Psoriasis
Conditions
Keywords
ABBV-0066, BI 655066, risankizumab
Brief summary
The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.
Detailed description
The efficacy analysis was performed in the Intent to Treat (ITT) set which included all participants who were randomized. The safety analysis was performed in the safety set which included all participants who received at least one dose of study drug. No participants were excluded from the efficacy analysis. Three participants in the FUMADERM® group discontinued after randomization prior to receiving any study drug and were thus not included in the safety set.
Interventions
DRUGFumaderm
Fumaderm tablet administered orally
DRUGrisankizumab
Risankizumab administered by subcutaneous (SC) injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant * Participant has stable moderate to severe plaque psoriasis (body surface area \[BSA\] \>10, Psoriasis Area and Severity Index \[PASI\] \>10, and Dermatology Quality of Life Index \[DLQI\] \>10) with or without psoriatic arthritis at Baseline * Must be naïve to and candidate for systemic therapy, as assessed by the investigator * Participant has an inadequate response, intolerance or contraindication to topical psoriasis treatment
Exclusion criteria
* Participants with non-plaque forms of psoriasis * Participant has previously received systemic therapy for psoriasis, whether biologic or non-biologic or photochemotherapy * Active systemic infection during the last 2 weeks (exception: common cold) prior to screening. * Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix * Participant has any condition or contraindication to Fumaderm that would preclude the patient's participation in the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24 | Week 24 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8 | Week 8 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12 | Week 12 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16 | Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20 | Week 20 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24 | Week 24 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4 | Week 4 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8 | Week 8 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12 | Week 12 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20 | Week 20 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24 | Week 24 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4 | Week 4 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8 | Week 8 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12 | Week 12 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16 | Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20 | Week 20 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4 | Week 4 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8 | Week 8 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12 | Week 12 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16 | Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20 | Week 20 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24 | Week 24 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4 | Baseline, Week 4 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data. |
| PASI: Change From Baseline to Week 8 | Baseline, Week 8 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data. |
| PASI: Change From Baseline to Week 12 | Baseline, Week 12 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data. |
| PASI: Change From Baseline to Week 16 | Baseline, Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data. |
| PASI: Change From Baseline to Week 20 | Baseline, Week 20 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data. |
| PASI: Change From Baseline to Week 24 | Baseline, Week 24 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data. |
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4 | Week 4 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8 | Week 8 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 | Week 12 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 | Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20 | Week 20 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24 | Week 24 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear at Week 4 | Week 4 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear at Week 8 | Week 8 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear at Week 12 | Week 12 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear at Week 16 | Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear at Week 20 | Week 20 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear at Week 24 | Week 24 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16 | Week 16 | The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data. |
| Percentage of Participants With PSS Score of 0 at Week 24 | Week 24 | The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data. |
| PSS Total Score: Change From Baseline to Week 16 | Baseline, Week 16 | The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data. |
| PSS Total Score: Change From Baseline to Week 24 | Baseline, Week 24 | The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data. |
| Summary of Patient Benefit Index (PBI) at Week 16 | Baseline, Week 16 | The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire \[PNQ\]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire \[PBQ\]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for did not apply to me (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data. |
| Summary of PBI at Week 24 | Baseline Week 24 | The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for did not apply to me (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data. |
| Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16 | Baseline, Week 16 | The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data. |
| NAPPA-CLIN Total Score: Change From Baseline to Week 24 | Baseline, Week 24 | The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data. |
| Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16 | Baseline, Week 16 | The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data. |
| PPASI: Change From Baseline to Week 24 | Baseline, Week 24 | The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data. |
| Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4 | Baseline, Week 4 | BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data. |
| BSA Affected by Psoriasis: Change From Baseline to Week 8 | Baseline, Week 8 | BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data. |
| BSA Affected by Psoriasis: Change From Baseline to Week 12 | Baseline, Week 12 | BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data. |
| BSA Affected by Psoriasis: Change From Baseline to Week 16 | Baseline, Week 16 | BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data. |
| BSA Affected by Psoriasis: Change From Baseline to Week 20 | Baseline, Week 20 | BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data. |
| BSA Affected by Psoriasis: Change From Baseline to Week 24 | Baseline, Week 24 | BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data. |
