Methods for reducing exacerbation rates of asthma using benralizumab

Abstract

Provided herein is are methods of reducing exacerbations of asthma in an asthma patient, comprising administering to the patient an effective amount of the anti-interleukin-5 receptor (IL-5R) antibody benralizumab or an antigen-binding fragment thereof.

1 . A method of reducing the annual exacerbation rate of asthma, comprising administering to an asthma patient an effective amount of benralizumab or an antigen-binding fragment thereof, wherein the administration reduces the patient's exacerbation rate. 
     
     
         2 . (canceled) 
     
     
         3 . (canceled) 
     
     
         4 . (canceled) 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . The method of  claim 1 , wherein the asthma is eosinophilic asthma. 
     
     
         8 . The method of  claim 1 , wherein the patient has a blood eosinophil count of at least 300 cells/μl. 
     
     
         9 . The method of  claim 1 , wherein, the patient has a forced expiratory volume (FEV 1 ) of at least 75% predicted value prior to the administration. 
     
     
         10 . The method of  claim 1 , wherein the patient has an asthma control questionnaire score of at least 1.5 prior to the administration. 
     
     
         11 . The method of  claim 1 , wherein at least two doses of benralizumab or an antigen-binding fragment thereof are administered to the patient. 
     
     
         12 . (canceled) 
     
     
         13 . The method of  claim 1 , wherein the annual exacerbation rate is reduced by at least 35%. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 13 , wherein the annual exacerbation rate is reduced by at least 50%. 
     
     
         16 . The method of  claim 15 , wherein the annual exacerbation rate is reduced by at least 60%. 
     
     
         17 . The method of  claim 1 , wherein the patient uses high-dose inhaled corticosteroids (ICS). 
     
     
         18 . The method of  claim 1 , wherein the patient uses long-acting β2 agonists (LABA). 
     
     
         19 . The method of  claim 1 , wherein the patient has a history of exacerbations. 
     
     
         20 . The method of  claim 19 , wherein the history of exacerbations comprises at least two exacerbations in the year prior to the administration of the benralizumab or antigen-binding fragment thereof. 
     
     
         21 . (canceled) 
     
     
         22 . The method of  claim 1 , wherein the benralizumab or antigen-binding fragment thereof is administered at about 2 mg to about 100 mg per dose. 
     
     
         23 . (canceled) 
     
     
         24 . The method of  claim 23 , wherein the benralizumab or antigen-binding fragment thereof is administered at about 30 mg per dose. 
     
     
         25 . (canceled) 
     
     
         26 . The method of  claim 1 , wherein the benralizumab or antigen-binding fragment thereof is administered once every four weeks to once every twelve weeks. 
     
     
         27 . (canceled) 
     
     
         28 . (canceled) 
     
     
         29 . The method of  claim 26 , wherein the benralizumab or antigen-binding fragment thereof is administered once every four weeks for twelve weeks and then once every eight weeks. 
     
     
         30 . The method of  claim 1 , wherein the benralizumab or antigen-binding fragment thereof is administered parenterally. 
     
     
         31 . The method of  claim 30 , wherein the benralizumab or antigen-binding fragment thereof is administered subcutaneously. 
     
     
         32 . The method of  claim 1 , wherein the benralizumab or antigen-binding fragment thereof is administered in addition to corticosteroid therapy. 
     
     
         33 - 48 . (canceled)