IP Library › Granted Patent US 10,577,414
Granted Patent B2
US 10,577,414 · App. 15/783,289 · Granted Mar 3, 2020

Use of reslizumab to treat moderate to severe eosinophilic asthma

Inventors: Christopher O'Brien (Lafayette Hill, PA); James Zangrilli (Philadelphia, PA); Tushar Shah (Flemington, NJ); Guy Brusselle (De Pinte, BE)
Assignee: Cephalon, Inc.
C07K16/244A61K8/63A61K9/0019A61K39/395A61K2039/505A61K2039/507A61K2039/545C07K2317/24C07K2317/76
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Quick Facts
Patent No.
US 10,577,414
App. No.
15/783,289
Granted
Mar 3, 2020
Kind
B2
Abstract

Disclosed herein are methods of treating moderate to severe eosinophilic asthma in a patient comprising administering a therapeutically effective dose of reslizumab to the patient whose symptoms are inadequately controlled with a current asthma therapeutic and wherein the patient's blood eosinophil levels are equal to or greater than 400/μL.

Claims (21)

1. A method of treating eosinophilic asthma in a patient comprising:

administering a therapeutically effective dose of reslizumab to the patient, wherein

in the 12 months prior to the administering, the patient had at least one asthma exacerbation requiring oral, intramuscular, or intravenous corticosteroid and

prior to the administering, the patient's symptoms are inadequately controlled with an asthma therapeutic comprising an inhaled corticosteroid, the inhaled corticosteroid comprising >500 mcg Fluticasone, >440 mcg Mometasone, >800 mcg Budesonide, >320 mcg Ciclesonide, >400 mcg Beclomethasone, or >2000 mcg Triamcinolone and the patient's blood eosinophil levels are equal to or greater than 400/μl.

2. The method of claim 1 , wherein the patient's blood eosinophil levels are equal to or greater than 500/μl, 600/μl, 700/μl, or 800/μl.

3. The method of claim 1 , wherein the therapeutically effective dose of reslizumab is about 0.3 mg/kg to about 3 mg/kg.

4. The method of claim 1 , wherein the therapeutically effective dose of reslizumab is administered intravenously or subcutaneously.

5. The method of claim 1 , wherein the therapeutically effective dose of reslizumab is administered once about every 4 weeks.

6. The method of claim 1 , wherein the inhaled corticosteroid is >500 mcg fluticasone.

7. The method of claim 1 , wherein the inhaled corticosteroid comprises ≥1000 mcg Fluticasone, >800 mcg Mometasone, ≥1600 mcg Budesonide, ≥320 mcg Ciclesonide, >1000 mcg Beclomethasone, or ≥2000 mcg Triamcinolone.

8. The method of claim 1 , wherein the asthma therapeutic further comprises a long acting beta 2 adrenoceptor agonist (LABA).

9. The method of claim 1 , wherein administration of the therapeutically effective dose of reslizumab leads to an improvement in lung function, as assessed by forced expiratory volume in 1 second (FEV 1 ), forced vital capacity, forced expiratory flow rate, or any combination thereof.

10. The method of claim 9 , wherein the improvement in lung function is equal to or greater than about 5% as compared to a patient not receiving reslizumab.

11. The method of claim 9 , wherein the improvement in lung function comprises a significantly improved FEV 1 treatment effect.

12. The method of claim 1 , wherein administration of the therapeutically effective dose of reslizumab leads to a reduction of clinical asthma exacerbations, reduction of use of systemic corticosteroids, improved asthma control questionnaire score, improved asthma quality of life questionnaire score, or any combination thereof.

13. The method of claim 12 , wherein the clinical asthma exacerbations are reduced by about 50% as compared to a patient not receiving reslizumab.

14. The method of claim 12 , wherein the use of systemic corticosteroids is reduced by about 50% as compared to a patient not receiving reslizumab.

15. The method of claim 1 , wherein the patient has late-onset asthma.

16. The method of claim 15 , wherein administration of the therapeutically effective dose of reslizumab leads to a greater than about 90 ml change in FEV 1 compared to a patient not receiving reslizumab.

17. The method of claim 15 , wherein administration of the therapeutically effective dose of reslizumab leads to an about 50% reduction in clinical asthma exacerbations compared to a patient not receiving reslizumab.

18. The method of claim 1 , wherein the oral, intramuscular, or intravenous corticosteroid use was for greater than or equal to 3 days.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 20, 2018
From: BRUSSELLE, GUY
To: UNIVERSITEIT GENT
Reel/Frame 046411/0447 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 20, 2018
From: O'BRIEN, CHRISTOPHER; ZANGRILLI, JAMES; SHAH, TUSHAR
To: CEPHALON, INC.
Reel/Frame 046411/0774 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 20, 2018
From: UNIVERSITEIT GENT
To: CEPHALON, INC.
Reel/Frame 046412/0630 →
Continuity (6)
Continuation 14838503 · Aug 28, 2015
Provisional Application 62047248 · Sep 8, 2014
Provisional Application 62091150 · Dec 12, 2014
Provisional Application 62168007 · May 29, 2015
Provisional Application 62191690 · Jul 13, 2015
Related Publication 20180030131A1 · Feb 1, 2018