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

A technology of atopic dermatitis and inhibitor, applied in the field of treatment of atopic dermatitis, can solve problems such as unsatisfied

Pending Publication Date: 2019-07-02
REGENERON PHARM INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, there is a clear unmet medical need for alternative treatments for AD, especially severe AD, among candidates for systemic therapy

Method used

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

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Experimental program
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Embodiment approach

[0100] In embodiment 1, the invention includes a method of treating severe atopic dermatitis (AD) comprising: (a) selecting a patient with severe AD, wherein the patient is resistant, inadequately responsive, or intolerant to systemic immunosuppressant therapy and / or when such treatment is not advisable; (b) administering one or more doses of an interleukin 4 receptor (IL-4R) inhibitor to the patient in need.

[0101] In embodiment 2, the invention includes the method of embodiment 1, wherein the treatment is not advisable due to safety and health risks to the patient and suboptimal efficacy.

[0102] In embodiment 3, the invention includes the method of embodiment 1 or 2, wherein the systemic immunosuppressant therapy is selected from the group consisting of cyclosporin A, methotrexate, mycophenolate mofetil, azathioprine, systemic corticosteroids, and interferon- gamma.

[0103] In embodiment 4, the invention includes the method of embodiment 3, wherein the systemic immunos...

Embodiment approach 13

[0112] In embodiment 13, the invention includes a method of treating severe AD comprising: (a) selecting a patient with severe AD, wherein the patient has previously been treated with a drug selected from the group consisting of cyclosporin A, an IgE inhibitor, a TNFα inhibitor, a CD11a inhibitor , CD20 inhibitors, antibiotics, IL-4R inhibitors, dupilumab, systemic immunosuppressants, topical corticosteroids, oral corticosteroids, calcineurin inhibitors, and phototherapy; and (b) as needed The patient is administered one or more doses of an IL-4R inhibitor.

[0113] In embodiment 14, the invention includes the method of embodiment 13, wherein the patient is resistant, underresponsive, or intolerant to the therapeutic agent.

[0114] In embodiment 15, the invention includes the method of embodiment 13 or 14, wherein the treatment is not advisable due to safety and health risks to the patient and suboptimal efficacy.

[0115] In embodiment 16, the invention includes the method ...

Embodiment 1

[0150] Example 1: Anti-IL-4R Antibodies in Adult Patients with Severe Atopic Dermatitis (AD) Insufficiently Controlled with or Intolerant to Cyclosporine A When Treatment Here is Medically Inadvisable clinical trials in

[0151] This is a 32-week double-blind, randomized, placebo-controlled, parallel-group study to confirm the efficacy, safety and tolerability of dupilumab in adults with severe AD. In adults, cyclosporine A (CSA) has not demonstrated sufficient efficacy, has unacceptable side effects, or for whom initial CSA is not medically advisable.

[0152] Dupilumab is a fully human anti-IL-4R antibody, comprising 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; the HCVR / LCVR amino acid sequence pair comprising SEQ ID NO:1 / 2 and heavy and light chain CDR sequences comprising SEQ ID NOs: 3-8.

[0153] The study included a 2-week screening period, a 2-week moderate-power TCS standardizati...

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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 ormore doses of an interleukin-4 receptor (IL-4R) inhibitor such as an anti-IL-4R antibody. In certain embodiments, the methods of the present invention are used to treat severe AD in a patient whose disease is not controlled with systemic therapy (e.g., cyclosporine A) or when such therapy is inadvisable.

Description

[0001] sequence statement [0002] This application contains a Sequence Listing that has been filed electronically in ASCII format and is hereby incorporated by reference in its entirety. This ASCII copy, created on September 11, 2017, is named SequenceList_29.TXT and is 10.9 kilobytes in size. technical field [0003] The present invention relates to methods for the treatment of atopic dermatitis. More specifically, the invention relates to the administration of an interleukin-4 receptor (IL-4R) inhibitor in an individual in need thereof. Background technique [0004] Atopic dermatitis (AD) is characterized by severe pruritic (i.e. itching), xerosis (dry skin) and eczematous lesions (characterized by erythema, infiltrates / papules, exudate crusts, exfoliation and lichenification) ) of chronic / relapsing inflammatory skin disease. It is often associated with other atopic disorders such as allergic rhinitis and asthma. Severe illness can be profoundly disabling due to sever...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/00A61P17/00
CPCC07K16/2866A61K45/06A61K39/3955A61K9/0019A61P17/00C07K2317/565C07K2317/56C07K2317/76C07K2317/90C07K2317/21A61K2039/505A61K2039/54A61K2039/545A61K2300/00A61K38/00A61K39/395C07K7/06C07K16/247A61K38/02
Inventor A·拉丁N·格拉哈姆B·阿金拉德G·皮罗奇X·孙T·胡尔奇B·S·舒梅尔A·班塞尔
Owner REGENERON PHARM INC
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