Methods for treating atopic dermatitis by administering an il-4r inhibitor

Abstract

The present invention provides methods for treating moderate-to-severe or severe atopic dermatitis (AD). The methods of the present invention comprise administering to a subject in need thereof one or more doses of an interleukin-4 receptor (IL-4R) inhibitor such as an anti-IL-4R antibody.

What is claimed is: 
     
         1 - 40 . (canceled) 
     
     
         41 . A method for treating moderate-to-severe or severe atopic dermatitis (AD), the method comprising administering to a subject with moderate-to-severe or severe AD an antibody or antigen-binding fragment thereof that specifically binds interleukin-4 receptor (IL-4R), wherein the antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (HCDR1, HCDR2, and HCDR3) and three light chain complementarity determining regions (LCDR1, LCDR2, and LCDR3), wherein the HCDR1 comprises the amino acid sequence of SEQ ID NO:3, the HCDR2 comprises the amino acid sequence of SEQ ID NO:4, the HCDR3 comprises the amino acid sequence of SEQ ID NO:5, the LCDR1 comprises the amino acid sequence of SEQ ID NO:6, the LCDR2 comprises the amino acid sequence of SEQ ID NO:7, and the LCDR3 comprises the amino acid sequence of SEQ ID NO:8;
 wherein for a patient <60 kg in weight, the antibody or antigen-binding fragment thereof is administered in an amount of 200 mg every two weeks (Q2W) with or without a loading dose; or for a patient ≥60 kg in weight the antibody or antigen-binding fragment thereof is administered in an amount of 300 mg every two weeks (Q2W) with or without a loading dose.   
     
     
         42 . The method of  claim 41 , wherein the patient is <60 kg in weight. 
     
     
         43 . The method of  claim 42 , wherein a loading dose of 400 mg of the antibody or antigen-binding fragment thereof is administered to the patient. 
     
     
         44 . The method of  claim 42 , wherein no loading dose is administered to the patient. 
     
     
         45 . The method of  claim 41 , wherein the patient is ≥60 kg in weight. 
     
     
         46 . The method of  claim 45 , wherein a loading dose of 600 mg of the antibody or antigen-binding fragment thereof is administered to the patient. 
     
     
         47 . The method of  claim 45 , wherein no loading dose is administered to the patient. 
     
     
         48 . The method of  claim 41 , wherein the patient is ≥12 to <18 years of age. 
     
     
         49 . The method of  claim 41 , wherein the patient has a history of inadequate response to topical AD therapy. 
     
     
         50 . The method of  claim 41 , wherein the patient is a patient for whom topical AD therapy is inadvisable due to adverse side effects or safety risks. 
     
     
         51 . The method of  claim 41 , wherein the patient has a history of inadequate response, intolerance, or contraindication to a systemic therapy. 
     
     
         52 . The method of  claim 41 , wherein the antibody or antigen-binding fragment thereof is administered in combination with a second therapeutic agent selected from the group consisting of a topical corticosteroid, a topical calcineurin inhibitor, an anti-histamine, an emollient, an anti-bacterial therapeutic, and a therapeutic agent for obstructive airway disease. 
     
     
         53 . The method of  claim 52 , wherein the antibody or antigen-binding fragment thereof is administered in combination with a topical corticosteroid or a topical calcineurin inhibitor. 
     
     
         54 . The method of  claim 41 , wherein the antibody or antigen-binding fragment thereof is administered as a monotherapy. 
     
     
         55 . The method of  claim 41 , 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. 
     
     
         56 . The method of  claim 41 , wherein the antibody or antigen-binding fragment thereof comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 9 and a light chain comprising the amino acid sequence of SEQ ID NO: 10. 
     
     
         57 . The method of  claim 41 , wherein the antibody is dupilumab or a bioequivalent thereof. 
     
     
         58 . The method of  claim 41 , wherein the antibody or antigen-binding fragment thereof is administered subcutaneously. 
     
     
         59 . The method of  claim 41 , wherein the antibody or antigen-binding fragment thereof is contained in a container selected from the group consisting of a glass vial, a syringe, a pre-filled syringe, an autoinjector, and a microinfuser. 
     
     
         60 . The method of  claim 59 , wherein the antibody or antigen-binding fragment thereof is contained in a pre-filled syringe. 
     
     
         61 . The method of  claim 60 , wherein the prefilled syringe is a single-dose pre-filled syringe. 
     
     
         62 . The method of  claim 59 , wherein the antibody or antigen-binding fragment thereof is contained in an autoinjector. 
     
     
         63 . The method of  claim 62 , wherein the autoinjector comprises a pre-filled syringe. 
     
     
         64 . The method of  claim 59 , wherein the antibody or antigen-binding fragment thereof is contained in a volume of 1.15 mL. 
     
     
         65 . The method of  claim 59 , wherein the antibody or antigen-binding fragment thereof is contained in a volume of 2.25 mL.