Adalimumab, Generalized Pustular Psoriasis (GPP), Japanese
Conditions
Keywords
efficacy, safety
Brief summary
The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not have an adequate response to their currently approved treatment.
Detailed description
This was a Phase 3, multicenter, open-label, single-arm study of adalimumab in Japanese participants with generalized pustular psoriasis (GPP). The study included a 30-day screening period, a 52-week treatment period, and a 70-day follow-up period. The dose regimen of adalimumab used in this study was 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Interventions
DRUGAdalimumab
Adalimumab pre-filled syringe, administered by subcutaneous injection
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of generalized pustular psoriasis * Total skin score of at least 3 and erythema with pustules (skin score of at least 1) at baseline in the Japan Dermatology Association (JDA) severity index of Generalized Pustular Psoriasis (GPP) in GPP Medical Care Guideline 2014 in Japan * Inadequate response to, or intolerance to, or contraindication to the currently approved GPP treatment (excluding infliximab) * Infliximab secondary failure, or intolerant to infliximab
Exclusion criteria
* Erythrodermic psoriasis, guttate psoriasis or sub-corneal pustular dermatosis at Screening * Drug-induced GPP * Cannot stop ongoing use of prohibited GPP treatments * Total JDA severity index of GPP of 14 or more in GPP Medical Care Guideline 2014 in Japan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Clinical Response at Week 16 | Baseline and Week 16 | Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Clinical Remission Over Time | Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical remission was defined as a total skin score of 0. |
| Mean Change From Baseline in the Total GPP Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). Negative values indicate improvement from baseline. |
| Mean Change From Baseline in JDA Severity Index of GPP Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as Mild, Moderate is 7-10, and Severe is 11-17. |
| Mean Change From Baseline in Total Skin Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline. |
| Mean Percent Change From Baseline in Total Skin Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline. |
| Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total systemic/laboratory test score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). Negative values indicate improvement from baseline. |
| Mean Change From Baseline in Total Erythema Area Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema (redness) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 75%; moderate, ≥ 25% and \< 75%; mild, \< 25%); and none (0%). Negative values indicate improvement from baseline. |
| Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema with pustules (small pockets of pus) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area with pustules is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and \< 50%; mild, \< 10%); and none (0%). Negative values indicate improvement from baseline. |
| Mean Change From Baseline in Total Edema Area Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of edema (swelling) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total area of edema is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and \< 50%; mild, \< 10%); and none (0%). Negative values indicate improvement from baseline. |
| Mean Change From Baseline in Body Temperature Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Body temperature (oral) was obtained at each visit prior to blood sampling. |
| Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Blood was drawn at each study visit, and white blood cell concentration was determined. |
| Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Blood was drawn at each study visit, and high-sensitivity C-reactive protein (hs-CRP) concentration was determined. |
| Mean Change From Baseline in Serum Albumin Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Blood was drawn at each study visit, and serum albumin concentration was determined. |
| Number of Participants Achieving Clinical Response Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 | Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0. |
| Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. Treatment Success was defined by at least a 2 grade improvement relative to baseline. |
| Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. |
| Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. |
| Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The proportion of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. |
| Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The proportion of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. |
| Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The proportion of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. |
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The mean change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline. |
| Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The percent change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline. |
| Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time | Week 8, Week 16, Week 24, Week 36, Week 52 | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | Baseline, Week 8, Week 16, Week 24, Week 36, Week 52 | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Negative values indicate improvement from baseline. |
| Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Baseline, Week 8, Week 16, Week 24, Week 36, Week 52 | The Short Form-36 Health Status Survey Version 2 (SF-36 V2) is a 36-item generic health-related quality of life questionnaire to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state. |
| Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52 | GPP-specific co-medications were documented at each scheduled study visit. |
| Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52 | Participants using topical co-medications for GPP were documented at each scheduled study visit. |
| Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as Mild, Moderate is 7-10, and Severe is 11-17. |
Participant flow
Pre-assignment details
The Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment.
