Psoriasis
Conditions
Keywords
Psoriasis, Ustekinumab, STELARA, Skin disease, Monoclonal
Brief summary
The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.
Detailed description
In this study, a proportion of subjects will receive study agent at its recommended dose and interval (45mg for subjects less than or equal to 100kg, or 90mg for subjects greater than 100kg; every 12 weeks after 2 starter doses at Weeks 0 and 4). The majority of subjects will have the opportunity to receive study agent less frequently during the randomization period depending on the subject's response. The study consists of a 4-week screening period; a 28-week open-label run-in period; a double-blind treatment period from Week 28 to Week 104; a 12 week post-treatment period; and a 20-week safety follow-up. Participants will be randomized for the double blind period into one of two study groups. Group 1 participants will receive an injection of the study medication at a 12 week dosing interval. Group 2 participants will undergo a placebo withdrawal and may receive study agents at an extended interval greater than 12 weeks. During the double-blind treatment period, subjects in Groups 1 and 2 will receive placebo as necessary to maintain the blind.
Interventions
Form = Injection, route = subcutaneous
Form = Injection, route = subcutaneous
DRUGPlacebo
Form = Injection, route = subcutaneous
Sponsors
Janssen Biotech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Eligibility Criteria * Male or female * Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the first administration of study agent (subjects with concurrent psoriatic arthritis may be enrolled). * Have plaque-type psoriasis covering at least 10% of their total BSA at screening and at the time of the first administration of study agent. * Have a PGA score of ≥ 3 at screening and at the time of the first administration of study agent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) | Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) | Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 | Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe. |
| The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response | Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (\>=) 75 percent (%) improvement in PASI score from baseline. |
| The Percentage of Participants With a PASI 75 Response Over Time | Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (\>=) 75 percent (%) improvement in PASI score from baseline. |
Countries
United States
Participant flow
Recruitment details
During this study, two subjects were transferred between sites and counted twice. Hence, a total of 478 subjects were enrolled in this trial.
Participants by arm
| Arm | Count |
|---|---|
| Ustekinumab 45 mg/Ustekinumab 90 mg Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (\<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (\>) 100 kg at Week 0. | 478 |
| Total | 478 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-Blind | Adverse Event | 0 | 4 | 15 |
| Double-Blind | Death | 0 | 1 | 0 |
| Double-Blind | Lack of Efficacy | 0 | 2 | 8 |
| Double-Blind | Lost to Follow-up | 0 | 6 | 12 |
| Double-Blind | Other | 0 | 2 | 10 |
| Double-Blind | Pregnancy | 0 | 0 | 3 |
| Double-Blind | Protocol Violation | 0 | 0 | 4 |
| Double-Blind | Withdrawal by Subject | 0 | 2 | 15 |
| Open-Label | Adverse Event | 11 | 0 | 0 |
| Open-Label | Lack of Efficacy | 4 | 0 | 0 |
| Open-Label | Lost to Follow-up | 7 | 0 | 0 |
| Open-Label | Not all 3 study drug injections received | 2 | 0 | 0 |
| Open-Label | Other | 1 | 0 | 0 |
| Open-Label | Protocol Violation | 4 | 0 | 0 |
| Open-Label | Static PGA-cleared/minimal not achieved | 58 | 0 | 0 |
| Open-Label | Withdrawal by Subject | 13 | 0 | 0 |
Baseline characteristics
| Characteristic | Ustekinumab 45 mg/Ustekinumab 90 mg |
|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 14.19 |
| Gender Female | 177 Participants |
| Gender Male | 301 Participants |
| Region of Enrollment United States | 478 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 73 / 478 | 39 / 76 | 131 / 302 |
| serious Total, serious adverse events | 14 / 478 | 7 / 76 | 21 / 302 |
Outcome results
Primary
The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1)
Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.
Time frame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])
Population: The subjects randomized at Week 28 data set was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) | 4.5 number of visits | 95% Confidence Interval 3.07 |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) | 4.1 number of visits | 95% Confidence Interval 2.93 |
Secondary
The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (\>=) 75 percent (%) improvement in PASI score from baseline.
Time frame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])
Population: The subjects randomized at Week 28 data set was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response | 5.8 number of visits | Standard Deviation 2.31 |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response | 5.4 number of visits | Standard Deviation 2.61 |
Secondary
The Percentage of Participants With a PASI 75 Response Over Time
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (\>=) 75 percent (%) improvement in PASI score from baseline.
