Psoriasis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.
Detailed description
The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example\[e.g\] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.
Interventions
DRUGGuselkumab
Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.
DRUGPlacebo
Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40.
DRUGSecukinumab
Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.
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
* Have a diagnosis of plaque-type psoriasis (with or without \[Psoriatic Arthritis\]PsA) for at least 6 months before the first administration of study drug * A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections * Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug * Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug * Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study
Exclusion criteria
* 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 previously received guselkumab or secukinumab * Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers * Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly * Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 | Week 48 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a PASI-90 Response at Week 12 | Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards. |
| Percentage of Participants Who Achieved a PASI-75 Response at Week 12 | Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. |
| Percentage of Participants Who Achieved a PASI-100 Response at Week 48 | Week 48 | 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline. |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48 | Week 48 | 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). |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48 | Week 48 | 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). |
| Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48 | Week 16 and 48 | Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. |
| Percentage of Participants Who Achieved 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. |
| Percentage of Participants Who Achieved a 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. |
| Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48 | Week 12 and 48 | Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16 | Week 16 | 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). |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12 | Week 12 | 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). |
| Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12 | Week 48 | 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. |
| Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16 | Week 48 | 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline. |
| Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56 | 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. |
| Percentage of Participants With IGA Responses Through Week 56 | Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56 | 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). |
| Percent Improvement From Baseline in PASI Through Week 56 | Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56 | 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. |
| Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48 | Week 24 up to Week 48 | 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported. |
Countries
Australia, Canada, Czechia, France, Germany, Hungary, Poland, Spain, United States
Participant flow
Pre-assignment details
Out of total 1,048 randomized participants, 534 were assigned to receive Guselkumab + Placebo and 514 subjects were assigned to receive Secukinumab.
Participants by arm
| Arm | Count |
|---|---|
| Guselkumab 100 mg + Placebo Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56. | 534 |
| Secukinumab 300 mg Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. | 514 |
| Total | 1,048 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 11 |
| Overall Study | Lack of Efficacy | 2 | 7 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Non-compliance | 2 | 0 |
| Overall Study | Other | 2 | 2 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Protocol Violation | 2 | 6 |
| Overall Study | Withdrawal by Subject | 7 | 19 |
Baseline characteristics
| Characteristic | Guselkumab 100 mg + Placebo | Total | Secukinumab 300 mg |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 8 Participants | 2 Participants |
| Age, Categorical >=65 years | 54 Participants | 99 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 474 Participants | 941 Participants | 467 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 13.67 | 45.8 years STANDARD_DEVIATION 13.63 | 45.3 years STANDARD_DEVIATION 13.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 63 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 502 Participants | 974 Participants | 472 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 30 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 16 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) White | 499 Participants | 979 Participants | 480 Participants |
| Region of Enrollment AUSTRALIA | 35 Participants | 71 Participants | 36 Participants |
| Region of Enrollment CANADA | 81 Participants | 158 Participants | 77 Participants |
| Region of Enrollment CZECH REPUBLIC | 27 Participants | 55 Participants | 28 Participants |
| Region of Enrollment FRANCE | 28 Participants | 58 Participants | 30 Participants |
| Region of Enrollment GERMANY | 66 Participants | 122 Participants | 56 Participants |
| Region of Enrollment HUNGARY | 25 Participants | 45 Participants | 20 Participants |
| Region of Enrollment POLAND | 119 Participants | 238 Participants | 119 Participants |
| Region of Enrollment SPAIN | 35 Participants | 68 Participants | 33 Participants |
| Region of Enrollment UNITED STATES | 118 Participants | 233 Participants | 115 Participants |
| Sex: Female, Male Female | 169 Participants | 341 Participants | 172 Participants |
| Sex: Female, Male Male | 365 Participants | 707 Participants | 342 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 534 | 0 / 511 |
| other Total, other adverse events | 249 / 534 | 254 / 511 |
| serious Total, serious adverse events | 33 / 534 | 37 / 511 |
Outcome results
Primary
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 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.
Time frame: Week 48
Population: FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 90 non-responders at Week 48.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 | 84.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 | 70.0 Percentage of participants |
p-value: <0.00195% CI: [9.2, 19.2]z-test
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved a PASI-100 Response at Week 48
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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline.
