Nova Patents
CA2868614A1

Methods of administering anti-tnf.alpha. antibodies

Abstract

Methods of treating disorders in which TFN.alpha. activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor a (hTNF.alpha.) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF.alpha. (e.g., Kd = 10-8 M or less), a slow off rate for hTNF.alpha. dissociation (e.g., Koff = 10-3 sec-1 or less) and neutralize hTNF.alpha. activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

CA2868614A1, drawing sheet 1
Sheet 1 of 6

Term

Term ended

Projected expiry passed 10 May 2022, 4.4 years ago.

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30 claims: 12 independent, 18 dependent

  1. 1
    CA 02868614 2014-10-22 What is claimed is:1. Use of a human anti-TNFa antibody, or an antigen binding portion thereof, in the manufacture of a medicament for inhibiting human TNFa activity in a human subject suffering from a disorder in which TNFa activity is detrimental wherein the medicament is adapted for administration as a unit dosage form comprising 40 mg of the anti-TNFa antibody, or antigen binding portion thereof.
  2. 9
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to any one of claims 1-8, wherein the medicament comprises at least one additional therapeutic agent.
  3. 10
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to any one of claims 1-8, wherein the medicament is adapted for administration as a unit dosage form in combination with at least one additional therapeutic agent.
  4. 11
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to one of claims 9 or 10, wherein the additional therapeutic agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a cytokine suppressive anti-inflammatory drug, and an anti-inflammatory cytokine.
  5. 13
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to one of claims 9 or 10, wherein the additional therapeutic drug is a DMARD. CA 02868614 2014-10-22
  6. 14
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to one of claims 9 or 10, wherein the additional therapeutic agent is methotrexate.
  7. 15
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to one of claims 9 or 10, wherein the additional therapeutic agent is selected from the group consisting of interleukin-1 inhibitor, OKT3, anti-CD25 antibody, anti-CDl la antibody, anti-CD54 antibody, anti-CD54 antibody, anti-CD45 antibody, anti-CD28 antibody, anti-CD80 antibody, anti-CD86 antibody, CDP-571/BAY-10-3356, cA2, 75 kdTNFR-IgG, 55 kdTNFRIgG, IDEC-CE9.1/SB 210396, DAB 486-IL-2, DAB 389-IL-2, Anti-Tac, IL-4, IL-10, IL-4 agonists, IL-10 agonists, IL-IRA, TNF-bp/s-TNFR, R973401, MK-966, Iloprost, thalidomide, thalidomide-related drugs, leflunomide, tranexamic acid, T-614, prostaglandin El, tenidap, naproxen, meloxicam, ibuprofen, piroxicam, diclofenac, indomethacin, sulfasalazine, azathioprine, ICE inhibitors, zap-70 inhibitors, lck inhibitors, VEGF inhibitors, VEGF-R inhibitors, corticosteroids, TNF-convertase inhibitors, anti-IL-12 antibodies, interleukin-11, interleukin-13, interleukin-17 inhibitors, gold, penicillamine, chloroquine, hydroxychloroquine, chlorambucil, cyclophosphamide, cyclosporin, total lymphoid irradiation, anti-thymocyte globulin, anti-CD4 antibodies, CD5-toxins, orally-administered peptides, collagen, lobenzarit disodium, Cytokine Regulating Agent HP228, Cytokine Regulating Agent HP466, ICAM-1 antisense phosphorothioate oligodeoxynucleotides, soluble complement receptor 1, prednisone, orgotein, glycosaminoglycan polysulphate, minocycline, anti-IL2R antibodies, marine lipids, botanical lipids, auranofin, phenylbutazone, meclofenamic acid, flufenamic acid, intravenous immune globulin, zileuton, mycophenolic acid, tacrolimus, sirolimus, amiprilose, cladribine, azaribine, budenoside, epidermal growth factor, aminosalicylates, 6-mercaptopurine, metronidazole, lipoxygenase inhibitors, mesalamine, olsalazine, balsalazide, antioxidants, thromboxane inhibitors, IL-1 receptor antagonists, anti-IL-Ιβ monoclonal antibodies, anti-IL-6 monoclonal antibodies, growth factors, elastase