Use of anti-TNFalpha antibodies and another drug

• US 20030206898A1
• Filed: 04/26/2002
• Published: 11/06/2003
• Est. Priority Date: 04/26/2002
• Status: Abandoned Application

• Current Assignee: Abbott Biotechnology Limited (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Biotechnology Limited (Abbott Laboratories Incorporated)
• Inventors: Fischkoff, Steven, Chartash, Elliot
• Application Number:
  US10/133,715
• Publication Number:
  US 20030206898A1
• Time in Patent Office: Days
• US Class Current: 424/130.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 31/215 of carboxylic acids
• CPC Class Codes: A61K 31/415 1,2-Diazoles
• CPC Class Codes: A61K 31/45 having oxo groups directly attached to the heterocyclic ring, e.g. cycloheximide
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/24 Heavy metals; Compounds thereof
• CPC Class Codes: A61K 33/242 Gold; Compounds thereof
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/16 : for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/12 : of the kidneys
• CPC Class Codes: A61P 17/02 : for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/04 : for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 19/06 : Antigout agents, e.g. antihyperuricemic or uricosuric agents
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 27/02 : Ophthalmic agents
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 33/06 : Antimalarials
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: C07K 16/241 : Tumor Necrosis Factors
• CPC Class Codes: C07K 2317/21 : from primates, e.g. man
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention is directed to a method of treating disorders in which TFNα activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor α (hTNFα) in combination with another drug which is useful for treating the disorder. 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 are also encompassed by the invention.

Claims

1. A method for treating a disorder in a human subject which disease is treatable with a TNFα

antibody or antigen binding fragment thereof, comprising administering a composition to the human subject in need thereof, on a biweekly dosing regimen such that the disorder is treated, said composition comprising an anti-TNFα

antibody or an antigen binding portion thereof and administering one or more other drug(s).

2. The method of claim 1, wherein the administration of the composition comprising an anti-TNFα

antibody or an antigen binding portion thereof is by subcutaneous injection.

3. The method of claim 1, wherein said anti-TNFα

antibody or an antigen binding portion thereof is a human anti-TNFα

antibody.

4. The method of claim 3, wherein said human antibody is D2E7.

5. The method of claim 4, wherein 40 mg of D2E7 is administered.

6. The method of claim 5, wherein the disease is an autoimmune disease.

7. The method of claim 6, wherein the autoimmune disease is rheumatoid arthritis.

8. The method of claim 7, wherein the other drug is a Disease Modifying Anti-Rheumatic Drug (DMARD), a Nonsteroidal Antiinflammatory Drug (NSAID), a steroid or any combination thereof.

9. The method of claim 8, wherein the DMARD is hydroxychloroquine, leflunomide, methotrexate, parenteral gold, oral gold, sulfasalazine or any combination thereof.

10. The method of claim 8, wherein the NSAID is Prednisone, Folic acid, Celecoxib, Rofecoxib, Paracetamol, Naproxen, Ibuprofen, Methylprednisolone, Tramadol, Di-gesic, Diclofenac, Vicodin, Triamcinolone, Lidocaine or any combination thereof.

11. The method of claim 7, wherein the other drug is multivitamins, calcium, folic acid, influenza virus vaccine polyvalent or any combination thereof.

12. A pharmaceutical composition comprising 40 mg of D2E7, one or more other drug(s) and a pharmaceutically acceptable carrier.

13. The pharmaceutical composition of claim 12, wherein the other drug is a Disease Modifying Anti-Rheumatic Drug (DMARD), a Nonsteroidal Antiinflammatory Drug (NSAID), a steroid or any combination thereof.

14. The pharmaceutical composition of claim 13, wherein the DMARD is hydroxychloroquine, leflunomide, methotrexate, parenteral gold, oral gold, sulfasalazine or any combination thereof.

15. The pharmaceutical composition of claim 13, wherein the NSAID is Prednisone, Folic acid, Celecoxib, Rofecoxib, Paracetamol, Naproxen, Ibuprofen, Methylprednisolone, Tramadol, Di-gesic, Diclofenac, Vicodin, Triamcinolone, Lidocaine or any combination thereof.

16. The pharmaceutical composition of claim 12, wherein the other drug is multivitamins, calcium, folic acid, influenza virus vaccine polyvalent or any combination thereof.

17. A kit comprising a formulation comprising:

a) a pharmaceutical composition comprising an anti-TNFα

antibody and a pharmaceutically acceptable carrier;

b) one or more pharmaceutical compositions, each composition comprising one or more other drug(s) and a pharmaceutically acceptable carrier; and

c) instructions for biweekly dosing of the pharmaceutical composition for the treatment of a disorder in which an anti-TNFα

antibody or a binding portion thereof is effective in treating.

18. The kit of claim 17, wherein the composition comprising the antibody is 40 mg of D2E7 and instructions pertain to treating rheumatoid arthritis.

19. A kit of claim 18, wherein the other composition or compositions comprise a Disease Modifying Anti-Rheumatic Drug (DMARD), a Nonsteroidal Antiinflammatory Drug (NSAID), a steroid or any combination thereof.

20. A kit of claim 19, wherein the DMARD is hydroxychloroquine, leflunomide, methotrexate, parenteral gold, oral gold, sulfasalazine or any combination thereof.

21. A kit of claim 19, wherein the NSAID is Prednisone, Folic acid, Celecoxib, Rofecoxib, Paracetamol, Naproxen, Ibuprofen, Methylprednisolone, Tramadol, Di-gesic, Diclofenac, Vicodin, Triamcinolone, Lidocaine or any combination thereof.

22. A kit according to claim 18, wherein the other drug is multivitamins, calcium, folic acid, influenza virus vaccine polyvalent or any combination thereof.