Methods for treating chronic rhinosinusitis with nasal polyps by administering an antibody antagonist of IL-4R
The present invention provides methods for decreasing a nasal polyp score in a subject. The methods include 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 or antigen binding fragment thereof.
1 . A method of treating inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in a subject in need thereof, the method comprising:
administering dupilumab subcutaneously to the subject at a dose of 300 mg;
wherein the dupilumab is administered as an add-on maintenance treatment;
wherein prior to the treatment the subject had a bilateral endoscopic nasal polyp score (NPS) of at least 5 points; and
wherein the subject achieves a decrease in NPS.
2 . The method of claim 1 , wherein the dose of 300 mg of the dupilumab is administered once a week or once every two weeks.
3 . The method of claim 2 , wherein the dose of 300 mg of the dupilumab is administered once every two weeks.
4 . The method of claim 3 , wherein the subject achieves a decrease in NPS of 1 point.
5 . The method of claim 4 , wherein the subject is on a background therapy comprising an intranasal corticosteroid (INCS).
6 . The method of claim 3 , wherein the subject achieves a decrease in NPS of 2 points.
7 . The method of claim 6 , wherein prior to the treatment the subject had at least 1 nasal surgery.
8 . A method of treating chronic rhinosinusitis with nasal polyps (CRSwNP) in a subject in need thereof, the method comprising administering dupilumab subcutaneously to the subject
at a dose of 300 mg once every two weeks.
9 . The method of claim 8 , wherein the subject is on a background therapy comprising an INCS.
10 . The method of claim 9 , wherein prior to the treatment the subject had loss of smell as measured by morning (AM) loss of smell score.
11 . The method of claim 10 , wherein the subject achieves a decrease in AM loss of smell score.
12 . The method of claim 11 , wherein prior to the treatment the subject had an AM loss of smell score of at least 2.
13 . The method of claim 12 , wherein the subject achieves a decrease in AM loss of smell score of at least 1 point.
14 . The method of claim 11 , wherein prior to the treatment the subject had at least 1 nasal surgery.
15 . The method of claim 11 , wherein the subject achieves a decrease in NPS.
16 . A method of treating inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in a subject in need thereof, the method comprising:
administering dupilumab subcutaneously to the subject at a dose of 300 mg;
wherein the dupilumab is administered as an add-on maintenance treatment;
wherein prior to the treatment the subject had a nasal congestion/obstruction (NC) score of at least 1 at baseline; and
wherein the subject achieves a decrease in NC score.
17 . The method of claim 16 , wherein the dose of 300 mg of dupilumab is administered once a week or once every 2 weeks.
18 . The method of claim 17 , wherein the dose of 300 mg of dupilumab is administered once every 2 weeks.
19 . The method of claim 18 , wherein the subject achieves an NC score of less than 1 point.
20 . The method of claim 19 , wherein prior to the treatment the subject had at least 1 nasal surgery.
21 . The method of claim 19 , wherein the subject achieves a decrease in NPS.
22 . The method of claim 18 , wherein the NC score is a morning (AM) NC score.
23 . The method of claim 18 , wherein the subject is on a background therapy comprising an INCS.
24 . A method of treating inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in a subject in need thereof, the method comprising:
administering dupilumab subcutaneously to the subject at a dose of 300 mg;
wherein the dupilumab is administered as an add-on maintenance treatment;
wherein prior to the treatment the subject had sinus opacification as measured by Lund-Mackay (LMK) sinus computed tomography (CT) scan total score; and
wherein the subject achieves a decrease in LMK sinus CT scan total score.
25 . The method of claim 24 , wherein the dose of 300 mg of dupilumab is administered once a week or once every 2 weeks.
26 . The method of claim 25 , wherein the dose of 300 mg of dupilumab is administered once every 2 weeks.
27 . The method of claim 26 , wherein prior to the treatment the subject had a LMK sinus CT scan total score of at least 18 points.
28 . The method of claim 27 , wherein the subject achieves a decrease in LMK sinus CT scan total score of at least 8 points.
29 . The method of claim 27 , wherein prior to the treatment the subject had at least 1 nasal surgery.
30 . The method of claim 27 , wherein the subject is on a background therapy comprising an INCS.