Methods for treating or preventing asthma by administering an IL-4R antagonist
AssigneesSanofi Biotechnology, Regeneron Pharmaceuticals, Inc.
InventorsGianluca Pirozzi, Franck Skobieranda, Yongtao Li, Neil Graham, Steven P. Weinstein
Life of this patent
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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.
Claims38
A method for add-on maintenance treatment of moderate to severe asthma in a subject in need thereof comprising administering to the subject an initial dose of 600 mg of an antibody that specifically binds to interleukin-4 receptor (IL-4R) comprising three heavy chain complementarity determining region (HCDR) sequences comprising SEQ ID NOs:
- 3, 4 and 5, and three light chain complementarity determining region (LCDR) sequences comprising SEQ ID NOs:
- 6, 7 and 8, and
- one or more secondary doses of 300 mg of the antibody.
A method for increasing forced expiratory volume in 1 second (FEV1) in liters to treat moderate to severe asthma in a subject in need thereof comprising administering to the subject a combination therapy comprising:
- i) one or more maintenance doses of an ICS,
- ii) one or more maintenance doses of a LABA,
- iii) an initial dose of 600 mg of an antibody that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs:
- 3, 4 and 5, and three LCDR sequences comprising SEQ ID NOs:
- 6, 7 and 8, and
- iv) one or more secondary doses of 300 mg of the antibody,
- wherein the ICS and LABA are administered for the duration of administration of the antibody.
A method for improving one or more moderate to severe asthma-associated parameter(s) in a subject in need thereof comprising administering to the subject a combination therapy comprising:
- i.) One or more maintenance doses of an ICS,
- ii) one or more maintenance doses of a LABA,
- iii) an initial dose of 600 mg of an antibody that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs:
- 3, 4 and 5, and three light chain complementarity determining region (LCDR) sequences comprising SEQ ID NOs:
- 6, 7 and 8, and
- iv) one or more secondary doses of 300 mg of the antibody,
- wherein the ICS and LABA are administered for the duration of administration of the antibody.
A method for reducing an asthma patient's dependence on one or both of ICS and LABA for the treatment of one or more moderate to severe asthma exacerbations comprising:
- (a) selecting a patient who has moderate-to-severe asthma that is uncontrolled with a background asthma therapy comprising an ICS, a LABA, or a combination thereof;
- and
- (b) administering to the patient a combination therapy comprising:
- i) one or more maintenance doses of an ICS,
- ii) one or more maintenance doses of a LABA,
- iii) an initial dose of 600 mg of an antibody that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs:
- 3, 4 and 5, and three LCDR sequences comprising SEQ ID NOs:
- 6, 7 and 8, and
- iv) one or more secondary doses of 300 mg of the antibody, wherein the ICS and LABA are administered for the duration of administration of the antibody.
A method for add-on maintenance treatment of moderate to severe asthma in a subject in need thereof comprising administering to the subject
- an initial dose of 400 mg of an antibody or that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs:
- 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs:
- 6, 7, and 8, and
- one or more secondary doses of 200 mg of the antibody.
A method for increasing FEV1 in liters to treat moderate to severe asthma in a subject in need thereof comprising administering to the subject a combination therapy comprising:
- i) one or more maintenance doses of an ICS,
- ii) one or more maintenance doses of a LABA,
- iii) an initial dose of 400 mg of an antibody that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs:
- 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs:
- 6, 7, and 8, and
- iv) one or more secondary doses of 200 mg of the antibody,
- wherein the ICS and LABA are administered for the duration of administration of the antibody.
A method for improving one or more moderate to severe asthma-associated parameter(s) in a subject in need thereof comprising administering to the subject a combination therapy comprising:
- i) one or more maintenance doses of an ICS,
- ii) one or more maintenance doses of a LABA,
- iii) an initial dose of 400 mg of an antibody that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs:
- 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs:
- 6, 7, and 8, and
- iv) one or more secondary doses of 200 mg of the antibody,
- wherein the ICS and LABA are administered for the duration of administration of the antibody.
A method for reducing an asthma patient's dependence on one or both of ICS and LABA for the treatment of one or more exacerbations of moderate to severe asthma comprising:
- (a) selecting a patient who has moderate to severe asthma that is uncontrolled with a background asthma therapy comprising an ICS, a LABA, or a combination thereof;
- and
- (b) administering to the patient a combination therapy comprising:
- i) one or more maintenance doses of an ICS,
- ii) one or more maintenance doses of a LABA,
- iii) an initial dose of 400 mg of an antibody that specifically binds to IL-4R comprising three HCDR sequences comprising SEQ ID NOs:
- 3, 4, and 5, and three LCDR sequences comprising SEQ ID NOs:
- 6, 7, and 8, and
- iv) one or more secondary doses of 200 mg of the antibody,
- wherein the ICS and LABA are administered for the duration of administration of the antibody.
A method for add-on maintenance treatment of moderate to severe asthma in a subject in need thereof, comprising administering to the subject by subcutaneous injection an initial dose of 600 mg of dupilumab, and one or more secondary doses of 300 mg of dupilumab administered every other week (q2w), wherein the subject is 12 years of age and above, and wherein the subject has an eosinophilic phenotype.
A method for add-on maintenance treatment of moderate to severe asthma in a subject in need thereof, comprising administering to the subject by subcutaneous injection an initial dose of 400 mg of dupilumab, and one or more secondary doses of 200 mg of dupilumab administered every other week (q2w), wherein the subject is 12 years of age and above, and wherein the subject has an eosinophilic phenotype.
Dependencies are inferred from the claim text.