Methods of treating plaque psoriasis

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

(i) selecting a subject who is suffering from plaque psoriasis; and

(ii) subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23;

thereby treating plaque psoriasis in the subject.

2. The method of claim 1 , wherein said subject has had a clinical diagnosis of plaque psoriasis for at least 6 months.

3. The method of claim 1 , wherein said subject has had stable plaque psoriasis for at least 2 months.

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

(i) selecting a subject who has not had a condition selected from the group consisting of previous exposure to systemic or biologic anti-IL-12 therapy; nonplaque psoriasis; inability to discontinue topical psoriasis therapies at least 2 weeks before treatment; ultraviolet B light phototherapy at least 2 weeks before treatment; psoralen-ultraviolet-light phototherapy at least 4 weeks before treatment; systemic therapies at least 4 weeks before treatment; biologic therapies at least 12 weeks before treatment; required intake of oral or injectable corticosteroids during treatment; an exacerbation of asthma requiring hospitalization in the 10 years prior to screening; an infection or risk factors for severe infection; a history of malignancies other than successfully treated basal cell carcinoma; and a history of major immunologic reaction to an immunoglobulin G-containing agent; and

(ii) subcutaneously administering to the subject about 100 mg to about 200 mg an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23;

thereby treating plaque psoriasis in the subject.

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

(i) selecting a subject who has not had vaccination with a live viral agent within 1 month; and

(ii) subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23;

thereby treating plaque psoriasis in the subject.

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

(i) subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23,

(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 plaque psoriasis in the subject.

7. The method of any one of claims 1 - 6 , wherein the antibody, or antigen-binding portion thereof, is administered biweekly.

8. The method of any one of claims 1 - 6 , wherein the antibody, or antigen-binding portion thereof, is administered weekly.

9. The method of any one of claims 1 - 6 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 200 mg.

10. The method of any one of claims 1 - 6 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 100 mg.

11. The method of any one of claims 1 - 6 , wherein the antibody, or antigen-binding portion thereof, binds to the epitope of the p40 subunit when the p40 subunit is bound to the p35 subunit of IL-12.

12. The method of any one of claims 1 - 6 , wherein the antibody, or antigen-binding portion thereof, binds to the epitope of the p40 subunit when the p40 subunit is bound to a p19 subunit of IL-23.

13. The method of any one of claims 1 - 6 , wherein the antibody, or antigen-binding portion thereof, binds 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.

14. The method of any one of claims 4 - 6 , wherein the plaque psoriasis is chronic plaque psoriasis.

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

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

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

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

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

20. The method of any one of claims 15 - 18 , wherein the PASI response is achieved by week 12 following initial administration of the antibody, or antigen-binding portion thereof, to the subject.

21. The method of claim 19 , wherein the PGA rating is achieved by week 12 following initial administration of the antibody, or antigen-binding portion thereof, to the subject.

22. A method of treating plaque psoriasis in a subject comprising subcutaneously administering to the subject about 100 mg to about 200 mg an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23, wherein the subject maintains at least a Psoriasis Area and Severity Index (PASI) 90 response for a period of at least about 12 weeks following initial administration of the antibody, or antigen-binding portion thereof, thereby treating plaque psoriasis in the subject.

23. The method of claim 22 , wherein the antibody, or antigen-binding portion thereof, is administered biweekly.

24. The method of claim 22 , wherein the antibody, or antigen-binding portion thereof, is administered weekly.

25. The method of claim 22 , wherein the antibody, or antigen-binding portion thereof, is administered in a single dose.

26. The method of claim 22 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 200 mg.

27. The method of claim 22 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 100 mg.

28. The method of claim 22 , wherein the plaque psoriasis is chronic plaque psoriasis.

29. A method of treating plaque psoriasis in a subject comprising subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23, wherein the subject maintains at least a Psoriasis Area and Severity Index (PASI) 75 response for a period of at least about 12 weeks following initial administration of the antibody, or antigen-binding portion thereof, thereby treating plaque psoriasis in the subject.

30. The method of claim 29 , wherein the antibody, or antigen-binding portion thereof, is administered biweekly.

31. The method of claim 29 , wherein the antibody, or antigen-binding portion thereof, is administered weekly.

32. The method of claim 29 , wherein the antibody, or antigen-binding portion thereof, is administered in a single dose.

33. The method of claim 29 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 200 mg.

34. The method of claim 29 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 100 mg.

35. The method of claim 29 , wherein the plaque psoriasis is chronic plaque psoriasis.

36. A method of treating plaque psoriasis in a subject comprising subcutaneously administering to the subject about 100 mg to about 200 mg an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23, wherein the subject exhibits an improved Psoriasis Area and Severity Index (PASI) score by about 8 weeks following initial administration of the antibody, or antigen-binding portion thereof, thereby treating plaque psoriasis in the subject.

