Psoriasis
Conditions
Brief summary
Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.
Interventions
BIOLOGICALPlacebo
Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
BIOLOGICALAdalimumab
Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA \>/=3 and candidates for systemic therapy; * Patients in good general health * Able to self-administer injections * Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis
Exclusion criteria
* Previous treatment with HUMIRA® * Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA) * Other active skin diseases or skin infections * Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis * Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix); * History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB); * History of moderate to severe congestive heart failure, * Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk; * History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease; * History of clinically significant drug or alcohol abuse in the last 12 months; * Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline; * Known hypersensitivity to the excipients of HUMIRA® as stated in the label; * Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. * Prior exposure to Tysabri® (natalizumab)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 | Week 16 | Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 | Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement. |
| Mean Change From Baseline in ESIF for Palms | Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28 | Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement. |
| Mean Change From Baseline in ESIF for Soles | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 | Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement. |
| Number of Subjects With Moderate Improvement in ESIF From Baseline | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 | Number of subjects that achieved \> 50% reduction from Baseline in ESIF. |
| Number of Subjects With Marked Improvement in ESIF From Baseline | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 | Number of subjects that achieved \> 75% reduction from Baseline in ESIF |
| Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Baseline and Weeks 8, 16, and 28 | For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis). |
| Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28 | Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe. |
| Number of Subjects With PGA of Clear or Almost Clear | Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28 | Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe. |
| Number of Subjects With PGA of Clear | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28 | Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe. |
| Number of Subjects With PASI 90 | Baseline and Weeks 16 and 28 | Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree). |
| Number of Subjects With PASI 75 | Baseline and Weeks 16 and 28 | Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree). |
| Number of Subjects With PASI 100 | Baseline and Weeks 16 and 28 | Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree). |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Baseline and Weeks 2, 8, 16, and 28 | The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement. |
| Number of Subjects Achieving a DLQI of 0 | Baseline and Weeks 2, 8, 16, and 28 | Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement. |
| Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain | Baseline and Weeks 16 and 28 | On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be). |
| Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | Baseline and Weeks 8, 16, and 28 | WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 \[psoriasis having no effect\] to 10 \[psoriasis completely prevented subject from working\]), % overall work impairment (on a scale from 0 \[psoriasis having no effect\] to 10 \[psoriasis completely prevented subject from working\]), and % activity impairment (on a scale from 0 \[psoriasis having no effect on daily activities\] to 10 \[psoriasis completely prevented subject from doing daily activities\]). |
| Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | Baseline and Weeks 2, 8, 16, and 28 | The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day). |
| Number of Subjects With Difficulties According to PHQ-9 | Baseline and Weeks 2, 8, 16, and 28 | Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score \> 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult). |
| Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 | Baseline and Weeks 16 and 28 | Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree). |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo/Adalimumab Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | 23 |
| Adalimumab 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. | 49 |
| Total | 72 |
Baseline characteristics
| Characteristic | Placebo/Adalimumab | Adalimumab | Total |
|---|---|---|---|
| Age Categorical < 40 years | 1 subjects | 11 subjects | 12 subjects |
| Age Categorical >= 60 years | 8 subjects | 9 subjects | 17 subjects |
| Age Categorical Between 40 and < 60 years | 14 subjects | 29 subjects | 43 subjects |
| Age Continuous | 54.8 years STANDARD_DEVIATION 11.4 | 49.0 years STANDARD_DEVIATION 11.41 | 50.9 years STANDARD_DEVIATION 11.65 |
| Region of Enrollment Canada | 14 participants | 29 participants | 43 participants |
| Region of Enrollment United States | 9 participants | 20 participants | 29 participants |
| Sex: Female, Male Female | 15 Participants | 28 Participants | 43 Participants |
| Sex: Female, Male Male | 8 Participants | 21 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 23 | 30 / 49 |
| serious Total, serious adverse events | 1 / 23 | 2 / 49 |
Outcome results
Primary
Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time frame: Week 16