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving Adalimumab 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 3 |
Baseline characteristics
| Characteristic | Participants Receiving Adalimumab |
|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 13.26 |
| Generalized Pustular Psoriasis (GPP) Duration | 10.6 years STANDARD_DEVIATION 12.59 |
| Prior GPP Therapy Granulocyte and Monocyte Absorbent Apheresis (GMA) | 2 Participants |
| Prior GPP Therapy Narrow-band ultraviolet B light (UVB) | 2 Participants |
| Prior GPP Therapy None of the above | 5 Participants |
| Prior GPP Therapy Psoralen and ultraviolet A light (PUVA) | 1 Participants |
| Prior Infliximab Use No | 7 Participants |
| Prior Infliximab Use Yes | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 9 / 10 |
| serious Total, serious adverse events | 3 / 10 |
Outcome results
Primary
Proportion of Participants Achieving Clinical Response at Week 16
Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0.
Time frame: Baseline and Week 16
Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving Adalimumab | Proportion of Participants Achieving Clinical Response at Week 16 | 7 Participants |
Secondary
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time
The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Baseline | PGA Grade 0 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Baseline | PGA Grade 1 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Baseline | PGA Grade 2 | 4 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Baseline | PGA Grade 3 | 3 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Baseline | PGA Grade 4 | 3 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Baseline | PGA Grade 5 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 2 | PGA Grade 0 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 2 | PGA Grade 1 | 3 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 2 | PGA Grade 2 | 5 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 2 | PGA Grade 3 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 2 | PGA Grade 4 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 2 | PGA Grade 5 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 4 | PGA Grade 0 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 4 | PGA Grade 1 | 7 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 4 | PGA Grade 2 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 4 | PGA Grade 3 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 4 | PGA Grade 4 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 4 | PGA Grade 5 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 8 | PGA Grade 0 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 8 | PGA Grade 1 | 8 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 8 | PGA Grade 2 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 8 | PGA Grade 3 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 8 | PGA Grade 4 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 8 | PGA Grade 5 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 12 | PGA Grade 0 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 12 | PGA Grade 1 | 4 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 12 | PGA Grade 2 | 2 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 12 | PGA Grade 3 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 12 | PGA Grade 4 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 12 | PGA Grade 5 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 16 | PGA Grade 0 | 2 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 16 | PGA Grade 1 | 5 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 16 | PGA Grade 2 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 16 | PGA Grade 4 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 16 | PGA Grade 5 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 24 | PGA Grade 0 | 1 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 24 | PGA Grade 1 | 5 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 24 | PGA Grade 2 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 24 | PGA Grade 3 | 2 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 24 | PGA Grade 4 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 24 | PGA Grade 5 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 36 | PGA Grade 0 | 2 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 36 | PGA Grade 1 | 4 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 36 | PGA Grade 2 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 36 | PGA Grade 3 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 36 | PGA Grade 4 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 36 | PGA Grade 5 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 52 | PGA Grade 0 | 3 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 52 | PGA Grade 1 | 2 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 52 | PGA Grade 2 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 52 | PGA Grade 3 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 52 | PGA Grade 4 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 52 | PGA Grade 5 | 0 Participants |
| Participants Receiving Adalimumab | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Week 16 | PGA Grade 3 | 0 Participants |
Secondary
Mean Change From Baseline in Body Temperature Over Time
Body temperature (oral) was obtained at each visit prior to blood sampling.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Body Temperature Over Time | Week 16 | -0.3 degrees Celsius | Standard Deviation 0.5 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Body Temperature Over Time | Week 24 | -0.5 degrees Celsius | Standard Deviation 1.04 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Body Temperature Over Time | Week 36 | -0.3 degrees Celsius | Standard Deviation 0.86 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Body Temperature Over Time | Week 2 | -0.3 degrees Celsius | Standard Deviation 0.68 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Body Temperature Over Time | Week 4 | -0.5 degrees Celsius | Standard Deviation 0.52 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Body Temperature Over Time | Week 8 | -0.3 degrees Celsius | Standard Deviation 0.5 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Body Temperature Over Time | Week 12 | -0.1 degrees Celsius | Standard Deviation 0.64 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Body Temperature Over Time | Week 52 | -0.1 degrees Celsius | Standard Deviation 0.64 |
Secondary
