A Phase 3 interventional study of Guselkumab and Fumaric Acid Esters in Psoriasis, sponsored by Janssen-Cilag G.m.b.H. Completed at 28 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Janssen-Cilag G.m.b.H · Phase 3, Interventional, and Treatment
The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 119 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Janssen-Cilag G.m.b.H is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants will receive Guselkumab 100 milligram (mg) administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) by single-use prefilled syringe (PFS) at weeks 0, 4, 12 and 20.
Drug: Guselkumab
Participants will receive Fumaderm initial/Fumaderm tablets by self administration at week 0. The individual FAE dose representing the optimal efficacy/tolerability ratio needs to be determined for each participant according to local prescription information. To this aim, FAE doses will be slowly increased beginning with increasing doses of Fumderm initial (containing 30 mg dimethylfumarate) over the first 3 weeks. Thereafter, participants will be switched to Fumaderm tablets (containing 120 mg dimethylfumarate) starting with 1 tablet per day. Fumaderm dose may be increased to a maximum of 3\*2 tablets per day. The decision to maintain, increase or decrease the FAE dose depends on efficacy, safety and tolerability.
Drug: Fumaric Acid Esters
Participants will receive 100 mg of Guselkumab as 100 mg/mL solution subcutaneously.
Participants will receive Fumaderm initial/ Fumaderm tablets through self-administration.
Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Time frame: At Week 24
Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
Time frame: At Week 24
Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
Time frame: At Week 24
Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
Time frame: At Week 24
Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24
The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (\>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score=average value\*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.
Time frame: Baseline and Week 24
Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24
The PSSD (7 day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
Time frame: Baseline and Week 24
Part I: Percentage of Participants Who Achieved an Absolute PASI Score Less Than or Equal to (=<) 1 at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. Percentage of Participants who Achieved an absolute PASI score less than or equal to (=\<) 1 were assessed.
Time frame: At Week 24
Part I: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score 0 at Week 24
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. 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: At Week 24
Part I: Change From Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24
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 24
Part I: Change From Baseline in DLQI Score at Week 24
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
Time frame: Baseline and Week 24
Part I: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of Absence of Disease (0) at Week 24
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). 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: At Week 24
Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24
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 24
Part IIb: Percentage of Participants With a PASI 75 Response at Week 32 Who Maintained Response at 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 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
Time frame: Week 56
Part IIb: Percentage of Participants With a PASI 90 Response at Week 32 Who Maintained Response at 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 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Time frame: Week 56
Part IIb: Percentage of Participants With DLQI Score of 0 or 1 at Week 32 Who Maintained Response at Week 56
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
Time frame: Week 56
Part IIb: Percentage of Participants With a PASI 75 Response at 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 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
Time frame: Week 56
Part IIb: Percentage of Participants With a PASI 90 Response at 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 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Time frame: Week 56
Part IIb: Percentage of Participants With a PASI 100 Response at 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 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
Time frame: Week 56
Part IIb: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
Time frame: Week 56
Part I/IIa: Percentage of Participants Who Achieved PASI 75 Response at Week 32
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this outcome measure (OM).
