JP6063398B2 - 抗ＴＮＦα薬に対する自己抗体を検出するためのアッセイ - Google Patents

抗ＴＮＦα薬に対する自己抗体を検出するためのアッセイ Download PDF

Info

Publication number
JP6063398B2
JP6063398B2 JP2013554602A JP2013554602A JP6063398B2 JP 6063398 B2 JP6063398 B2 JP 6063398B2 JP 2013554602 A JP2013554602 A JP 2013554602A JP 2013554602 A JP2013554602 A JP 2013554602A JP 6063398 B2 JP6063398 B2 JP 6063398B2
Authority
JP
Japan
Prior art keywords
tnfα
labeled
sample
drug
haca
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.)
Expired - Fee Related
Application number
JP2013554602A
Other languages
English (en)
Japanese (ja)
Other versions
JP2014508930A5 (enExample
JP2014508930A (ja
Inventor
シャラット スィン，
シャラット スィン，
シュウイ ロン ワン，
シュウイ ロン ワン，
リンダ オールマンド，
リンダ オールマンド，
スコット ハウエンシュタイン，
スコット ハウエンシュタイン，
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nestec SA
Original Assignee
Nestec SA
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 Nestec SA filed Critical Nestec SA
Publication of JP2014508930A publication Critical patent/JP2014508930A/ja
Publication of JP2014508930A5 publication Critical patent/JP2014508930A5/ja
Application granted granted Critical
Publication of JP6063398B2 publication Critical patent/JP6063398B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • G01N33/53—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
    • G01N33/94—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Pathology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2013554602A 2011-02-17 2012-02-16 抗ＴＮＦα薬に対する自己抗体を検出するためのアッセイ Expired - Fee Related JP6063398B2 (ja)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201161444097P 2011-02-17 2011-02-17
US61/444,097 2011-02-17
US201161484594P 2011-05-10 2011-05-10
US61/484,594 2011-05-10
US201161496501P 2011-06-13 2011-06-13
US61/496,501 2011-06-13
PCT/US2012/025437 WO2012154253A1 (en) 2011-02-17 2012-02-16 ASSAYS FOR DETECTING AUTOANTIBODIES TO ANTI-TNFα DRUGS

Publications (3)

Publication Number Publication Date
JP2014508930A JP2014508930A (ja) 2014-04-10
JP2014508930A5 JP2014508930A5 (enExample) 2015-03-19
JP6063398B2 true JP6063398B2 (ja) 2017-01-18

Family

ID=45809635

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2013554602A Expired - Fee Related JP6063398B2 (ja) 2011-02-17 2012-02-16 抗ＴＮＦα薬に対する自己抗体を検出するためのアッセイ

Country Status (16)

Country Link
US (1) US20140045276A1 (enExample)
EP (1) EP2676137B1 (enExample)
JP (1) JP6063398B2 (enExample)
KR (1) KR20140008397A (enExample)
CN (1) CN103502815B (enExample)
AU (1) AU2012254150B2 (enExample)
BR (1) BR112013020981A2 (enExample)
CA (1) CA2827609A1 (enExample)
DK (1) DK2676137T3 (enExample)
ES (1) ES2530175T3 (enExample)
IL (1) IL227853A (enExample)
MX (1) MX343327B (enExample)
RU (1) RU2013142278A (enExample)
SG (1) SG192770A1 (enExample)
WO (1) WO2012154253A1 (enExample)
ZA (1) ZA201306950B (enExample)

