An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.

Time frame: Week 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Time frame: Week 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.

Time frame: Baseline and Week 48

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).

Time frame: Baseline and Week 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).

Time frame: Baseline and Weeks 28, 48

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Time frame: Baseline and Week 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Time frame: Baseline and Weeks 28, 48

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

Time frame: Baseline and Week 16

Population: Population included participants randomized at Week 0 and with nail psoriasis at baseline.

NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

Time frame: Baseline and Weeks 28, 36, 48, 52

Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with nail psoriasis at baseline.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

Time frame: Baseline and Week 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

Time frame: Baseline and Weeks 8

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

Time frame: Baseline and Weeks 28, 36, 48, 52

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Time frame: Baseline and Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Time frame: Baseline and Weeks 2, 4, 8, 12, 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.

Time frame: Baseline and Weeks 28, 48

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.

Time frame: Baseline and Week 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.

Time frame: Baseline and Weeks 28, 36, 48, 52

Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here 'n' signifies the number of participants analyzed for specified category.

Change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.

Time frame: Baseline and Weeks 4, 8, 16

Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.

Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Week 16 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.

Time frame: Baseline and Week 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment. Here 'n' (number analyzed) signifies the number of participants analyzed for specified category.

Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Weeks 28 and 48 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.

Time frame: Baseline and Weeks 28, 48

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment. Here 'n' signifies the number of participants analyzed for specified category.

ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

Time frame: Weeks 28, 36, 48, and 52

Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening.

ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

Time frame: Weeks 4, 8, and 16

Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.

HAQ-DI response was defined as change of less than or equal to (\<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).

Time frame: Weeks 28, 36, 48, 52

Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening.

HAQ-DI response was defined as change of less than or equal to (\<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).

Time frame: Weeks 4, 8, and 16

Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.

Time frame: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.

Time frame: Weeks 2, 4, 8, 12, and 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

Time frame: Week 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

Time frame: Week 16

Population: Population included participants randomized at Week 0 and with baseline ss-IGA score \>= 2.

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

Time frame: Week 28, 48 and 52

Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline ss-IGA score \>= 2

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

Time frame: Weeks 28, 36, 48, and 52

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

Time frame: Weeks 8 and 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

Time frame: Weeks 28, 36, 48, and 52

Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline DLQI \<=1.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

Time frame: Weeks 8 and 16

Population: Population included participants randomized at Week 0 and with baseline DLQI \> 1.

The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Time frame: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Time frame: Weeks 2, 4, 8, 12, and 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of \>= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

Time frame: Week 28, 48 and 52

Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline ss-IGA score \>= 2.

The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of \>= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

Time frame: Week 16

Population: Population included participants randomized at Week 0 and with baseline ss-IGA score \>= 2.

NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

Time frame: Baseline and Week 16

Population: Population included participants randomized at Week 0 and with nail psoriasis at baseline.

NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

Time frame: Baseline and Weeks 28, 36, 48, 52

Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with nail psoriasis at baseline.

Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 28, 36, 48 and 52 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).

Time frame: Baseline and Weeks 28, 36, 48, 52

Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 4, 8 and 16 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 millimeter (mm) (no pain) to 100 mm (the worst pain imaginable).

Time frame: Baseline and Weeks 4, 8, 16

Population: Population included randomized participants at Week 0 and who had diagnosis of PsA at screening. Participants were analyzed according to assigned treatment they were randomized to, regardless of treatment they actually received. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from very well (0 cm) to very poor (10 cm).

Time frame: Baseline and Weeks 28, 36, 48, 52

Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from very well (0 centimeter \[cm\]) to very poor (10 cm).

Time frame: Baseline and Weeks 4, 8, 16

Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Time frame: Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52

Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Time frame: Baseline and Weeks 2, 4, 8, 12, 16

Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.

Percent change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.

Time frame: Weeks 28, 36, 48, and 52

Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here 'n' signifies the number of participants analyzed for specified category.

Percent change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.

Time frame: Weeks 4, 8, and 16

Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening. Here 'n' (number analyzed) signifies the number of participants analyzed for specified category.