WO2011140484A1 - Methods for diagnosing, staging, predicting risk for developing and identifying treatment responders for rheumatoid arthritis - Google Patents

Methods for diagnosing, staging, predicting risk for developing and identifying treatment responders for rheumatoid arthritis Download PDF

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Publication number
WO2011140484A1
WO2011140484A1 PCT/US2011/035584 US2011035584W WO2011140484A1 WO 2011140484 A1 WO2011140484 A1 WO 2011140484A1 US 2011035584 W US2011035584 W US 2011035584W WO 2011140484 A1 WO2011140484 A1 WO 2011140484A1
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WO
WIPO (PCT)
Prior art keywords
concentration
less
totmmp
healthy volunteer
subject
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2011/035584
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English (en)
French (fr)
Inventor
John Allan Todd
Quynh Anh Thue Lu
Sara Jane Le
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Singulex Inc
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Singulex Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Singulex Inc filed Critical Singulex Inc
Priority to EP11778442.1A priority Critical patent/EP2566971B1/en
Priority to CA 2798149 priority patent/CA2798149A1/en
Priority to AU2011249908A priority patent/AU2011249908A1/en
Priority to JP2013509303A priority patent/JP2013525820A/ja
Publication of WO2011140484A1 publication Critical patent/WO2011140484A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
    • G01N33/6869—Interleukin
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/564—Immunoassay; Biospecific binding assay; Materials therefor for pre-existing immune complex or autoimmune disease, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/34—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Corynebacterium (G)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/06—Gastro-intestinal diseases
    • G01N2800/065—Bowel diseases, e.g. Crohn, ulcerative colitis, IBS
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/10—Musculoskeletal or connective tissue disorders
    • G01N2800/101—Diffuse connective tissue disease, e.g. Sjögren, Wegener's granulomatosis
    • G01N2800/102—Arthritis; Rheumatoid arthritis, i.e. inflammation of peripheral joints
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/12—Pulmonary diseases
    • G01N2800/122—Chronic or obstructive airway disorders, e.g. asthma COPD
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/20—Dermatological disorders
    • G01N2800/205—Scaling palpular diseases, e.g. psoriasis, pytiriasis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/50—Determining the risk of developing a disease
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/56—Staging of a disease; Further complications associated with the disease

