MULTIPLE-VARIABLE DOSE REGIMEN FOR TREATING TNFALPHA-RELATED DISORDERS
Multiple-variable dose methods for treating TNFα-related disorders, including Crohn's disease and psoriasis, comprising administering TNFα inhibitors, including TNFα antibodies, are described. Multiple-variable dose methods include administration of a TNF-inhibitor in an induction or loading phase followed by administration of the agent in a maintenance or treatment phase, wherein the TNF-inhibitor is administered in a higher dosage during the induction phase.
1 - 53 . (canceled)
54 . A kit for the treatment of a disorder in which TNFα activity is detrimental comprising:
a) at least one container comprising an induction dose of a TNFα inhibitor;
b) at least one container comprising a treatment dose of a TNFα inhibitor; and
c) instructions for administration of the induction dose of the TNFα inhibitor within an induction phase and the treatment dose of the TNFα inhibitor within a treatment phase.
55 - 60 . (canceled)
61 . A kit for inducing clinical remission of Crohn's disease in a subject in need thereof, comprising:
(a) four containers each comprising about a 40 mg dose of an anti-TNFα antibody, wherein said four containers are used for administering a first dose of the antibody;
(b) two additional containers each comprising about a 40 mg dose of an anti-TNFα antibody, wherein said two containers are used for administering a second dose of the antibody; and
(c) instructions for administration, wherein said instructions describe that the second dose of the antibody is subcutaneously administered about two weeks following subcutaneous administration of the first dose of the antibody;
wherein the antibody comprises a heavy chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO:8; a CDR2 comprising the amino acid sequence of SEQ ID NO:6; and a CDR3 comprising the amino acid sequence of SEQ ID NO:4; and a light chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO:7; a CDR2 comprising the amino acid sequence of SEQ ID NO:5; and a CDR3 comprising the amino acid sequence of SEQ ID NO:3.
62 . The kit of claim 61 , wherein the heavy chain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and the light chain comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:1.
63 . The kit of claim 62 , wherein the heavy chain comprises an IgG1 heavy chain constant region and the light chain comprises a kappa light chain constant region.
64 . The kit of claim 61 , wherein each container comprises a prefilled syringe.
65 . The kit of claim 62 , wherein each container comprises a prefilled syringe.
66 . The kit of claim 63 , wherein each container comprises a prefilled syringe.
67 . The kit of claim 61 , wherein each container comprises a 40 mg dose of the antibody.
68 . The kit of claim 62 , wherein each container comprises a 40 mg dose of the antibody.
69 . The kit of claim 63 , wherein each container comprises a 40 mg dose of the antibody.
70 . The kit of claim 64 , wherein each container comprises a 40 mg dose of the antibody.
71 . The kit of claim 65 , wherein each container comprises a 40 mg dose of the antibody.
72 . The kit of claim 66 , wherein each container comprises a 40 mg dose of the antibody.
73 . A kit for inducing clinical remission of Crohn's disease in a subject in need thereof, comprising:
(a) four containers each comprising about a 40 mg dose of adalimumab, wherein said four containers are used for administering a first dose of adalimumab;
(b) two additional containers each comprising about a 40 mg dose of adalimumab, wherein said two containers are used for administering a second dose of adalimumab; and
(c) instructions for administration, wherein said instructions describe that the second dose of adalimumab is subcutaneously administered about two weeks following subcutaneous administration of the first dose of adalimumab.
74 . The kit of claim 73 , wherein the concentration of adalimumab is 50 mg/ml.
75 . The kit of claim 73 , wherein each container comprises a prefilled syringe.
76 . The kit of claim 74 , wherein each container comprises a prefilled syringe.
77 . The kit of claim 73 , wherein each container comprises a 40 mg dose of adalimumab.
78 . The kit of claim 74 , wherein each container comprises a 40 mg dose of adalimumab.
79 . The kit of claim 75 , wherein each container comprises a 40 mg dose of adalimumab.
80 . A kit for inducing clinical remission of Crohn's disease in a subject in need thereof, comprising:
(a) four containers each comprising a prefilled syringe comprising a 40 mg dose of adalimumab having a concentration of 50 mg/ml, wherein said four containers are used for administering a first dose of adalimumab;
(b) two additional containers each comprising a prefilled syringe comprising a 40 mg dose of adalimumab having a concentration of 50 mg/ml, wherein said two containers are used for administering a second dose of adalimumab; and
(c) instructions for administration, wherein said instructions describe that the second dose of adalimumab is subcutaneously administered about two weeks following subcutaneous administration of the first dose of adalimumab.