Psoriasis
Conditions
Keywords
Psoriasis, Ustekinumab, CNTO 1275
Brief summary
The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type psoriasis.
Detailed description
This is a multicenter (involving more than 1 study center), randomized (study medication assigned by chance), double-blind (neither the invesitigator nor the participant knows the identity of the study medication), placebo- controlled (1 of the study medications is inactive), parallel-group comparative study (different groups of participants will receive different treatments at the same time). The total duration of the study will be 78 weeks which will be comprised of: a screening period (6 weeks); an efficacy assessment period (64 weeks \[with a total of 7 treatments at Weeks 0, 4, 12, 16, 28, 40, and 52\]) and a follow-up assessment period (8 weeks). The efficacy assessment period will further include: a placebo-controlled treatment period (Weeks 0-12) and an active drug treatment period (Weeks 12-64). During the placebo-controlled treatment period, participants will receive ustekinumab (45 mg or 90 mg) subcutaneously (SC-into the muscles) or placebo SC. During the active drug treatment period, participants will continue treatment with 45 mg or 90 mg SC as assigned during the placebo-controlled treatment period; however, participants in the placebo group will be divided into 2 groups and will receive ustekinumab 45 mg (Placebo A) or 90 mg (Placebo B) SC. Efficacy will be evaluated primarily by analysis of psoriasis area and severity index (PASI) score. Participant safety will also be monitored.
Interventions
DRUGPlacebo (CP)
Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
DRUGUstekinumab 45 mg (CP)
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
DRUGUstekinumab 90 mg (CP)
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
DRUGPlacebo A (After CP)
After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
DRUGPlacebo B (After CP)
After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
DRUGUstekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
DRUGUstekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with psoriasis (psoriasis vulgaris and psoriatic arthritis) at least 6 months before registration * Participants with plaque type psoriasis covering at least 10 percent of total body surface area at the time of informed consent and at registration * Participants with a PASI score of greater than or equal to 12 at the time of informed consent and at registration * Female participants of childbearing potential or males, whose partner can be pregnant, must agree that he/she will continuously take an appropriate contraceptive measure for 1 year from the day of informed consent to termination of the final investigational treatment; in the case of childbearing potential females, pregnancy test at screening must be negative * Participants must agree not to receive Bacillus Calmette-Guérin (BCG) vaccination and live vaccine inoculation for 1 year after final treatment with the investigational product
Exclusion criteria
* Participants with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis * Participants with a medical history of tuberculosis infection or suspected tuberculosis infection * Participants with present or past history of chronic or recurrent infection (e.g., chronic or recurrent urinary tract infection or respiratory infection) * Participants with a current serious infection (e.g., sepsis, hepatitis, pneumonia, or pyelonephritis) or those who experienced a serious infection within the 2 month period before registration and including participants who received intravenous administration of antibiotics or antiviral agents within the 2 month period before registration * Participants with a current or past history of malignant tumors (except for basal cell carcinoma, intraepidermal squamous cell carcinoma in the skin and uterine cervical squamous cell carcinoma, whose treatment was completed and no sign suggesting a recurrence has been observed, and squamous cell carcinoma in the skin whose treatment was completed and no sign suggesting a recurrence has been observed in the past 5 years)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score | Week 12 | Percentage of participants with \>=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) Score | Week 64 | PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). |
| Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score | Week 64 | PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0. |
| Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | Week 64 | PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Week 28, 40, 52 and 64 | The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life). |
| Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Week 12, 28, 40, 52 and 64 | The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12 | Week 12 | The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life). |
| Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | Week 12, 28, 40,52 and 64 | The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails). |
| Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Week 12, 28, 40, 52 and 64 | The number of nails with psoriasis involvement was assessed by a dermatologist. |
| Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Week 12, 28, 40, 52 and 64 | Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable). |
| Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12 | Week 12 | Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 \[best\] to 5 \[worst\]. |
| Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | Week 64 | Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 \[best\] to 5 \[worst\]. |
| Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Week 12, 28, 40, 52 and 64 | The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo (CP) Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12). | 31 |
| Ustekinumab 45 mg (CP) Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12). | 64 |
| Ustekinumab 90 mg (CP) Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12). | 62 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Period 1: Controlled Period (CP) | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 1: Controlled Period (CP) | Onset of Tuberculosis Infection | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 1: Controlled Period (CP) | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 1: Controlled Period (CP) | Withdrawal by Subject | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period 1: Controlled Period (CP) | Withdrawal due to worsened symptoms | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 2: After Controlled Period | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Period 2: After Controlled Period | Onset of tuberculosis infection | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Period 2: After Controlled Period | Other | 0 | 0 | 0 | 0 | 1 | 4 | 0 |
| Period 2: After Controlled Period | Use of prohibited concomitant medication | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Period 2: After Controlled Period | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 1 | 1 |
| Period 2: After Controlled Period | Withdrawal due to worsened symptoms | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo (CP) | Ustekinumab 45 mg (CP) | Ustekinumab 90 mg (CP) | Total |
|---|---|---|---|---|
| Age, Continuous | 48.5 Years STANDARD_DEVIATION 12.7 | 46.6 Years STANDARD_DEVIATION 12.5 | 46.8 Years STANDARD_DEVIATION 12.8 | 47.0 Years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 26 Participants | 53 Participants | 47 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 32 | 42 / 64 | 36 / 62 | 14 / 15 | 13 / 13 | 61 / 64 | 60 / 62 |
| serious Total, serious adverse events | 2 / 32 | 0 / 64 | 3 / 62 | 1 / 15 | 1 / 13 | 5 / 64 | 4 / 62 |
Outcome results
Primary
Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score
Percentage of participants with \>=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.
Time frame: Week 12
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (CP) | Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score | 6.5 Percentage of participants |
| Ustekinumab 45 mg (CP) | Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score | 59.4 Percentage of participants |
| Ustekinumab 90 mg (CP) | Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score | 67.7 Percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.
Time frame: Week 12, 28, 40, 52 and 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 52: MCS(n=15,14,60,56) | 4.44 Unit on scale | Standard Deviation 5.198 |
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 28: MCS(n=15,15,64,59) | 6.19 Unit on scale | Standard Deviation 7.069 |
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 12: PCS(n=15,16,62,61) | -.88 Unit on scale | Standard Deviation 11.141 |
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 12: MCS(n=15,16,62,61) | 1.16 Unit on scale | Standard Deviation 5.263 |
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 40: MCS(n=15,15,61,57) | 4.90 Unit on scale | Standard Deviation 5.453 |
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 64: MCS(n=15,14,60,56) | 4.67 Unit on scale | Standard Deviation 5.362 |
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 40: PCS(n=15,15,61,57) | 2.12 Unit on scale | Standard Deviation 19.683 |
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 64: PCS(n=15,14,60,56) | 3.79 Unit on scale | Standard Deviation 15.519 |
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 52: PCS(n=15,14,60,56) | 4.03 Unit on scale | Standard Deviation 16.426 |
| Placebo (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 28: PCS(n=15,15,64,59) | 2.22 Unit on scale | Standard Deviation 15.064 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 52: MCS(n=15,14,60,56) | 5.93 Unit on scale | Standard Deviation 9.755 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 12: MCS(n=15,16,62,61) | 2.84 Unit on scale | Standard Deviation 7.994 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 64: PCS(n=15,14,60,56) | 6.10 Unit on scale | Standard Deviation 16.164 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 64: MCS(n=15,14,60,56) | 5.21 Unit on scale | Standard Deviation 7.958 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 28: PCS(n=15,15,64,59) | 6.42 Unit on scale | Standard Deviation 16.113 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 28: MCS(n=15,15,64,59) | 3.22 Unit on scale | Standard Deviation 6.621 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 12: PCS(n=15,16,62,61) | -1.03 Unit on scale | Standard Deviation 8.328 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 40: PCS(n=15,15,61,57) | 6.18 Unit on scale | Standard Deviation 15.914 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 40: MCS(n=15,15,61,57) | 5.27 Unit on scale | Standard Deviation 11.303 |
