Use of reslizumab to treat moderate to severe eosinophilic asthma

Patent metadata

Field	Value
Publication number	US-10577414-B2
Application number	US-201715783289-A
Country	US
Kind code	B2
Filing date	Oct 13, 2017
Priority date	Sep 8, 2014
Publication date	Mar 3, 2020
Grant date	Mar 3, 2020

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.

First claim

What is claimed:

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.

Assignees

• Cephalon Inc

Inventors

• O'Brien Christopher
• Zangrilli James
• Shah Tushar
• Brusselle Guy

Classifications

• C07K16/244 Primary

  Interleukins [IL] · CPC title

• A61P11/06

  Antiasthmatics · CPC title

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title

• A61K2039/507

  Comprising a combination of two or more separate antibodies · CPC title

• A61K39/395 Primary

  Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum · CPC title