Psoriasis
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.
Interventions
DRUGGuselkumab
Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.
DRUGPlacebo
Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A woman of childbearing potential must have a negative urine pregnancy test (beta-human chorionic gonadotropin) at screening and at Week 0 * Before randomization, a woman must be either: a) Not of childbearing potential: premenarchal; postmenopausal (greater than \[\>\] 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle-stimulating hormone level (FSH) \>40 International Units Per Liter \[IU/L\]); permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, b) Of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/ film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant) * Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug * Have a Psoriasis Area and Severity Index (PASI) greater than or equal to \[\>=\] 12 at screening and at baseline * Have an involved body surface area (BSA) \>= 10 percent (%) at screening and at baseline
Exclusion criteria
* Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months * Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly * Has a transplanted organ (with exception of a corneal transplant \>3 months before the first administration of study drug) * Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) * Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapy within 3 months before the first administration of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | Week 16 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study. |
| Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent (%) to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16 | Week 16 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. |
| Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16 | Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with \>=50% and \>= 75% improvement in PASI from baseline were considered PASI 50 and PASI 75 responders respectively. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. |
| Percent Improvement From Baseline in PASI Score at Week 16 | Baseline and Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. |
| Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16 | Week 16 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) were considered IGA cleared responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. |
| Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval) | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders while those achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16. |
| Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval) | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with \>=50%, \>= 75%, \>=90% and \>= 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16. |
| Percent Improvement From Baseline in PASI Score Through Week 40 | Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval) | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16. |
| Percentage of Participants Who Achieve a PASI 100 Response at Week 16 | Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with 100% improvement in PASI from baseline (PASI score=0) were considered PASI 100 responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. |
Countries
Canada, Poland, United States
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. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28. | 16 |
| Guselkumab Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind. | 62 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Active Treatment and Follow up (wk16-40) | Other | 0 | 6 | 0 |
| Active Treatment and Follow up (wk16-40) | Withdrawal by Subject | 0 | 2 | 0 |
| Placebo Controlled Period(Week[wk] 0-16) | Adverse Event | 1 | 0 | 0 |
| Placebo Controlled Period(Week[wk] 0-16) | Lack of Efficacy | 2 | 0 | 0 |
| Placebo Controlled Period(Week[wk] 0-16) | Lost to Follow-up | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Guselkumab |
|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 15.7 | 46 years STANDARD_DEVIATION 13.43 | 46.2 years STANDARD_DEVIATION 12.92 |
| Age, Customized >=18 to 65 years | 14 Participants | 72 Participants | 58 Participants |
| Age, Customized >=65 years | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 75 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 13 Participants | 68 Participants | 55 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 70 Participants | 57 Participants |
| Region of Enrollment Canada | 5 Participants | 24 Participants | 19 Participants |
| Region of Enrollment Poland | 5 Participants | 25 Participants | 20 Participants |
| Region of Enrollment United States | 6 Participants | 29 Participants | 23 Participants |
| Sex: Female, Male Female | 4 Participants | 25 Participants | 21 Participants |
| Sex: Female, Male Male | 12 Participants | 53 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 62 | 0 / 13 | 0 / 61 |
| other Total, other adverse events | 12 / 16 | 38 / 62 | 8 / 13 | 24 / 61 |
| serious Total, serious adverse events | 0 / 16 | 2 / 62 | 2 / 13 | 1 / 61 |
Outcome results
Primary
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study.
Time frame: Week 16
Population: Full analysis set (FAS) included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | 0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | 80.6 Percentage of participants |
p-value: <0.001Fisher Exact
Primary
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent (%) to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Time frame: Week 16
Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | 0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | 75.8 Percentage of participants |
p-value: <0.001Fisher Exact
Secondary
Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) were considered IGA cleared responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Time frame: Week 16
Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16 | 0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16 | 56.5 Percentage of participants |
Secondary
Percentage of Participants Who Achieve a PASI 100 Response at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with 100% improvement in PASI from baseline (PASI score=0) were considered PASI 100 responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Time frame: Week 16
Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieve a PASI 100 Response at Week 16 | 0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieve a PASI 100 Response at Week 16 | 50.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with \>=50% and \>= 75% improvement in PASI from baseline were considered PASI 50 and PASI 75 responders respectively. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Time frame: Week 16
Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16 | PASI 50 responders | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16 | PASI 75 responders | 0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16 | PASI 50 responders | 93.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16 | PASI 75 responders | 88.7 Percentage of participants |
Secondary
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders while those achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.