Time frame: Week 48
Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 100 non-responders at Week 48.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved a PASI-100 Response at Week 48 | 58.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved a PASI-100 Response at Week 48 | 48.4 Percentage of participants |
95% CI: [3.8, 15.5]
Secondary
Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48
Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time frame: Week 12 and 48
Population: FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 12 or 48 were considered as non-responders for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48 | 84.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48 | 80.2 Percentage of participants |
p-value: <0.00195% CI: [-0.2, 8.9]z-test
p-value: 0.062Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved a PASI-75 Response at Week 12
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time frame: Week 12
Population: FAS population included. Participants who met treatment failure criteria prior to Week 12 or who had a missing PASI score at Week 12 were considered PASI 75 non-responders at Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved a PASI-75 Response at Week 12 | 89.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved a PASI-75 Response at Week 12 | 91.6 Percentage of participants |
95% CI: [-6, 1.2]
Secondary
Percentage of Participants Who Achieved 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time frame: Week 16
Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 75 non-responders at Week 16.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved a PASI-75 Response at Week 16 | 92.7 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved a PASI-75 Response at Week 16 | 92.8 Percentage of participants |
95% CI: [-3.5, 3.1]
Secondary
Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48
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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.
Time frame: Week 24 up to Week 48
Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at any visit from Week 24 through 48 were considered as non-responders for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48 | 71.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48 | 61.5 Percentage of participants |
95% CI: [4.2, 15.3]
Secondary
Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48
Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
Time frame: Week 16 and 48
Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 16 or 48 were considered as non-responders for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48 | 72.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48 | 64.4 Percentage of participants |
95% CI: [2.3, 13.2]
Secondary
Percentage of Participants Who Achieved a PASI-90 Response at Week 12
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.
Time frame: Week 12
Population: FAS population included. Participants who met treatment failure criteria prior to Week 12, who had a missing PASI score at Week 12 were considered PASI 90 non-responders at Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved a PASI-90 Response at Week 12 | 69.1 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved a PASI-90 Response at Week 12 | 76.1 Percentage of participants |
95% CI: [-12.2, -1.7]
Secondary
Percentage of Participants Who Achieved a 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
Time frame: Week 16
Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 90 non-responders at Week 16.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved a PASI-90 Response at Week 16 | 78.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved a PASI-90 Response at Week 16 | 79.6 Percentage of participants |
95% CI: [-6.2, 3.4]
Secondary
Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time frame: Week 48
Population: Full analysis set included all the participants randomized at Week 0 and who achieved PASI 75 response at Week 12. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12 | 94.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12 | 87.5 Percentage of participants |
Secondary
Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders 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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.
Time frame: Week 48
Population: Full analysis set included all the participants randomized at Week 0 and who achieved PASI-90 response at Week 16. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16 | 92.1 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16 | 80.9 Percentage of participants |
Secondary
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56
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.
