In active psoriatic arthritisSTELARA® (ustekinumab) 4 Joint Symptom Relief After Only 3 Doses1-3*

Primary endpoint at Week 24
PSUMMIT I: ACR20 response among biologic-naïve patients through Week 241-3*

After only 3 doses, significantly more biologic-naïve patients taking STELARA® achieved ACR20 vs placebo.1-3*

  • In PSUMMIT I, ACR20 response was achieved at Week 24 in 42% (87/205) and 50% (101/204) of patients taking STELARA® 45 mg and 90 mg, respectively, vs 23% (47/206) of patients taking placebo (P<0.0001 vs placebo for each dose; primary endpoint)1-3*
  • In PsA studies, concomitant MTX use did not appear to influence the efficacy or safety of STELARA®1
CONSISTENT RESPONSE RATES AT 1 YEAR1-3*
PSUMMIT I: ACR20 response among biologic-naïve patients through Week 52 in an open-label extension1-3

 

 
 
  • In PSUMMIT I, ACR20 response was achieved at Week 52 in 56% (108/194) and 60% (114/189) of patients taking STELARA® 45 mg and 90 mg, respectively, and 65% (120/184) of patients in the placebo-crossover-to-45-mg group (P<0.0001 vs placebo for each dose)1-3*

 

*Previous exposure to anti-tumor necrosis factor (TNF) agents was not allowed. Two patients had prior exposure to biologics: 1 to alefacept and 1 to efalizumab.3

In this ITT analysis, early escape rules were not applied. Efficacy evaluations were based on the subjects’ initial randomized assignment. Subjects who qualified for early escape from the 45-mg group (and therefore received a 90-mg dose starting at Week 16) were counted in the 45-mg group. Concomitant medications were required to remain at stable doses through Week 52.3

 

See the Difference in Biologic-naïve Patients

Meaningful ACR20 response rates at Week 24 among patients in PSUMMIT II1,4

PRIMARY ENDPOINT ACR20 RESPONSE AT WEEK 24 (ALL PATIENTS)
  • ACR20 response rates were 44% (45/103) and 44% (46/105) among patients taking STELARA® 45 mg and 90 mg, respectively, compared with 20% (21/104) among those taking placebo (P<0.001 vs placebo for each dose) at Week 24 (primary endpoint)1,4

 

ACR20 response by prior therapy (PSUMMIT II)3,4§
ANTI-TNF–naïve patients through Week 24
ANTI-TNF–experienced through Week 24

 

 

In active psoriatic arthritis STELARA® 4 Improvement in Enthesitis Symptoms

Significant improvement in patients with measurable enthesitis at baseline in PSUMMIT I 2,3
PSUMMIT I: Median percentage improvement from baseline in enthesitis score (PsA-modified MASES index) at Week 24 2,3

 

  • Among patients with PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) ≥1 at baseline, 69% (96/140) and 61% (90/148) taking STELARA® 45 mg and 90 mg, respectively, had enthesitis at Week 24 vs 81% (111/137) taking placebo (P=0.0179 and P=0.0002, respectively, vs placebo)2
  • Enthesitis was measured only in patients with enthesitis tenderness present at baseline. The MASES index was modified for PsA to include 2 additional sites so that a total of 15 enthesitis sites were evaluated. Enthesitis scores range from 0 to 15 with diagnosis if the score is >02

 

View Week 100 data for enthesitis symptoms

In active psoriatic arthritisSTELARA® 4 Improvement in Dactylitis Symptoms

Significant improvement in patients with measurable dactylitis at baseline in PSUMMIT I 2,3
PSUMMIT I: Median percentage improvement from baseline in dactylitis score at Week 24 2,3

 

 

  • Among patients with dactylitis in 1 digit or more at baseline, 57% (56/99) and 56% (53/95) of patients taking STELARA® 45 mg and 90 mg, respectively, had dactylitis at Week 24 vs 76% (70/92) taking placebo (P=0.0050 and P=0.0038, respectively, vs placebo)2
  • Dactylitis was measured only in patients with dactylitis in 1 digit at baseline. Dactylitis was assessed in the 20 digits of the hands and feet on a scale of 0 to 3 (0=no dactylitis, 3=severe dactylitis) for a total of 60 points with diagnosis if the score is >02