Families Citing this family (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110229471A1 (en) 2008-11-26 2011-09-22 Cedars-Sinai Medical Center Methods of determining responsiveness to anti-tnf alpha therapy in inflammatory bowel disease
CN104634955B (zh) 2009-10-26 2016-09-14 雀巢产品技术援助有限公司 检测抗-tnf药物和自身抗体的试验
WO2012054532A1 (en) 2010-10-18 2012-04-26 Prometheus Laboratories Inc. Methods for determining anti-drug antibody isotypes
WO2013006810A1 (en) 2011-07-06 2013-01-10 Nestec Sa Assays for detecting neutralizing autoantibodies to biologic therapy with tnf alpha
WO2014055025A1 (en) * 2012-10-03 2014-04-10 Gyros Patent Ab Method and kit for analyte determination at acidic conditions
ES2638971T3 (es) 2012-10-05 2017-10-24 Nestec S.A. Métodos para predecir y monitorizar la cicatrización de la mucosa
BR112015012482A2 (pt) * 2012-11-30 2017-07-11 Nestec Sa ensaios para detecção de autoanticorpos neutralizantes à terapia com produtos biológicos
WO2014122600A1 (en) 2013-02-05 2014-08-14 Nestec S.A. Methods of selecting combination therapy for colorectal cancer patients
PT3387898T (pt) 2013-03-15 2020-06-17 Mayo Found Medical Education & Res Identificação e monitorização de imunoglobulinas monoclonais pela massa molecular
KR20240122922A (ko) 2013-03-27 2024-08-13 세다르스-신나이 메디칼 센터 Tl1a 기능 및 관련된 신호전달 경로의 저해에 의한 섬유증 및 염증의 완화 및 반전
KR20210107176A (ko) 2013-05-17 2021-08-31 세다르스-신나이 메디칼 센터 크론병과 연관된 tnfsf15와 dcr3의 변이체
EP3022295A4 (en) 2013-07-19 2017-03-01 Cedars-Sinai Medical Center Signature of tl1a (tnfsf15) signaling pathway
EP3654037A1 (en) 2013-12-03 2020-05-20 Prometheus Biosciences, Inc. Methods for predicting post-operative recurrence of crohn's disease
WO2015110989A1 (en) 2014-01-23 2015-07-30 Nestec S.A. Biomarker panel for assessment of mucosal healing
EP4137816B1 (en) 2014-02-11 2025-03-19 Genzyme Corporation Assays for detecting the presence or amount of an anti-drug antibody
JP6759104B2 (ja) 2014-04-04 2020-09-23 メイヨ・ファウンデーション・フォー・メディカル・エデュケーション・アンド・リサーチ 精密分子質量を用いた免疫グロブリンのアイソタイピング
CN104034896A (zh) * 2014-06-19 2014-09-10 华北制药集团新药研究开发有限责任公司 一种双抗体夹心elisa检测方法
US10690676B2 (en) 2014-07-29 2020-06-23 Mayo Roundation for Medical Education and Research Quantifying monoclonal antibody therapeutics by LC-MS/MS
MX2017004742A (es) * 2014-10-20 2017-07-20 Nestec Sa Métodos para la predicción de niveles de farmacos anti-tnf alfa y formación de autoanticuerpos.
CN107076761B (zh) * 2014-11-05 2020-05-05 豪夫迈·罗氏有限公司 用于测定针对效应子功能抑制的人或人源化药物抗体的抗药物抗体的方法
RU2017122720A (ru) 2014-12-05 2019-01-10 Нестек С.А. Непрямые однородные анализы по изменению подвижности для детекции биологических препаратов в образцах пациента
US11085931B2 (en) 2015-01-09 2021-08-10 W. Health L.P. Universal assay for determining the quantity of TNFα inhibitory drugs and their corresponding anti-drug-antibodies
WO2016135707A1 (en) 2015-02-27 2016-09-01 Nestec S.A. Diagnosis of major depressive disorder, mild cognitive impairment, and alzheimer's disease and other neurologic and psychiatric disorders
JP6968058B2 (ja) 2015-09-24 2021-11-17 メイヨ・ファウンデーション・フォー・メディカル・エデュケーション・アンド・リサーチ 質量分析法による免疫グロブリン遊離軽鎖の同定
ES2815224T3 (es) * 2015-11-06 2021-03-29 Promise Proteomics Un método para cuantificar anticuerpos terapéuticos
CN109462996A (zh) 2016-03-17 2019-03-12 西达-赛奈医疗中心 通过rnaset2诊断炎性肠病的方法
US11119096B2 (en) 2016-07-08 2021-09-14 W. Health L.P. Universal assay for determining the quantity of therapeutic monoclonal antibodies and their corresponding anti-drug-antibodies in samples
CN118443922A (zh) * 2016-09-06 2024-08-06 富士瑞必欧株式会社 肿瘤标记物的测定方法及测定试剂
US10955420B2 (en) 2016-09-07 2021-03-23 Mayo Foundation For Medical Education And Research Identification and monitoring of cleaved immunoglobulins by molecular mass
EP3681528B1 (en) 2017-09-13 2025-07-23 Mayo Foundation for Medical Education and Research Identification and monitoring of apoptosis inhibitor of macrophage
WO2019055632A1 (en) 2017-09-13 2019-03-21 Mayo Foundation For Medical Education And Research IDENTIFICATION AND MONITORING OF IMMUNOGLOBULIN CHAINS J
JP7161534B2 (ja) * 2017-11-29 2022-10-26 エフ．ホフマン－ラ ロシュ アーゲー 標的による干渉が抑制された抗薬物抗体アッセイ
JP7474240B2 (ja) * 2018-08-03 2024-04-24 ブリストル－マイヤーズ スクイブ カンパニー 抗薬物抗体を検出するための方法
WO2020112890A1 (en) 2018-11-29 2020-06-04 Cedars-Sinai Medical Center Rnaset2 compositions and methods of treatment therewith
US12378245B2 (en) 2019-02-11 2025-08-05 Phoenix Molecular Designs Crystalline forms of an RSK inhibitor
JP2020115139A (ja) * 2020-03-11 2020-07-30 国立大学法人千葉大学 血管炎の検査方法
CN112362649B (zh) * 2020-11-09 2024-07-12 长春金赛药业有限责任公司 一种rhGH中和抗体的检测方法
KR102562006B1 (ko) 2020-11-09 2023-08-02 바디텍메드(주) 항tnf-알파 약물 모니터링을 위한 신속 검출 키트
KR102568430B1 (ko) * 2020-11-16 2023-08-24 바디텍메드(주) 항 약물 항체의 신속 검출 방법
CN114236139A (zh) * 2021-12-30 2022-03-25 苏州和锐生物科技有限公司 一种TNF-α生物制剂的抗体检测试剂盒、制备方法

