Palmoplantar Pustulosis
Conditions
Keywords
Guselkumab, CNTO 1959, Placebo, Palmoplantar Pustulosis
Brief summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.
Detailed description
This is a phase 3, randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), multicenter (when more than one hospital works on a medical research study) placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) study in participants with palmoplantar pustulosis. The study will consist of 3 phases: screening phase (up to 6 weeks), treatment period (week 0 - week 60) and observational period (up to week 84). Participants will be assigned to 1 of 3 treatment groups (200 milligram \[mg\] guselkumab, 100 mg guselkumab or placebo group) using a stratified block randomization method in a 1:1:1 ratio at Week 0 and Group III (placebo) participants will be allocated in a 1:1 ratio to 1 of 2 treatment groups at Week 16. Participants will primarily be assessed for change from baseline in Palmo-Plantar Pustular Area and Severity Index (PPPASI) total score at Week 16. Safety will be monitored throughout the study.
Interventions
DRUGGuselkumab
Participants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.
DRUGPlacebo
Participants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.
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
* Has a diagnosis of palmoplantar pustulosis (with or without pustulotic arthro-osteitis, concurrent extra-palmoplantar lesions) for at least 24 weeks before screening * Has a \>= 12 PPPASI total score at screening and at baseline * Has a moderate or more severe pustules/vesicle on the palms or soles (\>= 2 PPPASI severity score) at screening and baseline * Has inadequate response to the treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or the phototherapy and/or systemic etretinate prior to or at screening. Inadequate response is defined as a case judged by the investigator * Before the first administration of study drug, a woman must be either: Not of childbearing potential: premenarchal; postmenopausal or Of childbearing potential and practicing a highly effective method of birth control
Exclusion criteria
* Has a diagnosis of plaque-type psoriasis * Has obvious improvement during screening (\>= 5 PPPASI total score improvement during the screening) * Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 12 weeks or a cardiac hospitalization within the last 12 weeks before screening * Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before screening or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 12 weeks before screening)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | Baseline and Week 16 | PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%,30%,30%, respectively, of total surface area(TSA) of palms, soles. Each area is assessed separately for erythema(E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces score range of 0-72 using formula, PPPASI=(E+P+D)Area\*0.2(RP)+(E+P+D)Area\*0.2 (LP)+(E+P+D)Area\*0.3(RS)+(E+P+D)Area\*0.3(LS). Higher a score more the severe disease. Participants who discontinue study agent as they met treatment failure(TF) criterion(lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | Week 16 | PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Change From Baseline in PPPASI Total Score | Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, which account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Change From Baseline in PPSI Total Score | Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PPPASI-50 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PPPASI-75 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-75 response represents participants who achieved at least a 75% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PPPASI-90 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-90 response represents participants who achieved at least a 90% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PPPASI-100 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-100 response represents participants who achieved at least a 100% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PPSI-50 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PPSI-75 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | Baseline and Week 16 | PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PPSI-100 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 72 and Week 84 | PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | The PGA documents the Physician's Global Assessment of the PPP overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) and had at least a 2-grade improvement from baseline were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Baseline, Week 16, 32, 52, 72 and Week 84 | The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a participant's QOL. It is a 10-item participant-reported outcome questionnaire that, in addition to evaluating overall QOL, can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Baseline, Week 16, 32, 52, 72 and Week 84 | SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Baseline, Week 16, 32, 52, 72 and Week 84 | SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Baseline, Week 16, 32, 52, 72 and Week 84 | EQ-5D is designed for self-completion by participants and consists of EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable. The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion their baseline value carried forward to the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
| Percentage of Participants Who Achieved a PPSI-90 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 90 response represents participants who achieved at least a 90% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo-controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg. | 53 |
| Guselkumab 100 mg Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug. | 54 |
| Guselkumab 200 mg Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug. | 52 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| After Controlled Period (Week 16 - 52) | Adverse Event | 0 | 1 | 1 | 5 | 4 |
| After Controlled Period (Week 16 - 52) | Lack of Efficacy | 0 | 2 | 0 | 2 | 0 |
| After Controlled Period (Week 16 - 52) | Other | 0 | 1 | 1 | 0 | 1 |
| After Controlled Period (Week 16 - 52) | Pregnancy | 0 | 0 | 0 | 1 | 1 |
| Observational Period (Week 60 - Week 84) | Other | 0 | 0 | 0 | 0 | 1 |
| Placebo Controlled Period (Week 0 - 16) | Adverse Event | 2 | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Guselkumab 200 mg | Guselkumab 100 mg |
|---|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 8.14 | 53.3 years STANDARD_DEVIATION 10.94 | 52.9 years STANDARD_DEVIATION 13.39 | 53.9 years STANDARD_DEVIATION 10.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 159 Participants | 52 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 53 Participants | 159 Participants | 52 Participants | 54 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment JAPAN | 53 Participants | 159 Participants | 52 Participants | 54 Participants |
| Sex: Female, Male Female | 44 Participants | 126 Participants | 36 Participants | 46 Participants |
| Sex: Female, Male Male | 9 Participants | 33 Participants | 16 Participants | 8 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 25 | 0 / 26 | 0 / 54 | 0 / 52 |
| other Total, other adverse events | 34 / 53 | 23 / 25 | 22 / 26 | 44 / 54 | 49 / 52 |
| serious Total, serious adverse events | 2 / 53 | 3 / 25 | 1 / 26 | 3 / 54 | 5 / 52 |
Outcome results
Primary
Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16
PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%,30%,30%, respectively, of total surface area(TSA) of palms, soles. Each area is assessed separately for erythema(E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces score range of 0-72 using formula, PPPASI=(E+P+D)Area\*0.2(RP)+(E+P+D)Area\*0.2 (LP)+(E+P+D)Area\*0.3(RS)+(E+P+D)Area\*0.3(LS). Higher a score more the severe disease. Participants who discontinue study agent as they met treatment failure(TF) criterion(lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline and Week 16
Population: Randomized analysis set: all randomized participants at Week 0, whether they received study treatment or not and had any post-baseline efficacy assessment. Missing values were imputed based on TF criterion, last observation carried forward (LOCF) method till Week 60;no imputation performed for missing data after Week 60 (in observational period).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | -7.79 Units on a scale | Standard Deviation 10.596 |
| Guselkumab 100 mg | Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | -15.08 Units on a scale | Standard Deviation 11.252 |
| Guselkumab 200 mg | Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | -11.07 Units on a scale | Standard Deviation 7.779 |
p-value: <0.00195% CI: [-11, -4.383]Mixed-Model for Repeated Measures
p-value: 0.01795% CI: [-7.468, -0.748]Mixed-Model for Repeated Measures
Secondary
Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline and Week 16
Population: Population included Randomized analysis set. The missing values were imputed based on Treatment Failure (TF) criterion and last scheduled observation carried forward (LOCF) method until Week 60; no imputation performed for missing data after Week 60 (in observational period).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | -2.0 Units on a scale | Standard Deviation 2.41 |
| Guselkumab 100 mg | Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | -3.9 Units on a scale | Standard Deviation 2.94 |
| Guselkumab 200 mg | Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | -3.0 Units on a scale | Standard Deviation 2.57 |
Secondary
Change From Baseline in PPPASI Total Score
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, which account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in PPPASI Total Score | Change at week 8 | -6.31 Units on a scale | Standard Deviation 7.986 |
| Placebo | Change From Baseline in PPPASI Total Score | Change at week 4 | -4.39 Units on a scale | Standard Deviation 6.805 |
| Placebo | Change From Baseline in PPPASI Total Score | Change at week 12 | -7.60 Units on a scale | Standard Deviation 9.197 |
