Concomitant treatment of rheumatoid arthritis with anti-TNF-alpha antibodies and methotrexate
DC CAFCFirst Claim
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1. A method of treating an individual suffering from rheumatoid arthritis who, despite prior treatment with methotrexate, still has active disease, defined as the presence of six or more swollen joints plus at least three of the following four secondary criteria:
- duration of morning stiffness ≧
45 minutes;
≧
6 tender or painful joints;
erythrocyte sedimentation rate (ESR) ≧
28 mm/hour; and
C-reactive protein (CRP) ≧
20 mg/l, which comprises administering to the individual, adjunctively and/or concomitantly, (1) multiple doses of a recombinant anti-human tumor necrosis factor-α
monoclonal antibody at intervals of weeks, which antibody (a) binds specifically to human tumor necrosis factor-α and
(b) inhibits binding of human tumor necrosis factor-α
to both p55 and p75 cell surface receptors and (2) multiple doses of methotrexate at intervals of a week or weeks, wherein the treatment reduces the individual'"'"'s signs and symptoms by greater than fifty percent (50%) according to the Paulus criteria for a significant duration of time.
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Abstract
Methods for treating and/or preventing a TNF-mediated disease in an individual are disclosed. Also disclosed is a composition comprising methotrexate and an anti-tumor necrosis factor antibody. TNF-mediated diseases include rheumatoid arthritis, Crohn'"'"'s disease, and acute and chronic immune diseases associated with transplantation.
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19 Claims
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1. A method of treating an individual suffering from rheumatoid arthritis who, despite prior treatment with methotrexate, still has active disease, defined as the presence of six or more swollen joints plus at least three of the following four secondary criteria:
- duration of morning stiffness ≧
45 minutes;
≧
6 tender or painful joints;
erythrocyte sedimentation rate (ESR) ≧
28 mm/hour; and
C-reactive protein (CRP) ≧
20 mg/l, which comprises administering to the individual, adjunctively and/or concomitantly, (1) multiple doses of a recombinant anti-human tumor necrosis factor-α
monoclonal antibody at intervals of weeks, which antibody (a) binds specifically to human tumor necrosis factor-α and
(b) inhibits binding of human tumor necrosis factor-α
to both p55 and p75 cell surface receptors and (2) multiple doses of methotrexate at intervals of a week or weeks, wherein the treatment reduces the individual'"'"'s signs and symptoms by greater than fifty percent (50%) according to the Paulus criteria for a significant duration of time. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
- duration of morning stiffness ≧
Specification