Use of il-1 beta binding antibodies for treating peripheral arterial disease

Abstract

The present invention relates to a method for treating or alleviating the symptoms of peripheral arterial disease (PAD) in a subject, comprising administering about 25 mg to about 300 mg of an IL-1β binding antibody or functional fragment thereof.

1 . A method for treating or alleviating the symptoms of peripheral arterial disease (PAD) in a subject, comprising administering about 25 mg to about 300 mg canakinumab, wherein the subject is exhibiting an ankle-brachial index less than 0.9 in at least one leg before treatment. 
     
     
         2 . The method according to  claim 1 , wherein the subject has moderate PAD. 
     
     
         3 . (canceled) 
     
     
         4 . The method according to  claim 1 , wherein the subject is exhibiting an ankle-brachial index between 0.5 and 0.85 in at least one leg before treatment. 
     
     
         5 . The method according to  claim 1 , wherein the subject is exhibiting an ankle-brachial index less than 0.5 in at least one leg before treatment. 
     
     
         6 . The method according to  claim 1 , wherein the subject has symptomatic intermittent claudication. 
     
     
         7 . The method according to  claim 1 , wherein the subject has improved vascular structure and function after 3 months of treatment. 
     
     
         8 . The method according to  claim 1 , wherein the subject has improved vascular structure and function after 12 months of treatment. 
     
     
         9 . The method according to  claim 1 , wherein reduced plaque burden in the peripheral artery walls of the subject is observed after at least 3 months of treatment. 
     
     
         10 . The method according to  claim 1 , wherein reduced plaque burden in the peripheral artery walls of the subject is observed after at least 12 months of treatment 
     
     
         11 . The method according to  claim 1 , wherein a reduced plaque burden compared to before treatment in the subject is determined in the superficial femoral artery after at least 3 months of treatment. 
     
     
         12 . The method according to  claim 1 , wherein a reduced plaque burden compared to before treatment in the subject is determined in the superficial femoral artery after at least 12 months of treatment. 
     
     
         13 . (canceled) 
     
     
         14 . The method according to  claim 1 , wherein canakinumab is administered every 2 weeks, twice a month, monthly, every 6 weeks, every 2 months, every 3 months, every 4 months, every 5 months, or every 6 months from the first administration. 
     
     
         15 . (canceled) 
     
     
         16 . The method according to  claim 1 , wherein the method comprises administering about 25, 50, 75, 80, 100, 125, 150, 175, 200, 225, 250, 275, 300 mg or any combination thereof canakinumab to the subject. 
     
     
         17 . The method according to  claim 1 , wherein the method comprises administering about 150 mg to about 300 mg canakinumab to the subject. 
     
     
         18 - 21 . (canceled) 
     
     
         22 . The method according to  claim 1 , further comprising administering an additional dose of about 25 mg to about 300 mg canakinumab to the subject at week 2, week 4, or week 6 from the first administration. 
     
     
         23 - 29 . (canceled) 
     
     
         30 . The method according to  claim 1 , wherein canakinumab is administered subcutaneously. 
     
     
         31 . The method according to  claim 30 , wherein canakinumab is administered in a reconstituted formulation comprising canakinumab at a concentration of 10-200 mg/ml, 270 mM sucrose, 30 mM histidine and 0.06% polysorbate 80, wherein the pH of the formulation is 6.5. 
     
     
         32 . The method according to  claim 30 , wherein canakinumab is administered in a liquid formulation comprising canakinumab at concentration: 10-200 mg/ml, mannitol, histidine and polysorbate 80, wherein the pH of the formulation is 6.1-6.9. 
     
     
         33 . The method according to  claim 1 , wherein canakinumab is administered to the subject in a liquid form or lyophilized form for reconstitution contained in a prefilled syringe. 
     
     
         34 . The method according to  claim 33 , wherein the prefilled syringe is contained in an autoinjector. 
     
     
         35 - 88 . (canceled)