Time frame: Week 32
Part I/IIa: Percentage of Participants Who Achieved PASI 90 Response at Week 32
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
Time frame: Week 32
Part I/IIa: Percentage of Participants Who Achieved PASI 100 Response at Week 32
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
Time frame: Week 32
Part I/IIa: Percentage of Participants With a DLQI Score of 0 or 1 at Week 32
DLQI is 10-item questionnaire that measures impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on participant's life; 2-6 =small effect on participant's life; 7-12 = moderate effect on participant's life; 13-18 =very large effect on participant's life; 19-30 =extremely large effect on participant's life. Higher score indicates low quality of life due to more severe disease. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
Time frame: Week 32
Part III: Percentage of Participants With a PASI 90 Response at Week 56 Who Maintained Response (That is Who Had PASI Score <=5) at Week 100 After Drug Withdrawal
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Time frame: Week 100
Part III: Time to Loss of Response (PASI >5) From Week 56 After Guselkumab Withdrawal at Week 100
The time to loss of response from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to first onset of loss of response (PASI \>5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Time frame: Week 100
Part III: Time to PASI >3 From Week 56 After Guselkumab Withdrawal at Week 100
The time to PASI\>3 from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to PASI response that is PASI \>3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Time frame: Week 100
Part III: Time to Loss of Response (PASI >5) From Week 52 After Guselkumab Withdrawal at Week 100
The time to loss of response from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to first onset of loss of response (PASI \>5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Time frame: Week 100
Part III: Time to PASI >3 From Week 52 After Guselkumab Withdrawal at Week 100
The time to PASI\>3 from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to PASI response that is PASI \>3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Time frame: Week 100
Part III: Percentage of Participants With PASI 90 Response at Week 56 Who Maintained PASI 90 Response at Week 100 After Drug Withdrawal
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Time frame: Week 100
Part III: Percentage of Participants Who Achieved PASI 100 Response at Week 100
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
Time frame: Week 100
Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Time frame: Week 100
Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100
The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (\>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score=average value\*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.
Time frame: Baseline (Week 56) and Week 100
Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 at Week 100
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. 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 100
Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 100
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. 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 100
Part III: Change From Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100
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 (Week 56) and Week 100
Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 100
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
Time frame: Week 100
Part III: Change From Baseline in DLQI Score at Week 100
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
Time frame: Baseline (Week 56) and Week 100
Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 Who Maintained Response at Week 100
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
Time frame: Week 100
Part III: Percentage of Participants Who Achieved Ss-IGA Score of Absence of Disease (0) at Week 100 in Participants With Scalp Psoriasis and Ss-IGA Score>=2 (at Least Mild Disease) at Baseline (Week 0)
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). 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 100
Part III: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of 0 or 1 at Week 100 in Participants With Scalp Psoriasis and an Ss-IGA Score >=2 (at Least Mild Disease) at Baseline (Week 0)
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). 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 100
Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100
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; 0 = worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Time frame: Baseline (Week 56) and Week 100
Part I/IIa: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs (TEAEs) were defined as AEs that occurred during active treatment period through Week 32 after the start of initial study drug administration or AEs that were present at Baseline but worsened in severity after the start of initial study drug administration. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Time frame: Up to Week 32
Part IIb: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as those AEs that occurred during the active treatment period from Week 32 to Week 56 or the safety follow-up period from Week 56 through Week 64 or those AEs that were present before Week 32 but worsened in severity after Week 32.
Time frame: Week 32 to Week 64
Part III: Percentage of Participants With Adverse Drug Reactions (ADRs) as a Measure of Safety and Tolerability
ADRs were defined as those adverse events with causality 'very likely', 'probable', or 'possible' that occurred during the follow-up extension period from Week 64 to Week 100 or those present before Week 64 but ongoing at Week 64.
Time frame: Week 64 to Week 100
| Milestone | Guselkumab (GUS) | Fumaric Acid Esters (FAE) | FAE to Guselkumab |
|---|---|---|---|
| Started | 60 | 59 | 0 |
| Treated | 60 | 58 | 0 |
| Completed | 56 | 36 | 0 |
| Not completed | 4 | 23 | 0 |
| Withdrew: Adverse event | 0 | 16 | 0 |
| Withdrew: Lost to follow-up | 2 | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 4 | 0 |
| Withdrew: Noncompliance with study drug | 0 | 1 | 0 |
| Milestone | Guselkumab (GUS) | Fumaric Acid Esters (FAE) | FAE to Guselkumab |
|---|---|---|---|
| Started | 56 | 35 | 0 |
| Pasi 75 responder at week 32 | 54 | 14 | 0 |
| Pasi 75 non-responder at week 32 | 1 | 20 | 0 |
| Completed | 55 | 34 | 0 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Milestone | Guselkumab (GUS) | Fumaric Acid Esters (FAE) | FAE to Guselkumab |
|---|---|---|---|
| Started | 55 | 14 | 20 |
| Completed | 54 | 10 | 20 |
| Not completed | 1 | 4 | 0 |
| Withdrew: Adverse event | 0 | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 2 | 0 |
| Milestone | Guselkumab (GUS) | Fumaric Acid Esters (FAE) | FAE to Guselkumab |
|---|---|---|---|
| Started | 36 | 0 | 12 |
| Completed | 32 | 0 | 10 |
| Not completed | 4 | 0 | 2 |
| Withdrew: Prohibited medication therapy | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 2 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
| Percentage of Participants | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 | 81.7 | 13.6 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
| Percentage of Participants | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24 | 90.0 | 27.1 |
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
| Percentage of Participants | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24 | 61.7 | 16.9 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
| Percentage of Participants | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24 | 31.7 | 3.4 |
The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (\>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score=average value\*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.
