Method for treating joint damage
Inventors
Totoritis, Mark • Shaw, Timothy Mark • Agarwal, Sunil • Yocum, David • Kelman, Ariella
Assignees
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Publication Number
US-10450379-B2
Publication Date
2019-10-22
Expiration Date
Abstract
Methods of treating joint damage in a subject eligible for treatment are provided involving administering an antagonist that binds to a B-cell surface marker, such as CD20 antibody, to the subject in an amount effective to slow progression of the joint damage as measured by radiography. Further provided are articles of manufacture useful for such methods.
Core Innovation
The invention relates to a method for the treatment of joint damage caused by rheumatoid arthritis in a subject or patient who has exhibited an inadequate response to one or more anti-tumor necrosis factor (TNF) inhibitors. The method includes administering a first course of rituximab consisting of two 1000 mg intravenous (IV) doses given 14 days apart, where the subject or patient responds.
After the first rituximab course, the method includes re-treating with a further course of rituximab at weeks 24 to 40. The further course consists of two 1000 mg IV doses given 14 days apart, and is administered when the subject or patient has active disease based on a disease activity score in 28 joints (DAS 28-erythrocyte sedimentation rate (ESR)) of ≥2.6.
The method slows or halts progression of structural joint damage for at least about 52 weeks. A radiographic test that measures joint damage as compared to baseline prior to the administration is performed at least about 52 weeks after the administration, wherein the amount of rituximab administered is effective in treating the joint damage.
Claims Coverage
The independent claims collectively cover treatment of rheumatoid-arthritis joint damage with an initial responding rituximab course followed by a further rituximab re-treatment course at weeks 24 to 40 for subjects or patients with active disease based on DAS28-ESR ≥2.6. The claims also require slowing or halting progression of structural joint damage for at least about 52 weeks and include radiographic comparison to baseline to assess effectiveness.
Further rituximab re-treatment for TNF-inadequate responders with active DAS28-ESR ≥2.6
A subject or patient has exhibited an inadequate response to one or more antitumor necrosis factor (TNF) inhibitors, received a prior course of treatment with two 1000 mg intravenous (IV) doses of rituximab given 14 days apart and responded, and receives a further course of treatment with two 1000 mg IV doses of rituximab given 14 days apart administered at weeks 24 to 40 when active disease based on DAS 28-ESR is ≥2.6.
Radiographic assessment to demonstrate effective treatment of joint damage
A method comprising intravenously administering a first course of 1000 mg rituximab on days 1 and 15, re-treating at weeks 24 to 40 with a further course of 1000 mg rituximab on days 1 and 15, and giving at least about 52 weeks after the administration a radiographic test that measures joint damage as compared to baseline prior to the administration, wherein the amount of rituximab administered is effective in treating the joint damage.
Slowing or halting structural joint damage for at least about 52 weeks with further rituximab at weeks 24 to 40
A method of slowing or halting progression of structural joint damage for at least about 52 weeks in a patient having rheumatoid arthritis with inadequate response to one or more anti-TNF inhibitors, comprising administering a first course of rituximab with two 1000 mg IV doses given 14 days apart and re-treating with a further course at weeks 24 to 40 consisting of two 1000 mg IV doses given 14 days apart when the patient has active disease based on DAS 28-ESR of ≥2.6.
The independent claims collectively require an initial rituximab course that the subject or patient responds to, then a further rituximab re-treatment course at weeks 24 to 40 for subjects or patients with active DAS28-ESR ≥2.6, with an endpoint of slowing or halting progression of structural joint damage for at least about 52 weeks and radiographic comparison to baseline in one claim.
Stated Advantages
Slows or halts progression of structural joint damage for at least about 52 weeks.
In connection with the radiographic test, the amount of rituximab administered is effective in treating the joint damage.
Documented Applications
Treatment of joint damage caused by rheumatoid arthritis in subjects or patients with inadequate response to one or more anti-tumor necrosis factor (TNF) inhibitors, including re-treatment with rituximab when DAS28-ESR is ≥2.6.
Radiographic assessment of joint damage as compared to baseline performed at least about 52 weeks after initial administration to evaluate the effectiveness of rituximab in treating joint damage.
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