| Placebo | Change From Baseline in PPPASI Total Score | Change at week 2 | -3.58 Units on a scale | Standard Deviation 5.303 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 28 | -15.44 Units on a scale | Standard Deviation 10.597 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 40 | -19.06 Units on a scale | Standard Deviation 11.683 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 84 | -22.60 Units on a scale | Standard Deviation 11.781 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 60 | -20.18 Units on a scale | Standard Deviation 11.88 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 32 | -16.92 Units on a scale | Standard Deviation 10.615 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 20 | -12.33 Units on a scale | Standard Deviation 9.672 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 72 | -22.09 Units on a scale | Standard Deviation 11.958 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 36 | -18.15 Units on a scale | Standard Deviation 11.372 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 52 | -20.04 Units on a scale | Standard Deviation 12.362 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 24 | -14.45 Units on a scale | Standard Deviation 9.878 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 48 | -19.54 Units on a scale | Standard Deviation 12.572 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 44 | -18.92 Units on a scale | Standard Deviation 12.099 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 52 | -18.88 Units on a scale | Standard Deviation 11.635 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 36 | -17.19 Units on a scale | Standard Deviation 11.199 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 48 | -19.18 Units on a scale | Standard Deviation 10.547 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 40 | -18.63 Units on a scale | Standard Deviation 10.812 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 44 | -18.77 Units on a scale | Standard Deviation 11.119 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 20 | -8.66 Units on a scale | Standard Deviation 11.032 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 60 | -19.62 Units on a scale | Standard Deviation 11.566 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 24 | -10.90 Units on a scale | Standard Deviation 10.759 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 84 | -21.19 Units on a scale | Standard Deviation 13.619 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 28 | -13.90 Units on a scale | Standard Deviation 11.383 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 32 | -15.63 Units on a scale | Standard Deviation 10.789 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 72 | -21.08 Units on a scale | Standard Deviation 11.855 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 36 | -18.87 Units on a scale | Standard Deviation 11.909 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 2 | -2.27 Units on a scale | Standard Deviation 6.832 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 4 | -6.43 Units on a scale | Standard Deviation 7.907 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 12 | -12.80 Units on a scale | Standard Deviation 9.706 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 8 | -10.60 Units on a scale | Standard Deviation 8.358 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 20 | -16.33 Units on a scale | Standard Deviation 11.35 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 24 | -17.86 Units on a scale | Standard Deviation 11.219 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 28 | -18.32 Units on a scale | Standard Deviation 11.425 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 32 | -18.52 Units on a scale | Standard Deviation 11.544 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 40 | -18.85 Units on a scale | Standard Deviation 12.356 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 44 | -18.91 Units on a scale | Standard Deviation 12.338 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 48 | -19.72 Units on a scale | Standard Deviation 12.506 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 52 | -19.95 Units on a scale | Standard Deviation 12.567 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 60 | -20.17 Units on a scale | Standard Deviation 12.829 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 72 | -22.13 Units on a scale | Standard Deviation 10.4 |
| Guselkumab 100 mg | Change From Baseline in PPPASI Total Score | Change at week 84 | -21.32 Units on a scale | Standard Deviation 10.458 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 24 | -15.38 Units on a scale | Standard Deviation 8.864 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 32 | -17.64 Units on a scale | Standard Deviation 9.792 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 4 | -5.28 Units on a scale | Standard Deviation 5.692 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 52 | -19.63 Units on a scale | Standard Deviation 9.776 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 28 | -16.86 Units on a scale | Standard Deviation 9.443 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 20 | -13.76 Units on a scale | Standard Deviation 8.278 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 2 | -3.02 Units on a scale | Standard Deviation 5.829 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 60 | -20.37 Units on a scale | Standard Deviation 10.098 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 8 | -7.94 Units on a scale | Standard Deviation 7.305 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 12 | -9.35 Units on a scale | Standard Deviation 8.121 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 84 | -22.56 Units on a scale | Standard Deviation 9.352 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 44 | -18.61 Units on a scale | Standard Deviation 10.093 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 40 | -18.54 Units on a scale | Standard Deviation 9.887 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 36 | -17.72 Units on a scale | Standard Deviation 10.083 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 72 | -22.05 Units on a scale | Standard Deviation 9.136 |
| Guselkumab 200 mg | Change From Baseline in PPPASI Total Score | Change at week 48 | -18.99 Units on a scale | Standard Deviation 9.686 |
Secondary
Change From Baseline in PPSI Total Score
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in PPSI Total Score | Change at week 4 | -0.7 Units on a scale | Standard Deviation 1.26 |
| Placebo | Change From Baseline in PPSI Total Score | Change at week 12 | -1.7 Units on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in PPSI Total Score | Change at week 8 | -1.2 Units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in PPSI Total Score | Change at week 2 | -0.5 Units on a scale | Standard Deviation 1.14 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 52 | -5.6 Units on a scale | Standard Deviation 3.51 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 20 | -3.1 Units on a scale | Standard Deviation 2.55 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 24 | -3.7 Units on a scale | Standard Deviation 2.35 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 28 | -3.8 Units on a scale | Standard Deviation 2.69 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 32 | -3.9 Units on a scale | Standard Deviation 2.68 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 36 | -4.8 Units on a scale | Standard Deviation 3.14 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 40 | -5.0 Units on a scale | Standard Deviation 3.35 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 44 | -5.0 Units on a scale | Standard Deviation 3.55 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 48 | -5.3 Units on a scale | Standard Deviation 3.58 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 60 | -5.5 Units on a scale | Standard Deviation 3.19 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 72 | -6.5 Units on a scale | Standard Deviation 2.64 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 84 | -7.5 Units on a scale | Standard Deviation 2.8 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 32 | -4.5 Units on a scale | Standard Deviation 3.28 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 20 | -2.6 Units on a scale | Standard Deviation 2.76 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 48 | -5.5 Units on a scale | Standard Deviation 2.9 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 72 | -6.6 Units on a scale | Standard Deviation 2.65 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 36 | -4.7 Units on a scale | Standard Deviation 3.39 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 84 | -6.6 Units on a scale | Standard Deviation 3.45 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 28 | -3.9 Units on a scale | Standard Deviation 3.22 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 40 | -5.3 Units on a scale | Standard Deviation 3.12 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 24 | -3.0 Units on a scale | Standard Deviation 3.15 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 44 | -5.5 Units on a scale | Standard Deviation 2.89 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 52 | -5.6 Units on a scale | Standard Deviation 3 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 60 | -6.0 Units on a scale | Standard Deviation 3.06 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 8 | -2.6 Units on a scale | Standard Deviation 2.48 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 20 | -4.0 Units on a scale | Standard Deviation 3.09 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 60 | -5.6 Units on a scale | Standard Deviation 3.18 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 24 | -4.5 Units on a scale | Standard Deviation 2.88 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 28 | -4.6 Units on a scale | Standard Deviation 2.89 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 84 | -6.0 Units on a scale | Standard Deviation 2.89 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 32 | -4.7 Units on a scale | Standard Deviation 3.07 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 36 | -4.9 Units on a scale | Standard Deviation 2.89 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 72 | -6.3 Units on a scale | Standard Deviation 2.59 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 40 | -5.1 Units on a scale | Standard Deviation 3.1 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 44 | -5.2 Units on a scale | Standard Deviation 3.3 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 48 | -5.3 Units on a scale | Standard Deviation 3.2 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 52 | -5.7 Units on a scale | Standard Deviation 3.12 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 2 | -0.5 Units on a scale | Standard Deviation 1.68 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 4 | -1.5 Units on a scale | Standard Deviation 2.14 |
| Guselkumab 100 mg | Change From Baseline in PPSI Total Score | Change at week 12 | -3.3 Units on a scale | Standard Deviation 2.53 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 48 | -6.3 Units on a scale | Standard Deviation 3.17 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 36 | -5.8 Units on a scale | Standard Deviation 3.18 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 28 | -5.2 Units on a scale | Standard Deviation 2.79 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 52 | -6.6 Units on a scale | Standard Deviation 3.17 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 60 | -6.9 Units on a scale | Standard Deviation 3.25 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 2 | -0.6 Units on a scale | Standard Deviation 1.35 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 20 | -3.8 Units on a scale | Standard Deviation 2.68 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 12 | -2.5 Units on a scale | Standard Deviation 2.58 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 4 | -1.3 Units on a scale | Standard Deviation 1.94 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 40 | -5.9 Units on a scale | Standard Deviation 3.01 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 72 | -7.7 Units on a scale | Standard Deviation 2.78 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 24 | -4.6 Units on a scale | Standard Deviation 2.71 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 44 | -5.9 Units on a scale | Standard Deviation 3.14 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 84 | -8.0 Units on a scale | Standard Deviation 2.79 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 32 | -5.6 Units on a scale | Standard Deviation 3.11 |