37. The method of claim 36 , wherein the subject exhibits an improved PASI score by about 4 weeks following initial administration of the antibody, or antigen binding portion thereof.

38. The method of claim 36 , wherein the subject exhibits an improved PASI score by about 2 weeks following initial administration of the antibody, or antigen binding portion thereof.

39. The method of claim 36 , wherein the subject exhibits an improved PASI score by about 1 week following initial administration of the antibody, or antigen binding portion thereof.

40. The method of claim 36 , wherein the antibody, or antigen-binding portion thereof, is administered biweekly.

41. The method of claim 36 , wherein the antibody, or antigen-binding portion thereof, is administered weekly.

42. The method of claim 36 , wherein the antibody, or antigen-binding portion thereof, is administered in a single dose.

43. The method of claim 36 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 200 mg.

44. The method of claim 36 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 100 mg.

45. The method of claim 36 , wherein the plaque psoriasis is chronic plaque psoriasis.

46. A method of treating plaque psoriasis in a subject comprising subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23, wherein the subject maintains at least a Psoriasis Area and Severity Index (PASI) 50 response for a period of at least about 12 weeks following initial administration of the antibody, or antigen-binding portion thereof, thereby treating plaque psoriasis in the subject.

47. The method of claim 46 , wherein the antibody, or antigen-binding portion thereof, is administered biweekly.

48. The method of claim 46 , wherein the antibody, or antigen-binding portion thereof, is administered weekly.

49. The method of claim 46 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 200 mg.

50. The method of claim 46 , wherein the plaque psoriasis is chronic plaque psoriasis.

51. The method of claim 46 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 100 mg.

52. A method of treating plaque psoriasis in a subject comprising subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23, wherein the subject maintains at least a Psoriasis Area and Severity Index (PASI) 50 response for a period of at least about 12 weeks following discontinuation of administration of the antibody, or antigen-binding portion thereof, thereby treating plaque psoriasis in the subject.

53. A method of treating plaque psoriasis in a subject comprising subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23, wherein the subject maintains at least a Psoriasis Area and Severity Index (PASI) 75 response for a period of at least about 12 weeks following discontinuation of administration of the antibody, or antigen-binding portion thereof, thereby treating plaque psoriasis in the subject.

54. A method of treating plaque psoriasis in a subject comprising subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23, wherein the subject maintains at least a Psoriasis Area and Severity Index (PASI) 90 response for a period of at least about 12 weeks following discontinuation of administration of the antibody, or antigen-binding portion thereof, thereby treating plaque psoriasis in the subject.

55. The method of any one of claims 52 - 54 , wherein the antibody, or antigen-binding portion thereof, is administered for at least about 12 weeks.

56. The method of any one of claims 52 - 54 , wherein the antibody, or antigen-binding portion thereof, is administered biweekly.

57. The method of any one of claims 52 - 54 , wherein the antibody, or antigen-binding portion thereof, is administered weekly.

58. The method of any one of claims 52 - 54 , wherein the antibody, or antigen-binding portion thereof, is administered in a single dose.

59. The method of any one of claims 52 - 54 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 200 mg.

60. The method of any one of claims 52 - 54 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 100 mg.

61. The method of any one of claims 52 - 54 , wherein the plaque psoriasis is chronic plaque psoriasis.

62. A method of treating plaque psoriasis in a subject comprising subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody which binds to human IL-12 and human IL-23 on a biweekly dosing regimen, such that plaque psoriasis is treated.

63. The method of claim 62 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 100 mg.

64. The method of claim 62 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 200 mg.

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

(i) selecting a subject who is suffering from chronic plaque psoriasis affecting about ≧20% body surface area; and

(ii) subcutaneously administering to the subject about 100 mg to about 200 mg of an antibody, or antigen-binding portion thereof, which binds to an epitope of the p40 subunit of IL-12 and/or IL-23;

thereby treating chronic plaque psoriasis in the subject.

66. The method of claim 65 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 100 mg.

67. The method of claim 65 , wherein the antibody, or antigen-binding portion thereof, is administered in a dose of about 200 mg.