HRP20130042T1 - Postupci lijeäśenja reumatoidnog artritisa - Google Patents
Postupci lijeäśenja reumatoidnog artritisa Download PDFInfo
- Publication number
- HRP20130042T1 HRP20130042T1 HRP20130042AT HRP20130042T HRP20130042T1 HR P20130042 T1 HRP20130042 T1 HR P20130042T1 HR P20130042A T HRP20130042A T HR P20130042AT HR P20130042 T HRP20130042 T HR P20130042T HR P20130042 T1 HRP20130042 T1 HR P20130042T1
- Authority
- HR
- Croatia
- Prior art keywords
- antibody
- fragment
- dose
- use according
- pharmaceutical composition
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 4
- 206010039073 rheumatoid arthritis Diseases 0.000 title claims 2
- 239000012634 fragment Substances 0.000 claims 15
- 239000008194 pharmaceutical composition Substances 0.000 claims 14
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 4
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 4
- 108010074051 C-Reactive Protein Proteins 0.000 claims 3
- 102100032752 C-reactive protein Human genes 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 210000003743 erythrocyte Anatomy 0.000 claims 2
- 238000004062 sedimentation Methods 0.000 claims 2
- 208000006386 Bone Resorption Diseases 0.000 claims 1
- 101001033249 Homo sapiens Interleukin-1 beta Proteins 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- 230000024279 bone resorption Effects 0.000 claims 1
- 210000000845 cartilage Anatomy 0.000 claims 1
- 238000010494 dissociation reaction Methods 0.000 claims 1
- 230000005593 dissociations Effects 0.000 claims 1
- 230000008595 infiltration Effects 0.000 claims 1
- 238000001764 infiltration Methods 0.000 claims 1
- 230000002757 inflammatory effect Effects 0.000 claims 1
- 238000010255 intramuscular injection Methods 0.000 claims 1
- 239000007927 intramuscular injection Substances 0.000 claims 1
- 238000010253 intravenous injection Methods 0.000 claims 1
- 238000010254 subcutaneous injection Methods 0.000 claims 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
- C07K16/245—IL-1
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Animal Behavior & Ethology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Public Health (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Rheumatology (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (16)
1. Farmaceutska smjesa koja sadrži anti-IL-1β protutijelo ili njegov fragment, za uporabu u liječenju reumatoidnog artritisa, gdje se protutijelo ili fragment protutijela veže za humani IL-1β s konstantom disocijacije od 1 pM ili manje, gdje se protutijelo ili njegov fragment natječe s vezanjem protutijela koje kao varijabilnu regiju lakog lanca ima SEQ ID NO: 5 i kao varijabilnu regiju teškog lanca ima SEQ ID NO: 6, gdje nakon primjene inicijalne doze protutijela ili fragmenta protutijela slijedi primjena jedne ili više sljedećih doza, gdje se inicijalna doza i svaka ili sljedeća doza daju u razmaku od jednom tjedno to jednom svakih šest mjeseci i gdje se protutijelo ili fragment protutijela daju u dozi od barem 0.01 mg/kg do 1 mg/kg protutijela ili njegovog fragmenta.
2. Farmaceutska smjesa za uporabu prema zahtjevu 1, gdje se protutijelo ili fragment treba primjenjivati kao fiksna doza, nezavisno od doze po težinskom omjeru subjekta.
3. Farmaceutska smjesa za uporabu prema zahtjevima 1-2, gdje se anti-IL-1β protutijelo ili fragment treba primjenjivati supkutanom, intravenskom ili intramuskularnom injekcijom.
4. Farmaceutska smjesa za uporabu prema zahtjevima 1-3, gdje se jedna ili više tih sljedećih doza primjenjuje u količini koja je jednaka, manja ili veća od inicijalne doze.
5. Farmaceutska smjesa za uporabu prema zahtjevima 1-4, gdje je doza protutijela ili fragmenta dovoljna za postizanje poboljšanja u jednom ili više ključnih kriterija odgovora prema ACR-u (American College of Rheumatology).