| Units on a scale | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Sign score | -59.8 ± 18.3 | -39.7 ± 26.7 |
| Symptom score | -52.0 ± 22.0 | -34.0 ± 25.4 |
The PSSD (7 day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
| Units on a scale | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Itch score | -5.85 ± 2.83 | -3.90 ± 2.86 |
| Pain score | -5.07 ± 2.86 | -2.93 ± 3.12 |
| Scaling score | -6.48 ± 2.25 | -4.43 ± 3.02 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. Percentage of Participants who Achieved an absolute PASI score less than or equal to (=\<) 1 were assessed.
| Percentage of Participants | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part I: Percentage of Participants Who Achieved an Absolute PASI Score Less Than or Equal to (=<) 1 at Week 24 | 66.7 | 10.2 |
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. 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 | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part I: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score 0 at Week 24 | 51.7 | 6.8 |
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.
| Change in BSA (% points) | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part I: Change From Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24 | -18.5 ± 10.4 | -9.2 ± 11.2 |
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
| Units on a scale | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part I: Change From Baseline in DLQI Score at Week 24 | -15.2 ± 5.1 | -9.4 ± 7.2 |
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). 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).
| Percentage of Participants | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part I: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of Absence of Disease (0) at Week 24 | 48.1 | 13.2 |
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.
| Units on a scale | Part I: Guselkumab (GUS) | Part I: Fumaric Acid Esters (FAE) |
|---|---|---|
| SF-36 PCS scores | 8.0 ± 6.9 | 2.3 ± 8.2 |
| SF-36 MCS scores | 5.8 ± 10.6 | 6.5 ± 9.3 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
| Percentage of Participants | Part IIb: Guselkumab (GUS) | Part IIb: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part IIb: Percentage of Participants With a PASI 75 Response at Week 32 Who Maintained Response at Week 56 | 98.1 | 64.3 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
| Percentage of Participants | Part IIb: Guselkumab (GUS) | Part IIb: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part IIb: Percentage of Participants With a PASI 90 Response at Week 32 Who Maintained Response at Week 56 | 85.2 | 35.7 |
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
| Percentage of Participants | Part IIb: Guselkumab (GUS) | Part IIb: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part IIb: Percentage of Participants With DLQI Score of 0 or 1 at Week 32 Who Maintained Response at Week 56 | 64.8 | 21.4 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
| Percentage of Participants | Part IIb: Guselkumab (GUS) | Part IIb: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part IIb: Percentage of Participants With a PASI 75 Response at Week 56 | 98.1 | 64.3 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
| Percentage of Participants | Part IIb: Guselkumab (GUS) | Part IIb: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part IIb: Percentage of Participants With a PASI 90 Response at Week 56 | 90.7 | 50.0 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
| Percentage of Participants | Part IIb: Guselkumab (GUS) | Part IIb: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part IIb: Percentage of Participants With a PASI 100 Response at Week 56 | 53.7 | 21.4 |
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
| Percentage of Participants | Part IIb: Guselkumab (GUS) | Part IIb: Fumaric Acid Esters (FAE) |
|---|---|---|
| Part IIb: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 | 72.2 | 28.6 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this outcome measure (OM).
