Compositions and methods for treating pain in subjects with rheumatoid arthritis

Patent metadata

Field	Value
Publication number	US-2020399380-A1
Application number	US-202016891984-A
Country	US
Kind code	A1
Filing date	Jun 3, 2020
Priority date	Jun 4, 2019
Publication date	Dec 24, 2020
Grant date	—

Abstract

The present disclosure relates to the use of an anti-IL6 receptor antibody for treating unacceptable pain in subjects with rheumatoid arthritis. Subjects with unacceptable pain can have, e.g., refractory pain or strict refractory pain.

First claim

1 . A method for treating unacceptable pain (UP) in a subject in need thereof who has rheumatoid arthritis, comprising administration of a therapeutically effective dose of an antibody that specifically binds IL-6 receptor, wherein the antibody comprises a heavy chain variable region comprising complementarity determining regions HCDR1, HCDR2, and HCDR3 and a light chain variable region comprising complementary determining regions LCDR1, LCDR2, and LCDR3, wherein:
(a) HCDR1 comprises the amino acid sequence of SEQ ID NO: 3; (b) HCDR2 comprises the amino acid sequence of SEQ ID NO: 4; (c) HCDR3 comprises the amino acid sequence of SEQ ID NO: 5; (d) LCDR1 comprises the amino acid sequence of SEQ ID NO: 6; (e) LCDR2 comprises the amino acid sequence of SEQ ID NO: 7; and (f) LCDR3 comprises the amino acid sequence of SEQ ID NO: 8.

2 . The method of claim 1 , wherein the antibody that specifically binds to the IL-6 receptor comprises a heavy chain variable region sequence SEQ ID NO: 1 and a light chain variable region sequence of SEQ ID NO: 2.

3 . The method of claim 1 , wherein the subject has refractory pain (RP) or strict RP.

4 . (canceled)

5 . The method of claim 1 , wherein the subject experiences a reduction in visual analog scale (VAS) to less than 40 mm after 24 weeks of treatment.

6 . (canceled)

7 . The method of claim 1 , wherein the subject has a Disease Activity Score (DAS) of from 3.2 to 5.1.

8 . The method of claim 1 , wherein the subject has a DAS of greater than 5.1.

9 . (canceled)

10 . The method of claim 1 , wherein the subject is administered subcutaneously at a dose of about 150 mg or about 200 mg of the antibody at least once every two weeks.

11 . (canceled)

12 . The method of claim 1 , wherein inflammation in the subject has been reduced by a disease-modifying antirheumatic drug (DMARD), selected from one or more of methotrexate, etanercept, infliximab, adalimumab, golimumab and certolizumab pegol.

13 - 20 . (canceled)

21 . The method of claim 1 , wherein the subject was previously ineffectively treated for rheumatoid arthritis, or is intolerant of one or more DMARDs, or wherein the subject is considered an inappropriate candidate for continued treatment with by administering at least one DMARD different from the antibody.

22 . The method of claim 21 , wherein the DMARD is methotrexate or a TNF-α antagonist.

23 - 29 . (canceled)

30 . A method for treating unacceptable pain (UP) in a subject in need thereof, comprising
(i) selecting a subject who has rheumatoid arthritis and UP; and (ii) administering to the subject a therapeutically effective dose of an antibody that specifically binds IL-6 receptor, wherein the antibody comprises a heavy chain variable region comprising complementarity determining regions HCDR1, HCDR2, and HCDR3 and a light chain variable region comprising complementary determining regions LCDR1, LCDR2, and LCDR3, wherein: (a) HCDR1 comprises the amino acid sequence of SEQ ID NO: 3; (b) HCDR2 comprises the amino acid sequence of SEQ ID NO: 4; (c) HCDR3 comprises the amino acid sequence of SEQ ID NO: 5; (d) LCDR1 comprises the amino acid sequence of SEQ ID NO: 6; (e) LCDR2 comprises the amino acid sequence of SEQ ID NO: 7; and (f) LCDR3 comprises the amino acid sequence of SEQ ID NO: 8.

31 . The method of claim 30 , wherein the antibody that specifically binds to the IL-6 receptor comprises a heavy chain variable region sequence SEQ ID NO: 1 and a light chain variable region sequence of SEQ ID NO: 2.

32 . The method of claim 30 , wherein the subject has refractory pain (RP) or strict RP.

33 . (canceled)

34 . The method of claim 30 , wherein the subject experiences a reduction in visual analog scale (VAS) to less than 40 mm after 24 weeks of treatment.

35 . (canceled)

36 . The method of claim 30 , wherein the subject has a Disease Activity Score (DAS) of from 3.2 to 5.1.

37 . The method of claim 30 , wherein the subject has a DAS of greater than 5.1.

38 . (canceled)

39 . The method of claim 30 , wherein the subject is administered a dose of about 150 mg or about 200 mg of the antibody at least once every two weeks, subcutaneously.

40 . (canceled)

41 . The method of claim 30 , wherein the inflammation in the subject has been reduced by a disease-modifying antirheumatic drug (DMARD), wherein the DMARD is selected from one or more of methotrexate, etanercept, infliximab, adalimumab, golimumab and certolizumab pegol.

42 - 49 . (canceled)

50 . The method of claim 41 , wherein the subject was previously ineffectively treated for rheumatoid arthritis or wherein the subject is considered an inappropriate candidate for continued treatment with one or more DMARDs or has an inadequate response to one or more DMARD different from the antibody.

51 . The method of claim 50 , wherein the DMARD is methotrexate or a TNF-α antagonist.

52 - 87 . (canceled)

Assignees

• Sanofi Biotechnology
• Regeneron Pharma

Inventors

• Boklage Susan
• Kimura Toshio
• Fiore Stefano
• St John Gregory
• Wei Wenhui
• Bykerk Vivian

Classifications

• C07K16/2866 Primary

  against receptors for cytokines, lymphokines, interferons · CPC title

• C07K16/241

  Tumor Necrosis Factors · CPC title

• C07K2317/565

  Complementarity determining region [CDR] · CPC title

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title

• A61K2039/505

  comprising antibodies · CPC title