Family Cites Families (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4459359A (en) * 1981-11-19 1984-07-10 New York Blood Center, Inc. Sensitive immunoassays of antigens or antibodies sequestered within immune complexes
FR2590674B1 (fr) * 1985-11-25 1989-03-03 Inst Nat Sante Rech Med Nouveaux reactifs de diagnostic
DE3631229A1 (de) 1986-09-13 1988-03-24 Basf Ag Monoklonale antikoerper gegen humanen tumornekrosefaktor (tnf) und deren verwendung
US5094740A (en) * 1990-02-16 1992-03-10 Glycomed, Inc. Two-dimensional electrophoretic separation of carbohydrates
GB9028123D0 (en) * 1990-12-28 1991-02-13 Erba Carlo Spa Monoclonal antibodies against human tumor necrosis factor alpha
US6074835A (en) 1996-04-12 2000-06-13 Regents Of The Univ. Of California Diagnosis, prevention and treatment of ulcerative colitis, and clinical subtypes thereof, using histone H1
US6033864A (en) 1996-04-12 2000-03-07 The Regents Of The University Of California Diagnosis, prevention and treatment of ulcerative colitis, and clinical subtypes thereof, using microbial UC pANCA antigens
US6406862B1 (en) 1998-10-06 2002-06-18 The United States Of America As Represented By The Secretary Of The Army Dip-stick assay for C-reactive protein
PT1159003E (pt) * 1999-03-02 2011-02-22 Centocor Inc Anti-tnf alfa na terapêutica da asma resistente a esteróides
US6309643B1 (en) 1999-04-30 2001-10-30 The Regents Of The University Of California IBD-associated microbial antigens and methods of using same
FR2802536B1 (fr) 1999-11-23 2003-06-13 Chru Lille Oligomannosides de synthese, leur preparation et leur utilisation a la detection d'anticorps et a la prevention d'infections
FR2806739B1 (fr) 2000-03-27 2005-02-18 Fond Jean Dausset Ceph Genes impliques dans les maladies inflammatoires de l'intestin et leur utilisation
US6838250B2 (en) 2000-03-31 2005-01-04 Ortho-Clinical Diagnostics, Inc. Immunoassay for C-reactive protein
US7138237B1 (en) 2000-05-19 2006-11-21 Cedars-Sinai Medical Center Diagnosis, prevention and treatment of Crohn's disease using the OmpC antigen
DK1330525T3 (da) 2000-10-30 2013-03-04 Univ Michigan NOD2-nukleinsyrer og proteiner
CA2427471C (en) 2000-10-30 2010-12-21 The Regents Of The University Of Michigan Nod2 nucleic acids and proteins
ES2325059T3 (es) 2000-11-14 2009-08-25 Techlab, Inc. Metodo para diferenciar el sindrome del intestino irritable de la enfermedad inflamatoria intestinal (ibd) y para seguir personas con ibd usando la lactoferrina endogena total como marcador.
EP1581119B1 (en) 2001-12-17 2013-01-30 Corixa Corporation Compositions and methods for the therapy and diagnosis of inflammatory bowel disease
US20040053263A1 (en) 2002-08-30 2004-03-18 Abreu Maria T. Mutations in NOD2 are associated with fibrostenosing disease in patients with Crohn's disease
DE60321027D1 (de) 2002-10-25 2008-06-26 Techlab Inc Diagnostisches panel ibd-first chek fur entzundliche darmerkrankung (ibd) und reizkolon
US7662569B2 (en) 2003-04-11 2010-02-16 Cedars-Sinai Medical Center Methods of assessing Crohn's disease patient phenotype by I2 serologic response
CA2549971A1 (en) 2003-11-03 2005-05-12 Duke University Methods of identifying individuals at risk of perioperative bleeding, renal dysfunction or stroke
EP1769244A4 (en) * 2004-06-30 2008-05-14 Dow Kenneth Centocor Inc DETECTION OR MEASUREMENT OF ANTIGEN PROTEIN ANTIBODIES IN BIOLOGICAL TISSUE OR SAMPLES
WO2006012472A1 (en) 2004-07-21 2006-02-02 Qualyst, Inc. Apparatus, kits and methods for evaluating binding interactions, for detecting and quantifying binding molecules, and for sample preparation
JP2007147367A (ja) * 2005-11-25 2007-06-14 Sekisui Chem Co Ltd サイトカイン産生能の測定方法
US20110066624A1 (en) 2006-08-01 2011-03-17 Divyank Turakhia system and method of generating related words and word concepts
CN104198705B (zh) 2006-09-21 2017-06-09 雀巢产品技术援助有限公司 检测稀有循环细胞内多种信号转导分子的基于抗体的阵列
NZ582618A (en) 2007-07-13 2012-07-27 Prometheus Lab Inc Drug selection for lung cancer therapy using antibody-based arrays
US20090035216A1 (en) * 2007-08-03 2009-02-05 Biomonitor Aps Method for determining in vivo biopharmaceutical concentration or bioavailability
WO2009022001A1 (en) * 2007-08-16 2009-02-19 Novartis Ag Improvement of drug tolerance in immunogenicity testing
WO2009091240A1 (en) * 2008-01-15 2009-07-23 Stichting Sanquin Bloedvoorziening Method and kits for detecting antibodies against therapeutic antibodies
ES2553390T3 (es) 2008-02-25 2015-12-09 Nestec S.A. Método para la detección de receptores truncados intracelulares
US20110195524A1 (en) * 2008-10-07 2011-08-11 Mats Inganas Semi-sequential assay for detection of an analyte in a sample
NZ596468A (en) 2009-05-14 2013-11-29 Nestec Sa Biomarkers for determining sensitivity of breast cancer cells to her2-targeted therapy
JP5795311B2 (ja) 2009-07-15 2015-10-14 ネステク ソシエテ アノニム 抗体ベースのアレイを使用する胃癌療法のための薬物選択
US8408369B2 (en) 2009-09-08 2013-04-02 GM Global Technology Operations LLC Bimetallic brake rotor
DK2491385T3 (en) 2009-10-20 2017-08-28 Diatech Holdings Inc PROXIMITY-MEDIED ASSAYS FOR DETECTING ONCOGEN FUSION PROTEINS
CN104634955B (zh) * 2009-10-26 2016-09-14 雀巢产品技术援助有限公司 检测抗-tnf药物和自身抗体的试验

