Methods for treating or preventing asthma by administering an il-4r antagonist

Abstract

The invention provides methods for treating or preventing asthma and associated conditions in a patient. The methods featured in the invention comprise administering to a subject in need thereof a therapeutic composition comprising an interleukin-4 receptor (IL-4R) antagonist, such as an anti-IL-4R antibody.

1 - 84 . (canceled) 
     
     
         85 . A method for treating a subject having moderate-to-severe asthma and co-morbid moderate-to-severe atopic dermatitis comprising:
 administering to the subject a loading dose of an antibody or an antigen-binding fragment thereof that specifically binds to interleukin-4 receptor (IL-4R); and   administering to the subject a plurality of maintenance doses of the antibody or the antigen-binding fragment thereof,   wherein the loading dose and the plurality of maintenance doses are administered as an add-on maintenance asthma therapy, and   wherein the antibody or antigen-binding fragment thereof comprises three heavy chain CDR sequences comprising SEQ ID NOs: 3, 4 and 5 respectively, and three light chain CDR sequences comprising SEQ ID NOs: 6, 7 and 8 respectively.   
     
     
         86 - 94 . (canceled) 
     
     
         95 . The method of  claim 85 , wherein the plurality of maintenance doses are administered once every other week (q2w). 
     
     
         96 . The method of  claim 85 , wherein the loading dose is about 600 mg of the antibody or the antigen-binding fragment thereof, and wherein each maintenance dose of antibody or antigen-binding fragment thereof is about 300 mg. 
     
     
         97 . The method of  claim 85 , wherein the loading dose is about 400 mg of the antibody or the antigen-binding fragment thereof, and wherein each maintenance dose of antibody or antigen-binding fragment thereof is about 200 mg. 
     
     
         98 . The method of  claim 85 , wherein the maintenance doses of antibody or antigen-binding fragment thereof are administered for at least 24 weeks. 
     
     
         99 . The method of  claim 85 , wherein the subject is 12 years of age or older. 
     
     
         100 . The method of  claim 85 , wherein the subject has a blood eosinophil count of greater than about 300 cells/μl. 
     
     
         101 . The method of  claim 85 , wherein the moderate-to-severe asthma is uncontrolled with ICS and one or two controller medications. 
     
     
         102 . The method of  claim 101 , wherein the controller medications are selected from a long-acting β 2  agonist and a leukotriene receptor antagonist. 
     
     
         103 . The method of  claim 85 , wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 1 and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 2. 
     
     
         104 . The method of  claim 103 , wherein the antibody is dupilumab. 
     
     
         105 . The method of  claim 85 , wherein the antibody or antigen-binding fragment thereof is administered by a prefilled needle and syringe, a prefilled autoinjector delivery device or a prefilled pen delivery device. 
     
     
         106 . A method for improving one or more asthma-associated parameter(s) in a subject having moderate-to-severe asthma and co-morbid moderate-to-severe atopic dermatitis comprising:
 administering to the subject a loading dose of an antibody or an antigen-binding fragment thereof that specifically binds to interleukin-4 receptor (TL-4R); and   administering to the subject a plurality of maintenance doses of the antibody or the antigen-binding fragment thereof,   wherein the loading dose and the plurality of maintenance doses are administered as an add-on maintenance asthma therapy, and   wherein the antibody or antigen-binding fragment thereof comprises three heavy chain CDR sequences comprising SEQ ID NOs: 3, 4 and 5 respectively, and three light chain CDR sequences comprising SEQ ID NOs: 6, 7 and 8 respectively.   
     
     
         107 . The method of  claim 106 , wherein the improvement in an asthma-associated parameter is selected from the group consisting of:
 (a) an improvement in lung function as measured by forced expiratory volume (FEV 1 ) or by forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75),   (b) a decrease in daily albuterol or levalbuterol use,   (c) a decrease in daily oral corticosteroids (OCS) use,   (d) a decrease of five-item Asthma Control Questionnaire (ACQ5) score, and   (e) a decrease of 22-item Sinonasal Outcome Test (SNOT-22) score.   
     
     
         108 . The method of  claim 106 , wherein the loading dose is about 600 mg of the antibody or the antigen-binding fragment thereof, and wherein each maintenance dose of antibody or antigen-binding fragment thereof is about 300 mg. 
     
     
         109 . The method of  claim 106 , wherein the loading dose is about 400 mg of the antibody or the antigen-binding fragment thereof, and wherein each maintenance dose of antibody or antigen-binding fragment thereof is about 200 mg. 
     
     
         110 . A method for reducing the incidence of asthma exacerbations in a subject having moderate-to-severe asthma and co-morbid moderate-to-severe atopic dermatitis comprising:
 administering to the subject a loading dose of an antibody or an antigen-binding fragment thereof that specifically binds to interleukin-4 receptor (TL-4R); and   administering to the subject a plurality of maintenance doses of the antibody or the antigen-binding fragment thereof,   wherein the loading dose and the plurality of maintenance doses are administered as an add-on maintenance asthma therapy, and   wherein the antibody or antigen-binding fragment thereof comprises three heavy chain CDR sequences comprising SEQ ID NOs: 3, 4 and 5 respectively, and three light chain CDR sequences comprising SEQ ID NOs: 6, 7 and 8 respectively.   
     
     
         111 . The method of  claim 110 , wherein the subject experiences a reduction in annualized severe asthma exacerbations. 
     
     
         112 . The method of  claim 110 , wherein the loading dose is about 600 mg of the antibody or the antigen-binding fragment thereof, and wherein each maintenance dose of antibody or antigen-binding fragment thereof is about 300 mg. 
     
     
         113 . The method of  claim 100 , wherein the loading dose is about 400 mg of the antibody or the antigen-binding fragment thereof, and wherein each maintenance dose of antibody or antigen-binding fragment thereof is about 200 mg.