Uses and Compositions for Treatment of Rheumatoid Arthritis

Abstract

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 maintaining clinical remission of rheumatoid arthritis in a subject, the method comprising administering to a subject who is in clinical remission from rheumatoid arthritis an antibody, or an antigen-binding portion thereof, that binds to human Tumor Necrosis Factor alpha (TNFα) in an amount effective to maintain clinical remission of rheumatoid arthritis in the subject, 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 clinical remission was induced by treatment of the subject with a TNFα inhibitor. 
     
     
         21 . The method of  claim 20 , wherein the TNFα inhibitor is adalimumab. 
     
     
         22 . The method of  claim 19 , wherein a subject having one or both of no tender joints and no swollen joints is in clinical remission. 
     
     
         23 . The method of  claim 19 , wherein a subject having a Disease Activity Score 28 (DAS28) <2.6 is in clinical remission. 
     
     
         24 . The method of  claim 19 , wherein a subject having a Health Assessment Questionnaire score of 0 is in clinical remission. 
     
     
         25 . The method of  claim 19 , wherein the antibody or antigen-binding portion thereof is continuously administered to the subject. 
     
     
         26 . The method of  claim 19 , wherein the antibody, or antigen-binding portion thereof, is administered to the subject for 6 years or longer. 
     
     
         27 . 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. 
     
     
         28 . The method of  claim 19 , wherein the antibody, or antigen-binding portion thereof, is adalimumab. 
     
     
         29 . The method of  claim 28 , wherein a 40 mg dose of adalimumab is subcutaneously administered biweekly to the subject. 
     
     
         30 . A method for obtaining clinical remission of rheumatoid arthritis in a subject and maintaining the clinical remission in the subject, the method comprising administering to a subject having rheumatoid arthritis an antibody, or an antigen-binding portion thereof, that binds to human Tumor Necrosis Factor alpha (TNFα) in an amount effective to obtain clinical remission of rheumatoid arthritis in the subject and maintain the clinical remission in the subject, 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. 
     
     
         31 . The method of  claim 30 , wherein clinical remission was induced by treatment with a TNFα inhibitor. 
     
     
         32 . The method of  claim 31 , wherein the TNFα inhibitor is adalimumab. 
     
     
         33 . The method of  claim 30 , wherein a subject having one or both of no tender joints and no swollen joints is in clinical remission. 
     
     
         34 . The method of  claim 30 , wherein a subject having a Disease Activity Score 28 (DAS28) <2.6 is in clinical remission. 
     
     
         35 . The method of  claim 30 , wherein a subject having a Health Assessment Questionnaire score of 0 is in clinical remission. 
     
     
         36 . The method of  claim 30 , wherein the antibody or antigen-binding portion thereof is continuously administered to the subject. 
     
     
         37 . The method of  claim 30 , wherein the antibody, or antigen-binding portion thereof, is administered to the subject for 6 years or longer. 
     
     
         38 . The method of  claim 30 , 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. 
     
     
         39 . The method of  claim 30 , wherein the antibody, or antigen-binding portion thereof, is adalimumab. 
     
     
         40 . The method of  claim 39 , wherein a 40 mg dose of adalimumab is subcutaneously administered biweekly to the subject.