| HADS Total Score-Depression: Change From Baseline to Week 24 | Baseline, Week 24 | The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data. |
| Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16 | Baseline, Week 16 | The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data. |
| SF-36 V2 PCS Score: Change From Baseline to Week 24 | Baseline, Week 24 | The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data. |
| SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16 | Baseline, Week 16 | The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data. |
| SF-36 V2 MCS Score: Change From Baseline to Week 24 | Baseline, Week 24 | The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data. |
| Patient's Global Assessment (PtGA): Change From Baseline to Week 16 | Baseline, Week 16 | The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (complete disease control) to 3 (uncontrolled disease). LOCF imputation was used for missing data. |
| PtGA: Change From Baseline to Week 24 | Baseline, Week 24 | The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (complete disease control) to 3 (uncontrolled disease). LOCF imputation was used for missing data. |
| Hospital Anxiety & Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16 | Baseline, Week 16 | The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data. |
| HADS Total Score-Anxiety: Change From Baseline to Week 24 | Baseline, Week 24 | The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data. |
| HADS Total Score-Depression: Change From Baseline to Week 16 | Baseline, Week 16 | The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data. |
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Week 16 | The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data. |
| Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24 | Week 24 | The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data. |
| DLQI Total Score: Change From Baseline to Week 16 | Baseline, Week 16 | The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data. |
| DLQI: Change From Baseline to Week 24 | Baseline, Week 24 | The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data. |
| Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4 | Week 4 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| PSSI: Change From Baseline at Week 24 | Baseline, Week 24 | The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data. |
| European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16 | Baseline, Week 16 | The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data. |
| EQ-5D-5L Total Score: Change From Baseline to Week 24 | Baseline, Week 24 | The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data. |
| EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16 | Baseline, Week 16 | The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data. |
| EQ-5D-5L VAS: Change From Baseline to Week 24 | Baseline, Week 24 | The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data. |
| Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16 | Baseline, Week 16 | The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data. |
| NAPSI: Change From Baseline to Week 24 | Baseline, Week 24 | The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data. |
| Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16 | Baseline, Week 16 | The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data. |
| Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24 | Baseline, Week 24 | The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data. |
| Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16 | Baseline, Week 16 | The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data. |
Countries
Germany
Participant flow
Recruitment details
Intent-to-treat (ITT) analysis set included all participants enrolled in the study (N = 120). Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 117).
Pre-assignment details
A total of 120 participants were enrolled and included in the ITT population; 3 randomized participants discontinued prior to receiving any study drug and were excluded from the safety population.
Participants by arm
| Arm | Count |
|---|---|
| Fumaderm Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows. | 60 |
| Risankizumab Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16. | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Other | 6 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Risankizumab | Total | Fumaderm |
|---|---|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 13.75 | 42.3 years STANDARD_DEVIATION 13.18 | 42.5 years STANDARD_DEVIATION 12.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 119 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 119 Participants | 60 Participants |
| Sex: Female, Male Female | 27 Participants | 49 Participants | 22 Participants |
| Sex: Female, Male Male | 33 Participants | 71 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 60 |
| other Total, other adverse events | 54 / 57 | 45 / 60 |
| serious Total, serious adverse events | 2 / 57 | 1 / 60 |
Outcome results
Primary
Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
Time frame: Week 24
Population: Intent to Treat (ITT) analysis set: all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24 | 10.0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24 | 83.3 percentage of participants |
Comparison: P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [61.3, 85.3]Cochran-Mantel-Haenszel
Secondary
Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4
BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 4
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4 | -0.3 percentage estimated body surface area | Standard Error 0.86 |
| Risankizumab | Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4 | -5.2 percentage estimated body surface area | Standard Error 0.86 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-6.9, -2.7]ANCOVA
Secondary
BSA Affected by Psoriasis: Change From Baseline to Week 12
BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 12
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | BSA Affected by Psoriasis: Change From Baseline to Week 12 | -6.0 percentage estimated body surface area | Standard Error 1.22 |
| Risankizumab | BSA Affected by Psoriasis: Change From Baseline to Week 12 | -16.2 percentage estimated body surface area | Standard Error 1.23 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-13.2, -7.2]ANCOVA
Secondary
BSA Affected by Psoriasis: Change From Baseline to Week 16
BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | BSA Affected by Psoriasis: Change From Baseline to Week 16 | -8.2 percentage estimated body surface area | Standard Error 1.22 |
| Risankizumab | BSA Affected by Psoriasis: Change From Baseline to Week 16 | -18.0 percentage estimated body surface area | Standard Error 1.22 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-12.8, -6.8]ANCOVA
Secondary
BSA Affected by Psoriasis: Change From Baseline to Week 20
BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 20
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | BSA Affected by Psoriasis: Change From Baseline to Week 20 | -9.7 percentage estimated body surface area | Standard Error 1.13 |