 

In active psoriatic arthritisSTELARA® 4 Improvement in Skin Symptoms

Significant improvement in Psoriasis Area and Severity Index (PASI) 75
response at Week 24 in PSUMMIT I 2,3
PSUMMIT I: Improvement in PASI 75 response through Week 242,3††

 

  • In PSUMMIT I, PASI 75 was achieved in 57% (83/145) and 62% (93/149) of patients taking STELARA® 45 mg and 90 mg, respectively, vs 11% (16/146) of patients taking placebo (P<0.0001 for both doses vs placebo) at Week 242,3††

 

††In patients with ≥3% BSA affected by psoriasis at baseline.3

 

See the efficacy data of STELARA® evaluated in plaque psoriasis clinical studies

STELARA® Has a Trial Population Reflecting 4 Hallmark Symptoms of PsA2

A unique therapy for the uniqueness of active psoriatic arthritis1,2

  • A median of 10 swollen joints and 19 tender joints reported by patients in the combined 45-mg/90-mg study population in the PSUMMIT I pivotal trial evaluating STELARA® for treatment of active PsA2

 

Trial Population

General Population

STELARA® (ustekinumab) Joint symptoms in the trial population and general population

Up to 24%
of patients develop
joint symptoms
before any other symptoms5§§

STELARA® (ustekinumab) trial population

Up to 78%
of patients present with
enthesitis6

STELARA® (ustekinumab) Dactylitis symptoms in the trial population and general population

Up to 48%
of patients present with
dactylitis7

STELARA® (ustekinumab) Skin symptoms in the trial population and general population

Up to 80%
of patients present with
psoriasis
before the onset of PsA8

§§In North America. The MAPP survey is a multinational, large-scale probability survey based on psoriasis and PsA national samplings of households in the United States, Canada, France, Germany, Italy, Spain, and the United Kingdom.5

 

References: 1. STELARA [package insert]. Horsham, PA: Janssen Biotech, Inc; 2016. 2. McInnes IB, Kavanaugh A, Gottlieb AB, et al; for the PSUMMIT 1 Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013;382(9894):780-789. 3. Data on file. Janssen Biotech, Inc. 4. Ritchlin C, Rahman P, Kavanaugh A, et al. Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014;73(6):990-999. 5. Lebwohl MG, Bachelez H, Barker J, et al. Patients perspectives in the management of psoriasis: results from the population-based multinational assessment of psoriasis and psoriatic arthritis survey. J Am Acad Dermatol. 2014;70(5):871-881. 6. Orbai AM, Weitz J, Siegel EL, et al. Systematic review of treatment effectiveness and outcome measures for enthesitis in psoriatic arthritis. J Rheumatol. 2014;41(11):2290-2294. 7. Dhir V, Aggarwal A. Psoriatic arthritis: a critical review. Clin Rev Allergy Immunol. 2013;44(2):141-148. 8. Farhey Y. Psoriatic arthritis–review of the immunologic, clinic and therapeutic aspects of an inflammatory systemic disease. Curr Rheumatol Rev. 2012;8(1):66-76.

 

In active psoriatic arthritisSTELARA® Long-Term Data

Consistent ACR20 Response Rate at Week 24 Through Week 100*

ACR20 RESPONSE AMONG BIOLOGIC-NAÏVE PATIENTS THROUGH WEEK 1001,2,3,
OPEN-LABEL EXTENSION (PSUMMIT I)

 

 

 

  • The percentage of biologic-naïve STELARA® patients who achieved significant improvement in joint symptoms
    peaked at Week 28 and remained consistent through Week 1002,3
  • Patients were randomized to receive STELARA® 45 mg, STELARA® 90 mg, or placebo as subcutaneous (subQ) injection at Weeks 0 and 4 and every 12 weeks thereafter. At Week 24, all remaining patients in the placebo group received STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter1

 

PSUMMIT I was considered an open-label trial after Week 24. At Week 24, all patients in the placebo group who were not eligible for early escape crossed over to STELARA® 45 mg. These patients continued at Week 28 and every 12 weeks thereafter. In this intent-to-treat (ITT) analysis, early escape rules were not applied. At Week 24, the data were unmasked to the sponsor for analysis. Study sites and patients remained masked to treatment assignment until study completion. Patients were considered nonresponders if they discontinued treatment due to an unsatisfactory therapeutic effect, initiated protocol-prohibited medications/therapies, or increased the dose of MTX or oral corticosteroids over baseline prior to Week 52. All placebo patients either entered early escape or crossed over to receive STELARA® 45 mg by Week 24 (n=189).1,2

 

*PSUMMIT I was considered an open-label trial after Week 24.

