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 risk of experiencing a cardiovascular (CV) event or a cerebrovascular event in a stable patient who has had a prior myocardial infarction (MI), comprising subcutaneously administering 50 mg to 300 mg of an IL-1β binding antibody or functional fragment thereof to the patient every three months, wherein said patient has a hsCRP level of ≧2 mg/L before administration of said antibody or functional fragment thereof, and wherein said IL-1β binding antibody or functional fragment thereof comprises:
a) the three complementarity determining regions (CDRs) set forth as SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5 and the three CDRs set forth as SEQ ID NO:6, SEQ ID NO:7, 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 according to claim 1 , wherein said IL-1β binding antibody or functional fragment thereof is first administered 2-5 weeks after the MI.
3. The method according to claim 1 , wherein said IL-1β binding antibody or functional fragment thereof is first administered 3 years after a CABG (Coronary Artery Bypass Graft) procedure.
4. The method according to claim 1 , wherein said CV event is selected from the group consisting of cardiovascular death and myocardial infarction (MI).
5. The method according to claim 1 , wherein said CV event is selected from the group consisting of hospitalization for unstable angina, acute coronary syndrome, other non-coronary ischemic event, any revascularization procedure, limb amputation, stent thrombosis, hospitalization or prolongation of hospitalization for heart failure, and coronary revascularization procedures.
6. The method according to claim 1 , wherein said cerebrovascular event is stroke.
7. The method according to claim 1 , wherein said method comprises administering 50 mg of the IL-1β binding antibody or functional fragment thereof.
8. The method according to claim 1 , wherein said method comprises administering 150 mg of the IL-1β binding antibody or functional fragment thereof.
9. The method according to claim 1 , wherein said method comprises administering 300 mg of the IL-1β binding antibody or functional fragment thereof.
10. The method according to claim 1 , wherein said 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.
11. The method according to claim 1 , wherein said IL-1β binding antibody is canakinumab.
12. A method of reducing the risk of experiencing cardiovascular death, stroke or myocardial infarction (MI) in a stable patient who has had a prior MI, comprising subcutaneously administering 50 mg-300 mg of canakinumab to the patient every three months, wherein said patient has a hsCRP level of ≧2 mg/L before administration of canakinumab.
13. A method of reducing the risk of experiencing cardiovascular death, stroke or myocardial infarction (MI) in a stable patient who has had a prior MI, comprising subcutaneously administering the patient 150 mg-300 mg of canakinumab at week 0 and week 2, and then every three months thereafter beginning at week 12.
14. The method of either claim 12 or 13 , wherein the first dose of canakinumab is administered no earlier than 28 days after the prior MI.