6. Farmaceutska smjesa za uporabu prema zahtjevima 1-5, gdje je doza protutijela ili fragmenta dovoljna za postizanje barem 20% poboljšanja u odgovoru ACR 50.
7. Farmaceutska smjesa za uporabu prema zahtjevima 5-6, gdje se poboljšanje očituje nakon 3 mjeseca ili dulje.
8. Farmaceutska smjesa za uporabu prema zahtjevima 1-7, gdje je doza protutijela ili fragmenta dovoljna za postizanje smanjenja upalne infiltracije.
9. Farmaceutska smjesa za uporabu prema zahtjevima 1-7, gdje je doza protutijela ili fragmenta dovoljna za postizanje smanjenja gubitka hrskavice.
10. Farmaceutska smjesa za uporabu prema zahtjevima 1-7, gdje je doza protutijela ili fragmenta dovoljna za postizanje smanjenja resorpcije kosti.
11. Farmaceutska smjesa za uporabu prema zahtjevima 1-7, gdje je doza protutijela ili fragmenta dovoljna za postizanje poboljšanja radiografskog odgovora.
12. Farmaceutska smjesa za uporabu prema zahtjevima 1-11, gdje je doza protutijela ili fragmenta dovoljna za postizanje barem 20% smanjenja razina C-reaktivnog proteina (CRP).
13. Farmaceutska smjesa za uporabu prema zahtjevima 1-11, gdje je doza protutijela ili fragmenta dovoljna za postizanje barem 20% smanjenja brzine sedimentacije eritrocita.
14. Farmaceutska smjesa za uporabu prema zahtjevima 1-11, gdje je doza protutijela ili fragmenta dovoljna za postizanje barem 20% smanjenja CRP-a i barem 20% smanjenja brzine sedimentacije eritrocita.
15. Farmaceutska smjesa za uporabu prema zahtjevima 1-14, gdje se postupak provodi zajedno s barem još jednim dodatnim postupkom liječenja, taj dodatni postupak liječenja obuhvaća primjenu barem jedne farmaceutske smjese koja sadrži djelatnu tvar koja nije 1L-1β protutijelo ili fragment.
16. Farmaceutska smjesa za uporabu prema bilo kojem od zahtjeva 1-15, gdje protutijelo ili njegov fragment kao varijabilnu regiju lakog lanca ima SEQ ID NO: 5 i kao varijabilnu regiju teškog lanca SEQ ID NO: 6.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US5971108P | 2008-06-06 | 2008-06-06 | |
| US9523208P | 2008-09-08 | 2008-09-08 | |
| PCT/US2009/046441 WO2009149370A1 (en) | 2008-06-06 | 2009-06-05 | Methods for the treatment of rheumatoid arthritis |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20130042T1 true HRP20130042T1 (hr) | 2013-03-31 |
Family
ID=40983388
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20130042AT HRP20130042T1 (hr) | 2008-06-06 | 2013-01-17 | Postupci lijeäśenja reumatoidnog artritisa |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20110189172A1 (hr) |
| EP (1) | EP2293816B1 (hr) |
| JP (2) | JP5607613B2 (hr) |
| AU (1) | AU2009256072B2 (hr) |
| CA (1) | CA2727171A1 (hr) |
| CY (1) | CY1113640T1 (hr) |
| DK (1) | DK2293816T3 (hr) |
| ES (1) | ES2398693T3 (hr) |
| HR (1) | HRP20130042T1 (hr) |
| PL (1) | PL2293816T3 (hr) |
| PT (1) | PT2293816E (hr) |
| WO (1) | WO2009149370A1 (hr) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8034014B2 (en) | 2007-03-06 | 2011-10-11 | Biomet Biologics, Llc | Angiogenesis initation and growth |