| Percentage of Participants | Part I/IIa: Guselkumab (GUS) | Part I/IIa: FAE |
|---|---|---|
| Part I/IIa: Percentage of Participants Who Achieved PASI 75 Response at Week 32 | 90.0 | 23.7 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
| Percentage of Participants | Part I/IIa: Guselkumab (GUS) | Part I/IIa: FAE |
|---|---|---|
| Part I/IIa: Percentage of Participants Who Achieved PASI 90 Response at Week 32 | 78.3 | 11.9 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
| Percentage of Participants | Part I/IIa: Guselkumab (GUS) | Part I/IIa: FAE |
|---|---|---|
| Part I/IIa: Percentage of Participants Who Achieved PASI 100 Response at Week 32 | 43.3 | 6.8 |
DLQI is 10-item questionnaire that measures impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on participant's life; 2-6 =small effect on participant's life; 7-12 = moderate effect on participant's life; 13-18 =very large effect on participant's life; 19-30 =extremely large effect on participant's life. Higher score indicates low quality of life due to more severe disease. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
| Percentage of Participants | Part I/IIa: Guselkumab (GUS) | Part I/IIa: FAE |
|---|---|---|
| Part I/IIa: Percentage of Participants With a DLQI Score of 0 or 1 at Week 32 | 63.3 | 16.9 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
| Percentage of Participants | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants With a PASI 90 Response at Week 56 Who Maintained Response (That is Who Had PASI Score <=5) at Week 100 After Drug Withdrawal | 47.2 | 25.0 |
The time to loss of response from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to first onset of loss of response (PASI \>5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
| Days | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Time to Loss of Response (PASI >5) From Week 56 After Guselkumab Withdrawal at Week 100 | 315 (301 to NA) | 293 (219 to 315) |
The time to PASI\>3 from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to PASI response that is PASI \>3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
| Days | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Time to PASI >3 From Week 56 After Guselkumab Withdrawal at Week 100 | 306 (227 to 308) | 226 (141 to 308) |
The time to loss of response from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to first onset of loss of response (PASI \>5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
| Days | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Time to Loss of Response (PASI >5) From Week 52 After Guselkumab Withdrawal at Week 100 | 336 (322 to NA) | 321 (251 to 350) |
The time to PASI\>3 from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to PASI response that is PASI \>3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
| Days | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Time to PASI >3 From Week 52 After Guselkumab Withdrawal at Week 100 | 334 (252 to 337) | 254 (173 to 329) |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
| Percentage of Participants | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants With PASI 90 Response at Week 56 Who Maintained PASI 90 Response at Week 100 After Drug Withdrawal | 13.9 | 8.3 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
| Percentage of Participants | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants Who Achieved PASI 100 Response at Week 100 | 5.6 | 0.0 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
| Percentage of Participants | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| PASI Score <=1 | 8.3 | 0.0 |
| PASI Score <=2 | 19.4 | 8.3 |
| PASI Score <=3 | 30.6 | 16.7 |
| PASI Score <=5 | 47.2 | 25.0 |
The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (\>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score=average value\*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.
| Units on a scale | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Symptom Score at Baseline (Week 56) | 3.4 ± 5.4 | 11.2 ± 13.2 |
| Change in Symptom score at Week 100 | 25.1 ± 24.7 | 30.7 ± 21.7 |
| Sign Score at Baseline (Week 56) | 5.4 ± 9.3 | 13.5 ± 12.9 |
| Change in Sign score at Week 100 | 29.4 ± 24.8 | 37.9 ± 28.7 |
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. 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 | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 at Week 100 | 8.3 | 0.0 |
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. 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 | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 100 | 30.6 | 16.7 |
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.
| Change in BSA (% points) | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Baseline (Week 56) | 0.9 ± 1.2 | 1.5 ± 2.1 |
| Change at Week 100 | 6.1 ± 6.3 | 9.1 ± 5.8 |
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
| Percentage of participants | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 100 | 25 | 8.3 |
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
| Units on a scale | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Baseline (Week 56) | 0.9 ± 1.3 | 3.5 ± 4.0 |
| Change at Week 100 | 5.3 ± 6.0 | 8.0 ± 5.4 |
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. 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 produces a total numeric score that can range 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. A higher score indicates a low quality of life due to more severe disease.
