Psoriasis
Conditions
Keywords
Psoriasis, Ustekinumab, STELARA
Brief summary
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (\>=) 6 through less than (\<) 12 years with moderate to severe chronic plaque psoriasis
Detailed description
This is an open label (identity of study drug will be known to participant and study staff) and multicenter (when more than one hospital or medical school team work on a medical research study) study. The participant population will be comprised of boys and girls who have had a diagnosis of plaque psoriasis for at least 6 months prior to first study drug administration and who have moderate to severe disease defined by Psoriasis Area and Severity Index score (PASI) \>=12, Physician's Global Assessment (PGA) \>=3, and Body Surface Area (BSA) \>=10 percent (%). The study consists of Screening Phase (up to 10 weeks before administration of the study drug), Treatment Period (Week 0 up to Week 52) and Safety follow up (Week 56). Participants will be primarily evaluated for efficacy, pharmacokinetics (PK) and safety. Following completion of the Week 52 visit, participants who have had a beneficial response from ustekinumab treatment as determined by the investigator, and who have not yet reached the age of 12 years or older in countries where marketing authorization for ustekinumab has been granted for the treatment of psoriasis in adolescent participants (12-17 years), and are willing to continue ustekinumab treatment, may enter the long-term extension period (from Week 56 through Week 264) of the study.
Interventions
DRUGUstekinumab 0.75 mg/kg
Participants weighing less than (\<) 60 kilograms will receive ustekinumab 0.75 milligram per kilogram (mg/kg) at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 0.75 mg/kg up to Week 248.
Participants weighing greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg will receive ustekinumab 45 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 45 mg up to Week 248.
Participants weighing \>100 kg will receive ustekinumab 90 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 90 mg up to Week 248.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Participants who have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months prior to first administration of study drug, with widespread lesions defined by Psoriasis Area and Severity Index score (PASI) greater than or equal to (\>=) 12, Physician's Global Assessment (PGA) \>=3, and involved body surface area (BSA) \>=10 percent (%) * Participants who are candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment) or have psoriasis considered by the investigator as poorly controlled with topical therapy after an adequate dose and duration of therapy * Participants who are considered eligible according to the protocol defined tuberculosis (TB) screening criteria * Participants must have positive protective antibody titers to varicella and measles prior to the first administration of study drug. In the absence of positive protective antibody titers, the participant must have documentation of age-appropriate vaccination for varicella and/or measles (that includes both doses of each vaccine) or verification of past varicella and/or measles infection documented by a health care provider * Participants must agree not to receive a live virus or live bacterial vaccination at least 2 weeks (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study drug, during the study, or within 15 weeks after the last administration of study drug * Participants must agree not to receive a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening, during the study, or within 12 months after the last administration of study drug
Exclusion criteria
* Participants who currently have nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular) * Have received any systemic immunosuppressants (example methotrexate \[MTX\], azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of the first administration of study drug * Have received any biologic agent (example ENBREL, HUMIRA) within the previous 3 months or 5 times the t1/2 of the agent, whichever is longer * Have a history of chronic or recurrent infectious disease * Have a history of latent or active granulomatous infection * Have any known malignancy or have a history of malignancy * Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Week 12 | The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. Treatment Failure (TF) criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12 | Baseline and Week 12 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Percentage of Participants Who Achieved PASI 90 Response at Week 12 | Week 12 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72 (disease severity). A higher score indicates more severe disease. Participants with \>=90% improvement in PASI from baseline were considered PASI 90 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Weeks 4, 8, 12, 16, 28, 40, and 52 | The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Weeks 4, 8, 12, 16, 28, 40, and 52 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as \>=50%, \>=75%, \>=90%, and 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 | Baseline and Weeks 4, 8, 12, 16, 28, 40, 52 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 100 responders were defined as 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | Week 12 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with \>=75% improvement in PASI from baseline were considered PASI 75 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 | Baseline and Weeks 4, 12, 28, 52 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1 | Week 12 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 | Weeks 4, 12, 28, and 52 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Change From Baseline in CDLQI Component Scores at Week 12 | Baseline and Week 12 | CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
| Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Weeks 80, 104, 128, 152, 176 | The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicated worse disease. |
| Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as \>=50%, \>=75%, \>=90%, and 100% improvement in PASI component from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy. |
Countries
Belgium, Canada, Germany, Hungary, Netherlands, Poland, South Korea, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ustekinumab Standard Dosage Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (\<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg, and 90 mg for participants with weight \> 100 kg. Participants had a safety follow-up till Week 56 (Main study period). During long-term extension (LTE) period, participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a q12w regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Long-Term Extension Period | Due to Long Term Extension Protocol-Specified Criteria | 22 |
| Long-Term Extension Period | Lost to Follow-up | 1 |
| Long-Term Extension Period | Other | 1 |
| Long-Term Extension Period | Trial Site Terminated by Sponsor | 1 |
| Long-Term Extension Period | Withdrawal by Subject | 3 |
| Main Study Period | Lack of Efficacy | 1 |
| Main Study Period | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Ustekinumab Standard Dosage |
|---|---|
| Age, Continuous | 8.9 years STANDARD_DEVIATION 1.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized White | 40 Participants |
| Region of Enrollment Belgium | 4 Participants |
| Region of Enrollment Canada | 2 Participants |
| Region of Enrollment Germany | 7 Participants |