Definitions

  • IL-17a (a)
  • totMMP-9 is less than 5.0 ng/ml, or IL-6 is greater than 1.0 pg/ml, the subject is predicted to have a high likelihood, medium likelihood or a low likeihood of inflammatory disease remission.
  • the term "subject” refers to a mammal that can be afflicted by a rheumatoid arthritis, but may or may not have such a disease.
  • the terms “subject” and “patient” are used herein interchangeably in reference.
  • the subject is a human.
  • the disclosure provides methods for predicting the risk for developing RA or other inflammatory disorder in a subject, comprising obtaining a sample from the subject, determining a concentration of each of IL-17A, IL-17A/F, and IL-17F, and optionally one or more of IL-IB, IL-6, totMMP-9, proMMP-9, cTnl, and combinations thereof in the sample, wherein when the subject has a concentration of IL-17A, IL-17A/F or IL-17F greater than healthy volunteer average concentrations for IL-17A, IL-17A/F or IL- 17F, in combination with a concentration of IL-IB less than healthy volunteer average concentrations for IL-1B, a concentration of IL-6 greater than healthy volunteer average concentrations for IL-6, and a concentration of totMMP-9 less than healthy volunteer average concentrations for totMMP-9, the subject is predicted to have a greater than normal risk of developing RA or other inflammatory disorder.
  • the disclosure provides methods for predicting the risk for developing RA or other inflammatory disorder in a subject, comprising obtaining a sample from the subject, determining a concentration of each of IL-17A, IL-17A/F, and IL-17F, and optionally one or more of IL-1B, IL-6, totMMP-9, proMMP-9, cTnl, and combinations thereof in the sample, wherein when the subject has a concentration of IL-17A greater than about 0.18 pg/ml, of IL-17A/F greater than about 1.35 pg/ml and of IL-17F of greater than about 116 pg/ml, in combination with one or more of a concentration of IL-1B less than about 1.1 pg/ml, a concentration of IL-6 greater than about 1.0 pg/ml, or a concentration of totMMP-9 less than about 5.0 ng/ml, the subject is predicted to have a greater than normal risk of developing RA.
  • the disclosure provides methods for predicting the likelihood of inflammatory disease remission in a subject, wherein when the concentrations of one or more of IL-17A is greater than 0.18 pg/ml, the concentration of IL-17-F is greater than 116 pg/ml, and the concentration of IL-17A/F is greater than 1.35 pg/ml, and wherein when the concentration of at least two of IL-1B is less than 1.1. pg/ml, totMMP-9 is less than 5.0 ng/ml, and IL-6 is greater than 1.0 pg/ml, the subject is predicted to have a low likelihood of inflammatory disease remission.
  • the disclosure provides methods for determining the severity of inflammatory disease in a subject, comprising obtaining a sample from the subject, determining a concentration of each of IL-17A, IL-17A/F, and IL-17F, and optionally one or more of IL-1B, IL-6, totMMP-9, proMMP-9, cTnl, and combinations thereof in the sample, wherein when the concentration of one of IL-17A is greater than 0.18 pg/ml, IL-17-F is greater than 116 pg/ml, or IL-17A/F is greater than 1.35 pg/ml, and wherein when the concentration of none or one of IL-IB is less than 1.1. pg/ml, totMMP-9 is less than 5.0 ng/ml, or IL-6 is greater than 1.0 pg/ml, the subject is determined to have mild inflammatory disease.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Cell Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Pathology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PCT/US2011/035584 2010-05-06 2011-05-06 Methods for diagnosing, staging, predicting risk for developing and identifying treatment responders for rheumatoid arthritis Ceased WO2011140484A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP11778442.1A EP2566971B1 (en) 2010-05-06 2011-05-06 Methods for diagnosing, staging, predicting risk for developing and identifying treatment responders for rheumatoid arthritis
CA 2798149 CA2798149A1 (en) 2010-05-06 2011-05-06 Methods for diagnosing, staging, predicting risk for developing and identifying treatment responders for rheumatoid arthritis
AU2011249908A AU2011249908A1 (en) 2010-05-06 2011-05-06 Methods for diagnosing, staging, predicting risk for developing and identifying treatment responders for rheumatoid arthritis
JP2013509303A JP2013525820A (ja) 2010-05-06 2011-05-06 関節リウマチの発症に関するリスクを診断し、病期分類し、予測し、治療レスポンダーを同定するための方法

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US33208110P 2010-05-06 2010-05-06
US61/332,081 2010-05-06
US201061428500P 2010-12-30 2010-12-30
US61/428,500 2010-12-30
US201161444702P 2011-02-19 2011-02-19
US61/444,702 2011-02-19

Publications (1)

Publication Number Publication Date
WO2011140484A1 true WO2011140484A1 (en) 2011-11-10

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US (2) US20110301053A1 (enExample)
EP (1) EP2566971B1 (enExample)
JP (1) JP2013525820A (enExample)
AU (1) AU2011249908A1 (enExample)
CA (1) CA2798149A1 (enExample)
WO (1) WO2011140484A1 (enExample)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130261016A1 (en) * 2012-03-28 2013-10-03 Meso Scale Technologies, Llc Diagnostic methods for inflammatory disorders
AU2014407088B2 (en) 2014-09-26 2021-09-23 Somalogic Operating Co., Inc. Cardiovascular risk event prediction and uses thereof

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EP2566971B1 (en) 2019-03-27
AU2011249908A1 (en) 2012-11-22
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US20110301053A1 (en) 2011-12-08

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