Methods of reducing the risk of experiencing a cardiovascular (CV) event or a cerebrovascular event in a patient that has suffered a qualifying CV event
The present invention relates to an IL-1β binding antibody or a functional fragment thereof for use in preventing or reducing risk of experiencing a recurrent cardiovascular (CV) event or a cerebrovascular event in a patient that has suffered of a qualifying CV event.
1. A method of reducing the risk of experiencing cardiovascular death in a stable patient who has had a prior myocardial infarction (MI), the method comprising subcutaneously administering 150 mg-300 mg of an IL-1β binding antibody or functional fragment thereof to the patient at week 0 and then every three months thereafter beginning at week 12, wherein the patient has an hsCRP level of ≥1 mg/L before administration of the IL-1β binding antibody or functional fragment thereof, and wherein the IL-1β binding antibody or functional fragment thereof comprises:
a) the three complimentary determining regions (CDRs) set forth as SEQ ID NO: 3, SEQ ID NO: 4, and SEQ ID NO: 5, and the three CDRs set forth as SEQ ID NO: 6, SEQ ID NO: 7, and SEQ ID NO: 8; or
b) a V H domain comprising SEQ ID NO: 1 and a V L domain comprising SEQ ID NO: 2.
2. The method of claim 1 , wherein the method comprises administering 300 mg of the IL-1β binding antibody or functional fragment thereof.
3. The method of claim 1 , wherein the first dose of the IL-1β binding antibody or functional fragment thereof is administered no earlier than 28 days after the prior MI.
4. The method according to claim 1 , wherein the IL-10 binding antibody or functional fragment thereof is canakinumab.
5. The method according to claim 1 , wherein the IL-1β binding antibody or functional fragment thereof is capable of inhibiting the binding of IL-1β to its receptor and has a K D for binding to IL-1β of 50 pM or less.
6. The method according to claim 1 , wherein the IL-1β binding antibody or functional fragment thereof is additionally administered to the patient at week 2.
7. The method of claim 1 , wherein the patient has an hsCRP level of ≥2 mg/L before administration of the IL-1β binding antibody or functional fragment thereof.
8. A method of reducing the risk of experiencing stroke in a stable patient who has had a prior myocardial infarction (MI), the method comprising subcutaneously administering 150 mg-300 mg of an IL-1β binding antibody or functional fragment thereof to the patient at week 0 and then every three months thereafter beginning at week 12, wherein the patient has an hsCRP level of ≥1 mg/L before administration of the IL-1β binding antibody or functional fragment thereof, and wherein the IL-1β binding antibody or functional fragment thereof comprises:
a) the three complimentary determining regions (CDRs) set forth as SEQ ID NO: 3, SEQ ID NO: 4, and SEQ ID NO: 5, and the three CDRs set forth as SEQ ID NO: 6, SEQ ID NO: 7, and SEQ ID NO: 8; or
b) a V H domain comprising SEQ ID NO: 1 and a V L domain comprising SEQ ID NO: 2.
9. The method of claim 8 , wherein the method comprises administering 300 mg of the IL-1β binding antibody or functional fragment thereof.
10. The method of claim 8 , wherein the first dose of the IL-1β binding antibody or functional fragment thereof is administered no earlier than 28 days after the prior MI.
11. The method according to claim 8 , wherein the IL-1β binding antibody or functional fragment thereof is canakinumab.
12. The method according to claim 8 , wherein the IL-1β binding antibody or functional fragment thereof is capable of inhibiting the binding of IL-1β to its receptor and has a K D for binding to IL-1β of 50 pM or less.
13. The method according to claim 8 , wherein the IL-1β binding antibody or functional fragment thereof is additionally administered to the patient at week 2.
14. The method of claim 8 , wherein the patient has an hsCRP level of ≥2 mg/L before administration of the IL-1β binding antibody or functional fragment thereof.
15. A method of reducing the risk of experiencing myocardial infarction (MI) in a stable patient who has had a prior MI, the method comprising subcutaneously administering 150 mg-300 mg of an IL-1β binding antibody or functional fragment thereof to the patient at week 0 and then every three months thereafter beginning at week 12, wherein the patient has an hsCRP level of ≥1 mg/L before administration of the IL-1β binding antibody or functional fragment thereof, and wherein the IL-1β binding antibody or functional fragment thereof comprises:
a) the three complimentary determining regions (CDRs) set forth as SEQ ID NO: 3, SEQ ID NO: 4, and SEQ ID NO: 5, and the three CDRs set forth as SEQ ID NO: 6, SEQ ID NO: 7, and SEQ ID NO: 8; or
b) a V H domain comprising SEQ ID NO: 1 and a V L domain comprising SEQ ID NO: 2.
16. The method of claim 15 , wherein the method comprises administering 300 mg of the IL-1β binding antibody or functional fragment thereof.
17. The method of claim 15 , wherein the first dose of the IL-1β binding antibody or functional fragment thereof is administered no earlier than 28 days after the prior MI.
18. The method according to claim 15 , wherein the IL-1β binding antibody or functional fragment thereof is canakinumab.
19. The method according to claim 15 , wherein the IL-1β binding antibody or functional fragment thereof is capable of inhibiting the binding of IL-1β to its receptor and has a K D for binding to IL-1β of 50 pM or less.
20. The method according to claim 15 , wherein the IL-1β binding antibody or functional fragment thereof is additionally administered to the patient at week 2.
21. The method of claim 15 , wherein the patient has an hsCRP level of ≥2 mg/L before administration of the IL-1β binding antibody or functional fragment thereof.