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Negative values indicate improvement from baseline.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | Week 8 | -4.2 units on a scale | Standard Deviation 6.55 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | Week 16 | -6.6 units on a scale | Standard Deviation 5.34 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | Week 24 | -4.8 units on a scale | Standard Deviation 7.59 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | Week 36 | -6.5 units on a scale | Standard Deviation 5.65 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | Week 52 | -8.0 units on a scale | Standard Deviation 7.18 |
Secondary
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time
Blood was drawn at each study visit, and high-sensitivity C-reactive protein (hs-CRP) concentration was determined.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Week 2 | -1.5 mg/dL | Standard Deviation 4.12 |
| Participants Receiving Adalimumab | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Week 4 | -1.6 mg/dL | Standard Deviation 4.05 |
| Participants Receiving Adalimumab | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Week 8 | -0.3 mg/dL | Standard Deviation 5.97 |
| Participants Receiving Adalimumab | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Week 12 | -1.7 mg/dL | Standard Deviation 4.76 |
| Participants Receiving Adalimumab | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Week 16 | -2.5 mg/dL | Standard Deviation 4.06 |
| Participants Receiving Adalimumab | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Week 24 | -1.5 mg/dL | Standard Deviation 5.63 |
| Participants Receiving Adalimumab | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Week 36 | -2.7 mg/dL | Standard Deviation 5.02 |
| Participants Receiving Adalimumab | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Week 52 | -3.8 mg/dL | Standard Deviation 4.73 |
Secondary
Mean Change From Baseline in JDA Severity Index of GPP Over Time
The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as Mild, Moderate is 7-10, and Severe is 11-17.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Baseline | Mild | 3 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Baseline | Missing | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 2 | Mild | 7 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 2 | Moderate | 3 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 2 | Severe | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 2 | Missing | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 4 | Mild | 9 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 4 | Moderate | 1 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 4 | Missing | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 8 | Mild | 8 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 8 | Moderate | 1 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 8 | Severe | 1 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 8 | Missing | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 12 | Mild | 7 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 12 | Severe | 1 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 12 | Missing | 2 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 16 | Mild | 7 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 16 | Moderate | 1 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 16 | Severe | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 16 | Missing | 2 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 24 | Mild | 7 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 24 | Moderate | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 24 | Missing | 2 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 36 | Mild | 6 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 36 | Severe | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 36 | Moderate | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 36 | Missing | 4 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 52 | Mild | 5 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 52 | Moderate | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 52 | Severe | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 52 | Missing | 5 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 4 | Severe | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 12 | Moderate | 0 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Baseline | Moderate | 6 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Baseline | Severe | 1 Participants |
| Participants Receiving Adalimumab | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Week 24 | Severe | 1 Participants |
Secondary
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time
The mean change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 2 | -12.9 units on a scale | Standard Deviation 12.83 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 4 | -17.4 units on a scale | Standard Deviation 14.66 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 8 | -14.9 units on a scale | Standard Deviation 17.55 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 12 | -14.3 units on a scale | Standard Deviation 20.03 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 16 | -19.1 units on a scale | Standard Deviation 17.27 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 24 | -16.8 units on a scale | Standard Deviation 19.61 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 36 | -28.1 units on a scale | Standard Deviation 17.67 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 52 | -26.7 units on a scale | Standard Deviation 22.24 |
Secondary
Mean Change From Baseline in Serum Albumin Over Time
Blood was drawn at each study visit, and serum albumin concentration was determined.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Serum Albumin Over Time | Week 2 | 0.0 g/dL | Standard Deviation 0.33 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Serum Albumin Over Time | Week 4 | 0.1 g/dL | Standard Deviation 0.44 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Serum Albumin Over Time | Week 8 | 0.1 g/dL | Standard Deviation 0.38 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Serum Albumin Over Time | Week 12 | -0.2 g/dL | Standard Deviation 0.59 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Serum Albumin Over Time | Week 16 | -0.0 g/dL | Standard Deviation 0.39 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Serum Albumin Over Time | Week 24 | -0.0 g/dL | Standard Deviation 0.26 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Serum Albumin Over Time | Week 36 | -0.1 g/dL | Standard Deviation 0.54 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Serum Albumin Over Time | Week 52 | -0.0 g/dL | Standard Deviation 0.43 |
Secondary
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time