| Guselkumab 200 mg | Change From Baseline in PPSI Total Score | Change at week 8 | -2.0 Units on a scale | Standard Deviation 2.17 |
Secondary
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 16, 32, 52, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 16 | 1.20 Units on a scale | Standard Deviation 7.823 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 84 | 1.72 Units on a scale | Standard Deviation 8.74 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 52 | 1.44 Units on a scale | Standard Deviation 9.98 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 32 | 2.19 Units on a scale | Standard Deviation 10.277 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 72 | 1.51 Units on a scale | Standard Deviation 10.679 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 32 | 1.10 Units on a scale | Standard Deviation 7.579 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 52 | 0.39 Units on a scale | Standard Deviation 7.431 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 84 | 0.78 Units on a scale | Standard Deviation 6.975 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 72 | 0.02 Units on a scale | Standard Deviation 8.686 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 52 | 1.69 Units on a scale | Standard Deviation 7.866 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 72 | 2.19 Units on a scale | Standard Deviation 7.112 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 16 | 0.64 Units on a scale | Standard Deviation 7.88 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 84 | 2.51 Units on a scale | Standard Deviation 8.428 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 32 | 0.52 Units on a scale | Standard Deviation 8.124 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 84 | 2.58 Units on a scale | Standard Deviation 7.977 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 32 | 0.59 Units on a scale | Standard Deviation 7.639 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 52 | 0.69 Units on a scale | Standard Deviation 7.354 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 72 | 0.92 Units on a scale | Standard Deviation 6.797 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score | Change at week 16 | 0.66 Units on a scale | Standard Deviation 7.055 |
Secondary
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 16, 32, 52, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 16 | 1.27 Units on a scale | Standard Deviation 9.177 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 32 | 5.46 Units on a scale | Standard Deviation 16.226 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 84 | 9.29 Units on a scale | Standard Deviation 19.175 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 72 | 9.02 Units on a scale | Standard Deviation 17.049 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 52 | 7.92 Units on a scale | Standard Deviation 14.58 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 84 | 9.01 Units on a scale | Standard Deviation 12.964 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 32 | 7.16 Units on a scale | Standard Deviation 11.507 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 52 | 8.18 Units on a scale | Standard Deviation 11.32 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 72 | 7.02 Units on a scale | Standard Deviation 11.806 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 84 | 7.06 Units on a scale | Standard Deviation 15.034 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 72 | 6.75 Units on a scale | Standard Deviation 15.098 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 32 | 8.31 Units on a scale | Standard Deviation 15.51 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 52 | 7.35 Units on a scale | Standard Deviation 17.32 |
| Guselkumab 100 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 16 | 4.67 Units on a scale | Standard Deviation 13.753 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 84 | 6.75 Units on a scale | Standard Deviation 13.619 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 32 | 4.82 Units on a scale | Standard Deviation 9.975 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 16 | 3.34 Units on a scale | Standard Deviation 10.259 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 72 | 7.55 Units on a scale | Standard Deviation 11.453 |
| Guselkumab 200 mg | Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score | Change at week 52 | 6.47 Units on a scale | Standard Deviation 11.466 |
Secondary
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a participant's QOL. It is a 10-item participant-reported outcome questionnaire that, in addition to evaluating overall QOL, can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 16, 32, 52, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 16 | -1.8 Units on a scale | Standard Deviation 4.71 |
| Guselkumab 100 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 72 | -5.5 Units on a scale | Standard Deviation 5.82 |
| Guselkumab 100 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 32 | -4.3 Units on a scale | Standard Deviation 5.25 |
| Guselkumab 100 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 52 | -4.8 Units on a scale | Standard Deviation 5.74 |
| Guselkumab 100 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 84 | -6.0 Units on a scale | Standard Deviation 5.29 |
| Guselkumab 200 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 72 | -5.8 Units on a scale | Standard Deviation 4.28 |
| Guselkumab 200 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 32 | -4.2 Units on a scale | Standard Deviation 5.09 |
| Guselkumab 200 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 84 | -5.6 Units on a scale | Standard Deviation 4.66 |
| Guselkumab 200 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 52 | -5.2 Units on a scale | Standard Deviation 5.1 |
| Guselkumab 100 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 32 | -5.2 Units on a scale | Standard Deviation 5.9 |
| Guselkumab 100 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 72 | -6.2 Units on a scale | Standard Deviation 5.78 |
| Guselkumab 100 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 52 | -5.7 Units on a scale | Standard Deviation 6.05 |
| Guselkumab 100 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 84 | -6.4 Units on a scale | Standard Deviation 5.59 |
| Guselkumab 100 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 16 | -5.0 Units on a scale | Standard Deviation 5.59 |
| Guselkumab 200 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 16 | -3.1 Units on a scale | Standard Deviation 3.49 |
| Guselkumab 200 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 32 | -4.2 Units on a scale | Standard Deviation 4.18 |
| Guselkumab 200 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 52 | -4.9 Units on a scale | Standard Deviation 5.24 |
| Guselkumab 200 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 84 | -6.3 Units on a scale | Standard Deviation 5.41 |
| Guselkumab 200 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score | Change at week 72 | -5.8 Units on a scale | Standard Deviation 5.2 |
Secondary
Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
EQ-5D is designed for self-completion by participants and consists of EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable. The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion their baseline value carried forward to the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 16, 32, 52, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 16 | -0.1 Units on a scale | Standard Deviation 14.33 |
| Guselkumab 100 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 52 | 13.0 Units on a scale | Standard Deviation 24.69 |
| Guselkumab 100 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 32 | 8.0 Units on a scale | Standard Deviation 25.36 |
| Guselkumab 100 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 72 | 13.0 Units on a scale | Standard Deviation 21.59 |
| Guselkumab 100 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 84 | 6.7 Units on a scale | Standard Deviation 24.71 |
| Guselkumab 200 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 32 | 6.5 Units on a scale | Standard Deviation 15.75 |
| Guselkumab 200 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 52 | 5.6 Units on a scale | Standard Deviation 16.28 |
| Guselkumab 200 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 72 | 8.7 Units on a scale | Standard Deviation 21.08 |
| Guselkumab 200 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 84 | 10.0 Units on a scale | Standard Deviation 19.55 |
| Guselkumab 100 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 32 | 10.2 Units on a scale | Standard Deviation 21.88 |
| Guselkumab 100 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 84 | 10.5 Units on a scale | Standard Deviation 21.53 |
| Guselkumab 100 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 16 | 8.3 Units on a scale | Standard Deviation 21.25 |
| Guselkumab 100 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 52 | 13.9 Units on a scale | Standard Deviation 22.19 |
| Guselkumab 100 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 72 | 12.9 Units on a scale | Standard Deviation 22.43 |
| Guselkumab 200 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 84 | 8.7 Units on a scale | Standard Deviation 18.42 |
| Guselkumab 200 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 32 | 5.9 Units on a scale | Standard Deviation 15.98 |
| Guselkumab 200 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 16 | 8.5 Units on a scale | Standard Deviation 15.59 |
| Guselkumab 200 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 72 | 10.5 Units on a scale | Standard Deviation 17.11 |
| Guselkumab 200 mg | Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score | Change at week 52 | 7.9 Units on a scale | Standard Deviation 15.19 |
Secondary
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
