FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Uncover Significant Clearance After Just 2 Doses1,2

 

PASI 75 response at Week 12 (PHOENIX 2)1,2
In PHOENIX 2:

The primary endpoint was PASI 75 at Week 12 (45 mg: 67% [273/409]; 90 mg: 76% [311/411]; placebo: 4% [15/410]; P<0.0001 vs placebo for each dose).1,2
Treatment success (defined as PGA score of Cleared or Minimal) was achieved at Week 12 in 7 of 10 patients in the 45-mg and 90-mg groups (68% [277/409] and 73% [300/411], respectively) compared with 4% (18/410) in the placebo group (P<0.0001).1,2 

PASI 75 response by prior therapy at Week 12 (PHOENIX 1 and PHOENIX 2)1,3

 

 

In a pooled subanalysis, patients treated with STELARA® achieved consistent efficacy, regardless of whether they had prior exposure to a biologic or were biologic-naïve (PASI 75 in 63% [360/571] vs 1% [4/287] of patients taking placebo and 74% [565/760] vs 5% [19/378] of patients taking placebo, respectively, at Week 12).3*

In PHOENIX 1:

The primary endpoint was PASI 75 at Week 12 (45 mg: 66% [170/256]; 90 mg: 66% [170/256]; placebo: 3% [8/255]; P<0.0001 vs placebo for each dose).1,4

Treatment success (defined as PGA score of Cleared or Minimal) was achieved in 6 of 10 patients taking STELARA® (45 mg: 59% [151/255] and 90 mg: 61% [156/256]) by Week 12 vs 4% (10/255) of patients taking placebo (P<0.0001 vs placebo for each dose).1,4

In PHOENIX 2:

The primary endpoint was PASI 75 at Week 12 (45 mg: 67% [273/409]; 90 mg: 76% [311/411]; placebo: 4% [15/410]; P<0.0001 vs placebo for each dose).1,2

Treatment success (defined as PGA score of Cleared or Minimal) was achieved at Week 12 in 7 of 10 patients in the 45-mg and 90-mg groups (68% [277/409] and 73% [300/411], respectively) compared with 4% (18/410) in the placebo group (P<0.0001).1,2 

 

*Post hoc analysis: PASI 75 responses were summarized by each treatment group and compared with placebo, adjusting for weight using pooled data from PHOENIX 1 and PHOENIX 2.

Approximately two-thirds of all patients had received prior phototherapy, 69% had received either prior conventional systemic or biologic therapy for the treatment of psoriasis, with 56% receiving prior conventional systemic therapy and 43% receiving prior biologic therapy.1

PASI 90 response at Week 12 (PHOENIX 2)1,2

At Week 12, PASI 90 was achieved by 42% (173/409) and 51% (209/411) of patients taking STELARA® 45 mg and 90 mg, respectively, vs 1% (3/410) of patients taking placebo (P<0.0001 vs placebo for each dose).2

 

For adults with moderate to severe plaque psoriasis

Discover Consistent Response Rates Over Time

 

PASI 75 response at Week 76 and in an open-label extension through 5 years1,3,5*
Patients who were rerandomized to continue every-12-week dosing after responding to STELARA® at Weeks 28 and 40 (PHOENIX 1)
In PHOENIX 1:

The primary endpoint was PASI 75 at Week 12 (45 mg: 66% [170/256]; 90 mg: 66% [170/256]; placebo: 3% [8/255]; P<0.0001 vs placebo for each dose).1,4

Treatment success (defined as PGA score of Cleared or Minimal) was achieved in 6 of 10 patients taking STELARA® (45 mg: 59% [151/255] and 90 mg: 61% [156/256]) by Week 12 vs 4% (10/255) of patients taking placebo (P<0.0001 vs placebo for each dose).1,4

Patients who were rerandomized to continue every-12-week dosing after responding to STELARA® at Weeks 28 and 40 demonstrated consistent results over time: 84% (134/159) of patients achieved PASI 75 response at Week 76; 78% (123/158) of patients achieved PASI 75 response at Week 100; 83% (123/149) of patients achieved PASI 75 response at Week 148; 81% (118/145) of patients achieved PASI 75 response at Week 196; and 80% (112/140) of patients achieved PASI 75 response at Week 244.3,5

PASI 90 response at Week 76 and in an open-label extension through 5 years3,5*
Patients who were rerandomized to every-12-week dosing after responding to STELARA® at Weeks 28 and 40 (PHOENIX 1)
In PHOENIX 1:

The primary endpoint was PASI 75 at Week 12 (45 mg: 66% [170/256]; 90 mg: 66% [170/256]; placebo: 3% [8/255]; P<0.0001 vs placebo for each dose).1,4

Treatment success (defined as PGA score of Cleared or Minimal) was achieved in 6 of 10 patients taking STELARA® (45 mg: 59% [151/255] and 90 mg: 61% [156/256]) by Week 12 vs 4% (10/255) of patients taking placebo (P<0.0001 vs placebo for each dose).1,4

In an open-label extension, patients who were rerandomized to continue treatment after responding to STELARA® at Weeks 28 and 40 demonstrated consistent results over time: 57% (90/159) of patients achieved PASI 90 response at Week 76; 57% (90/158) of patients achieved PASI 90 response at Week 100; 52% (77/149) of patients achieved PASI 90 response at Week 148; 56% (81/145) of patients achieved PASI 90 response at Week 196; and 54% (75/140) of patients achieved PASI 90 response at Week 244.3,5

References: 1. STELARA® (ustekinumab) [package insert]. Horsham, PA: Janssen Biotech, Inc. 2. Papp KA, Langley RG, Lebwohl M, et al; for the PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625):1675-1684. 3. Data on file. Janssen Biotech, Inc. 4. Leonardi CL, Kimball AB, Papp KA, et al; for the PHOENIX 1 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665-1674. 5. Kimball AB, Papp KA, Wasfi Y, et al; on behalf of the PHOENIX 1 investigators. Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study. J Eur Acad Dermatol Venereol. 2013;27(12):1535-1545.