| Percentage of participants | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 Who Maintained Response at Week 100 | 25 | 8.3 |
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). 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).
| Percentage of participants | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants Who Achieved Ss-IGA Score of Absence of Disease (0) at Week 100 in Participants With Scalp Psoriasis and Ss-IGA Score>=2 (at Least Mild Disease) at Baseline (Week 0) | 14.7 | 8.3 |
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). 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).
| Percentage of participants | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of 0 or 1 at Week 100 in Participants With Scalp Psoriasis and an Ss-IGA Score >=2 (at Least Mild Disease) at Baseline (Week 0) | 32.4 | 25.0 |
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; 0 = worst HRQL, 100=best HRQL. Higher scores indicate better health status.
| Units on a scale | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| SF-36 PCS scores: Baseline (Week 56) | 57.8 ± 3.0 | 54.9 ± 5.5 |
| SF-36 PCS scores: Change at Week 100 | -4.3 ± 6.7 | -3.7 ± 7.0 |
| SF-36 MCS scores: Baseline (Week 56) | 53.4 ± 6.2 | 44.2 ± 11.3 |
| SF-36 MCS scores: Change at Week 100 | -2.8 ± 5.9 | -3.1 ± 5.9 |
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs (TEAEs) were defined as AEs that occurred during active treatment period through Week 32 after the start of initial study drug administration or AEs that were present at Baseline but worsened in severity after the start of initial study drug administration. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
| Percentage of Participants | Part I/IIa: Guselkumab (GUS) | Part I/IIa: FAE |
|---|---|---|
| Part I/IIa: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability | 78.3 | 98.3 |
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as those AEs that occurred during the active treatment period from Week 32 to Week 56 or the safety follow-up period from Week 56 through Week 64 or those AEs that were present before Week 32 but worsened in severity after Week 32.
| Percentage of Participants | Part IIb: Guselkumab (GUS) | Part IIb: Fumaric Acid Esters (FAE) |
|---|---|---|
| PASI75 Responders | 79.6 | 92.9 |
| PASI75 Non-responders | 0 | 70.0 |
ADRs were defined as those adverse events with causality 'very likely', 'probable', or 'possible' that occurred during the follow-up extension period from Week 64 to Week 100 or those present before Week 64 but ongoing at Week 64.
| Percentage of Participants | Part III: Guselkumab (GUS) | Part III: FAE to Guselkumab |
|---|---|---|
| Part III: Percentage of Participants With Adverse Drug Reactions (ADRs) as a Measure of Safety and Tolerability | 5.6 | 0 |
Collected over Up to Week 100. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part I/IIa (Week 0 to Week 32): Guselkumab (GUS) | 0/60 (0%) | 3/60 (5%) | 47/60 (78.3%) |
| Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE) | 0/58 (0%) | 2/58 (3.4%) | 57/58 (98.3%) |
| Part IIb (Week 32 Through Week 56): Guselkumab (GUS) | 0/55 (0%) | 3/55 (5.5%) | 43/55 (78.2%) |
| Part IIb (Week 32 Through Week 56): Fumaric Acid Esters (FAE) | 0/14 (0%) | 1/14 (7.1%) | 13/14 (92.9%) |
| Part IIb (Week 32 Through Week 56): FAE to Guselkumab | 0/20 (0%) | 2/20 (10%) | 14/20 (70%) |
| Part III (Week 64 Through Week 100): Guselkumab | 0/36 (0%) | 0/36 (0%) | 2/36 (5.6%) |