| Risankizumab | BSA Affected by Psoriasis: Change From Baseline to Week 20 | -19.3 percentage estimated body surface area | Standard Error 1.13 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-12.4, -6.8]ANCOVA
Secondary
BSA Affected by Psoriasis: Change From Baseline to Week 24
BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | BSA Affected by Psoriasis: Change From Baseline to Week 24 | -9.8 percentage estimated body surface area | Standard Error 1.19 |
| Risankizumab | BSA Affected by Psoriasis: Change From Baseline to Week 24 | -19.8 percentage estimated body surface area | Standard Error 1.19 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-12.9, -7.1]ANCOVA
Secondary
BSA Affected by Psoriasis: Change From Baseline to Week 8
BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 8
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | BSA Affected by Psoriasis: Change From Baseline to Week 8 | -3.5 percentage estimated body surface area | Standard Error 1.33 |
| Risankizumab | BSA Affected by Psoriasis: Change From Baseline to Week 8 | -12.8 percentage estimated body surface area | Standard Error 1.33 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-12.6, -6.1]ANCOVA
Secondary
Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16
The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16 | -0.4 units on a scale | Standard Error 0.51 |
| Risankizumab | Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16 | -2.7 units on a scale | Standard Error 0.51 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-3.6, -1.1]ANCOVA
Secondary
DLQI: Change From Baseline to Week 24
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | DLQI: Change From Baseline to Week 24 | -11.2 units on a scale | Standard Error 0.87 |
| Risankizumab | DLQI: Change From Baseline to Week 24 | -18.8 units on a scale | Standard Error 0.87 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-9.7, -5.5]ANCOVA
Secondary
DLQI Total Score: Change From Baseline to Week 16
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | DLQI Total Score: Change From Baseline to Week 16 | -9.7 units on a scale | Standard Error 0.94 |
| Risankizumab | DLQI Total Score: Change From Baseline to Week 16 | -17.0 units on a scale | Standard Error 0.94 |
Comparison: P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.p-value: <0.00195% CI: [-9.6, -5.1]ANCOVA
Secondary
EQ-5D-5L Total Score: Change From Baseline to Week 24
The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | EQ-5D-5L Total Score: Change From Baseline to Week 24 | 0.106 units on a scale | Standard Error 0.0155 |
| Risankizumab | EQ-5D-5L Total Score: Change From Baseline to Week 24 | 0.165 units on a scale | Standard Error 0.0152 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: 0.00295% CI: [0.022, 0.096]ANCOVA
Secondary
EQ-5D-5L VAS: Change From Baseline to Week 24
The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | EQ-5D-5L VAS: Change From Baseline to Week 24 | 11.6 units on a scale | Standard Error 2.29 |
| Risankizumab | EQ-5D-5L VAS: Change From Baseline to Week 24 | 28.4 units on a scale | Standard Error 2.23 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [11.4, 22.2]ANCOVA
Secondary
EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16
The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16 | 11.0 units on a scale | Standard Error 2.32 |
| Risankizumab | EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16 | 26.0 units on a scale | Standard Error 2.28 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [9.4, 20.5]ANCOVA
Secondary
European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16
The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16 | 0.083 units on a scale | Standard Error 0.0179 |
| Risankizumab | European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16 | 0.171 units on a scale | Standard Error 0.0176 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [0.045, 0.13]ANCOVA
Secondary
HADS Total Score-Anxiety: Change From Baseline to Week 24
The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | HADS Total Score-Anxiety: Change From Baseline to Week 24 | -1.8 units on a scale | Standard Error 0.49 |
| Risankizumab | HADS Total Score-Anxiety: Change From Baseline to Week 24 | -4.0 units on a scale | Standard Error 0.48 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-3.5, -1.1]ANCOVA
Secondary
HADS Total Score-Depression: Change From Baseline to Week 16
The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | HADS Total Score-Depression: Change From Baseline to Week 16 | -1.8 units on a scale | Standard Error 0.5 |
| Risankizumab | HADS Total Score-Depression: Change From Baseline to Week 16 | -4.9 units on a scale | Standard Error 0.5 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-4.3, -1.9]ANCOVA
Secondary
HADS Total Score-Depression: Change From Baseline to Week 24
The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | HADS Total Score-Depression: Change From Baseline to Week 24 | -1.7 units on a scale | Standard Error 0.54 |
| Risankizumab | HADS Total Score-Depression: Change From Baseline to Week 24 | -4.8 units on a scale | Standard Error 0.53 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-4.4, -1.8]ANCOVA
Secondary
Hospital Anxiety & Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16
The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Hospital Anxiety & Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16 | -2.2 units on a scale | Standard Error 0.48 |
| Risankizumab | Hospital Anxiety & Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16 | -4.3 units on a scale | Standard Error 0.47 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-3.2, -0.9]ANCOVA
Secondary
Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16
The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16 | -2.2 units on a scale | Standard Error 2.13 |
| Risankizumab | Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16 | -13.6 units on a scale | Standard Error 2.14 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.p-value: <0.00195% CI: [-16.6, -6.2]ANCOVA
Secondary
NAPPA-CLIN Total Score: Change From Baseline to Week 24
The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | NAPPA-CLIN Total Score: Change From Baseline to Week 24 | -0.7 units on a scale | Standard Error 0.53 |
| Risankizumab | NAPPA-CLIN Total Score: Change From Baseline to Week 24 | -3.7 units on a scale | Standard Error 0.54 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-4.3, -1.6]ANCOVA
Secondary
NAPSI: Change From Baseline to Week 24
The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | NAPSI: Change From Baseline to Week 24 | -4.4 units on a scale | Standard Error 2.18 |
| Risankizumab | NAPSI: Change From Baseline to Week 24 | -18.1 units on a scale | Standard Error 2.19 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.p-value: <0.00195% CI: [-19.1, -8.4]ANCOVA
Secondary
Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16
The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16 | -0.76 units on a scale | Standard Error 0.251 |
| Risankizumab | Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16 | -1.04 units on a scale | Standard Error 0.249 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: 0.35295% CI: [-0.9, 0.32]ANCOVA
Secondary
Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16
The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16 | -4.2 units on a scale | Standard Error 3.11 |
| Risankizumab | Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16 | -21.4 units on a scale | Standard Error 2.86 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.p-value: <0.00195% CI: [-24.8, -9.8]ANCOVA
Secondary
Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24
The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24 | -6.0 units on a scale | Standard Error 3.03 |
| Risankizumab | Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24 | -27.5 units on a scale | Standard Error 2.79 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.p-value: <0.00195% CI: [-28.8, -14.2]ANCOVA
Secondary
PASI: Change From Baseline to Week 12
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time frame: Baseline, Week 12
Population: ITT analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PASI: Change From Baseline to Week 12 | -7.69 units on a scale | Standard Error 0.788 |
| Risankizumab | PASI: Change From Baseline to Week 12 | -16.49 units on a scale | Standard Error 0.793 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-10.72, -6.87]ANCOVA
Secondary
PASI: Change From Baseline to Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PASI: Change From Baseline to Week 16 | -9.11 units on a scale | Standard Error 0.777 |
| Risankizumab | PASI: Change From Baseline to Week 16 | -16.89 units on a scale | Standard Error 0.782 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-9.68, -5.88]ANCOVA
Secondary
PASI: Change From Baseline to Week 20
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time frame: Baseline, Week 20
Population: ITT analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PASI: Change From Baseline to Week 20 | -9.46 units on a scale | Standard Error 0.894 |
| Risankizumab | PASI: Change From Baseline to Week 20 | -17.35 units on a scale | Standard Error 0.899 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-10.07, -5.71]ANCOVA
Secondary
PASI: Change From Baseline to Week 24
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PASI: Change From Baseline to Week 24 | -9.31 units on a scale | Standard Error 0.953 |
| Risankizumab | PASI: Change From Baseline to Week 24 | -17.69 units on a scale | Standard Error 0.959 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-10.71, -6.06]ANCOVA
Secondary
PASI: Change From Baseline to Week 8
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
Time frame: Baseline, Week 8
Population: ITT analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PASI: Change From Baseline to Week 8 | -5.61 units on a scale | Standard Error 0.759 |
| Risankizumab | PASI: Change From Baseline to Week 8 | -15.18 units on a scale | Standard Error 0.763 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-11.43, -7.72]ANCOVA
Secondary
Patient's Global Assessment (PtGA): Change From Baseline to Week 16
The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (complete disease control) to 3 (uncontrolled disease). LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Patient's Global Assessment (PtGA): Change From Baseline to Week 16 | -1.0 units on a scale | Standard Error 0.11 |
| Risankizumab | Patient's Global Assessment (PtGA): Change From Baseline to Week 16 | -1.9 units on a scale | Standard Error 0.11 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-1.2, -0.7]ANCOVA
Secondary
Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 12
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12 | 1.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12 | 23.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [10.4, 32.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 16
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16 | 1.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16 | 35.0 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [20.7, 45.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 20
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20 | 6.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20 | 48.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [27.3, 55.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 24
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24 | 5.0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24 | 50.0 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [30.9, 58.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 4
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4 | 0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4 | 0 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: 0.99195% CI: [-2, 2.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 8
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8 | 1.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8 | 5.0 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: 0.32395% CI: [-3.2, 9.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 12
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12 | 46.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12 | 100 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [40.4, 65.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 16
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16 | 60.0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16 | 100 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [27.3, 51.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 20
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20 | 63.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20 | 100 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [24.1, 48.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 24
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24 | 53.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24 | 100 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [33.7, 59]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 4
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4 | 6.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4 | 53.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [32.8, 60.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 8
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8 | 28.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8 | 91.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [50.2, 76.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 12
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12 | 20.0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12 | 86.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [53.3, 79.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 16
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | 26.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | 93.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [53.8, 79.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 20
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20 | 38.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20 | 95.0 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [43, 70]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 24