In this ITT analysis, early escape rules were not applied. Efficacy evaluations were based on the subjects’ initial randomized assignment. Subjects who qualified for early escape from the 45-mg group (and therefore received a 90-mg dose starting at Week 16) were counted in the 45-mg group. Concomitant medications were required to remain at stable doses through Week 52.2

At Week 24, all remaining patients in the placebo group, who did not qualify for early escape, crossed over to STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter.1,2

 

 

Consistent ACR50 and ACR70 Response Rates 4 Biologic-Naïve Patients*

ACR50 RESPONSE AMONG BIOLOGIC-NAÏVE PATIENTS THROUGH WEEK 1001,2,3,†
OPEN-LABEL EXTENSION (PSUMMIT I)

 

ACR70 RESPONSE AMONG BIOLOGIC-NAÏVE PATIENTS THROUGH WEEK 1001,2,3,†
OPEN-LABEL EXTENSION (PSUMMIT I)

 

  • The percentage of biologic-naïve STELARA® patients who achieved ACR50 or ACR70 response peaked at Week 28 and remained consistent through Week 1001,2,3

 

  • Patients  in the PSUMMIT I clinical trial were randomized to receive STELARA® 45 mg, STELARA® 90 mg, or placebo as subQ injection at Weeks 0 and 4 and every 12 weeks thereafter. At Week 24, all remaining patients in the placebo group received STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter1,2

*PSUMMIT I was considered an open-label trial after Week 24.

In this ITT analysis, early escape rules were not applied. Efficacy evaluations were based on the subjects’ initial randomized assignment. Subjects who qualified for early escape from the 45-mg group (and therefore received a 90-mg dose starting at Week 16) were counted in the 45-mg group. Concomitant medications were required to remain at stable doses through Week 52.2

At Week 24, all remaining patients in the placebo group, who did not qualify for early escape, crossed over to STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter.1,2

Improvement in Enthesitis Seen at Week 24 With Consistent Results Through Week 100*

PERCENTAGE OF BIOLOGIC-NAÏVE PATIENTS WITH NO SIGNS OF RESIDUAL ENTHESITIS THROUGH WEEK 1001,2,3,§
OPEN-LABEL EXTENSION (PSUMMIT I)

 

  • More than 50% of biologic-naïve patients treated with STELARA® who had enthesitis at baseline showed no signs of residual enthesitis by Week 1002,3

 

*PSUMMIT  I was considered an open-label trial after Week 24.

In this ITT analysis, early escape rules were not applied. Efficacy evaluations were based on the subjects’ initial randomized assignment. Subjects who qualified for early escape from the 45-mg group (and therefore received a 90-mg dose starting at Week 16) were counted in the 45-mg group. Concomitant medications were required to remain at stable doses through Week 52.11

At Week 24, all remaining patients in the placebo group, who did not qualify for early escape, crossed over to STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter.7,11

§Patients who did not receive a dose of STELARA®  in the crossover to STELARA®  45 mg from placebo group were excluded from the enthesitis/dactylitis analysis.11

 

Improvement in Dactylitis Seen at Week 24 With Consistent Results Through Week 100*

PERCENTAGE OF BIOLOGIC-NAÏVE PATIENTS WITH NO SIGNS OF RESIDUAL ENTHESITIS THROUGH WEEK 1001,2,3,†
OPEN-LABEL EXTENSION (PSUMMIT I)

 

  • Nearly 70% of biologic-naïve patients treated with STELARA® who had dactylitis at baseline showed no signs of residual dactylitis by Week 1002,3

 

*PSUMMIT I was considered an open-label trial after Week 24.

