Method of Treating Signs and Symptoms of Osteoarthritis
AssigneePfizer Inc.
InventorsChristine Ruth WEST, Mark Thomas BROWN
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Abstract
The present invention relates to the treatment of signs and symptoms of osteoarthritis with an anti-nerve growth factor (NGF) antibody.
Claims29
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.
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.
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.
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.
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.
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.
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.
The method according to any one of the preceding claims, wherein the patient has moderate to severe osteoarthritis pain.
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 in the osteoarthritic joint;
- b) WOMAC Physical Function subscale measure of in the osteoarthritic joint;
- and/or c) a PGA-OA measure of fair, poor, or very poor.
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.
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.
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.
The method according to any one of the preceding claims, wherein the OA is of the hip, knee, shoulder or hand.
The method according to any one of the preceding claims, wherein the treatment with the anti-NGF antibody averts opioid addiction in the patient.
The method according to any one of the preceding claims, wherein the analgesic therapy comprises the administration of an opioid to the patient.
The method according to any one of the preceding claims, wherein the analgesic therapy comprises the administration of tramadol to the patient.
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.
The method according to any one of the preceding claims, wherein the anti-NGF antibody comprises a HCDR1 having the sequence shown in SEQ ID NO:3, a HCDR2 having the sequence shown in SEQ ID NO:4, a HCDR3 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 N0:8.
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.
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.
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.
Dependencies are inferred from the claim text.