Time frame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing PASI score were considered as non-responders for the specific visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 36: >=75% improvement | 93.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 56: 100% improvement | 50.4 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 1: 100% improvement | 0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 1: >=90% improvement | 0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 1: >=75% improvement | 2.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 1: >=50% improvement | 10.7 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 2: 100% improvement | 0.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 2: >=90% improvement | 1.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 2: >=75% improvement | 6.4 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 2: >=50% improvement | 30.9 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 3: 100% improvement | 1.7 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 3: >=90% improvement | 5.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 3: >=75% improvement | 19.5 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 3: >=50% improvement | 56.4 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 4: 100% improvement | 4.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 4: >=90% improvement | 13.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 4: >=75% improvement | 39.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 4: >=50% improvement | 73.4 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 8: 100% improvement | 20.0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 8: >=90% improvement | 48.7 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 8: >=75% improvement | 76.4 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 8: >=50% improvement | 95.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 12: 100% improvement | 37.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 12: >=90% improvement | 69.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 12: >=75% improvement | 89.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 12: >=50% improvement | 96.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 16: 100% improvement | 47.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 16: >=90% improvement | 78.5 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 16: >=75% improvement | 92.7 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 16: >=50% improvement | 97.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 20: 100% improvement | 51.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 20: >=90% improvement | 80.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 20: >=75% improvement | 93.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 20: >=50% improvement | 97.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 24: 100% improvement | 54.7 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 24: >=90% improvement | 83.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 24: >=75% improvement | 94.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 24: >=50% improvement | 97.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 28: 100% improvement | 57.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 28: >=90% improvement | 85.4 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 28: >=75% improvement | 94.0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 28: >=50% improvement | 97.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 32: 100% improvement | 57.5 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 32:>=90 % improvement | 84.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 32: >=75% improvement | 94.0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 32: >=50% improvement | 97.0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 36: 100% improvement | 58.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 36: >=90% improvement | 84.5 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 36: >=50% improvement | 97.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 40: 100% improvement | 58.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 40: >=90% improvement | 84.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 40: >=75% improvement | 92.9 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 40: >=50% improvement | 95.9 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 44: 100% improvement | 58.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 44: >=90% improvement | 84.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 44: >=75% improvement | 92.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 44: >=50% improvement | 94.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 48: 100% improvement | 58.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 48: >=90% improvement | 84.5 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 48: >=75% improvement | 92.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 48: >=50% improvement | 94.0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 56: >=90% improvement | 77.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 56: >=75% improvement | 88.0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 56: >=50% improvement | 91.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 36: >=75% improvement | 87.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 28: 100% improvement | 51.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 40: >=50% improvement | 90.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 44: >=90% improvement | 72.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 20: >=75% improvement | 92.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 44: >=50% improvement | 91.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 20: >=50% improvement | 95.1 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 1: >=90% improvement | 0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 36: >=50% improvement | 92.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 1: >=75% improvement | 1.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 24: 100% improvement | 50.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 1: >=50% improvement | 12.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 56: 100% improvement | 27.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 2: 100% improvement | 0.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 24: >=90% improvement | 78.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 2: >=90% improvement | 2.7 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 40: 100% improvement | 48.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 2: >=75% improvement | 11.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 24: >=75% improvement | 90.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 2: >=50% improvement | 42.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 48: 100% improvement | 48.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 3: 100% improvement | 1.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 24: >=50% improvement | 93.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 3: >=90% improvement | 8.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 40: >=90% improvement | 73.7 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 3: >=75% improvement | 28.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 56: >=75% improvement | 70.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 3: >=50% improvement | 66.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 28: >=90% improvement | 77.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 4: 100% improvement | 5.1 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 40: >=75% improvement | 85.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 4: >=90% improvement | 21.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 28: >=75% improvement | 90.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 4: >=75% improvement | 50.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 48: >=90% improvement | 70.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 4: >=50% improvement | 85.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 28: >=50% improvement | 93.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 8: 100% improvement | 27.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 56: >=90% improvement | 51.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 8: >=90% improvement | 62.1 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 32: 100% improvement | 50.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 8: >=75% improvement | 86.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 44: 100% improvement | 49.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 8: >=50% improvement | 96.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 32:>=90 % improvement | 77.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 12: 100% improvement | 42.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 48: >=75% improvement | 83.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 12: >=90% improvement | 76.1 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 32: >=75% improvement | 89.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 12: >=75% improvement | 91.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 56: >=50% improvement | 82.1 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 12: >=50% improvement | 96.1 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 32: >=50% improvement | 93.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 16: 100% improvement | 46.1 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 44: >=75% improvement | 85.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 16: >=90% improvement | 79.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 36: 100% improvement | 50.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 16: >=75% improvement | 92.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 48: >=50% improvement | 89.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 16: >=50% improvement | 96.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 36: >=90% improvement | 75.7 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 20: 100% improvement | 48.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 1: 100% improvement | 0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | Week 20: >=90% improvement | 81.1 Percentage of participants |
Secondary
Percentage of Participants With IGA Responses Through Week 56
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).