The PGA documents the Physician's Global Assessment of the PPP overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Almost clear (1) | 5.7 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Clear (0) | 0 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Mild (2) | 5.7 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Moderate (3) | 37.7 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Mild (2) | 15.1 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Moderate (3) | 39.6 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Severe (4) | 32.1 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Almost clear (1) | 0 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Severe (4) | 47.2 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Moderate (3) | 43.4 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Almost clear (1) | 0 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Very severe (5) | 7.5 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Very severe (5) | 7.5 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Mild (2) | 15.1 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Clear (0) | 0 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Severe (4) | 28.3 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Very severe (5) | 5.7 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Almost clear (1) | 0 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Clear (0) | 0 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Clear (0) | 0 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Mild (2) | 7.5 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Very severe (5) | 7.5 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Mild (2) | 17.0 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Moderate (3) | 39.6 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Clear (0) | 0 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Severe (4) | 41.5 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Severe (4) | 45.3 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Moderate (3) | 43.4 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Very severe (5) | 7.5 Percentage of participants |
| Placebo | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Almost clear (1) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Severe (4) | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Almost clear (1) | 19.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Moderate (3) | 4.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Almost clear (1) | 24.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Moderate (3) | 32.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Mild (2) | 36.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Moderate (3) | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Mild (2) | 24.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Almost clear (1) | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Severe (4) | 12.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Mild (2) | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Moderate (3) | 40.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Severe (4) | 14.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Clear (0) | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Almost clear (1) | 32.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Mild (2) | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Mild (2) | 24.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Almost clear (1) | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Mild (2) | 52.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Almost clear (1) | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Mild (2) | 32.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Almost clear (1) | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Very severe (5) | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Clear (0) | 4.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Moderate (3) | 48.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Clear (0) | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Almost clear (1) | 38.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Mild (2) | 38.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Severe (4) | 12.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Severe (4) | 16.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Moderate (3) | 36.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Almost clear (1) | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Moderate (3) | 32.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Almost clear (1) | 12.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Very severe (5) | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Severe (4) | 4.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Mild (2) | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Almost clear (1) | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Severe (4) | 12.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Almost clear (1) | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Severe (4) | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Moderate (3) | 36.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Mild (2) | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Clear (0) | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Very severe (5) | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Severe (4) | 16.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Moderate (3) | 32.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Mild (2) | 36.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Mild (2) | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Moderate (3) | 19.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Moderate (3) | 48.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Clear (0) | 4.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Clear (0) | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Severe (4) | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week48: Moderate (3) | 40.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Severe (4) | 16.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Severe (4) | 16.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Almost clear (1) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Mild (2) | 42.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Severe (4) | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Severe (4) | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Very severe (5) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Mild (2) | 29.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Almost clear (1) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Mild (2) | 38.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Mild (2) | 46.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Severe (4) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Moderate (3) | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Almost clear (1) | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Severe (4) | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Severe (4) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Severe (4) | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Almost clear (1) | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Mild (2) | 46.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Moderate (3) | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Moderate (3) | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Severe (4) | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Moderate (3) | 30.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Moderate (3) | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Almost clear (1) | 19.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Mild (2) | 42.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Mild (2) | 46.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Very severe (5) | 4.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Almost clear (1) | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Almost clear (1) | 54.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Clear (0) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Severe (4) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Moderate (3) | 19.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Mild (2) | 50.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Almost clear (1) | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Severe (4) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Clear (0) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Moderate (3) | 12.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Severe (4) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week48: Moderate (3) | 30.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Mild (2) | 38.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Moderate (3) | 12.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Almost clear (1) | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Moderate (3) | 30.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Mild (2) | 50.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Almost clear (1) | 37.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Moderate (3) | 30.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Mild (2) | 50.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Almost clear (1) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Mild (2) | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Severe (4) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Moderate (3) | 42.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Severe (4) | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Very severe (5) | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Almost clear (1) | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Mild (2) | 38.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Mild (2) | 18.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Mild (2) | 31.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Almost clear (1) | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Severe (4) | 7.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Moderate (3) | 37.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Almost clear (1) | 16.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Almost clear (1) | 24.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Moderate (3) | 33.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Severe (4) | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Mild (2) | 42.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Severe (4) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Almost clear (1) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Mild (2) | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Moderate (3) | 46.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Severe (4) | 48.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Very severe (5) | 3.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Almost clear (1) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Mild (2) | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Moderate (3) | 53.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Almost clear (1) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Moderate (3) | 61.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Severe (4) | 20.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Almost clear (1) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Moderate (3) | 48.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Severe (4) | 20.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Almost clear (1) | 7.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Severe (4) | 38.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Moderate (3) | 44.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Severe (4) | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Mild (2) | 38.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Moderate (3) | 44.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Almost clear (1) | 14.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Mild (2) | 40.