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1. WO2020157629 - MÉTHODE DE TRAITEMENT DES SIGNES ET SYMPTÔMES DE L'ARTHROSE

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Claims

claimed:

1. A method for treating signs and symptoms of osteoarthritis (OA) in a patient , the method comprising administering to the patient an anti-nerve growth factor (NGF) antibody at a dose of 2.5 mg every 8 weeks via subcutaneous injection; wherein the patient has a history of inadequate pain relief or intolerance to analgesic therapy and the treatment with the anti-NGF antibody effectively improves signs and symptoms of OA by at least 16 weeks after the start of treatment with the anti- NGF antibody.

2. A method for treating signs and symptoms of osteoarthritis (OA) in a patient, the method comprising administering to the patient an anti-nerve growth factor (NGF) antibody at a dose of 5 mg every 8 weeks via subcutaneous injection; wherein the patient has a history of inadequate pain relief or intolerance to analgesic therapy and the treatment with the anti-NGF antibody effectively improves signs and symptoms of OA by at least 16 weeks after the start of treatment with the anti-NGF antibody.

3. The method according to claim 1 or 2, wherein the anti-NGF antibody is tanezumab.

4. The method according to any one of claims 1 to 3, wherein the treatment effectively improves OA signs and symptoms as measured by WOMAC Pain subscale, WOMAC Physical Function subscale and/or Patient Global Assessment of OA (PGA-OA).

5. The method according to any one of claims 1 to 4, wherein the treatment effectively improves signs and symptoms of OA by at least 24 weeks after start of treatment.

6. The method according to any one of claims 1 to 5, wherein the treatment effectively improves signs and symptoms of OA by at least 56 weeks after start of treatment.

7. The method according to any one of the preceding claims, wherein the treatment effectively improves WOMAC Pain, WOMAC Physical Function and/or PGA-OA compared to a baseline value prior to or at start of treatment.

8. The method according to claim 7, wherein the treatment further improves one or more clinical measures selected from a) reduction in WOMAC Pain subscale of > 50% at week 16 and/or week 24 of treatment; b) reduction in WOMAC Pain subscale from baseline to week 2 of treatment; or c) reduction in average pain score in index joint from baseline at week 1 of treatment.

9. The method according to any one of the preceding claims, wherein the patient was previously treated with the analgesic therapy prior to administering the anti-NGF antibody.

10. The method according to any one of the preceding claims, wherein the patient is not administered an NSAID during the treatment with the anti-NGF antibody.

11. The method according to any one of the preceding claims, wherein the patient is subjected to radiographic assessment of the osteoarthritic joint prior to starting treatment with the anti-NGF antibody.

12. The method according to any one of the preceding claims, wherein the patient is subjected to radiographic assessment of the osteoarthritic joint during treatment with the anti-NGF antibody.

13. The method according to claim 1 1 or 12, wherein if radiographic assessment identified rapidly progressive osteoarthritis of the joint, the patient is excluded from the treatment with the anti-NGF antibody.

14. The method according to any one of the preceding claims, wherein the patient has moderate to severe osteoarthritis pain.

15. The method according to any one of the preceding claims, wherein the patient, prior to administering the anti-NGF antibody, has a) WOMAC Pain subscale measure of >5 in the osteoarthritic joint; b) WOMAC Physical Function subscale measure of >5 in the osteoarthritic joint; and/or c) a PGA-OA measure of fair, poor, or very poor.

16. The method according to any one of the preceding claims, wherein the patient, prior to administering the anti-NGF antibody, has a Kellgren-Lawrence x- ray grade of >2.

17. The method according to any one of the preceding claims, wherein the method further comprises conducting a radiographic assessment of the osteoarthritic joint at regular intervals.

18. The method according to any one of claim 1 , or claims 3 to 17 when dependent on claim 1 , wherein the 2.5 mg dose is increased to 5 mg after at least one eight week dose.

19. The method according to any one of the preceding claims, wherein the anti- NGF antibody is administered for at least two or more doses at eight weekly intervals.

20. The method according to any one of the preceding claims, wherein the OA is of the hip, knee, shoulder or hand.

21. The method according to any one of the preceding claims, wherein the treatment with the anti-NGF antibody averts opioid addiction in the patient.

22. The method according to any one of the preceding claims, wherein the analgesic therapy comprises the administration of an opioid to the patient.

23. The method according to any one of the preceding claims, wherein the analgesic therapy comprises the administration of tramadol to the patient.

24. The method according to any one of claims 1 to 21 , wherein the analgesic therapy comprises the administration of an NSAID to the patient.

25. The method according to any one of the preceding claims, wherein the anti- NGF antibody comprises three CDRs from the variable heavy chain region having the sequence shown in SEQ ID NO: 1 and three CDRs from the variable light chain region having the sequence shown in SEQ ID NO: 2.

26. The method according to any one of the preceding claims, wherein the anti- NGF antibody comprises a FICDR1 having the sequence shown in SEQ ID NO:3, a FICDR2 having the sequence shown in SEQ ID NO:4, a FICDR3 having the sequence shown in SEQ ID NO:5, a LCDR1 having the sequence shown in SEQ ID NO:6, a LCDR2 having the sequence shown in SEQ ID NO:7, and a LCDR3 having the sequence shown in SEQ ID NO:8.

27. The method according to any one of the preceding claims, wherein the anti- NGF antibody comprises a variable heavy chain region having the sequence shown in SEQ ID NO: 1 and a variable light chain region having the sequence shown in SEQ ID NO: 2.

28. The method according to any one of the preceding claims, wherein the anti- NGF antibody comprises a heavy chain having the sequence shown in SEQ ID NO: 9 and a light chain having the sequence shown in SEQ ID NO: 10, wherein the C-terminal lysine (K) of the heavy chain amino acid sequence of SEQ ID NO: 9 is optional.

29. The method according to any one of the preceding claims, wherein the anti- NGF antibody comprises a heavy chain having the sequence shown in SEQ ID NO: 11 and a light chain having the sequence shown in SEQ ID NO: 10.