Uses and compositions for treatment of rheumatoid arthritis
AssigneeAbbVie Biotechnology Ltd.
InventorsHartmut Kupper, Jeffrey D. Kent, Mary A. Cifaldi, John L. Perez, Gerd R. Burmester, Philip Mease, Daniel J. Lovell, Edward Keystone, Arthur Kavanaugh
Life of this patent
Estimating the term…
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.
Claims46
A method of preventing Pneumococcal disease and treating rheumatoid arthritis (RA) in a subject comprising administering a pneumococcal vaccine and a human TNFα antibody, or antigen-binding portion thereof, to the subject, such that Pneumococcal disease is prevented and rheumatoid arthritis is treated.
A method of treating late-onset RA comprising administering a human TNFα antibody, or antigen-binding portion thereof, to a patient having late-onset RA.
A method of determining the efficacy of a TNFα inhibitor for treating RA in a subject comprising
- determining an ACR response of a patient population having RA and who was administered the TNFα inhibitor,
- wherein an ACR response selected from the group consisting of an ACR20 response in at least about 80% of the patient population, an ACR50 response in at least about 62% of the patient population, and an ACR70 response in at least about 20% of the patient population, indicates that the TNFα inhibitor is an effective TNFα inhibitor for the treatment of RA in a subject.
(canceled)
A method of treating RA in a subject comprising administering an effective TNFα inhibitor, wherein the effective TNFα inhibitor was identified as providing an ACR response selected from the group consisting of an ACR20 response in at least about 80% of a patient population who received the effective TNFα inhibitor for the treatment of RA, an ACR50 response in at least about 62% of a patient population who received the effective TNFα inhibitor for the treatment of RA, and an ACR70 response in at least about 20% of a patient population who received the effective TNFα inhibitor for the treatment of RA.
(canceled)
A method for predicting the efficacy of a TNFα inhibitor for the treatment of rheumatoid arthritis (RA) in a subject comprising using the combination of a C-reactive protein (CRP) level of the subject and a Patient Activity Score (PAS) of the subject, wherein an improvement in the CRP level and the PAS score early in the treatment of the patient with the TNFα inhibitor indicates that the TNFα inhibitor is an effective TNFα inhibitor for the treatment of RA in the subject.
(canceled)
A method for determining the efficacy of a TNFα inhibitor for the treatment of rheumatoid arthritis (RA) in a subject comprising
- determining a Simplified Disease Activity Score (SDAI) of a patient population having RA and who was administered the TNFα inhibitor, wherein a mean SDAI of no greater than about 3.3 in at least about 11% of the patient population indicates that the TNFα inhibitor is an effective TNFα inhibitor for treating RA.
(canceled)
26-30. (canceled)
A method for determining the efficacy of a human TNFα antibody, or antigen-binding portion thereof, for treating RA in a subject comprising
- determining a EULAR response of a patient population having RA and who was administered the human TNFα antibody, or antigen-binding portion thereof,
- wherein a moderate EULAR response in at least about 83% of the patient population or a good EULAR response in at least about 35% of the patient population, indicates that the human TNFα antibody, or antigen-binding portion thereof, is an effective human TNFα antibody, or antigen-binding portion thereof, for the treatment of RA.
33-34. (canceled)
A method of treating RA in a subject comprising administering an effective human TNFα antibody, or antigen-binding portion thereof, for the treatment of RA in a subject, wherein the effective human TNFα antibody, or antigen-binding portion thereof, was identified as achieving either a moderate EULAR response in at least about 83% of a patient population who was administered the human TNFα antibody, or antigen-binding portion thereof, or a good EULAR response in at least about 35% of a patient population who was administered the human TNFα antibody, or antigen-binding portion thereof.
(canceled)
A method for determining the efficacy of a human TNFα antibody, or antigen-binding portion thereof, for treating RA in a subject who has failed prior infliximab treatment comprising
- determining an ACR20 response of a patient population having RA who has failed previous infliximab treatment and who was administered the human TNFα antibody, or antigen-binding portion thereof,
- wherein an ACR20 response in at least about 50% of the patient population indicates that the human TNFα antibody, or antigen-binding portion thereof is an effective human TNFα antibody, or antigen-binding portion thereof, for the treatment of RA in a subject who has failed prior infliximab treatment.
41-44. (canceled)
47-50. (canceled)
An article of manufacture comprising
- a) a packaging material;
- b) a TNFα antibody, or antigen-binding portion thereof;
- and
- c) a label or package insert indicating either that patients with RA receiving treatment with the TNFα antibody, or antigen-binding portion thereof, can be administered a pneumonococcal vaccine concurrently with the TNFα antibody, or antigen-binding portion thereof, or that in studies of the TNFα antibody, or antigen-binding portion thereof, observed malignancies included melanoma and/or granulose cell tumor of the ovary.
An article of manufacture comprising
- a) a packaging material;
- b) pneumonococcal or influenza virus vaccine;
- and
- c) a label or package insert contained within the packaging material indicating that patients receiving the pneumonococcal or influenza virus vaccine can be safely administered a TNFα inhibitor.
(canceled)
56-59. (canceled)
Dependencies are inferred from the claim text.