The Short Form-36 Health Status Survey Version 2 (SF-36 V2) is a 36-item generic health-related quality of life questionnaire to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Physical Component Summary- Week 8 | 4.7 units on a scale | Standard Deviation 19.05 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Physical Component Summary- Week 16 | 9.2 units on a scale | Standard Deviation 17.48 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Physical Component Summary- Week 24 | 8.2 units on a scale | Standard Deviation 15.94 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Physical Component Summary- Week 52 | 12.0 units on a scale | Standard Deviation 21.42 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Mental Component Summary- Week 8 | 0.6 units on a scale | Standard Deviation 8.71 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Mental Component Summary- Week 16 | 0.9 units on a scale | Standard Deviation 8.03 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Mental Component Summary- Week 24 | 2.0 units on a scale | Standard Deviation 8.32 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Mental Component Summary- Week 36 | 1.6 units on a scale | Standard Deviation 18.26 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Mental Component Summary- Week 52 | 6.4 units on a scale | Standard Deviation 7.79 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | Physical Component Summary- Week 36 | 4.9 units on a scale | Standard Deviation 23.39 |
Secondary
Mean Change From Baseline in the Total GPP Score Over Time
The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). Negative values indicate improvement from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in the Total GPP Score Over Time | Week 4 | -3.8 units on a scale | Standard Deviation 2.15 |
| Participants Receiving Adalimumab | Mean Change From Baseline in the Total GPP Score Over Time | Week 8 | -3.2 units on a scale | Standard Deviation 2.57 |
| Participants Receiving Adalimumab | Mean Change From Baseline in the Total GPP Score Over Time | Week 12 | -3.1 units on a scale | Standard Deviation 2.85 |
| Participants Receiving Adalimumab | Mean Change From Baseline in the Total GPP Score Over Time | Week 16 | -4.6 units on a scale | Standard Deviation 1.85 |
| Participants Receiving Adalimumab | Mean Change From Baseline in the Total GPP Score Over Time | Week 24 | -3.8 units on a scale | Standard Deviation 3.15 |
| Participants Receiving Adalimumab | Mean Change From Baseline in the Total GPP Score Over Time | Week 36 | -5.5 units on a scale | Standard Deviation 2.07 |
| Participants Receiving Adalimumab | Mean Change From Baseline in the Total GPP Score Over Time | Week 52 | -6.0 units on a scale | Standard Deviation 2.55 |
| Participants Receiving Adalimumab | Mean Change From Baseline in the Total GPP Score Over Time | Week 2 | -2.9 units on a scale | Standard Deviation 2.08 |
Secondary
Mean Change From Baseline in Total Edema Area Over Time
The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of edema (swelling) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total area of edema is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and \< 50%; mild, \< 10%); and none (0%). Negative values indicate improvement from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Edema Area Over Time | Week 2 | -9.1 units on a scale | Standard Deviation 9.45 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Edema Area Over Time | Week 4 | -12.8 units on a scale | Standard Deviation 11.29 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Edema Area Over Time | Week 8 | -12.4 units on a scale | Standard Deviation 17.3 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Edema Area Over Time | Week 12 | -6.3 units on a scale | Standard Deviation 31.96 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Edema Area Over Time | Week 16 | -15.4 units on a scale | Standard Deviation 17.3 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Edema Area Over Time | Week 24 | -14.0 units on a scale | Standard Deviation 17.72 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Edema Area Over Time | Week 36 | -21.2 units on a scale | Standard Deviation 14.68 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Edema Area Over Time | Week 52 | -18.6 units on a scale | Standard Deviation 14.31 |
Secondary
Mean Change From Baseline in Total Erythema Area Over Time
The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema (redness) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 75%; moderate, ≥ 25% and \< 75%; mild, \< 25%); and none (0%). Negative values indicate improvement from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area Over Time | Week 8 | -19.7 units on a scale | Standard Deviation 26.62 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area Over Time | Week 12 | -23.0 units on a scale | Standard Deviation 26.28 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area Over Time | Week 16 | -34.6 units on a scale | Standard Deviation 27.3 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area Over Time | Week 2 | -17.0 units on a scale | Standard Deviation 20.08 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area Over Time | Week 4 | -21.6 units on a scale | Standard Deviation 22.81 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area Over Time | Week 24 | -27.6 units on a scale | Standard Deviation 29.48 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area Over Time | Week 36 | -48.3 units on a scale | Standard Deviation 27.72 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area Over Time | Week 52 | -44.6 units on a scale | Standard Deviation 37.5 |
Secondary
Mean Change From Baseline in Total Erythema Area With Pustules Over Time
The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema with pustules (small pockets of pus) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area with pustules is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and \< 50%; mild, \< 10%); and none (0%). Negative values indicate improvement from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Week 4 | -11.7 units on a scale | Standard Deviation 9.01 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Week 8 | -8.3 units on a scale | Standard Deviation 11.42 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Week 12 | -8.3 units on a scale | Standard Deviation 14.63 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Week 16 | -11.8 units on a scale | Standard Deviation 10.65 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Week 36 | -13.3 units on a scale | Standard Deviation 12.44 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Week 24 | -7.1 units on a scale | Standard Deviation 16.75 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Week 52 | -14.8 units on a scale | Standard Deviation 13.31 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Week 2 | -9.3 units on a scale | Standard Deviation 8.96 |
