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DK1737491T3 - Dosisregime med flere variende doser til behandling af Crohns sygdom og ulcerøs kolitis - Google Patents

Dosisregime med flere variende doser til behandling af Crohns sygdom og ulcerøs kolitis Download PDF

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Publication number
DK1737491T3
DK1737491T3 DK05777317.8T DK05777317T DK1737491T3 DK 1737491 T3 DK1737491 T3 DK 1737491T3 DK 05777317 T DK05777317 T DK 05777317T DK 1737491 T3 DK1737491 T3 DK 1737491T3
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Prior art keywords
antibody
tnfa
present disclosure
disease
dose
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DK05777317.8T
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English (en)
Inventor
Rebecca S Hoffman
Elliot Chartash
Lori K Taylor
George Richard Granneman
Philip Yan
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Abbvie Biotechnology Ltd
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Publication of DK1737491T3 publication Critical patent/DK1737491T3/da

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    • 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
    • C07K16/241—Tumor Necrosis Factors
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
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  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (5)

1. Isoleret humant anti-TNFa-antistof til anvendelse ved behandling af Crohns sygdom eller ulcerøs kolitis, hvor behandlingen skal udføres med en fremgangsmåde med flere varierende doser, omfattende enten (i) subkutan indgivelse af en induktionsdosis på 160 mg af det humane anti-TNFa-antistof til et individ med behov herfor, efterfulgt af subkutan indgivelse af en induktionsdosis på 80 mg af det humane anti-TNFa-antistof til individet, efterfulgt af subkutan indgivelse af mindst en behandlingsdosis på 40 mg af det humane anti-TNFa-antistof til individet, således at behandling af Crohns sygdom eller ulcerøs kolitis finder sted, eller (ii) subkutan indgivelse af mindst en induktionsdosis på 160 mg af det humane anti-TNFa-antistof til et individ med behov herfor og efterfølgende subkutan indgivelse af mindst en behandlingsdosis på 80 mg af det humane anti-TNFa-antistof til individet, således at behandling af Crohns sygdom finder sted, hvor det humane anti-TNFa-antistof er D2E7 (adalimumab).
2. Humant anti-TNFa-antistof til anvendelse ifølge krav 1, til anvendelse ved behandling af Crohns sygdom.
3. Humant anti-TNFa-antistof til anvendelse ifølge krav 1, til anvendelse ved behandling af ulcerøs kolitis.
4. Humant anti-TNFa-antistof til anvendelse ifølge et hvilket som helst af kravene 1-3, hvor behandlingsdosen indgives 2 uger efter induktionsdosen.
5. Humant anti-TNFa-antistof til anvendelse ifølge et hvilket som helst af kravene 1-4, hvor der indgives mere end en behandlingsdosis, og hvor behandlingsdoserne indgives hver anden uge (hver 2. uge).
DK05777317.8T 2004-04-09 2005-04-11 Dosisregime med flere variende doser til behandling af Crohns sygdom og ulcerøs kolitis DK1737491T3 (da)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US56113904P 2004-04-09 2004-04-09
US56171004P 2004-04-12 2004-04-12
US56910004P 2004-05-07 2004-05-07
PCT/US2005/012007 WO2005110452A2 (en) 2004-04-09 2005-04-11 MULTIPLE-VARIABLE DOSE REGIMEN FOR TREATING TNFα-RELATED DISORDERS

Publications (1)

Publication Number Publication Date
DK1737491T3 true DK1737491T3 (da) 2017-02-06

Family

ID=35006312

Family Applications (1)

Application Number Title Priority Date Filing Date
DK05777317.8T DK1737491T3 (da) 2004-04-09 2005-04-11 Dosisregime med flere variende doser til behandling af Crohns sygdom og ulcerøs kolitis

Country Status (22)

Country Link
US (16) US8889136B2 (da)
EP (4) EP2338516A3 (da)
JP (5) JP5748317B2 (da)
KR (8) KR101378873B1 (da)
CN (5) CN102614512A (da)
AU (1) AU2005244261B2 (da)
BR (1) BRPI0509326A (da)
CA (4) CA2970891A1 (da)
CY (1) CY1118564T1 (da)
DK (1) DK1737491T3 (da)
ES (1) ES2611286T3 (da)
HK (1) HK1104454A1 (da)
HU (1) HUE031558T2 (da)
IL (3) IL178430A (da)
LT (1) LT1737491T (da)
MX (1) MXPA06011677A (da)
NZ (3) NZ591362A (da)
PL (1) PL1737491T3 (da)
PT (1) PT1737491T (da)
TW (4) TW201705980A (da)
WO (1) WO2005110452A2 (da)
ZA (1) ZA200608097B (da)

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