| US20080269762A1 (en) * | 2007-04-25 | 2008-10-30 | Biomet Manufacturing Corp. | Method and device for repair of cartilage defects |
| US8637029B2 (en) | 2007-12-20 | 2014-01-28 | Xoma Technology Ltd. | Methods for the treatment of gout |
| US8753690B2 (en) * | 2008-02-27 | 2014-06-17 | Biomet Biologics, Llc | Methods and compositions for delivering interleukin-1 receptor antagonist |
| EP2259774B1 (en) | 2008-02-27 | 2012-12-12 | Biomet Biologics, LLC | Methods and compositions for delivering interleukin-1 receptor antagonist |
| JP5844258B2 (ja) | 2009-08-27 | 2016-01-13 | バイオメット、バイオロジクス、リミテッド、ライアビリティー、カンパニーＢｉｏｍｅｔ Ｂｉｏｌｏｇｉｃｓ， Ｌｌｃ | インターロイキン−１受容体アンタゴニストの生産のための植込み型装置 |
| US20110052561A1 (en) * | 2009-08-27 | 2011-03-03 | Biomet Biologics,LLC | Osteolysis treatment |
| JP2013536841A (ja) | 2010-09-03 | 2013-09-26 | バイオメット、バイオロジクス、リミテッド、ライアビリティー、カンパニー | インターロイキン−１受容体アンタゴニストを送達するための方法および組成物 |
| NZ607510A (en) | 2010-09-10 | 2014-10-31 | Apexigen Inc | Anti-il-1 beta antibodies and methods of use |
| US9011846B2 (en) | 2011-05-02 | 2015-04-21 | Biomet Biologics, Llc | Thrombin isolated from blood and blood fractions |
| EP2828295A1 (en) * | 2012-03-19 | 2015-01-28 | INSERM - Institut National de la Santé et de la Recherche Médicale | Method and pharmaceutical composition for use in the treatment or the prevention of aneurysm |
| KR102345999B1 (ko) * | 2012-11-05 | 2021-12-30 | 델레넥스 쎄라퓨틱스 아게 | Il-1 베타 결합성분 |
| EP2931750B8 (en) | 2012-12-17 | 2021-11-03 | Cell Medica Inc. | Antibodies against il-1 beta |
| US9878011B2 (en) | 2013-03-15 | 2018-01-30 | Biomet Biologics, Llc | Treatment of inflammatory respiratory disease using biological solutions |
| US9758806B2 (en) | 2013-03-15 | 2017-09-12 | Biomet Biologics, Llc | Acellular compositions for treating inflammatory disorders |
| US20140271589A1 (en) | 2013-03-15 | 2014-09-18 | Biomet Biologics, Llc | Treatment of collagen defects using protein solutions |
| US9895418B2 (en) | 2013-03-15 | 2018-02-20 | Biomet Biologics, Llc | Treatment of peripheral vascular disease using protein solutions |
| US9950035B2 (en) | 2013-03-15 | 2018-04-24 | Biomet Biologics, Llc | Methods and non-immunogenic compositions for treating inflammatory disorders |
| US10143725B2 (en) | 2013-03-15 | 2018-12-04 | Biomet Biologics, Llc | Treatment of pain using protein solutions |
| US10208095B2 (en) | 2013-03-15 | 2019-02-19 | Biomet Manufacturing, Llc | Methods for making cytokine compositions from tissues using non-centrifugal methods |
| EP3074507B1 (en) | 2013-11-26 | 2022-01-05 | Biomet Biologics, LLC | Methods of mediating macrophage phenotypes |
| CN107074941A (zh) | 2014-11-10 | 2017-08-18 | 豪夫迈·罗氏有限公司 | 双特异性抗体和用于眼科学的方法 |
| US10441635B2 (en) | 2014-11-10 | 2019-10-15 | Biomet Biologics, Llc | Methods of treating pain using protein solutions |
| CA2963606A1 (en) | 2014-11-10 | 2016-05-19 | F.Hoffmann-La Roche Ag | Anti-ang2 antibodies and methods of use |
