Methods for treating digitally-identified il-4/il-13 related disorders by administering an anti-il4r-alpha antibody

Abstract

Disclosed are methods of treating various disorders with anti-IL-4Rα antibodies and fragments thereof.

1 . A method of treating a subject exhibiting at least one symptom of an anti-interleukin-4 receptor alpha (IL-4Rα)-related disorder with an anti-IL-4Rα antibody, the method comprising:
 (a) clustering, by a computer system, a subset of patients from a plurality of patients, wherein the subset of patients comprises a characteristic or a plurality of characteristics related to an IL-4/IL-13 pathway; 
 (b) identifying in the subset of patients the IL-4Rα-related disorder based on one or more symptoms associated with the characteristic or the plurality of characteristics related to the IL-4/IL-13 pathway, wherein the IL-4Rα-related disorder is selected from the group consisting of arthritis, asthma, a cicatricial alopecia, lichen simplex chronicus, a blood-related disorder, an eye-related disorder, a kidney-related disorder, a prostate-related disorder, Kawasaki's disease, a thyroid-related disorder, a blood-vessel-related disorder, a pregnancy-related disorder, or a cancer; 
 (c) administering a therapeutically effective amount of the anti-IL-4Rα antibody to, a subject identified in the subset of step (b), 
 wherein the anti-IL-4Rα antibody comprises:
 a variable heavy chain CDR1 of SEQ ID NO: 1 (GFTFRDYA); 
 a variable heavy chain CDR2 of SEQ ID NO: 2 (ISGSGGNT); 
 a variable heavy chain CDR3 of SEQ ID NO: 3 (AKDRLSITIRPRYYGLDV); 
 a variable light chain CDR1 of SEQ ID NO: 4 (QSLLYSIGYNY); 
 a variable light chain CDR2 of SEQ ID NO: 5 (LGS); and 
 a variable light chain CDR3 of SEQ ID NO: 6 (MQALQTPYT). 
 
 
     
     
         2 . A method of treating a subject exhibiting at least one symptom of an anti-interleukin-4 receptor alpha (IL-4Rα)-related disorder with an anti-IL-4Rα antibody, the method comprising administering a therapeutically effective amount of the anti-IL-4Rα antibody to the subject,
 wherein the IL-4Rα-related disorder is selected from the group consisting of arthritis, a cicatricial alopecia, lichen simplex chronicus, a blood-related disorder, an eye-related disorder, a kidney-related disorder, a prostate-related disorder, Kawasaki's disease, a thyroid-related disorder, a blood-vessel-related disorder, a pregnancy-related disorder, or a cancer, and 
 wherein the anti-IL-4Rα antibody comprises:
 a variable heavy chain CDR1 of SEQ ID NO: 1 (GFTFRDYA); 
 a variable heavy chain CDR2 of SEQ ID NO: 2 (ISGSGGNT); 
 a variable heavy chain CDR3 of SEQ ID NO: 3 (AKDRLSITIRPRYYGLDV); 
 a variable light chain CDR1 of SEQ ID NO: 4 (QSLLYSIGYNY); 
 a variable light chain CDR2 of SEQ ID NO: 5 (LGS); and 
 a variable light chain CDR3 of SEQ ID NO: 6 (MQALQTPYT). 
 
 
     
     
         3 . The method of  claim 2 , further comprising, prior to administering the therapeutically effective amount of the anti-IL-4Rα antibody:
 clustering, by a computer system, a subset of patients from a plurality of patients, wherein the subset of patients comprises a characteristic or a plurality of characteristics related to an IL-4/IL-13 pathway; 
 identifying in the subset of patients the IL-4Rα-related disorder based on one or more symptoms associated with the characteristic or the plurality of characteristics related to the IL-4/IL-13 pathway; and 
 selecting the subject exhibiting the one or more symptoms of the IL-4Rα-related disorder in the identifying step. 
 
     
     
         4 . The method of  claim 1 , wherein the cicatricial alopecia is dissecting cellulitis. 
     
     
         5 . The method of  claim 1 , wherein the cicatricial alopecia is folliculitis keloidalis. 
     
     
         6 . The method of  claim 1 , wherein the anti-IL-4Rα antibody comprises a heavy chain variable region (VH) comprising SEQ ID NO: 13 and a light chain variable region (VL) comprising SEQ ID NO: 14. 
     
     
         7 . The method of  claim 1 , wherein the anti-IL-4Rα antibody comprises a heavy chain comprising SEQ ID NO: 17 and a light chain comprising SEQ ID NO: 18. 
     
     
         8 . The method of  claim 1 , wherein the anti-IL-4Rα antibody is formulated as a pharmaceutical composition comprising an acceptable carrier. 
     
     
         9 . The method of  claim 1 , wherein the subject is human. 
     
     
         10 . The method of  claim 1 , wherein the administering is intradermal, intramuscular, intraperitoneal, intravenous, intranasal, or epidural administration. 
     
     
         11 . The method of  claim 1 , wherein the administering is subcutaneous. 
     
     
         12 . The method of  claim 1 , wherein the administering is via a pre-filled syringe, a pre-filled pen, or an autoinjector. 
     
     
         13 . The method of  claim 1 , wherein the anti-IL-4Rα antibody is administered to the subject as an initial dose followed by a secondary dose. 
     
     
         14 . The method of  claim 13 , wherein the initial dose is about 600 mg and the secondary dose is about 300 mg. 
     
     
         15 . The method of  claim 13 , wherein the initial dose is about 400 mg and the secondary dose is about 200 mg. 
     
     
         16 . The method of  claim 13 , wherein the secondary dose is administered every 1 to 14 weeks after the initial dose. 
     
     
         17 . The method of  claim 16 , wherein the secondary dose is administered every 2 weeks. 
     
     
         18 . The method of  claim 1 , wherein the anti-IL-4Rα antibody is administered at a dose of about 0.0001 mg/kg to about 10 mg/kg of patient body weight. 
     
     
         19 . The method of  claim 1 , further comprising administering a second therapeutic agent selected from a second antibody or antigen binding fragment thereof, a soluble cytokine receptor, an IgE antagonist, or an anti-asthma medication. 
     
     
         20 . The method of  claim 19 , wherein the anti-asthma medication is a corticosteroid, a non-steroidal agent, a beta agonist, a leukotriene antagonist, a xanthine, fluticasone, salmeterol, or albuterol.