| Ustekinumab 45 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 52: PCS(n=15,14,60,56) | 6.58 Unit on scale | Standard Deviation 16.496 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 28: MCS(n=15,15,64,59) | 6.84 Unit on scale | Standard Deviation 10.086 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 64: PCS(n=15,14,60,56) | 8.27 Unit on scale | Standard Deviation 15.468 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 40: MCS(n=15,15,61,57) | 6.61 Unit on scale | Standard Deviation 9.674 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 28: PCS(n=15,15,64,59) | 8.54 Unit on scale | Standard Deviation 14.538 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 64: MCS(n=15,14,60,56) | 5.11 Unit on scale | Standard Deviation 10.504 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 52: MCS(n=15,14,60,56) | 5 Unit on scale | Standard Deviation 10.386 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 52: PCS(n=15,14,60,56) | 8.33 Unit on scale | Standard Deviation 16.365 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 12: MCS(n=15,16,62,61) | 5.28 Unit on scale | Standard Deviation 9.797 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 40: PCS(n=15,15,61,57) | 8.95 Unit on scale | Standard Deviation 15.476 |
| Ustekinumab 90 mg (CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 12: PCS(n=15,16,62,61) | 7.76 Unit on scale | Standard Deviation 14.536 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 64: MCS(n=15,14,60,56) | 6.89 Unit on scale | Standard Deviation 9.433 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 12: PCS(n=15,16,62,61) | 5.14 Unit on scale | Standard Deviation 12.036 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 28: PCS(n=15,15,64,59) | 6.23 Unit on scale | Standard Deviation 11.721 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 28: MCS(n=15,15,64,59) | 7.24 Unit on scale | Standard Deviation 11.932 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 40: PCS(n=15,15,61,57) | 3.58 Unit on scale | Standard Deviation 16.339 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 40: MCS(n=15,15,61,57) | 8.34 Unit on scale | Standard Deviation 10.415 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 52: PCS(n=15,14,60,56) | 6.19 Unit on scale | Standard Deviation 13.608 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 52: MCS(n=15,14,60,56) | 7.69 Unit on scale | Standard Deviation 8.998 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 64: PCS(n=15,14,60,56) | 6.70 Unit on scale | Standard Deviation 12.99 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 | Change at Week 12: MCS(n=15,16,62,61) | 5.77 Unit on scale | Standard Deviation 10.45 |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
Time frame: Week 12
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. N (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12 | -0.3 Units on scale | Standard Deviation 5.25 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12 | -8.0 Units on scale | Standard Deviation 6.45 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12 | -7.4 Units on scale | Standard Deviation 6.52 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
Time frame: Week 28, 40, 52 and 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -6.4 Unit on scale | Standard Deviation 6.74 |
| Placebo (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,56) | -6.5 Unit on scale | Standard Deviation 6.46 |
| Placebo (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,57) | -6.3 Unit on scale | Standard Deviation 5.92 |
| Placebo (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -5.8 Unit on scale | Standard Deviation 6.05 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,56) | -6.5 Unit on scale | Standard Deviation 6.08 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,57) | -5.5 Unit on scale | Standard Deviation 6.6 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -5.7 Unit on scale | Standard Deviation 6.96 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -6.2 Unit on scale | Standard Deviation 6.14 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,57) | -7.3 Unit on scale | Standard Deviation 7.01 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,56) | -7.7 Unit on scale | Standard Deviation 6.98 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -7.4 Unit on scale | Standard Deviation 6.92 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -7.5 Unit on scale | Standard Deviation 6.46 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -7.9 Unit on scale | Standard Deviation 6.43 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,56) | -7.9 Unit on scale | Standard Deviation 6.62 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -7.6 Unit on scale | Standard Deviation 6.59 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,57) | -7.8 Unit on scale | Standard Deviation 6.96 |
Secondary
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64
Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).