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Severe (4) | 7.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Almost clear (1) | 14.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Mild (2) | 46.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Moderate (3) | 33.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Severe (4) | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Mild (2) | 46.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Moderate (3) | 31.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Severe (4) | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Clear (0) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Almost clear (1) | 22.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Mild (2) | 44.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Moderate (3) | 29.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Severe (4) | 3.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Mild (2) | 37.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Severe (4) | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Clear (0) | 3.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Almost clear (1) | 24.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Mild (2) | 40.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Moderate (3) | 25.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Clear (0) | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Almost clear (1) | 29.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Mild (2) | 35.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week48: Moderate (3) | 27.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Severe (4) | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Clear (0) | 7.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Almost clear (1) | 24.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Mild (2) | 40.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Moderate (3) | 24.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Severe (4) | 3.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Clear (0) | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Almost clear (1) | 25.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Mild (2) | 38.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Moderate (3) | 20.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Severe (4) | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Clear (0) | 11.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Almost clear (1) | 28.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Moderate (3) | 17.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Very severe (5) | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Clear (0) | 4.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Almost clear (1) | 33.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Mild (2) | 42.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Moderate (3) | 13.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Severe (4) | 6.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Severe (4) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Mild (2) | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Almost clear (1) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Clear (0) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Severe (4) | 9.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Severe (4) | 30.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Severe (4) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Clear (0) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Moderate (3) | 44.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Mild (2) | 34.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Almost clear (1) | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Mild (2) | 17.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Almost clear (1) | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Mild (2) | 50.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Almost clear (1) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week48: Moderate (3) | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 12: Clear (0) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Severe (4) | 36.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Moderate (3) | 48.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Moderate (3) | 13.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Clear (0) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Mild (2) | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Almost clear (1) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Moderate (3) | 30.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Almost clear (1) | 21.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 8: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Very severe (5) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Clear (0) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Mild (2) | 51.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Severe (4) | 48.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Moderate (3) | 38.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Moderate (3) | 53.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Moderate (3) | 21.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Mild (2) | 9.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Almost clear (1) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Very severe (5) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Severe (4) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 4: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Very severe (5) | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 52: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Severe (4) | 36.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Moderate (3) | 44.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Almost clear (1) | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Clear (0) | 5.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Mild (2) | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Almost clear (1) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Clear (0) | 16.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Almost clear (1) | 44.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 2: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Severe (4) | 2.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Moderate (3) | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Mild (2) | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Moderate (3) | 9.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Mild (2) | 34.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Mild (2) | 36.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Moderate (3) | 21.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Mild (2) | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Severe (4) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Severe (4) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Mild (2) | 38.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Almost clear (1) | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Severe (4) | 9.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Almost clear (1) | 38.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Almost clear (1) | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 32: Clear (0) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 84: Almost clear (1) | 37.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 36: Severe (4) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Clear (0) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Severe (4) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Moderate (3) | 38.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Mild (2) | 40.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Almost clear (1) | 13.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 60: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Mild (2) | 38.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 28: Clear (0) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Moderate (3) | 28.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Severe (4) | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Moderate (3) | 42.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 48: Severe (4) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Mild (2) | 42.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Almost clear (1) | 13.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Very severe (5) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 24: Clear (0) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 72: Clear (0) | 13.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Almost clear (1) | 32.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 20: Clear (0) | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Very severe (5) | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Clear (0) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Mild (2) | 32.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Severe (4) | 19.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 40: Very severe (5) | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 44: Moderate (3) | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score | Week 16: Moderate (3) | 50.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 8 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 16 | 5.7 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 12 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 40 | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 36 | 12.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 20 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 52 | 32.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 24 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 28 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 48 | 36.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 32 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 60 | 24.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 44 | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 72 | 23.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 84 | 42.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 32 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 24 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 28 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 52 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 60 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 20 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 36 | 19.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 40 | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 44 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 48 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 72 | 37.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 84 | 54.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 48 | 31.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 60 | 35.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 20 | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 44 | 27.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 28 | 14.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 24 | 14.