Claims for Patent: 10,450,379

Summary for Patent: 10,450,379

Title:	Method for treating joint damage
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.
Inventor(s):	Totoritis; Mark (Rancho Santa Fe, CA), Shaw; Timothy Mark (Hertfordshire, GB), Agarwal; Sunil (Corte Madera, CA), Yocum; David (San Mateo, CA), Kelman; Ariella (Hillsborough, CA)
Assignee:	Genetech, Inc. (South San Francisco, CA) F. Hoffmann-La Roche AG (Basel, CH) Biogen Inc. (Cambridge, MA)
Application Number:	16/384,333
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,450,379
Patent Claims:	1. A method for the treatment of joint damage caused by rheumatoid arthritis in a subject, wherein (a) the subject has exhibited an inadequate response to one or more antitumor necrosis factor (TNF) inhibitors; (b) the subject received a prior course of treatment with two 1000 mg intravenous (IV) doses of rituximab given 14 days apart and responded to the prior course of treatment and (c) the treatment comprises administering a further course of treatment with two 1000 mg IV doses of rituximab given 14 days apart and administered at weeks 24 to 40, wherein the subject to whom the further course of treatment is administered has active disease based on a disease activity score in 28 joints (DAS 28-erythrocyte sedimentation rate [ESR]) of .gtoreq.2.6, wherein the method slows or halts progression of structural joint damage for at least about 52 weeks in the subject. 2. The method of claim 1 wherein the further course is administered at about week 24. 3. The method of claim 1 further comprising administering methotrexate (MTX) to the subject. 4. The method of claim 3 further comprising administering corticosteroid to the subject prior to each rituximab administration. 5. A method for treating joint damage caused by rheumatoid arthritis in a subject who has exhibited an inadequate response to one or more anti-tumor necrosis factor (TNF) inhibitors comprising: (a) intravenously administering to the subject a first course of 1000 mg of rituximab on days 1 and 15 to which the subject responds; (b) re-treating the subject at weeks 24 to 40 with a further course of 1000 mg of rituximab administered on days 1 and 15 of the re-treatment, wherein the subject who is re-treated has active rheumatoid arthritis based on clinical assessment of disease activity score in 28 joints (DAS28-erythrocyte sedimentation rate [ESR]) of .gtoreq.2.6; and (c) giving the subject at least about 52 weeks after the administration in (a), 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. 6. The method of claim 5 further comprising administering methotrexate (MTX) to the subject. 7. The method of claim 6 wherein the MTX is administered at a dose of about 10-25 mg/week. 8. The method of claim 6 further comprising administering corticosteroid to the subject. 9. The method of claim 8 comprising administering 100 mg IV methylprednisolone prior to each rituximab administration. 10. The method of claim 5 wherein the radiographic test measures a total modified Sharp score (TSS). 11. The method of claim 10 wherein the subject has no progression of structural damage compared to baseline as measured by TSS. 12. The method of claim 5 wherein the further course is administered at about week 24. 13. The method of claim 11 wherein the further course is administered at about week 24. 14. A method of slowing or halting progression of structural joint damage for at least about 52 weeks in a patient having rheumatoid arthritis which has exhibited an inadequate response to one or more anti-tumor necrosis factor (TNF) inhibitors comprising: (a) administering to the patient a first course of treatment with rituximab consisting of two 1000 mg intravenous (IV) doses of rituximab given 14 days apart, to which the patient responds; and (b) re-treating the patient with a further course of treatment with rituximab at weeks 24 to 40, wherein the further course consists of two 1000 mg intravenous (IV) doses of rituximab given 14 days apart and the patient has active disease based on a disease activity score in 28 joints (DAS 28-erythrocyte sedimentation rate [ESR]) of .gtoreq.2.6. 15. The method of claim 14 further comprising administering methotrexate (MTX) to the patient. 16. The method of claim 15 further comprising administering corticosteroid to the patient prior to each rituximab administration. 17. The method of claim 14 which halts progression of structural joint damage for at least 52 weeks in the patient. 18. The method of claim 14 wherein the further course is administered at about week 24.

Details for Patent 10,450,379

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2025-11-15
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2025-11-15