inhibitors, pyridinyl-imidazole compounds, glucuronide-conjugated prodrugs of prednisolone, dexamethasone, dextran-conjugated prodrugs of prednisolone, slow-release mesalazine, antagonists of Platelet Activating Factor (PAF), ciprofloxacin, lignocaine, prednisolone, méthylprednisolone, cyclophosphamide, 4aminopyridine, tizanidine, interferon-pia, interferon-β lb, Copolymer 1, hyperbaric oxygen, intravenous immunoglobulin, clabribine, hypertonic saline solutions, antibiotics, intravenous gamma globulin, continuous hemofiltration, carbapenems, antagonists of cytokines such as TNFa, IL-Ιβ, IL-6 and/or IL-8, SK&F 107647, tetravalent guanylhydrazone CNI-1493, Tissue Factor Pathway Inhibitor, PHP, iron chelators and chelates, diethylenetriamine pentaacetic acid iron (III) complex, lisofylline, PGG-Glucan, apolipoprotein A-l reconstituted with lipids, chiral CA 02868614 2014-10-22 hydroxamic acids, anti-endotoxin antibodies, E5531, rBPI21, Synthetic Anti-Endotoxin Peptides, surfactant replacement therapy and anti-IL-8 antibodies.
  8. 16
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to any one of claims 1-8, wherein the disorder is an autoimmune disease.
  9. 19
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to any one of claims 1-8, wherein the disorder is sepsis.
  10. 21
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to any one of claims 1-8, wherein the disorder is selected from the group consisting of an intestinal disorder, an infectious disease, transplant rejection or graft-versus-host disease, a malignancy, a pulmonary disorder, a cardiac disorder.
  11. 25
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to any one of claims 1-8, wherein the disorder is selected from the group consisting of cytomegalovirus infection secondary to transplantation, fever and myalgias due to infection and cachexia secondary infection, and allograft rejection.
  12. 26
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to any one of claims 1-8, wherein the disorder is selected from the group consisting of stimulating tumor growth, enhancing metastatic potential and mediating cytotoxicity in malignancies, and inhibiting tumor growth or metastasis.
  13. 27
    Use of a human anti-TNFa antibody, or an antigen binding portion thereof, according to any one of claims 1-8, wherein the disorder is selected from the group consisting of inflammatory bone disorders, bone resorption disease, hepatitis, alcoholic hepatitis, viral hepatitis, fulminant hepatitis, coagulation disturbances, burns, reperfusion injury, keloid formation, scar tissue formation, pyrexia, periodontal disease, obesity, and radiation toxicity, septic shock, endotoxic shock, gram negative sepsis, malaria, meningitis, AIDS, bacterial meningitis, AIDS-related complex (ARC), cerebral malaria, cachexia, and toxic shock syndrome.
  14. 28
    Use of the antibody D2E7, or an antigen binding portion thereof, in the manufacture of a medicament for inhibiting human TNFa activity in a human subject suffering from an autoimmune disorder in which TNFa activity is detrimental, wherein the medicament is adapted for administration as a unit dosage form comprising 40 mg of the antibody D2E7, or an antigen binding portion thereof.
  15. 29
    Use of the antibody D2E7, or an antigen binding portion thereof, in the manufacture of a medicament for inhibiting human TNFa activity in a human subject suffering from an intestinal disorder in which TNFa activity is detrimental, wherein the medicament is adapted for administration as a unit dosage form comprising 40 mg of the antibody D2E7, or antigen binding portion thereof. CA 02868614 2014-10-22
  16. 30
    A pharmaceutical composition useful for inhibiting human TNFa activity in a human subject suffering from a disorder in which TNFa activity is detrimental, comprising a D2E7 antibody, or an antigen binding portion thereof, in association with a pharmaceutically acceptable carrier, wherein the pharmaceutical composition comprises 40 mg of the D2E7 antibody, or antigen binding portion thereof.
Independent claims16