Also Published As

Publication number Publication date
MX2013009570A (es) 2013-09-06
SG192770A1 (en) 2013-09-30
IL227853A0 (en) 2013-09-30
AU2012254150B2 (en) 2015-08-13
EP2676137B1 (en) 2014-12-31
CN103502815B (zh) 2015-09-23
AU2012254150A1 (en) 2013-05-02
JP2014508930A (ja) 2014-04-10
BR112013020981A2 (pt) 2016-10-11
KR20140008397A (ko) 2014-01-21
CN103502815A (zh) 2014-01-08
MX343327B (es) 2016-11-01
ES2530175T3 (es) 2015-02-26
RU2013142278A (ru) 2015-03-27
EP2676137A1 (en) 2013-12-25
US20140045276A1 (en) 2014-02-13
ZA201306950B (en) 2015-04-29
NZ614170A (en) 2015-04-24
HK1191688A1 (en) 2014-08-01
WO2012154253A1 (en) 2012-11-15
IL227853A (en) 2017-07-31
CA2827609A1 (en) 2012-11-15
DK2676137T3 (en) 2015-01-19

Similar Documents

Publication Publication Date Title
EP2676137B1 (en) Assays for detecting autoantibodies to anti-tnf drugs
US9784748B2 (en) Methods for determining anti-drug antibody isotypes
US11160863B2 (en) Methods of disease activity profiling for personalized therapy management
JP6181646B2 (ja) Ｔｎｆアルファによる生物学的治療に対する中和自己抗体の検出のためのアッセイ
US20140051184A1 (en) Mobility shift assays for detecting anti-tnf alpha drugs and autoantibodies thereto
JP2016502091A (ja) 生物学的治療に対する中和自己抗体の検出のためのアッセイ
HK1191688B (en) ASSAYS FOR DETECTING AUTOANTIBODIES TO ANTI-TNFα DRUGS
NZ614170B2 (en) Assays for detecting autoantibodies to anti-tnf? drugs
RU2574976C2 (ru) Способы определения изотипа антител против лекарственных препаратов

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20150128

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20150128

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20151014

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20151020

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20160621

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160916

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20161213

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20161216

R150 Certificate of patent or registration of utility model

Ref document number: 6063398

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

S111 Request for change of ownership or part of ownership

Free format text: JAPANESE INTERMEDIATE CODE: R313111

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

LAPS Cancellation because of no payment of annual fees