USES AND COMPOSITIONS FOR TREATMENT OF RHEUMATOID ARTHRITIS
The invention provides methods, uses and compositions for the treatment of rheumatoid arthritis. The invention describes methods and uses for treating rheumatoid arthritis wherein a TNFα inhibitor, such as a human TNFα antibody, or antigen-binding portion thereof. Also described are methods for determining the efficacy of a TNFα inhibitor for treatment of rheumatoid arthritis in a subject.
1 - 18 . (canceled)
19 . A method for treating a subject having late onset rheumatoid arthritis (LORA), the method comprising administering to the subject an effective amount of an antibody, or an antigen-binding portion thereof, that binds to human Tumor Necrosis Factor alpha (TNFα) to thereby treat the LORA, wherein the antibody, or antigen-binding portion thereof, comprises a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7; and comprises a heavy chain variable region (HCVR) comprising a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 8.
20 . The method of claim 19 , wherein the subject has had LORA for three years or less, prior to administering the antibody or antigen-binding portion thereof.
21 . The method of claim 19 , wherein the subject has had LORA for more than three years prior to administering the antibody or antigen-binding portion thereof.
22 . The method of claim 19 , wherein the subject is 65 years of age or older.
23 . The method of claim 19 , wherein the subject is 75 years of age or older.
24 . The method of claim 19 , wherein treatment of the subject results in a change in Disease Activity Score 28 (DAS28) of at least −2.0.
25 . The method of claim 19 , wherein treatment of the subject results in a change in Disease Activity Score 28 (DAS28) of at least −2.3.
26 . The method of claim 20 , wherein treatment of the subject results in a change in Disease Activity Score 28 (DAS28) of at least −2.3.
27 . The method of claim 21 , wherein treatment of the subject results in a change in Disease Activity Score 28 (DAS28) of at least −2.0.
28 . The method of claim 19 , wherein the antibody, or an antigen-binding portion thereof, is administered to the subject for at least 12 weeks.
29 . The method of claim 20 , wherein treatment of the subject results in an ACR20 at 12 weeks.
30 . The method of claim 20 , wherein treatment of the subject results in an ACR50 at 12 weeks.
31 . The method of claim 20 , wherein treatment of the subject results in an ACR70 at 12 weeks.
32 . The method of claim 21 , wherein treatment of the subject results in an ACR20 at 12 weeks.
33 . The method of claim 21 , wherein treatment of the subject results in an ACR50 at 12 weeks.
34 . The method of claim 21 , wherein treatment of the subject results in an ACR70 at 12 weeks.
35 . The method of claim 19 , wherein the antibody, or antigen-binding portion thereof, comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 1 and comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 2.
36 . The method of claim 19 , wherein the antibody, or antigen-binding portion thereof, is adalimumab.
37 . The method of claim 36 , wherein a 40 mg dose of adalimumab is subcutaneously administered biweekly to the subject.
38 . The method of claim 19 , wherein the antibody, or an antigen-binding portion thereof, is administered to the subject for at least 233 days.
39 . The method of claim 19 , wherein the antibody, or an antigen-binding portion thereof, is administered to the subject for at least 96 weeks.