In this ITT analysis, early escape rules were not applied. Efficacy evaluations were based on the subjects’ initial randomized assignment. Subjects who qualified for early escape from the 45-mg group (and therefore received a 90-mg dose starting at Week 16) were counted in the 45-mg group. Concomitant medications were required to remain at stable doses through Week 52.11

At Week 24, all remaining patients in the placebo group, who did not qualify for early escape, crossed over to STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter.7,11

§Patients who did not receive a dose of STELARA®  in the crossover to STELARA®  45 mg from placebo group were excluded from the enthesitis/dactylitis analysis.11 

PASI 75 Achieved by Week 24 With Consistent Results Through Week 100*

 

In PSUMMIT I, PASI 75 was achieved in 57% (83/145) and 62% (93/149) of patients taking STELARA® 45 mg and 90 mg, respectively, vs 11% (16/146) of patients taking placebo (P<0.0001 for both doses vs placebo) at Week 24.1,2,†

OPEN-LABEL EXTENSION (PSUMMIT I)

 

  • At Week 24 through Week 100, a majority of biologic–naïve patients receiving STELARA® achieved PASI 751,2,3

 

*PSUMMIT I was considered an open-label trial after Week 24.  

In patients with ≥3% BSA affected by psoriasis at baseline.11  

In this ITT analysis, early escape rules were not applied. Efficacy evaluations were based on the subjects’ initial randomized assignment. Subjects who qualified for early escape from the 45-mg group (and therefore received a 90-mg dose starting at Week 16) were counted in the 45-mg group. Concomitant medications were required to remain at stable doses through Week 52.11  

§At Week 24, all remaining patients in the placebo group, who did not qualify for early escape, crossed over to STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter.7,11

 

Improvement in Daily Activities at Week 24, With Consistent Results to Week 100*

OPEN-LABEL EXTENSION (PSUMMIT I)

 

  • At Week 24 through Week 100, more than half of biologic–naïve patients receiving STELARA® had significant improvement in performing daily activities as measured by HAQ-DI scores1,2,3

 

*PSUMMIT I was considered an open-label trial after Week 24.  

In this ITT analysis, early escape rules were not applied. Efficacy evaluations were based on the subjects’ initial randomized assignment. Subjects who qualified for early escape from the 45-mg group (and therefore received a 90-mg dose starting at Week 16) were counted in the 45-mg group. Concomitant medications were required to remain at stable doses through Week 52.11  

At Week 24, all remaining patients in the placebo group, who did not qualify for early escape, crossed over to STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter.7,11  

§Responders had a clinically meaningful improvement in HAQ-DI scores, which was defined as ≥0.3 points.2  

||P<0.0001.

At Week 108, the Safety Profile For STELARA® Was Consistent With Results at Week 52

SAFETY DATA THROUGH WEEK 1082,3,†
OPEN-LABEL EXTENSION (PSUMMIT I)

 

*PSUMMIT I was considered an open-label trial after Week 24.

Combined 45 mg group: includes those randomized to 45 mg and those who switched from 45 mg to 90 mg.2

1 of these was from the placebo crossover to 45 mg group.2

 

References: 1. McInnes IB, Kavanaugh A, Gottlieb AB, et al; for the PSUMMIT 1 Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT I trial. Lancet. 2013;382(9894):780-789.  2. Data on file. Janssen Biotech, Inc. 3. Kavanaugh A, Puig L, Gottlieb AB, et al; on behalf of the PSUMMIT 1 Study Group. Maintenance of clinical efficacy and radiographic benefit through two years of ustekinumab therapy in patients with active psoriatic arthritis: results from a randomized, placebo-controlled phase III trial. Arthritis Care Res (Hoboken). 2015;67(12):1739-1749. 

close tooltip
Trial population

STELARA® (ustekinumab) trial population

General population

Up to 24% of patients develop joint symptoms before any other symptoms5*

*In North America. The MAPP survey is a multinational, large-scale probability survey based on psoriasis and PsA national samplings of households in the United States, Canada, France, Germany, Italy, Spain, and the United Kingdom.

close tooltip
Trial population

STELARA® (ustekinumab) Enthesitis symptoms in the trial population and general population

General population

Up to 78% of patients present with enthesitis6

close tooltip
Trial population

General population

Up to 48% of patients present with dactylitis7

close tooltip
Trial population

STELARA® (ustekinumab) trial population

General population

Up to 80% of patients present with psoriasis before the onset of PsA8