Methods of inhibiting the lowering of antihuman TNF-α antibody
The present invention provides an antihuman TNF-α antibody activity lowering inhibitor comprising a protein source(s) and/or carbohydrate source(s), in the treatment of inflammatory bowel syndrome with repeated administration of anti-TNF-α antibody; and a kit preparation wherein a freeze-dried antihuman TNF-α antibody and the activity lowering inhibitor in the above repeated administration of the anti-TNF-α antibody are separately contained in a plastic container so that they can communicate with each other. According to the present invention, in the drug therapy to the patients with inflammatory bowel syndrome, therapeutic agents which inhibit the inflammation for long periods without accompanying serious side effects can be provided.
1. A method of inhibiting the lowering of antihuman TNF-α antibody activity comprising administering to a subject suffering from inflammatory bowel disease that has or is undergoing a treatment regimen involving repeated administration of anti-TNF-α antibody an effective amount of a protein source(s), carbohydrate source(s) or a combination thereof,
wherein the protein source(s) comprises the amino acids at least in the following contents by dry weight of the protein source(s):
L-isoleucine
2.0 to 8.0
W/W %
L-leucine
4.0 to 15.0
W/W %
L-lysine
4.0 to 15.0
W/W %
L-methionine
2.0 to 6.0
W/W %
L-phenylalanine
4.0 to 12.0
W/W %
L-threonine
1.0 to 8.0
W/W %
L-triptophan
0.5 to 3.0
W/W %
L-valine
2.0 to 6.0
W/W %
L-histidine
1.0 to 8.0
W/W %
L-arginine
5.0 to 9.0
W/W %
L-alanine
4.0 to 8.0
W/W %
L-asparaginic acid
2.0 to 15.0
W/W %
L-glutamine
0 to 15.0
W/W %
Glycin
1.0 to 12.0
W/W %
L-proline
2.0 to 6.0
W/W %
L-serine
1.0 to 10.0
W/W %
L-tyrosine
0.1 to 3.0
W/W %
L-cystein
0 to 10.0
W/W %
L-glutaminic acid
0 to 10.0
W/W %,
and
wherein the carbohydrate source(s) is at least one kind of sugar selected from the group consisting of glucose, fructose, maltose, sorbitol, xylitol and glycerin.
2. The method according to claim 1 , wherein the protein source(s) is animal proteins, vegetable proteins or a combination thereof.
3. The method according to claim 1 , wherein the protein source(s) is milk proteins, soybean protein isolates or a combination thereof.
4. The method according to claim 1 , further comprising administering a lipid source(s).
5. The method according to claim 4 , wherein the lipid source(s) comprises fats containing at least one kind of ω3 fatty acid(s), which is selected from the group consisting of α-linolenic acid, eicosapentaenoic acid and docosahexaenoic acid.
6. The method according to claim 4 , wherein the protein source(s), carbohydrate source(s), and lipid source(s) are administered in a single composition and said protein source(s) is in an amount of 5 to 30 W/W % by dry weight; the carbohydrate source(s) is in an amount of 40 to 90 W/W % by dry weight; and the lipid source(s) is in an amount of 0 to 30 W/W % by dry weight, wherein the weight percentage is relative to the total weight of same composition.
7. The method according to claim 6 , wherein amounts of the protein source(s), the carbohydrate source(s) and the lipid source(s), relative to the total weight of the composition, are the following amounts by dry weight:
Protein source(s);
L-isoleucine
0.2 to 1.5
W/W %
L-leucine
0.5 to 2.0
W/W %
L-lysine
0.5 to 2.0
W/W %
L-methionine
0.2 to 1.5
W/W %
L-phenylalanine
0.5 to 2.0
W/W %
L-threonine
0.2 to 1.5
W/W %
L-triptophan
0.05 to 0.5
W/W %
L-valine
0.2 to 1.5
W/W %
L-histidine
0.5 to 2.0
W/W %
L-arginine
0.5 to 2.5
W/W %
L-alanine
0.5 to 2.0
W/W %
L-asparaginic acid
1.0 to 4.0
W/W %
L-glutamine
1.0 to 4.0
W/W %
Glycin
0.2 to 1.5
W/W %
L-proline
0.2 to 1.5
W/W %
L-serine
0.5 to 2.5
W/W %
L-tyrosine
0.05 to 0.5
W/W %
Carbohydrate source(s);
Dextrin
70 to 85
W/W %
Lipid source(s);
Soybean oil
0.1 to 10
W/W %.
8. The method according to claim 1 , wherein the antihuman TNF-α antibody is a monoclonal antibody selected from the group consisting of a chimeric antibody, humanized antibody and human antibody.
9. The method according to claim 8 , wherein the antihuman TNF-α antibody is at least one selected from the group consisting of Infliximab, Adalimumab and Etanercept.
10. The method according to claim 9 , wherein the antihuman TNF-α antibody is Infliximab.
11. The method according to claim 1 , wherein the inflammatory bowel disease is Crohn's disease.
12. The method according to claim 11 , wherein the Crohn's disease is in the active stage and/or it accompanies the external fistula.
13. The method according to claim 1 , wherein said administering further has an immune-deterioration-inhibiting effect, reduces concurrent infections or a combination thereof.
14. The method according to claim 1 , wherein said administering is orally or enterally.
15. The method according to claim 1 , wherein said administering is in the central vein.