Secondary
Mean Change From Baseline in Total Skin Score Over Time
The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Skin Score Over Time | Week 24 | -2.6 units on a scale | Standard Deviation 1.92 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Skin Score Over Time | Week 36 | -3.8 units on a scale | Standard Deviation 1.47 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Skin Score Over Time | Week 2 | -1.9 units on a scale | Standard Deviation 1.66 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Skin Score Over Time | Week 4 | -2.4 units on a scale | Standard Deviation 1.65 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Skin Score Over Time | Week 8 | -2.3 units on a scale | Standard Deviation 1.49 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Skin Score Over Time | Week 12 | -2.3 units on a scale | Standard Deviation 1.98 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Skin Score Over Time | Week 16 | -3.1 units on a scale | Standard Deviation 1.36 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Skin Score Over Time | Week 52 | -4.2 units on a scale | Standard Deviation 1.79 |
Secondary
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time
The Generalized Pustular Psoriasis (GPP) total systemic/laboratory test score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). Negative values indicate improvement from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Week 4 | -1.4 units on a scale | Standard Deviation 0.97 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Week 24 | -1.1 units on a scale | Standard Deviation 1.64 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Week 36 | -1.7 units on a scale | Standard Deviation 1.21 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Week 52 | -1.8 units on a scale | Standard Deviation 1.3 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Week 2 | -1.0 units on a scale | Standard Deviation 1.05 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Week 8 | -0.9 units on a scale | Standard Deviation 1.45 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Week 12 | -0.9 units on a scale | Standard Deviation 1.25 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Week 16 | -1.5 units on a scale | Standard Deviation 1.2 |
Secondary
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time
Blood was drawn at each study visit, and white blood cell concentration was determined.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Week 2 | -1220.0 cells/µL | Standard Deviation 1970.22 |
| Participants Receiving Adalimumab | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Week 4 | -1770.0 cells/µL | Standard Deviation 2572.96 |
| Participants Receiving Adalimumab | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Week 8 | -810.0 cells/µL | Standard Deviation 3104.28 |
| Participants Receiving Adalimumab | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Week 12 | -1650.0 cells/µL | Standard Deviation 2857.57 |
| Participants Receiving Adalimumab | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Week 16 | -2562.5 cells/µL | Standard Deviation 2960.18 |
| Participants Receiving Adalimumab | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Week 24 | -1162.5 cells/µL | Standard Deviation 4444.88 |
| Participants Receiving Adalimumab | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Week 36 | -2550.0 cells/µL | Standard Deviation 3229.09 |
| Participants Receiving Adalimumab | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Week 52 | -2760.0 cells/µL | Standard Deviation 2966.99 |
Secondary
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time
The percent change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 4 | -59.7 percentage change from baseline | Standard Deviation 24.65 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 12 | -45.0 percentage change from baseline | Standard Deviation 39.2 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 16 | -55.5 percentage change from baseline | Standard Deviation 31.89 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 24 | -43.6 percentage change from baseline | Standard Deviation 46.26 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 36 | -79.0 percentage change from baseline | Standard Deviation 24.13 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 52 | -33.7 percentage change from baseline | Standard Deviation 117.4 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 2 | -44.2 percentage change from baseline | Standard Deviation 27.47 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | Week 8 | -43.9 percentage change from baseline | Standard Deviation 45.01 |
Secondary
Mean Percent Change From Baseline in Total Skin Score Over Time
The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Total Skin Score Over Time | Week 12 | -39.9 percentage change from baseline | Standard Deviation 30.36 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Total Skin Score Over Time | Week 16 | -54.6 percentage change from baseline | Standard Deviation 20.77 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Total Skin Score Over Time | Week 24 | -46.6 percentage change from baseline | Standard Deviation 33.15 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Total Skin Score Over Time | Week 36 | -67.9 percentage change from baseline | Standard Deviation 13.58 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Total Skin Score Over Time | Week 52 | -72.3 percentage change from baseline | Standard Deviation 16.34 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Total Skin Score Over Time | Week 2 | -33.8 percentage change from baseline | Standard Deviation 27.71 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Total Skin Score Over Time | Week 4 | -43.4 percentage change from baseline | Standard Deviation 27.28 |
| Participants Receiving Adalimumab | Mean Percent Change From Baseline in Total Skin Score Over Time | Week 8 | -42.9 percentage change from baseline | Standard Deviation 27.12 |
Secondary
Number of Participants Achieving Clinical Remission Over Time
The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical remission was defined as a total skin score of 0.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Remission Over Time | Week 2 | 0 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Remission Over Time | Week 4 | 1 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Remission Over Time | Week 8 | 0 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Remission Over Time | Week 12 | 0 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Remission Over Time | Week 16 | 0 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Remission Over Time | Week 24 | 0 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Remission Over Time | Week 36 | 0 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Remission Over Time | Week 52 | 0 participants |