Time frame: Week 12, 28, 40, 52 and 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=2,1,6,13) | 0.5 Unit on scale | Standard Deviation 0.71 |
| Placebo (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=2,0,6,11) | -4.0 Unit on scale | Standard Deviation 5.66 |
| Placebo (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=2,0,6,11) | -7.5 Unit on scale | Standard Deviation 10.61 |
| Placebo (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=2,0,6,11) | -16.0 Unit on scale | Standard Deviation 22.63 |
| Placebo (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=2,0,6,12) | -8.0 Unit on scale | Standard Deviation 11.31 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=2,0,6,11) | NA Unit on scale | — |
| Ustekinumab 45 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=2,0,6,11) | NA Unit on scale | — |
| Ustekinumab 45 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=2,1,6,13) | 23.0 Unit on scale | — |
| Ustekinumab 45 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=2,0,6,12) | NA Unit on scale | — |
| Ustekinumab 45 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=2,0,6,11) | NA Unit on scale | — |
| Ustekinumab 90 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=2,1,6,13) | -38.5 Unit on scale | Standard Deviation 28.93 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=2,0,6,12) | -30.0 Unit on scale | Standard Deviation 37.97 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=2,0,6,11) | -29.3 Unit on scale | Standard Deviation 33.17 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=2,0,6,11) | -35.0 Unit on scale | Standard Deviation 35.49 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=2,0,6,11) | -35.3 Unit on scale | Standard Deviation 38.55 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=2,0,6,11) | -28.1 Unit on scale | Standard Deviation 26.55 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=2,0,6,12) | -24.8 Unit on scale | Standard Deviation 27.17 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=2,1,6,13) | -9.3 Unit on scale | Standard Deviation 18.23 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=2,0,6,11) | -30.2 Unit on scale | Standard Deviation 25 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=2,0,6,11) | -27.2 Unit on scale | Standard Deviation 28.38 |
Secondary
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64
The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).
Time frame: Week 12, 28, 40, 52 and 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,57) | -9.4 Unit on scale | Standard Deviation 9.07 |
| Placebo (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=15,16,62,61) | 0.1 Unit on scale | Standard Deviation 3.7 |
| Placebo (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,56) | -10.4 Unit on scale | Standard Deviation 8.6 |
| Placebo (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -10.0 Unit on scale | Standard Deviation 9.52 |
| Placebo (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -10.6 Unit on scale | Standard Deviation 9.12 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,57) | -8.5 Unit on scale | Standard Deviation 9.67 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -8.1 Unit on scale | Standard Deviation 8.9 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,56) | -6.5 Unit on scale | Standard Deviation 10.86 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=15,16,62,61) | 0.1 Unit on scale | Standard Deviation 4.76 |
| Ustekinumab 45 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -7.6 Unit on scale | Standard Deviation 10.1 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,56) | -10.6 Unit on scale | Standard Deviation 9.06 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=15,16,62,61) | -8.6 Unit on scale | Standard Deviation 9.63 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -10.8 Unit on scale | Standard Deviation 9.45 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,57) | -11.3 Unit on scale | Standard Deviation 9.92 |
| Ustekinumab 90 mg (CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -10.7 Unit on scale | Standard Deviation 9.71 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,56) | -14.5 Unit on scale | Standard Deviation 10.64 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -13.2 Unit on scale | Standard Deviation 10.75 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=15,16,62,61) | -12.0 Unit on scale | Standard Deviation 11.8 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -14.3 Unit on scale | Standard Deviation 10.17 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,57) | -14.0 Unit on scale | Standard Deviation 10.53 |
Secondary
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64
The number of nails with psoriasis involvement was assessed by a dermatologist.