| Region of Enrollment Hungary | 10 Participants |
| Region of Enrollment Netherlands | 1 Participants |
| Region of Enrollment Poland | 12 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 28 |
| other Total, other adverse events | 27 / 44 | 17 / 28 |
| serious Total, serious adverse events | 3 / 44 | 1 / 28 |
Outcome results
Primary
Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. Treatment Failure (TF) criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Week 12
Population: Full analysis set (FAS): all enrolled and treated participants who received at least 1 injection of ustekinumab (partial or complete). Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | 77.3 percentage of participants |
Secondary
Change From Baseline in CDLQI Component Scores at Week 12
CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Baseline and Week 12
Population: FAS. Participants who met TF criteria prior to Week 12 were assigned 0 change. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in CDLQI Component Scores at Week 12 | Symptoms and feelings | -1.9 units on a scale | Standard Deviation 1.81 |
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in CDLQI Component Scores at Week 12 | Leisure | -1.7 units on a scale | Standard Deviation 2.19 |
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in CDLQI Component Scores at Week 12 | School or holidays | -0.5 units on a scale | Standard Deviation 0.8 |
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in CDLQI Component Scores at Week 12 | Personal relationships | -0.8 units on a scale | Standard Deviation 1.71 |
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in CDLQI Component Scores at Week 12 | Sleep | -0.4 units on a scale | Standard Deviation 0.91 |
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in CDLQI Component Scores at Week 12 | Treatment | -0.9 units on a scale | Standard Deviation 1.14 |
Secondary
Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12
CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Baseline and Week 12
Population: FAS. For participants meeting one or more TF criteria, were considered to have 0 improvement from baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this outcome measure at both baseline and Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12 | -6.3 units on a scale | Standard Deviation 6.43 |
Secondary
Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52
CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Baseline and Weeks 4, 12, 28, 52
Population: FAS. Participants who met TF criteria prior to Week 12 were assigned 0 change. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 | Week 4 | -4.1 units on a scale | Standard Deviation 4.88 |
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 | Week 12 | -6.3 units on a scale | Standard Deviation 6.43 |
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 | Week 28 | -6.6 units on a scale | Standard Deviation 5.79 |
| Ustekinumab Standard Dose (Main Study) | Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 | Week 52 | -6.4 units on a scale | Standard Deviation 6.1 |
Secondary
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as \>=50%, \>=75%, \>=90%, and 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Weeks 4, 8, 12, 16, 28, 40, and 52
Population: FAS. Participants who met 1 or more TF criteria were considered as non-responders after TF. In addition, participants with missing data at Week 12 were also considered as non-responders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 4: PASI 100 | 2.4 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 4: PASI 90 | 16.7 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 4: PASI 75 | 26.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 4: PASI 50 | 52.4 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 8: PASI 100 | 17.1 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 8: PASI 90 | 43.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 8: PASI 75 | 58.5 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 8: PASI 50 | 82.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 12: PASI 100 | 34.1 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 12: PASI 90 | 63.6 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 12: PASI 75 | 84.1 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 12: PASI 50 | 93.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 16: PASI 100 | 40.5 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 16: PASI 90 | 66.7 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 16: PASI 75 | 83.3 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 16: PASI 50 | 97.6 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 28: PASI 100 | 38.1 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 28: PASI 90 | 81.0 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 28: PASI 75 | 92.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 28: PASI 50 | 92.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 40: PASI 100 | 42.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 40: PASI 90 | 78.6 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 40: PASI 75 | 90.5 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 40: PASI 50 | 92.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 52: PASI 100 | 53.7 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 52: PASI 90 | 70.7 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 52: PASI 75 | 87.8 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 52: PASI 50 | 92.7 percentage of participants |
Secondary
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as \>=50%, \>=75%, \>=90%, and 100% improvement in PASI component from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Week 12
Population: FAS. Participants meeting one or more TF criteria were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Induration: PASI 100 | 43.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Induration: PASI 90 | 61.4 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Induration: PASI 75 | 77.3 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Induration: PASI 50 | 93.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Scaling: PASI 100 | 38.6 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Scaling: PASI 90 | 63.6 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Scaling: PASI 75 | 84.1 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Scaling: PASI 50 | 90.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Erythema: PASI 100 | 38.6 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Erythema: PASI 90 | 61.4 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Erythema: PASI 75 | 81.8 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Erythema: PASI 50 | 93.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Head: PASI 100 | 52.3 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Head: PASI 90 | 65.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Head: PASI 75 | 79.5 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Head: PASI 50 | 93.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Trunk: PASI 100 | 61.4 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Trunk: PASI 90 | 61.4 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Trunk: PASI 75 | 79.5 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Trunk: PASI 50 | 88.6 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Upper extremities: PASI 100 | 65.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Upper extremities: PASI 90 | 65.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Upper extremities: PASI 75 | 79.5 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Upper extremities: PASI 50 | 84.1 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Lower extremities: PASI 100 | 68.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Lower extremities: PASI 90 | 68.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Lower extremities: PASI 75 | 72.7 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 | Lower extremities: PASI 50 | 93.2 percentage of participants |
