In active psoriatic arthritisACR Response Rates Over Time1-3

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 placebo1-3

 
  • 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

In this intent-to-treat analysis, patients were considered treatment failures if they initiated any protocol-prohibited medications, increased the dose of MTX or oral corticosteroids above baseline, or discontinued study agent due to unsatisfactory therapeutic effect for PsA, or an adverse event (AE) of worsening PsA or psoriasis. Missing data last-observation-carried-forward rules were applied. The patients who early escaped at Week 16 were considered treatment failures and had Week 16 data carried forward through Week 24.1,3

ACR20 RESPONSE AMONG BIOLOGIC-NAÏVE PATIENTS THROUGH WEEK 1003,4*
Open-Label Extension (PSUMMIT I)

 

Consistent ACR20 response through Week 100

  • The percentage of biologic-naïve STELARA® patients who achieved significant improvement in joint symptoms peaked at Week 28 and remained consistent through Week 1003,4
  • Patients were randomized to receive STELARA® 45 mg, STELARA® 90 mg, or placebo as subcutaneous 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 thereafter2

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 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).2,3

 

*PSUMMIT I was considered an open-label trial after Week 24.3

In this intent-to-treat 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

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.3

 
ACR50 RESPONSE RATES OF BIOLOGIC-NAÏVE PATIENTS THROUGH WEEK 1002-4*
Open-Label Extension (PSUMMIT I)
  • Patients in the PSUMMIT I clinical trial were randomized to receive STELARA® 45 mg, STELARA® 90 mg, or placebo as subcutaneous 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 thereafter2
  • In PSUMMIT I, ACR50 response was achieved at Week 24 in 25% (51/205) and 28% (57/204) of patients taking STELARA® 45 mg and 90 mg, respectively, vs 9% (18/206) of patients taking placebo2
ACR70 RESPONSE RATES OF BIOLOGIC-NAÏVE PATIENTS THROUGH WEEK 1002-4*
Open-Label Extension (PSUMMIT I)
  • Patients in the PSUMMIT I clinical trial were randomized to receive STELARA® 45 mg, STELARA® 90 mg, or placebo as subcutaneous 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 thereafter2
  • In PSUMMIT I, ACR70 response was achieved at Week 24 in 12% (25/205) and 14% (29/204) of patients taking STELARA® 45 mg and 90 mg, respectively, vs 2% (5/206) of patients taking placebo2

The percentage of biologic-naïve STELARA® patients who achieved ACR50 or ACR70 response plateaued at Week 28 and remained consistent through Week 1002,4

*PSUMMIT I was considered an open-label trial after Week 24.3

In this intent-to-treat 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

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.3

In active psoriatic arthritisImprovement 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 1002-4*

More than 50% of biologic-naïve patients treated with STELARA® who had enthesitis at baseline showed no signs of residual enthesitis by Week 1003,4

Note: Enthesitis was measured only in patients with enthesitis at baseline. The MASES index was modified for PsA to include 2 additional sites (left and right insertion of the plantar fascia) so that a total of 15 enthesitis sites were evaluated. Enthesitis scores range from 0 to 15, with diagnosis if the score is >0.

*PSUMMIT I was considered an open-label trial after Week 24.3

In this intent-to-treat 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

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 there after.3

§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.3

In active psoriatic arthritisImprovement in Dactylitis Seen at Week 24 With Consistent Results Through Week 100

PERCENTAGE OF BIOLOGIC-NAÏVE PATIENTS WITH NO SIGNS OF RESIDUAL DACTYLITIS THROUGH WEEK 1002-4*

Nearly 70% of biologic-naïve patients treated with STELARA® who had dactylitis at baseline showed no signs of residual dactylitis by Week 1003,4

 

Note: 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 was >0.

*PSUMMIT I was considered an open-label trial after Week 24.3

In this intent-to-treat 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

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.3

§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.3

 

IN ACTIVE PSORIATIC ARTHRITISImprovement in Skin Symptoms at Week 24 With Consistent Results Through Week 100

PERCENTAGE OF BIOLOGIC-NAÏVE PATIENTS WITH ≥3% INITIAL BSA ACHIEVING PASI 75 BY WEEK 24
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

PERCENTAGE OF BIOLOGIC-NAÏVE PATIENTS WITH ≥3% INITIAL BSA ACHIEVING PASI 75 THROUGH WEEK 1003,4*
Open-Label Extension (PSUMMIT I)

At Week 24 through Week 100, a majority of biologic-naïve patients receiving STELARA® achieved PASI 752-4

BSA=body surface area.

*PSUMMIT I was considered an open-label trial after Week 24.3

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

In this intent-to-treat 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

§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.3

PERCENTAGE OF BIOLOGIC-NAÏVE PATIENTS WHO WERE HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX (HAQ-DI) RESPONDERS THROUGH WEEK 1002-4*†‡§

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 scores2-4

*PSUMMIT I was considered an open-label trial after Week 24.3

In this intent-to-treat 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

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.3

§Responders had a clinically meaningful improvement in HAQ-DI scores, which was defined as ≥0.3 points.3

||P<0.0001.

Patients who did not receive a dose of STELARA® in the crossover to STELARA® 45 mg from placebo group were excluded from the HAQ-DI analysis.3

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. 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. 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.

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

General population

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