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 32 | 16.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 36 | 22.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 84 | 37.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 40 | 24.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 72 | 40.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 4 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 2 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 52 | 31.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 12 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 16 | 7.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 8 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 16 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 84 | 53.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 40 | 28.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 20 | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 4 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 24 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 2 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 28 | 17.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 44 | 34.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 52 | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 32 | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 12 | 5.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 60 | 50.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 72 | 52.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 36 | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) | Week 48 | 28.8 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) and had at least a 2-grade improvement from baseline were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 12 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 16 | 5.7 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 44 | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 20 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 24 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 40 | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 28 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 36 | 12.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 32 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 60 | 24.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 72 | 23.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 52 | 32.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 84 | 42.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 48 | 36.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 24 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 44 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 48 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 52 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 40 | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 28 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 32 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 20 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 84 | 54.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 72 | 37.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 36 | 19.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 60 | 26.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 72 | 40.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 2 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 12 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 16 | 7.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 28 | 14.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 32 | 16.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 36 | 22.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 44 | 27.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 84 | 37.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 4 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 20 | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 24 | 14.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 40 | 24.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 48 | 31.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 52 | 31.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 60 | 35.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 40 | 28.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 16 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 4 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 84 | 53.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 12 | 5.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 48 | 28.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 72 | 52.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 44 | 34.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 8 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 52 | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 36 | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 28 | 17.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 2 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 32 | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 24 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 20 | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement | Week 60 | 50.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PPPASI-100 Response
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-100 response represents participants who achieved at least a 100% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 8 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 16 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 12 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 4 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 52 | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 48 | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 44 | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 40 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 36 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 32 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 84 | 4.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 72 | 4.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 60 | 4.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 52 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 32 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 36 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 40 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 44 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 48 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 60 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 72 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 84 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 40 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 36 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 52 | 7.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 12 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 4 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 16 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 44 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 60 | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 84 | 2.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 72 | 8.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 48 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 32 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 32 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 36 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 12 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 40 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 72 | 11.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 44 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 8 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 48 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 4 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 52 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 84 | 14.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 60 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 28 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 16 | 1.9 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PPPASI-50 Response
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 12 | 26.4 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 8 | 11.3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 2 | 1.9 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 4 | 5.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 60 | 80.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 52 | 76.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 48 | 68.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 44 | 64.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 40 | 68.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 36 | 64.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 32 | 68.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 28 | 56.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 84 | 85.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 24 | 56.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 20 | 52.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 72 | 90.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 52 | 73.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 20 | 42.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 24 | 42.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 28 | 65.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 32 | 61.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 36 | 73.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 40 | 76.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 44 | 76.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 48 | 84.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 60 | 80.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 72 | 83.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 84 | 87.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 32 | 74.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 12 | 48.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 84 | 88.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 36 | 81.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 72 | 88.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 40 | 81.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 8 | 29.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 44 | 79.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 48 | 83.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 4 | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 28 | 74.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 52 | 83.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 60 | 79.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 24 | 79.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 20 | 64.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 2 | 3.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 24 | 59.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 32 | 73.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 60 | 84.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 52 | 84.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 36 | 75.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 8 | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 2 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 84 | 95.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 40 | 80.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 20 | 51.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 72 | 93.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 44 | 76.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 4 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 28 | 75.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 12 | 30.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 48 | 80.8 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 16