| US9763800B2 (en) | 2015-03-18 | 2017-09-19 | Biomet C. V. | Implant configured for hammertoe and small bone fixation |
| CN113444177A (zh) * | 2020-03-27 | 2021-09-28 | 中山康方生物医药有限公司 | 抗IL-1β的抗体、其药物组合物及其用途 |
| CN115281149A (zh) * | 2021-05-12 | 2022-11-04 | 四川大学华西医院 | 一种临床前类风湿关节炎(Pre-RA)小鼠模型 |
Family Cites Families (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0569687B1 (en) * | 1984-05-18 | 2002-08-21 | New England Medical Center Hospitals, Inc. | Human IL-1 cDNA sequences encoding biologically-active human IL-1 proteins |
| US4762914A (en) * | 1984-05-18 | 1988-08-09 | Auron Philip E | Truncated protein of interleukin-1 |
| US5077219A (en) * | 1984-05-18 | 1991-12-31 | New England Medical Center Hospitals | Human IL-1 cDNA sequences encoding biologically-active human IL-1 proteins |
| US5484887A (en) * | 1984-06-19 | 1996-01-16 | Immunex Corporation | Homogeneous interleukin 1 |
| US5122459A (en) * | 1984-12-31 | 1992-06-16 | Immunex Corporation | Gene encoding biologically active human interleukin 1 |
| US4772685A (en) * | 1985-10-02 | 1988-09-20 | Merck & Co., Inc. | Immunogenic peptides of human interleukin-1 and the corresponding anti-peptide antibodies |
| US4935343A (en) * | 1986-08-08 | 1990-06-19 | Syntex (U.S.A.) Inc. | Monoclonal antibodies for interleukin-1β |
| US5474899A (en) * | 1987-05-13 | 1995-12-12 | Cistron Biotechnology, Inc. | Selective immunoassay for IL-1 β |
| DE68925935T2 (de) * | 1988-10-01 | 1996-08-14 | Otsuka Pharma Co Ltd | Antikörper gegen Interleukin-1-beta |
| DK0460052T3 (da) * | 1989-02-27 | 1999-03-08 | New England Medical Center Inc | Inhibitorer af IL-1's biologiske aktivitet |
| IE922437A1 (en) * | 1991-07-25 | 1993-01-27 | Idec Pharma Corp | Recombinant antibodies for human therapy |
| DE69233782D1 (de) * | 1991-12-02 | 2010-05-20 | Medical Res Council | Herstellung von Autoantikörpern auf Phagenoberflächen ausgehend von Antikörpersegmentbibliotheken |
| US5869619A (en) * | 1991-12-13 | 1999-02-09 | Xoma Corporation | Modified antibody variable domains |
| CA2507749C (en) * | 1991-12-13 | 2010-08-24 | Xoma Corporation | Methods and materials for preparation of modified antibody variable domains and therapeutic uses thereof |
| WO1994000470A1 (en) * | 1992-06-30 | 1994-01-06 | The Wistar Institute Of Anatomy And Biology | DEVELOPMENTAL EMBRYONIC MOUSE cDNA LIBRARIES |
| US5959085A (en) * | 1993-11-23 | 1999-09-28 | Schering Corporation | Human monoclonal antibodies against human cytokines and methods of making and using such antibodies |
| US5817476A (en) * | 1995-06-07 | 1998-10-06 | Genetics Institute, Inc. | Polynucleotides encoding interleukin-1 receptor intracellular ligand proteins |
| GB0001448D0 (en) * | 2000-01-21 | 2000-03-08 | Novartis Ag | Organic compounds |
| EP2241328A1 (en) * | 2000-05-12 | 2010-10-20 | Immunex Corporation | Interleukin-1 inhibitors in the treatment of diseases |
| GB0020685D0 (en) * | 2000-08-22 | 2000-10-11 | Novartis Ag | Organic compounds |