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24 | 33.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24 | 98.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [52.5, 77.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 4
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4 | 3.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4 | 13.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: 0.04795% CI: [0.1, 19.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 8
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8 | 8.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8 | 75.0 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [53.8, 79.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 12
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12 | 5.0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12 | 61.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [43.2, 70]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 16
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16 | 11.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16 | 76.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [51.5, 78.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 20
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20 | 16.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20 | 83.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [53.3, 79.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 4
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4 | 0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4 | 1.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: 0.39295% CI: [-2.1, 5.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Time frame: Week 8
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8 | 1.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8 | 38.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [23.8, 49.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
Time frame: Week 16
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | 10.0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | 48.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [23.6, 53.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
Time frame: Week 24
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24 | 10.0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24 | 66.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [42.7, 70.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear at Week 12
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 12
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear at Week 12 | 3.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear at Week 12 | 21.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: 0.00195% CI: [7.1, 29.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear at Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 16
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear at Week 16 | 3.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear at Week 16 | 36.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [20.2, 45.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear at Week 20
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 20
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear at Week 20 | 6.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear at Week 20 | 48.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [27.3, 55.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear at Week 24
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 24
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear at Week 24 | 5.0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear at Week 24 | 51.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [32.6, 60.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear at Week 4
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 4
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear at Week 4 | 0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear at Week 4 | 1.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: 0.39295% CI: [-2.1, 5.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear at Week 8
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 8
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear at Week 8 | 1.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear at Week 8 | 10.0 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: 0.04895% CI: [0.1, 16.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 12
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 | 33.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 | 90.0 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [42.7, 70.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 16
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 | 31.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 | 91.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [46.3, 73.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 20
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20 | 48.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20 | 93.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [30.8, 59.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 24
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24 | 38.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24 | 93.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [41.2, 68.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 8
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8 | 15.0 percentage of participants |
| Risankizumab | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8 | 81.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [53.4, 80]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Time frame: Week 4
Population: ITT analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4 | 3.3 percentage of participants |
| Risankizumab | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4 | 33.3 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [17.1, 42.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
Time frame: Week 16
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16 | 5.0 percentage of participants |
| Risankizumab | Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16 | 25.0 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: 0.00195% CI: [7.6, 31.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With PSS Score of 0 at Week 24
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
Time frame: Week 24
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fumaderm | Percentage of Participants With PSS Score of 0 at Week 24 | 3.3 percentage of participants |
| Risankizumab | Percentage of Participants With PSS Score of 0 at Week 24 | 41.7 percentage of participants |
Comparison: P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).p-value: <0.00195% CI: [25, 51.5]Cochran-Mantel-Haenszel
Secondary
PPASI: Change From Baseline to Week 24
The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PPASI: Change From Baseline to Week 24 | -0.87 units on a scale | Standard Error 0.242 |
| Risankizumab | PPASI: Change From Baseline to Week 24 | -1.17 units on a scale | Standard Error 0.24 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: 0.31595% CI: [-0.88, 0.29]ANCOVA
Secondary
Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data.