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | 34.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | 57.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | 36.5 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PPPASI-75 Response
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-75 response represents participants who achieved at least a 75% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 16 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 8 | 1.9 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 12 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 52 | 44.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 48 | 48.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 44 | 40.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 40 | 44.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 36 | 36.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 32 | 24.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 28 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 20 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 24 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 84 | 61.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 72 | 52.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 60 | 40.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 52 | 46.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 20 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 24 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 28 | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 32 | 30.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 36 | 38.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 40 | 46.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 44 | 50.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 48 | 50.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 60 | 50.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 72 | 66.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 84 | 66.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 40 | 44.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 8 | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 36 | 48.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 52 | 55.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 12 | 13 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 4 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 16 | 20.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 44 | 50.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 60 | 63.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 24 | 27.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 84 | 68.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 20 | 24.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 72 | 73.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 28 | 42.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 2 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 48 | 51.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 32 | 48.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 32 | 48.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 36 | 55.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 12 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 40 | 57.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 72 | 72.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 44 | 57.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 8 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 48 | 59.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 4 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 52 | 59.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 84 | 81.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 20 | 13.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 24 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 60 | 69.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 28 | 36.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 16 | 11.5 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PPPASI-90 Response
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-90 response represents participants who achieved at least a 90% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 12 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 8 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 16 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 40 | 16.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 48 | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 44 | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 36 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 32 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 84 | 47.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 72 | 28.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 60 | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 52 | 32.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 32 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 36 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 40 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 44 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 48 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 52 | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 60 | 34.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 72 | 29.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 84 | 41.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 48 | 24.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 24 | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 36 | 16.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 28 | 11.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 52 | 29.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 84 | 31.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 12 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 32 | 14.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 72 | 37.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 16 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 44 | 20.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 2 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 20 | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 4 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 40 | 16.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 60 | 35.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 60 | 44.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 32 | 19.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 36 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 40 | 17.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 44 | 17.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 72 | 52.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 48 | 28.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 28 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 20 | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 52 | 36.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 12 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 8 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 16 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 4 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 24 | 9.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 84 | 51.2 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PPSI-100 Response
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PPSI-100 Response | Week 16 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-100 Response | Week 12 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-100 Response | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-100 Response | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-100 Response | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 72 | 4.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 44 | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 40 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 36 | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 32 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 52 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 84 | 9.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 60 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 48 | 8.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 84 | 4.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 52 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 60 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 32 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 40 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 44 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 48 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 72 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 36 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 4 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 52 | 11.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 32 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 36 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 84 | 6.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 48 | 3.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 40 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 60 | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 72 | 11.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 44 | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 12 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 16 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 4 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 12 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 40 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 72 | 15.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 60 | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 28 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 16 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 48 | 5.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 44 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 32 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 84 | 20.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 52 | 5.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 36 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-100 Response | Week 8 | 0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PPSI-50 Response