Time frame: Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)
Population: FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Non-responder imputation was used to impute missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 20: IGA of cleared (0) or minimal (1) | 46.2 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 8: IGA of mild or better (<=2) | 12.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 12: IGA of cleared (0) | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 12: IGA of cleared (0) or minimal (1) | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 12: IGA of mild or better (<=2) | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 20: IGA of cleared (0) | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 8: IGA of cleared (0) or minimal (1) | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 20: IGA of mild or better (<=2) | 92.3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 24: IGA of cleared (0) | 38.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 24: IGA of cleared (0) or minimal (1) | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 24: IGA of mild or better (<=2) | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 28: IGA of cleared (0) | 61.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 28: IGA of cleared (0) or minimal (1) | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 28: IGA of mild or better (<=2) | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 32: IGA of cleared (0) | 69.2 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 32: IGA of cleared (0) or minimal (1) | 92.3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 32: IGA of mild or better (<=2) | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 40: IGA of cleared (0) | 61.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 40: IGA of cleared (0) or minimal (1) | 92.3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 40:IGA of mild or better (<=2) | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 4: IGA of cleared (0) | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 4: IGA of cleared (0) or minimal (1) | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 4: IGA of mild or better (<=2) | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 8: IGA of cleared (0) | 0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 4: IGA of mild or better (<=2) | 54.8 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 8: IGA of cleared (0) or minimal (1) | 56.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 28: IGA of cleared (0) or minimal (1) | 87.1 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 8: IGA of mild or better (<=2) | 85.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 40: IGA of cleared (0) or minimal (1) | 71.0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 12: IGA of cleared (0) | 35.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 28: IGA of mild or better (<=2) | 95.2 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 12: IGA of cleared (0) or minimal (1) | 67.7 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 4: IGA of cleared (0) or minimal (1) | 19.4 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 12: IGA of mild or better (<=2) | 91.9 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 32: IGA of cleared (0) | 66.1 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 20: IGA of cleared (0) | 67.7 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 40:IGA of mild or better (<=2) | 79.0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 20: IGA of cleared (0) or minimal (1) | 85.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 32: IGA of cleared (0) or minimal (1) | 82.3 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 20: IGA of mild or better (<=2) | 93.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 8: IGA of cleared (0) | 19.4 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 24: IGA of cleared (0) | 71.0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 32: IGA of mild or better (<=2) | 90.3 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 24: IGA of cleared (0) or minimal (1) | 87.1 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 4: IGA of cleared (0) | 4.8 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 24: IGA of mild or better (<=2) | 88.7 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 40: IGA of cleared (0) | 53.2 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40 | Week 28: IGA of cleared (0) | 64.5 Percentage of participants |
Secondary
Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Time frame: Week 16
Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16 | 0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16 | 93.5 Percentage of participants |
Secondary
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with \>=50%, \>= 75%, \>=90% and \>= 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)
Population: FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Non-responder imputation was used to impute missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 20: >=75% improvement | 30.8 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 8: >= 90% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 20: >=50% improvement | 69.2 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 12: >= 75% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 24: 100% improvement | 30.8 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 4: >= 50% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 24: >=90% improvement | 61.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 12: >= 50% improvement | 12.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 24: >=75% improvement | 84.6 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 8: >= 75% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 24: >=50% improvement | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 16: 100% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 28: 100% improvement | 53.8 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 4: >= 75% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 28: >=90% improvement | 84.6 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 16: >=90% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 28: >=75% improvement | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 8: >= 50% improvement | 6.3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 28: >50% improvement | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 16: >=75% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 32: 100% improvement | 61.