Compositions for the treatment of rheumatoid arthritis and methods of using same
AssigneesSanofi Biotechnology, Regeneron Pharmaceuticals, Inc.
InventorsXiaohong Huang, Martine Jasson, Vanessa Marks, Allen Radin
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Abstract
The present invention provides compositions and methods of treating and improving the symptoms of rheumatoid arthritis using an antibody or antigen-binding fragment thereof that specifically binds human interleukin-6 receptor (hIL-6R) with a DMARD.
Claims24
A method of improving at least one symptom of rheumatoid arthritis, the method comprising subcutaneously administering, to a subject who is determined to have rheumatoid arthritis and have had an inadequate response to a prior treatment with at least one Disease Modifying Antirheumatic Drug (DMARD) other than an IL-6R antagonist, a dose of about 150 mg to about 200 mg of a human antibody once every two weeks, wherein the human antibody specifically binds human interleukin-6 receptor (IL-6R) and comprises:
- three heavy chain complementarity determining regions (HCDRs) of a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and three light chain CDRs (LCDRs) of a light chain variable region comprising the amino acid sequence of SEQ ID NO:
- 3,
- and wherein an improvement in at least one symptom of rheumatoid arthritis is characterized in that the subject achieves at least a 20% improvement in an American College of Rheumatology (ACR) core set disease index after at least 12 weeks of treatment comprising the human antibody.
A method of improving at least one symptom of rheumatoid arthritis, the method comprising subcutaneously administering, to a subject who is determined to have moderate-to-severe rheumatoid arthritis and have had an inadequate response to a prior treatment with at least one Disease Modifying Antirheumatic Drug (DMARD) other than an IL-6R antagonist, a dose of about 150 mg of a human antibody once every two weeks, wherein the human antibody specifically binds human interleukin-6 receptor (IL-6R) and comprises;
- three heavy chain complementarity determining regions (HCDRs) of a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and three light chain CDRs (LCDRs) of a light chain variable region comprising the amino acid sequence of SEQ ID NO:3,
- and wherein an improvement in at least one symptom of rheumatoid arthritis is characterized in that the subject achieves at least a 20% improvement in an ACR core set disease index after at least 12 weeks of treatment comprising the human antibody.
A method of improving at least one symptom of rheumatoid arthritis, the method comprising subcutaneously administering, to a subject who is determined to have moderate-to-severe rheumatoid arthritis and have had an inadequate response to a prior treatment with at least one Disease Modifying Antirheumatic Drug (DMARD), a dose of about 200 mg of a human antibody once every two weeks, wherein the human antibody specifically binds human interleukin-6 receptor (IL-6R) and comprises:
- three heavy chain complementarity determining regions (HCDRs) of a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and three light chain CDRs (LCDRs) of a light chain variable region comprising the amino acid sequence of SEQ ID NO:3,
- and wherein an improvement in at least one symptom of rheumatoid arthritis is characterized in that the subject achieves at least a 20% improvement in an ACR core set disease index after at least 12 weeks of treatment comprising the human antibody.
Dependencies are inferred from the claim text.