| Part III (Week 64 Through Week 100): FAE to Guselkumab | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Event | Part I/IIa (Week 0 to Week 32): Guselkumab (GUS) | Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE) | Part IIb (Week 32 Through Week 56): Guselkumab (GUS) | Part IIb (Week 32 Through Week 56): Fumaric Acid Esters (FAE) | Part IIb (Week 32 Through Week 56): FAE to Guselkumab | Part III (Week 64 Through Week 100): Guselkumab | Part III (Week 64 Through Week 100): FAE to Guselkumab |
|---|---|---|---|---|---|---|---|
| Psoriatic ArthropathyMusculoskeletal and connective tissue disorders | 0/60 | 0/58 | 0/55 | 1/14 | 0/20 | 0/36 | 0/12 |
| Myocardial InfarctionCardiac disorders | 0/60 | 0/58 | 0/55 | 0/14 | 1/20 | 0/36 | 0/12 |
| Clavicle FractureInjury, poisoning and procedural complications | 0/60 | 0/58 | 0/55 | 0/14 | 1/20 | 0/36 | 0/12 |
| TonsillitisInfections and infestations | 0/60 | 0/58 | 1/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| Limb InjuryInjury, poisoning and procedural complications | 0/60 | 0/58 | 1/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| Post Procedural HaemorrhageInjury, poisoning and procedural complications | 0/60 | 0/58 | 1/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| Radius FractureInjury, poisoning and procedural complications | 0/60 | 0/58 | 1/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| SarcoidosisImmune system disorders | 0/60 | 1/58 | 0/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| LipomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/60 | 1/58 | 0/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| Thymus EnlargementBlood and lymphatic system disorders | 1/60 | 0/58 | 0/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| Event | Part I/IIa (Week 0 to Week 32): Guselkumab (GUS) | Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE) | Part IIb (Week 32 Through Week 56): Guselkumab (GUS) | Part IIb (Week 32 Through Week 56): Fumaric Acid Esters (FAE) | Part IIb (Week 32 Through Week 56): FAE to Guselkumab | Part III (Week 64 Through Week 100): Guselkumab | Part III (Week 64 Through Week 100): FAE to Guselkumab |
|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 7/60 | 34/58 | 0/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| NasopharyngitisInfections and infestations | 25/60 | 19/58 | 28/55 | 8/14 | 8/20 | 0/36 | 0/12 |
| LymphopeniaBlood and lymphatic system disorders | 0/60 | 21/58 | 0/55 | 5/14 | 1/20 | 0/36 | 0/12 |
| FlushingVascular disorders | 0/60 | 19/58 | 0/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| Abdominal Pain UpperGastrointestinal disorders | 2/60 | 18/58 | 0/55 | 1/14 | 0/20 | 0/36 | 0/12 |
| Abdominal PainGastrointestinal disorders | 1/60 | 9/58 | 0/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| HeadacheNervous system disorders | 9/60 | 8/58 | 3/55 | 1/14 | 0/20 | 0/36 | 0/12 |
| PyelonephritisInfections and infestations | 0/60 | 0/58 | 0/55 | 2/14 | 0/20 | 0/36 | 0/12 |
| NauseaGastrointestinal disorders | 1/60 | 6/58 | 0/55 | 0/14 | 0/20 | 0/36 | 0/12 |
| PsoriasisSkin and subcutaneous tissue disorders | 2/60 | 6/58 | 0/55 | 1/14 | 1/20 | 0/36 | 0/12 |
| Age, Continuous(years) | Guselkumab (GUS) | Fumaric Acid Esters (FAE) | Total |
|---|---|---|---|
| Mean | 39 ± 13.98 | 45.8 ± 13.72 | 42.4 ± 14.2 |
| Sex: Female, Male(Participants) | Guselkumab (GUS) | Fumaric Acid Esters (FAE) | Total |
|---|---|---|---|
| Female | 20 | 17 | 37 |
| Male | 40 | 42 | 82 |
| Race (NIH/OMB)(Participants) | Guselkumab (GUS) | Fumaric Acid Esters (FAE) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 57 | 57 | 114 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Guselkumab (GUS) | Fumaric Acid Esters (FAE) | Total |
|---|---|---|---|
| Germany | 60 | 59 | 119 |
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Janssen-Cilag G.m.b.H