HRP20180299T1 - Compositions for the treatment of rheumatoid arthritis and methods of using the same - Google Patents

Compositions for the treatment of rheumatoid arthritis and methods of using the same Download PDF

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Publication number
HRP20180299T1
HRP20180299T1 HRP20180299TT HRP20180299T HRP20180299T1 HR P20180299 T1 HRP20180299 T1 HR P20180299T1 HR P20180299T T HRP20180299T T HR P20180299TT HR P20180299 T HRP20180299 T HR P20180299T HR P20180299 T1 HRP20180299 T1 HR P20180299T1
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HR
Croatia
Prior art keywords
antibody
subject
use according
weeks
treatment
Prior art date
Application number
HRP20180299TT
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Croatian (hr)
Inventor
Xiaohong Huang
Martine JASSON
Vanessa MARKS
Allen Radin
Original Assignee
Sanofi Biotechnology
Regeneron Pharmaceuticals, Inc.
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Filing date
Publication date
Priority claimed from EP12769684.7A external-priority patent/EP2766039B1/en
Application filed by Sanofi Biotechnology, Regeneron Pharmaceuticals, Inc. filed Critical Sanofi Biotechnology
Publication of HRP20180299T1 publication Critical patent/HRP20180299T1/en

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    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C19/00—Alloys based on nickel or cobalt
    • C22C19/03—Alloys based on nickel or cobalt based on nickel
    • C22C19/05—Alloys based on nickel or cobalt based on nickel with chromium
    • C22C19/058—Alloys based on nickel or cobalt based on nickel with chromium without Mo and W
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/421—1,3-Oxazoles, e.g. pemoline, trimethadione
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4706—4-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/655—Azo (—N=N—), diazo (=N2), azoxy (>N—O—N< or N(=O)—N<), azido (—N3) or diazoamino (—N=N—N<) compounds
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39541—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21D—WORKING OR PROCESSING OF SHEET METAL OR METAL TUBES, RODS OR PROFILES WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21D22/00—Shaping without cutting, by stamping, spinning, or deep-drawing
    • B21D22/02—Stamping using rigid devices or tools
    • B21D22/022—Stamping using rigid devices or tools by heating the blank or stamping associated with heat treatment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21J—FORGING; HAMMERING; PRESSING METAL; RIVETING; FORGE FURNACES
    • B21J1/00—Preparing metal stock or similar ancillary operations prior, during or post forging, e.g. heating or cooling
    • B21J1/06—Heating or cooling methods or arrangements specially adapted for performing forging or pressing operations
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C19/00—Alloys based on nickel or cobalt
    • C22C19/03—Alloys based on nickel or cobalt based on nickel
    • C22C19/05—Alloys based on nickel or cobalt based on nickel with chromium
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/10—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of nickel or cobalt or alloys based thereon
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mechanical Engineering (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Materials Engineering (AREA)
  • Metallurgy (AREA)
  • Rheumatology (AREA)
  • Thermal Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Endocrinology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (10)