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 8: 100% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 32: >=90% improvement | 84.6 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 16: >=50% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 32: >=75% improvement | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 12: 100% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 4: 100% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 32: >=50% improvement | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 20: 100% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 40: 100% improvement | 53.8 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 4: >= 90% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 40: >=90% improvement | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 20: >=90% improvement | 7.7 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 40: >=75% improvement | 100.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 12: >= 90% improvement | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 40: >=50% improvement | 100.0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 32: >=75% improvement | 90.3 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 4: 100% improvement | 3.2 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 4: >= 90% improvement | 4.8 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 4: >= 75% improvement | 12.9 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 4: >= 50% improvement | 33.9 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 8: 100% improvement | 16.1 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 8: >= 90% improvement | 33.9 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 8: >= 75% improvement | 56.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 8: >= 50% improvement | 80.6 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 12: 100% improvement | 30.6 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 12: >= 90% improvement | 54.8 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 12: >= 75% improvement | 77.4 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 12: >= 50% improvement | 90.3 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 16: 100% improvement | 50.0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 16: >=90% improvement | 75.8 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 16: >=75% improvement | 88.7 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 16: >=50% improvement | 93.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 20: 100% improvement | 66.1 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 20: >=90% improvement | 85.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 20: >=75% improvement | 91.9 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 20: >=50% improvement | 95.2 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 24: 100% improvement | 71.0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 24: >=90% improvement | 82.3 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 24: >=75% improvement | 88.7 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 24: >=50% improvement | 95.2 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 28: 100% improvement | 64.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 28: >=90% improvement | 85.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 28: >=75% improvement | 95.2 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 28: >50% improvement | 96.8 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 32: 100% improvement | 64.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 32: >=90% improvement | 85.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 40: >=50% improvement | 79.0 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 32: >=50% improvement | 93.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 40: 100% improvement | 53.2 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 40: >=90% improvement | 66.1 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses | Week 40: >=75% improvement | 79.0 Percentage of participants |
Secondary
Percent Improvement From Baseline in PASI Score at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
Time frame: Baseline and Week 16
Population: FAS included all randomized participants who received at least 1 injection of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Imputation was applied only for participants who met treatment failure and their missing values were counted as zero.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Improvement From Baseline in PASI Score at Week 16 | 8.72 Percent improvement | Standard Deviation 18.229 |
| Guselkumab | Percent Improvement From Baseline in PASI Score at Week 16 | 91.53 Percent improvement | Standard Deviation 16.756 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent Improvement From Baseline in PASI Score Through Week 40
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.
Time frame: Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval)
Population: FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Imputation was applied only for participants who met treatment failure and their missing values were counted as zero.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 12 | 13.76 Percent improvement | Standard Deviation 24.143 |
| Placebo | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 32 | 96.16 Percent improvement | Standard Deviation 5.602 |
| Placebo | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 24 | 88.74 Percent improvement | Standard Deviation 12.092 |
| Placebo | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 40 | 97.70 Percent improvement | Standard Deviation 3.443 |
| Placebo | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 20 | 62.65 Percent improvement | Standard Deviation 20.76 |
| Placebo | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 4 | 5.58 Percent improvement | Standard Deviation 13.97 |
| Placebo | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 28 | 95.68 Percent improvement | Standard Deviation 6.162 |
| Placebo | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 8 | 10.45 Percent improvement | Standard Deviation 21.54 |
| Guselkumab | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 28 | 96.30 Percent improvement | Standard Deviation 7.504 |
| Guselkumab | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 12 | 84.97 Percent improvement | Standard Deviation 20.52 |
| Guselkumab | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 20 | 94.77 Percent improvement | Standard Deviation 13.179 |
| Guselkumab | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 24 | 95.89 Percent improvement | Standard Deviation 10.164 |
| Guselkumab | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 8 | 71.76 Percent improvement | Standard Deviation 26.984 |
| Guselkumab | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 32 | 96.64 Percent improvement | Standard Deviation 7.143 |
| Guselkumab | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 40 | 92.47 Percent improvement | Standard Deviation 13.289 |
| Guselkumab | Percent Improvement From Baseline in PASI Score Through Week 40 | Week 4 | 40.99 Percent improvement | Standard Deviation 26.377 |