoassay on a sample from the subject to generate a score based on a set of quantitative data, wherein the set of quantitative data comprises expression data for a set of biomarkers comprising chitinase 3-like 1 (cartilage glycoprotein-39) (CHI3L1); C-reactive protein, pentraxin-related (CRP); epidermal growth factor (beta-urogastrone) (EGF); interleukin 6 (interferon, beta 2) (IL6); leptin (LEP); matrix metallopeptidase 1 (interstitial collagenase) (MMP1); matrix metallopeptidase 3 (stromelysin 1, progelatinase) (MMP3); resistin (RETN); serum amyloid A1 (SAA1); tumor necrosis factor receptor superfamily, member 1A (TNFRSF1A); vascular cell adhesion molecule 1 (VCAM1); and, vascular endothelial growth factor A (VEGFA), wherein the score is calculated by an interpretation function, wherein the score is on a scale of 1-100, wherein the score is low if the score is <30, wherein the score is moderate if the score is 30-44, and wherein the score is high if the score is >44;

c) 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; and

d) reducing the dose or frequency of the one or more of DMARD therapy and administration of a therapeutic compound, or by reversing the bariatric surgery if the score is low or moderate.

11. The method of claim 10 , wherein performance of the immunoassay comprises:

obtaining the sample, wherein the sample comprises the protein markers;

contacting the sample with a plurality of distinct reagents;

generating a plurality of distinct complexes between the reagents and markers; and

detecting the complexes to generate the data.

12. The method of claim 10 , wherein the immunoassay comprises a multiplex assay.

13. The method of claim 10 , wherein the therapeutic regimen prevents radiographic progression.

14. The method of claim 10 , wherein the arthritic disorder is rheumatoid arthritis.

15. The method of claim 10 , wherein the arthritic disorder is early rheumatoid arthritis.

16. The method of claim 10 , wherein the score is predictive of a clinical assessment of patients having the arthritic disorder.

17. The method of claim 10 , wherein the score is predictive of a clinical assessment comprising one of a DAS, a DAS28, a DAS28-CRP, a DAS28-ESR, a Sharp score, a tender joint count (TJC), and a swollen joint count (SJC).

18. The method of claim 10 , wherein the therapeutic compound is selected from MTX, azathioprine (AZA), bucillamine (BUC), chloroquine (CQ), ciclosporin, doxycycline (DOXY), hydroxychloroquine (HCQ), intramuscular gold (IM gold), leflunomide (LEF), levofloxacin (LEV), sulfasalazine (SSZ), certolizumab, apremilast, folinic acid, D-pencillamine, gold auranofin, gold aurothioglucose, gold thiomalate, cyclophosphamide, chlorambucil, infliximab, adalimumab, etanercept, golimumab, anakinra, abatacept, rituximab, and tocilizumab.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 6, 2021
From: CRESCENDO BIOSCIENCE, INC.
To: LABORATORY CORPORATION OF AMERICA HOLDINGS
Reel/Frame 057709/0825 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 30, 2021
From: SASSO, ERIC
To: CRESCENDO BIOSCIENCE, INC.
Reel/Frame 057036/0977 →
Continuity (4)
Continuation 15938463 · Mar 28, 2018
Continuation PCTUS2016054318 · Sep 29, 2016
Provisional Application 62234468 · Sep 29, 2015
Related Publication 20210208139A1 · Jul 8, 2021
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