Methods for treating atopic dermatitis by administering an IL-4R antagonist

A method of treating moderate-to-severe atopic dermatitis (AD) in a subject in need thereof, the method comprising:

• administering an anti-interleukin-4-receptor (IL-4R) antibody or an antigen-binding fragment thereof to a subject having moderate-to-severe AD, wherein the subject is resistant, non-responsive, or inadequately responsive to treatment with a topical corticosteroid or a topical calcineurin inhibitor, or is a subject for whom topical treatments are inadvisable;
• wherein the anti-IL-4R antibody or antigen-binding fragment thereof comprises a heavy chain complementarity determining region (HCDR) 1 comprising the amino acid sequence of SEQ ID NO:148, an HCDR2 comprising the amino acid sequence of SEQ ID NO:150, an HCDR3 comprising the amino acid sequence of SEQ ID NO:152, a light chain complementarity determining region (LCDR)1 comprising the amino acid sequence of SEQ ID NO:156, an LCDR2 comprising the amino acid sequence of LGS, and an LCDR3 comprising the amino acid sequence of SEQ ID NO:160;
• and
• wherein the anti-IL-4R antibody or antigen-binding fragment thereof is administered to the subject in a dosing regimen comprising an initial dose followed by one or more secondary doses, wherein the initial dose is 600 mg of the anti-IL-4R antibody or antigen-binding fragment thereof, the secondary dose is 300 mg of the anti-IL-4R antibody or antigen-binding fragment thereof, and each secondary dose is administered 1 to 2 weeks after the immediately preceding dose;
• wherein treatment results in an improvement in an AD-associated parameter from baseline to Week 16, wherein the improvement in the AD-associated parameter is:
• (i) a decrease from baseline in Eczema Area and Severity Index (EASI) score of at least 50%;
• (ii) a decrease from baseline in Investigator's Global Assessment (IGA) score of ≥2;
• and/or
• (iii) an improvement in IGA score to an IGA score of 0 or 1.