1. Protutijelo za upotrebu u postupku liječenja reumatoidnog artritisa kod subjekta naznačeno time da se sastoji od davanja subjektu učinkovite količine protutijela i metotreksata, pri čemu protutijelo sadrži varijabilnu regiju teškog lanca sekvence SEQ ID NO:2 varijabilnu regiju lakog lanca sekvence SEQ ID NO:3 i protutijelo se primjenjuje u količini između 100 mg i 200 mg kroz dva tjedna, te pri čemu je subjekt (1) prethodno liječen od reumatoidnog artritisa primjenom metotreksata i (2) prethodno neučinkovito liječen od reumatoidnog artritisa primjenom antagonista TNF-α odabranog iz skupine koju čine etanercept, infliksimab, adalimumab, golimumab i certolizumab pegol.1. An antibody for use in the treatment of rheumatoid arthritis in a subject characterized by administering to the subject an effective amount of the antibody and methotrexate, wherein the antibody comprises the heavy chain variable region of the sequence SEQ ID NO:2 the light chain variable region of the sequence SEQ ID NO:3 and the antibody is administered in an amount between 100 mg and 200 mg for two weeks, and wherein the subject is (1) previously treated for rheumatoid arthritis using methotrexate and (2) previously ineffectively treated for rheumatoid arthritis using a TNF-α antagonist selected from the group consists of etanercept, infliximab, adalimumab, golimumab and certolizumab pegol. 2. Protutijelo za uporabu prema zahtjevu 1, naznačeno time da je subjekt prethodno neučinkovito liječen od reumatoidnog artritisa primjenom metotreksata.2. The antibody for use according to claim 1, characterized in that the subject has previously been ineffectively treated for rheumatoid arthritis using methotrexate. 3. Protutijelo za uporabu prema zahtjevu 2, naznačeno time da je metotreksat primjenjivan u količini između 6 do 25 mg tjedno.3. Antibody for use according to claim 2, characterized in that methotrexate is administered in an amount between 6 to 25 mg per week. 4. Protutijelo za uporabu prema bilo kojem od zahtjeva 1 do 3, naznačeno time da se protutijelo primjenjuje u količini od 150 mg na dva tjedna ili 200 mg na dva tjedna.4. Antibody for use according to any one of claims 1 to 3, characterized in that the antibody is administered in an amount of 150 mg per two weeks or 200 mg per two weeks. 5. Protutijelo za uporabu prema bilo kojem od zahtjeva 1-4, naznačeno time da subjekt postiže poboljšanje od 20% prema indeksu za osnovni skup bolesti od American College of Rheumatology nakon 12 tjedana liječenja.5. The antibody for use according to any one of claims 1-4, wherein the subject achieves a 20% improvement in the American College of Rheumatology Core Disease Index after 12 weeks of treatment. 6. Protutijelo za uporabu prema bilo kojem od zahtjeva 1-4, naznačeno time da subjekt postiže poboljšanje od 50% prema indeksu za osnovni skup bolesti od American College of Rheumatology nakon 12 tjedana liječenja.6. The antibody for use according to any one of claims 1-4, wherein the subject achieves a 50% improvement in the American College of Rheumatology Core Disease Index after 12 weeks of treatment. 7. Protutijelo za uporabu prema bilo kojem od zahtjeva 1-4, naznačeno time da subjekt postiže poboljšanje od 70% prema indeksu za osnovni skup bolesti od American College of Rheumatology nakon 12 tjedana liječenja.7. The antibody for use according to any one of claims 1-4, wherein the subject achieves a 70% improvement in the American College of Rheumatology Core Disease Index after 12 weeks of treatment. 8. Protutijelo za uporabu prema bilo kojem od zahtjeva 1 do 3, naznačeno time da je subjekt tretiran s navedenim antagonistom anti-TNF-α tijekom najmanje 3 mjeseca u posljednje 2 godine ili je subjekt bio netolerantan na najmanje jedan antagonist TNF-α.8. The antibody for use according to any one of claims 1 to 3, characterized in that the subject has been treated with said anti-TNF-α antagonist for at least 3 months in the last 2 years or the subject has been intolerant to at least one TNF-α antagonist. 9. Protutijelo za uporabu prema bilo kojem od zahtjeva 1 do 8, naznačeno time da protutijelo je sarilumab.9. The antibody for use according to any one of claims 1 to 8, characterized in that the antibody is sarilumab. 10. Protutijelo za uporabu prema bilo kojem od zahtjeva 1 do 9, naznačeno time da se antitijelo subjektu daje potkožno.10. The antibody for use according to any one of claims 1 to 9, characterized in that the antibody is administered to the subject subcutaneously.
HRP20180299TT 2011-10-11 2018-02-19 Compositions for the treatment of rheumatoid arthritis and methods of using the same HRP20180299T1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201161545864P 2011-10-11 2011-10-11
EP12305889 2012-07-20
EP12769684.7A EP2766039B1 (en) 2011-10-11 2012-10-10 Compositions for the treatment of rheumatoid arthritis and methods of using the same
PCT/EP2012/070052 WO2013053751A1 (en) 2011-10-11 2012-10-10 Compositions for the treatment of rheumatoid arthritis and methods of using same

Publications (1)

Publication Number Publication Date
HRP20180299T1 true HRP20180299T1 (en) 2018-04-20

Family

ID=61906559

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20180299TT HRP20180299T1 (en) 2011-10-11 2018-02-19 Compositions for the treatment of rheumatoid arthritis and methods of using the same

Country Status (6)

Country Link
JP (1) JP2021167333A (en)
KR (1) KR20200039028A (en)
CY (1) CY1120074T1 (en)
HR (1) HRP20180299T1 (en)
IL (2) IL265949B (en)
SG (1) SG10201914052TA (en)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS52643B (en) * 2006-06-02 2013-06-28 Regeneron Pharmaceuticals Inc. High affinity antibodies to human il-6 receptor
JO3030B1 (en) * 2009-06-26 2016-09-05 Galapagos Nv Novel Compound Useful for the Treatment of Degenerative and Inflammatory Diseases
JO3417B1 (en) * 2010-01-08 2019-10-20 Regeneron Pharma Stabilized formulations containing anti-interleukin-6 receptor (il-6r) antibodies

Also Published As

Publication number Publication date
IL265949B (en) 2021-10-31
CY1120074T1 (en) 2018-12-12
KR20200039028A (en) 2020-04-14
IL286709A (en) 2021-10-31
SG10201914052TA (en) 2020-03-30
JP2021167333A (en) 2021-10-21
IL265949A (en) 2019-05-30

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