Methods of determining dose of IL-31 agonist to treat pulmonary inflammation

• US 8,029,775 B2
• Filed: 08/26/2010
• Issued: 10/04/2011
• Est. Priority Date: 01/10/2007
• Status: Active Grant

• Current Assignee: Zymogenetics Incorporated (Bristol-Myers Squibb Company)
• Original Assignee: Zymogenetics Incorporated (Bristol-Myers Squibb Company)
• Inventors: Chadwick, Eric M., Mudri, Sherri L., Bilsborough, Janine M.
• Primary Examiner(s): Saoud; Christine J
• Assistant Examiner(s): Lockard; Jon M
• Application Number:
  US12/869,421
• Publication Number:
  US 20110008820A1
• Time in Patent Office: 404 Days
• Field of Search: None
• US Class Current: 424/85.2
• CPC Class Codes: A61K 38/20 Interleukins [IL]
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Use of IL-31 agonists, including IL-31, are used to treat agonists are used to treat asthma, airway hyper-responsiveness or allergic rhinitis. The method comprise inhibiting, reducing, limiting or minimizing production of proinflammatory cytokines and include administration of the IL-31 agonist during sensitization or challenge resulting in the asthma, airway hyper-responsiveness or allergic rhinitis state.

Claims

1. A method for determining the optimum dose of an IL-31 agonist to treat asthma, airway hyper-responsiveness or allergic rhinitis comprising:

a) taking a first sample of lung tissue or BAL fluid from a patient with asthma, airway hyper-responsiveness or allergic rhinitis;

b) measuring the level of proinflammatory cytokines expressed in the first sample;

c) administering an amount of the IL-31 agonist to the patient, wherein the IL-31 agonist is a polypeptide comprising amino acid residues 27-164 of SEQ ID NO;

2;

d) taking a second sample of lung tissue or BAL fluid from the patient;

e) measuring the level of proinflammatory cytokines expressed in the second sample;

f) comparing the level of proinflammatory cytokines expressed in the first sample to the level of proinflammatory cytokines expressed in the second sample; and

g) determining the level of the IL-31 agonist that is sufficient to reduce the level of proinflammatory cytokines in the second sample.

2. The method of claim 1, wherein the proinflammatory cytokines are IL-5 or IL-13.

3. The method of claim 1, wherein the proinflammatory cytokines are IL-5 and IL-13.

4. The method of claim 1, wherein the IL-31 agonist is administered in a pharmaceutical composition.

5. A method for determining if a dose of an IL-31 agonist is sufficient to treat asthma, airway hyper-responsiveness or allergic rhinitis comprising:

a) taking a first sample of lung tissue or BAL fluid from a patient with asthma, airway hyper-responsiveness or allergic rhinitis;

b) measuring the level of proinflammatory cytokines expressed in the first sample;

c) administering an amount of the IL-31 agonist to the patient, wherein the IL-31 agonist is a polypeptide comprising amino acid residues 27-164 of SEQ ID NO;

2;

d) taking a second sample of lung tissue or BAL fluid from the patient;

e) measuring the level of proinflammatory cytokines expressed in the second sample;

f) comparing the level of proinflammatory cytokines expressed in the first sample to the level of proinflammatory cytokines expressed in the second sample such that the level of proinflammatory cytokines in the second sample are reduced compared to the level of proinflammatory cytokines in the first sample; and

g) determining if the level of the IL-31 agonist that is sufficient to reduce the level of proinflammatory cytokines in the second sample.

6. The method of claim 5, wherein the proinflammatory cytokines are IL-5 or IL-13.

7. The method of claim 5, wherein the proinflammatory cytokines are IL-5 and IL-13.

8. The method of claim 5, wherein the IL-31 agonist is administered in a pharmaceutical composition.

9. A method for determining the optimum dose of an IL-31 agonist to treat asthma, airway hyper-responsiveness or allergic rhinitis comprising:

a) taking a sample of lung tissue or BAL fluid from a patient with asthma, airway hyper-responsiveness or allergic rhinitis;

b) measuring the level of proinflammatory cytokines expressed in the sample;

c) administering an amount of the IL-31 agonist to the patient, wherein the IL-31 agonist is a polypeptide comprising amino acid residues 27-164 of SEQ ID NO;

2;

d) comparing the level of proinflammatory cytokines expressed in the sample to the level of proinflammatory cytokines expressed a standard control or reference number; and

e) comparing the level of proinflammatory cytokines expressed in the first sample to the level of proinflammatory cytokines expressed in a standard control or reference number such that the level of proinflammatory cytokines in the sample are reduced compared to the level of proinflammatory cytokines in the control; and

f) determining the level of the IL-31 agonist that is sufficient to reduce the level of proinflammatory cytokines in the second sample.

10. The method of claim 9, wherein the proinflammatory cytokines are IL-5 or IL-13.

11. The method of claim 9, wherein the proinflammatory cytokines are IL-5 and IL-13.

12. The method of claim 9, wherein the IL-31 agonist is administered in a pharmaceutical composition.