Time frame: Week 12, 28, 40, 52 and 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,56) | -1.5 Nails | Standard Deviation 2.77 |
| Placebo (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=15,16,62,61) | 0.9 Nails | Standard Deviation 2.64 |
| Placebo (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -1.3 Nails | Standard Deviation 2.92 |
| Placebo (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -0.1 Nails | Standard Deviation 2.8 |
| Placebo (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,57) | -1.8 Nails | Standard Deviation 3.23 |
| Ustekinumab 45 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -0.1 Nails | Standard Deviation 1.13 |
| Ustekinumab 45 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,56) | -1.1 Nails | Standard Deviation 3.2 |
| Ustekinumab 45 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,57) | -1.4 Nails | Standard Deviation 3.34 |
| Ustekinumab 45 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=15,16,62,61) | -0.1 Nails | Standard Deviation 0.25 |
| Ustekinumab 45 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -1.1 Nails | Standard Deviation 3.32 |
| Ustekinumab 90 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,56) | -2.6 Nails | Standard Deviation 3.18 |
| Ustekinumab 90 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=15,16,62,61) | 0 Nails | Standard Deviation 1.96 |
| Ustekinumab 90 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -1.8 Nails | Standard Deviation 2.89 |
| Ustekinumab 90 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,57) | -2.8 Nails | Standard Deviation 3.32 |
| Ustekinumab 90 mg (CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -2.6 Nails | Standard Deviation 3.38 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 52 (n=15,14,60,57) | -1.92 Nails | Standard Deviation 3.36 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 12 (n=15,16,62,61) | 0 Nails | Standard Deviation 1.83 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 40 (n=15,15,61,56) | -1.8 Nails | Standard Deviation 3.34 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 28 (n=15,15,64,59) | -1.4 Nails | Standard Deviation 3.03 |
| Ustekinumab 90 mg (After CP) | Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 | Change at Week 64 (n=15,14,60,56) | -1.8 Nails | Standard Deviation 3.43 |
Secondary
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 \[best\] to 5 \[worst\].
Time frame: Week 12
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12 | 9.7 Percentage of participants |
| Ustekinumab 45 mg (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12 | 57.8 Percentage of participants |
| Ustekinumab 90 mg (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12 | 69.4 Percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 \[best\] to 5 \[worst\].
Time frame: Week 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0 (cleared) | 13.3 Percentage of participants |
| Placebo (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0, 1 or 2 (mild) | 73.3 Percentage of participants |
| Placebo (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0 or 1 (minimal) | 53.3 Percentage of participants |
| Ustekinumab 45 mg (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0 (cleared) | 21.4 Percentage of participants |
| Ustekinumab 45 mg (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0, 1 or 2 (mild) | 71.4 Percentage of participants |
| Ustekinumab 45 mg (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0 or 1 (minimal) | 71.4 Percentage of participants |
| Ustekinumab 90 mg (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0 or 1 (minimal) | 53.3 Percentage of participants |
| Ustekinumab 90 mg (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0 (cleared) | 21.7 Percentage of participants |
| Ustekinumab 90 mg (CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0, 1 or 2 (mild) | 83.3 Percentage of participants |
| Ustekinumab 90 mg (After CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0 (cleared) | 28.6 Percentage of participants |
| Ustekinumab 90 mg (After CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0, 1 or 2 (mild) | 82.1 Percentage of participants |
| Ustekinumab 90 mg (After CP) | Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 | PGA score= 0 or 1 (minimal) | 69.6 Percentage of participants |
Secondary
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
Time frame: Week 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | >= 50% Treatment Response | 80 Percentage of participants |
| Placebo (CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | 100% Treatment Response | 13.3 Percentage of participants |
| Placebo (CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | >= 90% Treatment Response | 60 Percentage of participants |
| Ustekinumab 45 mg (CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | >= 50% Treatment Response | 71.4 Percentage of participants |
| Ustekinumab 45 mg (CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | 100% Treatment Response | 21.4 Percentage of participants |
| Ustekinumab 45 mg (CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | >= 90% Treatment Response | 50 Percentage of participants |