Time frame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing IGA score were considered as non-responders for the specific visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 4: mild or better (=<2) | 85.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 20: cleared (0) | 56.9 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 1: cleared (0) | 0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 1: cleared (0) or minimal (1) | 3.4 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 1: mild or better (=<2) | 27.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 2: cleared (0) or minimal (1) | 12.4 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 2: mild or better (=<2) | 54.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 3: cleared (0) | 2.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 3: cleared (0) or minimal (1) | 27.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 3: mild or better (=<2) | 75.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 4: cleared (0) | 6.7 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 4: cleared (0) or minimal (1) | 44.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 2: cleared (0) | 0.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 8: cleared (0) | 29.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 8: cleared (0) or minimal (1) | 76.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 8: mild or better (=<2) | 96.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 12: cleared (0) | 46.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 12: cleared (0) or minimal (1) | 85.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 12: mild or better (=<2) | 96.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 16: cleared (0) | 55.4 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 16: mild or better (=<2) | 96.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 16: cleared (0) or minimal (1) | 86.7 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 20: cleared (0) or minimal (1) | 87.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 20: mild or better (=<2) | 95.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 24: cleared (0) | 61.0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 24: cleared (0) or minimal (1) | 88.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 24: mild or better (=<2) | 96.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 28: cleared (0) | 62.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 28: cleared (0) or minimal (1) | 87.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 28: mild or better (<=2) | 95.5 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 32: cleared (0) | 63.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 32: cleared (0) or minimal (1) | 88.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 32: mild or better (=<2) | 95.5 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 36: cleared (0) | 60.7 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 36: cleared (0) or minimal (1) | 86.5 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 36: mild or better (=<2) | 95.5 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 40: cleared (0) | 63.1 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 40: cleared (0) or minimal (1) | 86.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 40: mild or better (=<2) | 93.6 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 44: cleared (0) | 62.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 44: cleared (0) or minimal (1) | 86.0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 44: mild or better (=<2) | 92.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 48: cleared (0) | 62.2 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 48: cleared (0) or minimal (1) | 85.0 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 48: mild or better (=<2) | 92.7 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 56: cleared (0) | 54.3 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 56: cleared (0) or minimal (1) | 78.8 Percentage of participants |
| Guselkumab 100 mg + Placebo | Percentage of Participants With IGA Responses Through Week 56 | Week 56: mild or better (=<2) | 87.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 56: cleared (0) or minimal (1) | 58.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 2: cleared (0) | 0.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 16: cleared (0) or minimal (1) | 86.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 24: cleared (0) | 56.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 40: cleared (0) | 52.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 1: cleared (0) | 0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 24: cleared (0) or minimal (1) | 82.7 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 1: cleared (0) or minimal (1) | 2.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 48: cleared (0) | 50.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 1: mild or better (=<2) | 34.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 24: mild or better (=<2) | 91.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 2: cleared (0) or minimal (1) | 20.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 40: cleared (0) or minimal (1) | 78.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 2: mild or better (=<2) | 63.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 28: cleared (0) | 56.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 3: cleared (0) | 3.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 56: cleared (0) | 29.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 3: cleared (0) or minimal (1) | 39.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 28: cleared (0) or minimal (1) | 82.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 3: mild or better (=<2) | 82.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 40: mild or better (=<2) | 87.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 4: cleared (0) | 9.7 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 28: mild or better (<=2) | 90.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 4: cleared (0) or minimal (1) | 59.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 48: cleared (0) or minimal (1) | 74.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 4: mild or better (=<2) | 92.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 32: cleared (0) | 54.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 8: cleared (0) | 35.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 44: cleared (0) | 51.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 8: cleared (0) or minimal (1) | 83.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 32: cleared (0) or minimal (1) | 81.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 8: mild or better (=<2) | 96.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 56: mild or better (=<2) | 76.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 12: cleared (0) | 50.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 32: mild or better (=<2) | 90.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 12: cleared (0) or minimal (1) | 86.4 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 44: cleared (0) or minimal (1) | 76.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 12: mild or better (=<2) | 95.3 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 36: cleared (0) | 53.7 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 16: cleared (0) | 53.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 48: mild or better (=<2) | 86.8 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 16: mild or better (=<2) | 94.7 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 36: cleared (0) or minimal (1) | 79.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 20: cleared (0) | 53.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 44: mild or better (=<2) | 87.5 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 20: cleared (0) or minimal (1) | 85.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 36: mild or better (=<2) | 88.9 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With IGA Responses Through Week 56 | Week 20: mild or better (=<2) | 93.2 Percentage of participants |
Secondary
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48
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).