Time frame: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112
Population: The Analysis population was subjects randomized at Week 28 data set. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 52 (n=69, 274) | 82.6 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 36 (n=74, 288) | 93.2 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 80 (n=65, 258) | 81.5 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 56 (n=68, 271) | 85.3 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 84 (n=63, 258) | 84.1 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 44 (n=71, 278) | 90.1 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 88 (n=64, 257) | 81.3 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 60 (n=68, 268) | 91.2 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 92 (n=64, 254) | 84.4 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 32 (n=75, 297) | 92.0 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 96 (n=62, 254) | 82.3 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 64 (n=69, 268) | 79.7 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 104 (n=65, 250) | 81.5 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 48 (n=69, 269) | 89.9 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 108 (n=63, 244) | 82.5 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 68 (n=69, 264) | 85.5 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 112 (n=58, 242) | 74.1 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 40 (n=73, 280) | 86.3 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 72 (n=66, 262) | 83.3 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 76 (n=66, 264) | 77.3 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 100 (n=64, 250) | 76.6 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a PASI 75 Response Over Time | Week 28 (n=76, 302) | 96.1 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 100 (n=64, 250) | 75.6 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 32 (n=75, 297) | 81.1 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 36 (n=74, 288) | 78.8 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 40 (n=73, 280) | 77.5 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 44 (n=71, 278) | 83.5 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 48 (n=69, 269) | 82.9 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 52 (n=69, 274) | 84.7 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 56 (n=68, 271) | 83.8 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 60 (n=68, 268) | 82.8 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 64 (n=69, 268) | 83.2 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 68 (n=69, 264) | 79.9 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 72 (n=66, 262) | 83.6 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 76 (n=66, 264) | 79.9 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 80 (n=65, 258) | 76.4 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 84 (n=63, 258) | 74.8 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 88 (n=64, 257) | 78.2 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 92 (n=64, 254) | 77.2 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 96 (n=62, 254) | 79.1 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 104 (n=65, 250) | 79.2 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 108 (n=63, 244) | 79.9 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 112 (n=58, 242) | 77.7 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a PASI 75 Response Over Time | Week 28 (n=76, 302) | 95.7 percentage of participants |
Secondary
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.
Time frame: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112
Population: The Analysis population was subjects randomized at Week 28 data set. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 28 (n=76, 302) | 100 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 32 (n=75, 297) | 78.7 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 36 (n=74, 288) | 75.7 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 40 (n=73, 280) | 67.1 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 44 (n=71, 278) | 74.6 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 48 (n=69, 269) | 69.6 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 52 (n=69, 274) | 71.0 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 56 (n=68, 271) | 73.5 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 60 (n=68, 268) | 70.6 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 64 (n=69, 268) | 59.4 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 68 (n=69, 264) | 75.4 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 72 (n=66, 262) | 74.2 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 76 (n=66, 264) | 60.6 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 80 (n=65, 258) | 67.7 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 84 (n=63, 258) | 68.3 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 88 (n=64, 257) | 57.8 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 92 (n=64, 254) | 65.6 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 96 (n=62, 254) | 58.1 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 100 (n=64, 250) | 59.4 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 104 (n=65, 250) | 64.6 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 108 (n=63, 244) | 60.3 percentage of participants |
| Group 1: Ustekinumab q12w Maintenance Regimen (MR) | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 112 (n=58, 242) | 53.4 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 72 (n=66, 262) | 63.7 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 96 (n=62, 254) | 56.3 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 32 (n=75, 297) | 71.0 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 76 (n=66, 264) | 58.7 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 36 (n=74, 288) | 59.0 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 108 (n=63, 244) | 58.6 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 40 (n=73, 280) | 56.4 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 80 (n=65, 258) | 53.5 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 44 (n=71, 278) | 68.3 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 100 (n=64, 250) | 50.8 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 48 (n=69, 269) | 69.9 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 84 (n=63, 258) | 55.0 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 52 (n=69, 274) | 66.4 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 28 (n=76, 302) | 100 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 56 (n=68, 271) | 61.3 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 88 (n=64, 257) | 60.7 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 60 (n=68, 268) | 67.9 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 104 (n=65, 250) | 56.4 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 64 (n=69, 268) | 65.7 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 92 (n=64, 254) | 57.9 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 68 (n=69, 264) | 57.2 percentage of participants |
| Group 2: Ustekinumab Subject-tailored Fixed-interval MR | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Week 112 (n=58, 242) | 55.0 percentage of participants |