| US20030026806A1 (en) * | 2000-10-27 | 2003-02-06 | Amgen Inc. | Antibodies and other selective IL-1 binding agents that allow binding to IL-1 receptor but not activation thereof |
| US20030166069A1 (en) * | 2000-11-28 | 2003-09-04 | Amgen, Inc. | Interleukin-1 receptor antagonist-like molecules and uses thereof |
| US6727234B2 (en) * | 2001-04-03 | 2004-04-27 | University Of Iowa Research Foundation | Isoprenoid analog compounds and methods of making and use thereof |
| WO2003010282A2 (en) * | 2001-07-26 | 2003-02-06 | Eli Lilly And Company | Interleukin-1 beta antibodies |
| US20050152850A1 (en) * | 2004-01-09 | 2005-07-14 | Engebretson Steven P. | Methods and compositions for facilitating metabolic control |
| US7732478B2 (en) * | 2004-01-09 | 2010-06-08 | The Trustees Of Columbia University In The City Of New York | Methods for facilitating metabolic control |
| US8618054B2 (en) * | 2004-05-05 | 2013-12-31 | Valorisation-Rechereche Société en Commandite | Interleukin-1 receptor antagonists, compositions, and methods of treatment |
| PL2163562T3 (pl) * | 2005-06-21 | 2014-03-31 | Xoma Us Llc | Przeciwciała wiążące IL-1 beta i ich fragmenty |
| EP3332807B1 (en) * | 2005-10-26 | 2023-02-22 | Novartis AG | Use of anti il-1beta antibodies |
| CN103405768A (zh) * | 2006-12-20 | 2013-11-27 | 爱克索马技术有限公司 | 用于治疗IL-1β相关疾病的方法 |
| US8637029B2 (en) * | 2007-12-20 | 2014-01-28 | Xoma Technology Ltd. | Methods for the treatment of gout |
-
2009
- 2009-06-05 EP EP09759528A patent/EP2293816B1/en active Active
- 2009-06-05 WO PCT/US2009/046441 patent/WO2009149370A1/en active Application Filing
- 2009-06-05 US US12/996,516 patent/US20110189172A1/en not_active Abandoned
- 2009-06-05 CA CA2727171A patent/CA2727171A1/en not_active Abandoned
- 2009-06-05 PT PT97595284T patent/PT2293816E/pt unknown
- 2009-06-05 JP JP2011512700A patent/JP5607613B2/ja active Active
- 2009-06-05 PL PL09759528T patent/PL2293816T3/pl unknown
- 2009-06-05 AU AU2009256072A patent/AU2009256072B2/en active Active
- 2009-06-05 ES ES09759528T patent/ES2398693T3/es active Active
- 2009-06-05 DK DK09759528.4T patent/DK2293816T3/da active
-
2013
- 2013-01-17 HR HRP20130042AT patent/HRP20130042T1/hr unknown
- 2013-02-05 CY CY20131100102T patent/CY1113640T1/el unknown
-
2014
- 2014-08-28 JP JP2014173653A patent/JP5809338B2/ja active Active
Also Published As
| Publication number | Publication date |
|---|---|
| PT2293816E (pt) | 2013-02-13 |
| EP2293816B1 (en) | 2012-11-07 |
| WO2009149370A1 (en) | 2009-12-10 |
| AU2009256072B2 (en) | 2015-05-28 |
| JP5809338B2 (ja) | 2015-11-10 |
| US20110189172A1 (en) | 2011-08-04 |
| EP2293816A1 (en) | 2011-03-16 |
| CY1113640T1 (el) | 2016-06-22 |
| JP2011522832A (ja) | 2011-08-04 |
| JP2015007098A (ja) | 2015-01-15 |
| JP5607613B2 (ja) | 2014-10-15 |
| PL2293816T3 (pl) | 2013-04-30 |
| AU2009256072A1 (en) | 2009-12-10 |
| ES2398693T3 (es) | 2013-03-21 |
| CA2727171A1 (en) | 2009-12-10 |
| DK2293816T3 (da) | 2013-02-04 |
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