Time frame: Week 48
Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) non-responders at Week 48.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48 | 62.2 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48 | 50.4 Percentage of participants |
95% CI: [5.8, 17.4]
Secondary
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12
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).
Time frame: Week 12
Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 12 or who had a missing IGA score at Week 12 were considered non-responders for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12 | 85.6 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12 | 86.4 Percentage of participants |
95% CI: [-5, 3.3]
Secondary
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16
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).
Time frame: Week 16
Population: Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing IGA score at Week 16 were considered non-responders for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16 | 86.7 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16 | 86.6 Percentage of participants |
95% CI: [-4.2, 3.9]
Secondary
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48
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).
Time frame: Week 48
Population: FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) or minimal (1) non-responders at Week 48.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guselkumab 100 mg + Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48 | 85.0 Percentage of participants |
| Secukinumab 300 mg | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48 | 74.9 Percentage of participants |
95% CI: [4.9, 14.5]
Secondary
Percent Improvement From Baseline in PASI Through Week 56
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%-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 could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Time frame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56
Population: Full analysis set included all the participants randomized at Week 0. Here 'n' signifies the number of participants analyzed at specified point. Zero percent improvement was assigned from the point when participants met treatment failure criteria and no other data imputation was applied.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 1 | 20.30 Percent improvement | Standard Deviation 20.743 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 2 | 37.85 Percent improvement | Standard Deviation 23.567 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 3 | 52.76 Percent improvement | Standard Deviation 24.186 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 4 | 64.63 Percent improvement | Standard Deviation 22.862 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 8 | 84.36 Percent improvement | Standard Deviation 17.278 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 12 | 90.85 Percent improvement | Standard Deviation 14.484 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 16 | 93.65 Percent improvement | Standard Deviation 12.849 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 20 | 94.35 Percent improvement | Standard Deviation 11.525 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 24 | 95.27 Percent improvement | Standard Deviation 9.848 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 28 | 95.58 Percent improvement | Standard Deviation 9.663 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 32 | 95.74 Percent improvement | Standard Deviation 9.336 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 36 | 95.45 Percent improvement | Standard Deviation 11.119 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 40 | 95.78 Percent improvement | Standard Deviation 10.456 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 44 | 95.45 Percent improvement | Standard Deviation 12.293 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 48 | 95.76 Percent improvement | Standard Deviation 11.629 |
| Guselkumab 100 mg + Placebo | Percent Improvement From Baseline in PASI Through Week 56 | Week 56 | 93.35 Percent improvement | Standard Deviation 16.116 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 56 | 81.67 Percent improvement | Standard Deviation 27.627 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 1 | 24.72 Percent improvement | Standard Deviation 20.711 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 24 | 93.75 Percent improvement | Standard Deviation 14.314 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 2 | 44.56 Percent improvement | Standard Deviation 23.6 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 40 | 91.77 Percent improvement | Standard Deviation 17.733 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 3 | 60.57 Percent improvement | Standard Deviation 21.871 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 28 | 92.96 Percent improvement | Standard Deviation 16.835 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 4 | 72.80 Percent improvement | Standard Deviation 19.478 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 48 | 90.87 Percent improvement | Standard Deviation 19.181 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 8 | 89.40 Percent improvement | Standard Deviation 13.579 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 32 | 92.95 Percent improvement | Standard Deviation 16.641 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 12 | 92.60 Percent improvement | Standard Deviation 13.703 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 44 | 91.34 Percent improvement | Standard Deviation 18.246 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 16 | 93.94 Percent improvement | Standard Deviation 12.123 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 36 | 92.40 Percent improvement | Standard Deviation 17.125 |
| Secukinumab 300 mg | Percent Improvement From Baseline in PASI Through Week 56 | Week 20 | 94.41 Percent improvement | Standard Deviation 12.152 |