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PPSI-50 Response | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-50 Response | Week 12 | 7.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-50 Response | Week 8 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-50 Response | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-50 Response | Week 16 | 11.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 40 | 48.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 72 | 61.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 32 | 40.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 48 | 52.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 36 | 48.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 44 | 48.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 60 | 56.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 20 | 24.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 84 | 81.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 52 | 52.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 24 | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 28 | 40.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 60 | 65.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 52 | 57.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 24 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 20 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 32 | 46.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 48 | 50.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 40 | 53.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 72 | 83.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 84 | 79.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 28 | 34.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 44 | 57.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 36 | 46.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 60 | 61.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 2 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 4 | 9.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 8 | 24.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 48 | 51.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 12 | 27.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 16 | 35.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 20 | 38.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 24 | 48.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 28 | 50.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 32 | 53.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 36 | 48.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 40 | 57.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 44 | 50.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 52 | 61.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 72 | 71.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 84 | 66.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 44 | 65.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 32 | 57.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 24 | 42.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 20 | 28.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 16 | 19.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 28 | 48.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 52 | 69.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 8 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 4 | 5.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 12 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 60 | 75.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 84 | 83.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 72 | 81.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 40 | 63.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 36 | 63.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 48 | 69.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-50 Response | Week 2 | 0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PPSI-75 Response
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PPSI-75 Response | Week 12 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-75 Response | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-75 Response | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-75 Response | Week 8 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-75 Response | Week 16 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 52 | 36.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 36 | 16.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 40 | 28.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 48 | 32.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 44 | 32.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 72 | 33.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 20 | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 84 | 57.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 60 | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 32 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 32 | 19.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 52 | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 40 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 84 | 45.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 44 | 23.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 28 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 48 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 36 | 19.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 72 | 37.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 60 | 30.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 40 | 22.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 48 | 33.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 4 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 12 | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 16 | 11.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 20 | 14.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 24 | 16.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 28 | 11.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 32 | 16.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 36 | 20.4 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 44 | 31.5 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 52 | 33.3 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 60 | 37.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 72 | 40.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 84 | 33.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 48 | 34.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 28 | 17.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 24 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 4 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 52 | 42.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 20 | 9.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 16 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 60 | 48.1 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 12 | 5.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 8 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 84 | 62.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 40 | 26.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 72 | 56.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 44 | 30.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 32 | 28.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-75 Response | Week 36 | 28.8 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a PPSI-90 Response
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 90 response represents participants who achieved at least a 90% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a PPSI-90 Response | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-90 Response | Week 12 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-90 Response | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-90 Response | Week 16 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a PPSI-90 Response | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 40 | 8.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 60 | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 32 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 36 | 4.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 72 | 23.8 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 84 | 28.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 48 | 16.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 52 | 20.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 44 | 12.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 40 | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 32 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 84 | 29.2 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 44 | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 28 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 60 | 15.4 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 72 | 16.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 52 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 36 | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 48 | 7.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 24 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 4 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 8 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 12 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 16 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 20 | 0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 28 | 3.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 32 | 3.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 36 | 1.9 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 40 | 5.6 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 44 | 16.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 48 | 11.1 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 52 | 16.7 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 60 | 13.0 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 72 | 22.2 Percentage of participants |
| Guselkumab 100 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 84 | 17.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 60 | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 44 | 11.5 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 16 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 12 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 84 | 32.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 48 | 17.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 8 | 1.9 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 72 | 25.0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 52 | 17.3 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 4 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 36 | 9.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 32 | 7.7 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 2 | 0 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 28 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 40 | 9.6 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 24 | 3.8 Percentage of participants |
| Guselkumab 200 mg | Percentage of Participants Who Achieved a PPSI-90 Response | Week 20 | 1.9 Percentage of participants |