Time frame: Baseline, Week 4
Population: ITT analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4 | -2.37 units on a scale | Standard Error 0.669 |
| Risankizumab | Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4 | -9.56 units on a scale | Standard Error 0.673 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.p-value: <0.00195% CI: [-8.82, -5.56]ANCOVA
Secondary
Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16
The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16 | -14.6 units on a scale | Standard Error 1.01 |
| Risankizumab | Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16 | -21.2 units on a scale | Standard Error 1.01 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-9, -4.1]ANCOVA
Secondary
PSSI: Change From Baseline at Week 24
The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PSSI: Change From Baseline at Week 24 | -13.9 units on a scale | Standard Error 1.25 |
| Risankizumab | PSSI: Change From Baseline at Week 24 | -22.0 units on a scale | Standard Error 1.25 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-11.1, -5]ANCOVA
Secondary
PSS Total Score: Change From Baseline to Week 16
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PSS Total Score: Change From Baseline to Week 16 | -5.5 units on a scale | Standard Error 0.52 |
| Risankizumab | PSS Total Score: Change From Baseline to Week 16 | -8.7 units on a scale | Standard Error 0.51 |
Comparison: P-values were calculated by stratified van Elteren test.p-value: <0.00195% CI: [-4.5, -2]van Elteren test
Secondary
PSS Total Score: Change From Baseline to Week 24
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PSS Total Score: Change From Baseline to Week 24 | -5.6 units on a scale | Standard Error 0.49 |
| Risankizumab | PSS Total Score: Change From Baseline to Week 24 | -9.5 units on a scale | Standard Error 0.48 |
Comparison: P-values were calculated by stratified van Elteren test.p-value: <0.00195% CI: [-5.1, -2.7]van Elteren test
Secondary
PtGA: Change From Baseline to Week 24
The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (complete disease control) to 3 (uncontrolled disease). LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | PtGA: Change From Baseline to Week 24 | -1.0 units on a scale | Standard Error 0.11 |
| Risankizumab | PtGA: Change From Baseline to Week 24 | -2.0 units on a scale | Standard Error 0.11 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [-1.3, -0.8]ANCOVA
Secondary
SF-36 V2 MCS Score: Change From Baseline to Week 24
The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | SF-36 V2 MCS Score: Change From Baseline to Week 24 | 3.56 units on a scale | Standard Error 1.494 |
| Risankizumab | SF-36 V2 MCS Score: Change From Baseline to Week 24 | 11.41 units on a scale | Standard Error 1.47 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [4.31, 11.38]ANCOVA
Secondary
SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16
The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16 | 4.20 units on a scale | Standard Error 1.493 |
| Risankizumab | SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16 | 10.86 units on a scale | Standard Error 1.472 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [3.11, 10.2]ANCOVA
Secondary
SF-36 V2 PCS Score: Change From Baseline to Week 24
The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 24
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | SF-36 V2 PCS Score: Change From Baseline to Week 24 | 3.68 units on a scale | Standard Error 1.104 |
| Risankizumab | SF-36 V2 PCS Score: Change From Baseline to Week 24 | 8.31 units on a scale | Standard Error 1.083 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [2.01, 7.25]ANCOVA
Secondary
Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16
The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16 | 2.87 units on a scale | Standard Error 1.153 |
| Risankizumab | Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16 | 7.36 units on a scale | Standard Error 1.135 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: 0.00295% CI: [1.74, 7.23]ANCOVA
Secondary
Summary of Patient Benefit Index (PBI) at Week 16
The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire \[PNQ\]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire \[PBQ\]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for did not apply to me (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline, Week 16
Population: ITT analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Summary of Patient Benefit Index (PBI) at Week 16 | 1.970 units on a scale | Standard Deviation 1.1971 |
| Risankizumab | Summary of Patient Benefit Index (PBI) at Week 16 | 3.118 units on a scale | Standard Deviation 0.8246 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [0.764, 1.528]ANCOVA
Secondary
Summary of PBI at Week 24
The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for did not apply to me (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.
Time frame: Baseline Week 24
Population: ITT analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fumaderm | Summary of PBI at Week 24 | 1.997 units on a scale | Standard Deviation 1.271 |
| Risankizumab | Summary of PBI at Week 24 | 3.316 units on a scale | Standard Deviation 0.7487 |
Comparison: P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.p-value: <0.00195% CI: [0.936, 1.704]ANCOVA