Methods of treating Crohn's disease or ulcerative colitis using an induction dosing regimen comprising anti-TNF-alpha antibody
The invention relates to a multiple-variable dose method for treating a disorder in which TNFα activity is detrimental, comprising administering to a subject in need thereof a first induction dose of an anti-TNFα antibody which ranges from 161 to 320 mg such that a threshold level of TNFα inhibitor is achieved within an induction phase; and subsequently administering to the subject at least one treatment dose of the TNFα inhibitor within a treatment phase, such that treatment occurs.
1. A method of treating Crohn's disease or ulcerative colitis, the method comprising administering a multiple-variable dose to a subject in need thereof comprising administering a first induction dose of an anti-TNFα antibody in the amount of 161 to 320 mg such that a threshold level of the anti-TNFα antibody is achieved within an induction phase; administering a second induction dose of the anti-TNFα antibody in the amount of 80 to 160 mg subsequent to the first induction dose; and administering at least one treatment dose of the anti-TNFα antibody for subsequent administration within a treatment phase, such that treatment of the Crohn's disease or ulcerative colitis occurs,
wherein the anti-TNFα antibody is administered subcutaneously in a liquid formulation containing 100 mg/mL of the anti-TNFα antibody.
2. The method of claim 1 , wherein the treatment dose is 40-60% of the first or second induction dose.
3. The method of claim 1 , wherein the treatment dose ranges from 20 to 160 mg.
4. The method of claim 1 , wherein the treatment dose comprises 80 mg.
5. The method of claim 1 , wherein the first induction dose comprises 200 mg.
6. The method of claim 1 , wherein the treatment dose is for administration 2 weeks following the second induction dose.
7. The method of claim 1 , wherein the anti-TNFα antibody is adalimumab.
8. The method of claim 1 , wherein the anti-TNFα antibody is administered in combination with methotrexate.
9. The method of claim 1 , wherein the subcutaneous administration occurs through a needle with an outer diameter between 0.1 and 0.5 mm.
10. The method of claim 9 , wherein the subcutaneous administration occurs through a needle with an outer diameter between 0.25 and 0.5 mm.
11. The method of claim 1 , wherein the first induction dose comprises 161 mg, the second induction dose comprises 80 mg, and the treatment dose ranges from 20 to 160 mg.
12. The method of claim 11 , wherein the treatment dose comprises 80 mg.
13. The method of claim 11 , wherein the treatment dose is for administration 2 weeks following the second induction dose.
14. The method of claim 11 , wherein the anti-TNFα antibody is adalimumab.
15. The method of claim 1 , wherein the first induction dose comprises 161 mg, the second induction dose comprises 80 mg, and the treatment dose comprises 80 mg, wherein the treatment dose is for administration 2 weeks following the second induction dose.
16. The method of claim 15 , wherein the anti-TNFα antibody is adalimumab.
17. The method of claim 1 , wherein the treatment phase comprises a first treatment dose and a second treatment dose, wherein the first treatment dose is administered for a period sufficient to achieve mucosal healing prior to administration of the second treatment dose.
18. The method of claim 17 , wherein the first induction dose comprises 161 mg, the second induction dose comprises 160 mg, the first treatment dose is 160 mg, and the second treatment dose is 40-60% of the first induction dose.
19. The method of claim 18 , wherein the first induction dose comprises 161 mg, the second induction dose comprises 160 mg, the first treatment dose comprises 160 mg, and the second treatment dose comprises 80 mg.
20. The method of claim 17 , wherein the first induction dose comprises 161 mg, the second induction dose comprises 160 mg, the first treatment dose comprises 160 mg, and the second treatment dose comprises 40 mg.
21. The method of claim 17 , wherein the anti-TNFα antibody is adalimumab.
22. The method of claim 18 , wherein the anti-TNFα antibody is adalimumab.
23. The method of claim 19 , wherein the anti-TNFα antibody is adalimumab.
24. The method of claim 20 , wherein the anti-TNFα antibody is adalimumab.