IP Library Granted Patent US 9,051,368
Granted Patent B2
US 9,051,368 · App. 12/813,303 · Granted Jun 9, 2015

Methods for treating psoriasis by administering an antibody which binds an epitope of the p40 subunit of IL-12 and/or IL-23

View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 9,051,368
App. No.
12/813,303
Granted
Jun 9, 2015
Kind
B2
Abstract

The invention provides a method of treating psoriasis in a subject by administering to a subject an antibody capable of binding to the p40 subunit of IL-12 and/or IL-23.

Claims (32)

1. A method of treating psoriasis in a subject comprising the steps of:

(i) selecting a subject who has not had a condition selected from the group consisting of

(a) inability to discontinue topical psoriasis therapies at least 2 weeks before the treatment of psoriasis;

(b) psoralen-ultraviolet-light phototherapy at least 4 weeks before the treatment of psoriasis;

(c) biologic therapies at least 12 weeks before the treatment of psoriasis;

(d) an exacerbation of asthma requiring hospitalization in the prior 10 years; and

(e) a history of major immunologic reaction to an immunoglobulin G-containing agent; and

(ii) subcutaneously administering to the subject about 200 mg of an antibody, or antigen-binding portion thereof, which is capable of binding to an epitope of the p40 subunit of IL-12 and/or IL-23 in a single dose; or subcutaneously administering to the subject about 100 mg of the antibody, or antigen-binding portion thereof, for at least 12 weeks;

thereby treating psoriasis in the subject.

2. A method of treating psoriasis in a subject comprising the steps of:

(i) subcutaneously administering about 200 mg of an antibody, or antigen-binding portion thereof, which is capable of binding to an epitope of the p40 subunit of IL-12 and/or IL-23 to the subject, in a single dose; or subcutaneously administering about 100 mg of the antibody, or antigen-binding portion thereof, to the subject for at least 12 weeks,

(ii) monitoring the subject for a clinically significant abnormal laboratory result selected from the group consisting of aspartate transaminase or alanine transaminase >5 times the upper limit of normal; serum total bilirubin >3 times the upper limit of normal; serum creatinine >3 times the upper limit of normal; creatine phosphokinase >5 times the upper limit of normal; hemoglobin <8 g/dL; white blood cell count <2×10 9 /L; and platelet count <75×10 9 /L;

(iii) continuing administration of the antibody, or antigen-binding portion thereof, in a subject in which the clinically significant abnormal laboratory result is not detected;

thereby treating psoriasis in the subject.

3. The method of any one of claim 1 or 2 , wherein the antibody, or antigen-binding portion thereof, is administered biweekly.

4. The method of any one of claim 1 or 2 , wherein the antibody, or antigen-binding portion thereof, is administered weekly.

5. The method of any one of claim 1 or 2 , wherein the antibody, or antigen-binding portion thereof, is administered in a single dose of about 200 mg.

6. The method of any one of claim 1 or 2 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 100 mg for at least 12 weeks.

7. The method of any one of claim 1 or 2 , wherein the antibody, or antigen-binding portion thereof, is capable of binding to the epitope of the p40 subunit when the p40 subunit is bound to the p35 subunit of IL-12.

8. The method of any one of claim 1 or 2 , wherein the antibody, or antigen-binding portion thereof, is capable of binding to the epitope of the p40 subunit when the p40 subunit is bound to a p19 subunit of IL-23.

9. The method of any one of claim 1 or 2 , wherein the antibody, or antigen-binding portion thereof, is capable of binding to the epitope of the p40 subunit when the p40 subunit is bound to the p35 subunit of IL-12 and when the p40 subunit is bound to a p19 subunit of IL-23.

10. The method of any one of claim 1 or 2 , wherein the psoriasis is chronic psoriasis.

11. The method of claim 10 , wherein the chronic psoriasis is chronic plaque psoriasis.

12. The method of claim 1 or 2 , wherein at least a Psoriasis Area and Severity Index (PASI) 50 response is achieved in the subject.

13. The method of claim 1 or 2 , wherein at least a Psoriasis Area and Severity Index (PASI) 75 response is achieved in the subject.

14. The method of claim 1 or 2 , wherein at least a Psoriasis Area and Severity Index (PASI) 90 response is achieved in the subject.

15. The method of claim 1 or 2 , wherein at least a Psoriasis Area and Severity Index (PASI) 100 response is achieved in the subject.

16. The method of claim 1 or 2 , wherein at least a clear or minimal Physician's Global Assessment (PGA) rating is achieved in the subject.

17. The method of any one of claims 13 - 15 , wherein the PASI response is achieved by week 12 following initial administration of the antibody, or antigen-binding portion thereof, to the subject.

18. The method of claim 16 , wherein the PGA rating is achieved by week 12 following initial administration of the antibody, or antigen-binding portion thereof, to the subject.

19. A method of treating psoriasis in a subject comprising subcutaneously administering about 200 mg of an antibody, or antigen-binding portion thereof, which is capable of binding to an epitope of the p40 subunit of IL-12 and/or IL-23 to the subject, in a single dose, thereby treating psoriasis in the subject.

20. A method of treating psoriasis in a subject comprising subcutaneously administering about 100 mg of an antibody, or antigen-binding portion thereof, which is capable of binding to an epitope of the p40 subunit of IL-12 and/or IL-23 to the subject, for at least 12 weeks, thereby treating psoriasis in the subject.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2014
From: PAULSON, SUSAN K.
To: ABBOTT LABORATORIES
Reel/Frame 034477/0242 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2014
From: VALDES, JOAQUIN M.
To: ABBOTT LABORATORIES
Reel/Frame 034477/0260 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2014
From: CHARTASH, ELLIOT KEITH
To: ABBOTT LABORATORIES
Reel/Frame 034477/0317 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2014
From: BARCHUK, WILLIAM T.
To: ABBOTT LABORATORIES
Reel/Frame 034477/0326 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2014
From: KIMBALL, ALEXANDRA B.
To: THE GENERAL HOSPITAL CORPORATION
Reel/Frame 034477/0388 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2014
From: THE GENERAL HOSPITAL CORPORATION
To: ABBOTT LABORATORIES
Reel/Frame 034477/0402 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 17, 2013
From: ABBOTT LABORATORIES
To: ABBVIE INC.
Reel/Frame 030235/0856 →