Secondary
Number of Participants Achieving Clinical Response Over Time
Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Response Over Time | Week 2 | 5 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Response Over Time | Week 4 | 6 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Response Over Time | Week 8 | 6 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Response Over Time | Week 12 | 5 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Response Over Time | Week 24 | 6 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Response Over Time | Week 36 | 6 participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Clinical Response Over Time | Week 52 | 5 participants |
Secondary
Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time
The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as Mild, Moderate is 7-10, and Severe is 11-17.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time | Week 8 | 5 Participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time | Week 12 | 5 Participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time | Week 16 | 5 Participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time | Week 24 | 5 Participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time | Week 36 | 5 Participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time | Week 52 | 4 Participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time | Week 2 | 4 Participants |
| Participants Receiving Adalimumab | Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time | Week 4 | 6 Participants |
Secondary
Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Time frame: Week 8, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time | Week 8 | 1 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time | Week 16 | 0 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time | Week 24 | 1 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time | Week 36 | 0 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time | Week 52 | 2 Participants |
Secondary
Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time
The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Week 2 | 4 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Week 4 | 8 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Week 8 | 8 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Week 12 | 5 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Week 16 | 7 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Week 24 | 6 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Week 36 | 6 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Week 52 | 5 Participants |
Secondary
Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time
The proportion of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | Week 2 | 4 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | Week 4 | 6 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | Week 8 | 6 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | Week 12 | 5 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | Week 16 | 5 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | Week 24 | 4 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | Week 36 | 5 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | Week 52 | 4 Participants |
Secondary
Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time
The proportion of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | Week 2 | 2 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | Week 4 | 2 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | Week 8 | 2 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | Week 12 | 2 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | Week 16 | 4 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | Week 24 | 4 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | Week 36 | 5 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | Week 52 | 3 Participants |
Secondary
Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time
The proportion of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Week 2 | 1 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Week 4 | 2 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Week 8 | 1 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Week 12 | 1 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Week 16 | 0 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Week 24 | 1 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Week 36 | 3 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Week 52 | 3 Participants |
Secondary
Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time
The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. Treatment Success was defined by at least a 2 grade improvement relative to baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Population: Participants with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Week 4 | 5 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Week 8 | 4 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Week 16 | 5 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Week 24 | 4 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Week 36 | 5 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Week 52 | 3 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Week 2 | 3 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Week 12 | 3 Participants |
Secondary
Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study
GPP-specific co-medications were documented at each scheduled study visit.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52
Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Etretinate | 3 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Methotrexate | 2 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Oral steroids | 1 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Cyclosporine | 2 Participants |
Secondary
Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study
Participants using topical co-medications for GPP were documented at each scheduled study visit.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52
Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving Adalimumab | Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Corticosteroid | 7 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Vitamin D3 | 0 Participants |
| Participants Receiving Adalimumab | Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Tacrolimus | 0 Participants |