Secondary
Percentage of Participants Who Achieved PASI 90 Response at Week 12
PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72 (disease severity). A higher score indicates more severe disease. Participants with \>=90% improvement in PASI from baseline were considered PASI 90 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Week 12
Population: FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved PASI 90 Response at Week 12 | 63.6 percentage of participants |
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with \>=75% improvement in PASI from baseline were considered PASI 75 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Week 12
Population: FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | 84.1 percentage of participants |
Secondary
Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1
CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Week 12
Population: FAS with CDLQI score \> 1 at baseline. Participants who met 1 or more TF criteria prior to Week 12 or with missing data were considered as nonresponders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1 | 61.5 percentage of participants |
Secondary
Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1
CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Weeks 4, 12, 28, and 52
Population: FAS with CDLQI \> 1 at baseline. Participants who met 1 or more TF criteria were considered as nonresponders after TF. In addition, participants with missing data at Week 12 were considered as nonresponders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 | Week 4 | 37.8 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 | Week 12 | 61.5 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 | Week 28 | 62.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 | Week 52 | 58.3 percentage of participants |
Secondary
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52
The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Weeks 4, 8, 12, 16, 28, 40, and 52
Population: FAS. Participants who met 1 or more TF criteria were considered as non-responders after TF. In addition, participants with missing data at Week 12 were also considered as non-responders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 52: PGA Score 0 | 56.1 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 4: PGA Score 0 | 4.8 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 4: PGA Score 0 or 1 | 33.3 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 4: PGA Score 0 or 1 or 2 | 66.7 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 8: PGA Score 0 | 26.8 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 8: PGA Score 0 or 1 | 63.4 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 8: PGA Score 0 or 1 or 2 | 85.4 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 12: PGA Score 0 | 38.6 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 12: PGA Score 0 or 1 | 77.3 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 12: PGA Score 0 or 1 or 2 | 90.9 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 16: PGA Score 0 | 45.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 16: PGA Score 0 or 1 | 85.7 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 16: PGA Score 0 or 1 or 2 | 95.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 28: PGA Score 0 | 45.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 28: PGA Score 0 or 1 | 83.3 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 28: PGA Score 0 or 1 or 2 | 95.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 40: PGA Score 0 | 52.4 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 40: PGA Score 0 or 1 | 76.2 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 40: PGA Score 0 or 1 or 2 | 90.5 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 52: PGA Score 0 or 1 | 75.6 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 52: PGA Score 0 or 1 or 2 | 90.2 percentage of participants |
Secondary
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176
The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicated worse disease.
Time frame: Weeks 80, 104, 128, 152, 176
Population: FAS; all participants enrolled in the LTE who received at least an injection of ustekinumab at Week 56 (partial or complete). Here N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed): participants evaluated at given timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 80: PGA score 0 | 64 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 80: PGA score 0 or 1 | 80 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 80: PGA score 0 or 1 or 2 | 100 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 104: PGA score 0 | 50 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 104: PGA score 0 or 1 | 70 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 104: PGA score 0 or 1 or 2 | 100 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 128: PGA score 0 | 60 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 128: PGA score 0 or 1 | 80 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 128: PGA score 0 or 1 or 2 | 95 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 152: PGA score 0 | 53.8 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 152: PGA score 0 or 1 | 61.5 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 152: PGA score 0 or 1 or 2 | 100 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 176: PGA score 0 | 33.3 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 176: PGA score 0 or 1 | 66.7 percentage of participants |
| Ustekinumab Standard Dose (Main Study) | Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 | Week 176: PGA score 0 or 1 or 2 | 100 percentage of participants |
Secondary
Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 100 responders were defined as 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time frame: Baseline and Weeks 4, 8, 12, 16, 28, 40, 52
Population: FAS. For participants meeting one or more TF criteria, were considered to have 0% improvement from baseline. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ustekinumab Standard Dose (Main Study) | Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 4 | 52.9 percent change | Standard Deviation 27.33 |
| Ustekinumab Standard Dose (Main Study) | Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 8 | 78.9 percent change | Standard Deviation 21.44 |
| Ustekinumab Standard Dose (Main Study) | Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 12 | 89.7 percent change | Standard Deviation 13.8 |
| Ustekinumab Standard Dose (Main Study) | Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 16 | 90.4 percent change | Standard Deviation 13.77 |
| Ustekinumab Standard Dose (Main Study) | Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 28 | 90.4 percent change | Standard Deviation 21.55 |
| Ustekinumab Standard Dose (Main Study) | Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 40 | 89.9 percent change | Standard Deviation 23.01 |
| Ustekinumab Standard Dose (Main Study) | Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 | Week 52 | 89.1 percent change | Standard Deviation 24.28 |