| Ustekinumab 90 mg (CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | >= 90% Treatment Response | 50 Percentage of participants |
| Ustekinumab 90 mg (CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | >= 50% Treatment Response | 91.7 Percentage of participants |
| Ustekinumab 90 mg (CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | 100% Treatment Response | 18.3 Percentage of participants |
| Ustekinumab 90 mg (After CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | >= 50% Treatment Response | 89.3 Percentage of participants |
| Ustekinumab 90 mg (After CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | 100% Treatment Response | 17.9 Percentage of participants |
| Ustekinumab 90 mg (After CP) | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score | >= 90% Treatment Response | 55.4 Percentage of participants |
Secondary
Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
Time frame: Week 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (CP) | Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score | 70.78 Percentage of treatment response | Standard Deviation 38.816 |
| Ustekinumab 45 mg (CP) | Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score | 63.07 Percentage of treatment response | Standard Deviation 43.608 |
| Ustekinumab 90 mg (CP) | Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score | 78.86 Percentage of treatment response | Standard Deviation 25.91 |
| Ustekinumab 90 mg (After CP) | Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score | 82.36 Percentage of treatment response | Standard Deviation 26.798 |
Secondary
Psoriasis Area and Severity Index (PASI) Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
Time frame: Week 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (CP) | Psoriasis Area and Severity Index (PASI) Score | 10.83 Units on a scale | Standard Deviation 16.149 |
| Ustekinumab 45 mg (CP) | Psoriasis Area and Severity Index (PASI) Score | 8.29 Units on a scale | Standard Deviation 9.975 |
| Ustekinumab 90 mg (CP) | Psoriasis Area and Severity Index (PASI) Score | 6.60 Units on a scale | Standard Deviation 9.06 |
| Ustekinumab 90 mg (After CP) | Psoriasis Area and Severity Index (PASI) Score | 4.94 Units on a scale | Standard Deviation 7.493 |
Secondary
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Time frame: Week 12, 28, 40,52 and 64
Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 40 (n=9,7,42,36) | 31.6 Unit on scale | Standard Deviation 40.17 |
| Placebo (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 12 (n=9,8,43,40) | 11.1 Unit on scale | Standard Deviation 33.33 |
| Placebo (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 52 (n=9,7,42,37) | 48.0 Unit on scale | Standard Deviation 47.62 |
| Placebo (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 28 (n=9,7,44,38) | 34.9 Unit on scale | Standard Deviation 42.17 |
| Placebo (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 64 (n=9,7,42,36) | 51.5 Unit on scale | Standard Deviation 45.2 |
| Ustekinumab 45 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 40 (n=9,7,42,36) | 38.1 Unit on scale | Standard Deviation 48.8 |
| Ustekinumab 45 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 28 (n=9,7,44,38) | 34.5 Unit on scale | Standard Deviation 44.21 |
| Ustekinumab 45 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 52 (n=9,7,42,37) | 38.1 Unit on scale | Standard Deviation 48.8 |
| Ustekinumab 45 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 12 (n=9,8,43,40) | 6.3 Unit on scale | Standard Deviation 17.68 |
| Ustekinumab 45 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 64 (n=9,7,42,36) | 39.3 Unit on scale | Standard Deviation 45.32 |
| Ustekinumab 90 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 64 (n=9,7,42,36) | 56.6 Unit on scale | Standard Deviation 43.24 |
| Ustekinumab 90 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 12 (n=9,8,43,40) | 7.7 Unit on scale | Standard Deviation 95.14 |
| Ustekinumab 90 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 28 (n=9,7,44,38) | 52.0 Unit on scale | Standard Deviation 39.59 |
| Ustekinumab 90 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 40 (n=9,7,42,36) | 59.9 Unit on scale | Standard Deviation 45.87 |
| Ustekinumab 90 mg (CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 52 (n=9,7,42,37) | 60.0 Unit on scale | Standard Deviation 45.96 |
| Ustekinumab 90 mg (After CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 64 (n=9,7,42,36) | 67.8 Unit on scale | Standard Deviation 37.49 |
| Ustekinumab 90 mg (After CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 52 (n=9,7,42,37) | 61.4 Unit on scale | Standard Deviation 48.28 |
| Ustekinumab 90 mg (After CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 28 (n=9,7,44,38) | 51.6 Unit on scale | Standard Deviation 49.97 |
| Ustekinumab 90 mg (After CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 12 (n=9,8,43,40) | 10.0 Unit on scale | Standard Deviation 66.06 |
| Ustekinumab 90 mg (After CP) | Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score | NAPSI Score at Week 40 (n=9,7,42,36) | 61.1 Unit on scale | Standard Deviation 53.17 |