Population: Analysis was based on the intention to treat (ITT) subject population. Subjects who did not achieve PGA assessments at Week 16 were imputed as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/Adalimumab | Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 | 1 subjects |
| Adalimumab | Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 | 15 subjects |
Comparison: The primary null hypothesis for this study was that there was no difference in the proportion of subjects that achieved PGA clear or almost clear at Week 16 between the adalimumab and placebo groups. Analysis was done using a two-sided Fisher's exact test at alpha level=0.05.p-value: 0.014Fisher Exact
Secondary
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Time frame: Baseline and Weeks 2, 8, 16, and 28
Population: Analysis was based on the ITT subject population and performed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Week 2 | -3.43 units on a scale | Standard Deviation 3.435 |
| Placebo/Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Week 8 | -3.09 units on a scale | Standard Deviation 5.008 |
| Placebo/Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Week 16 | -4.22 units on a scale | Standard Deviation 4.936 |
| Placebo/Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Week 28 (open-label) | -4.74 units on a scale | Standard Deviation 4.731 |
| Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Week 28 (open-label) | -5.18 units on a scale | Standard Deviation 7.499 |
| Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Week 2 | -4.35 units on a scale | Standard Deviation 4.741 |
| Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Week 16 | -4.78 units on a scale | Standard Deviation 7.269 |
| Adalimumab | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Week 8 | -4.08 units on a scale | Standard Deviation 5.541 |
Secondary
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Population: Analysis was based on the ITT subject population and performed using last observation carried forward (LOCF) method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 16 | -5.04 units on a scale | Standard Deviation 6.568 |
| Placebo/Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 2 | -2.35 units on a scale | Standard Deviation 4.074 |
| Placebo/Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 20 (open-label) | -6.43 units on a scale | Standard Deviation 8.805 |
| Placebo/Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 8 | -3.04 units on a scale | Standard Deviation 7.327 |
| Placebo/Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 24 (open-label) | -5.83 units on a scale | Standard Deviation 9.267 |
| Placebo/Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 4 | -1.91 units on a scale | Standard Deviation 7.019 |
| Placebo/Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 28 (open-label) | -5.83 units on a scale | Standard Deviation 8.574 |
| Placebo/Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 12 | -5.30 units on a scale | Standard Deviation 6.825 |
| Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 28 (open-label) | -11.96 units on a scale | Standard Deviation 10.261 |
| Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 2 | -6.24 units on a scale | Standard Deviation 7.685 |
| Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 4 | -7.73 units on a scale | Standard Deviation 9.064 |
| Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 8 | -9.33 units on a scale | Standard Deviation 9.335 |
| Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 16 | -10.92 units on a scale | Standard Deviation 12.46 |
| Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 20 (open-label) | -11.69 units on a scale | Standard Deviation 11.353 |
| Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 24 (open-label) | -11.51 units on a scale | Standard Deviation 11.502 |
| Adalimumab | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Week 12 | -10.80 units on a scale | Standard Deviation 11.175 |
Secondary
Mean Change From Baseline in ESIF for Palms
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.
Time frame: Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28
Population: Analysis was based on the ITT subject population and performed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 2 | -1.78 units on a scale | Standard Deviation 3.464 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 12 | -3.39 units on a scale | Standard Deviation 4.639 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 20 (open-label) | -3.87 units on a scale | Standard Deviation 5.81 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 16 | -2.65 units on a scale | Standard Deviation 4.914 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 24 (open-label) | -3.74 units on a scale | Standard Deviation 5.387 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 4 | -1.57 units on a scale | Standard Deviation 4.326 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 28 (open-label) | -3.52 units on a scale | Standard Deviation 4.87 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 8 | -2.09 units on a scale | Standard Deviation 4.889 |
| Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 28 (open-label) | -6.59 units on a scale | Standard Deviation 5.244 |
| Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 16 | -5.80 units on a scale | Standard Deviation 6.285 |
| Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 2 | -3.33 units on a scale | Standard Deviation 4.095 |
| Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 4 | -4.33 units on a scale | Standard Deviation 4.543 |
| Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 8 | -5.35 units on a scale | Standard Deviation 4.829 |
| Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 20 (open-label) | -6.16 units on a scale | Standard Deviation 5.669 |
| Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 24 (open-label) | -6.08 units on a scale | Standard Deviation 5.947 |
| Adalimumab | Mean Change From Baseline in ESIF for Palms | Week 12 | -5.53 units on a scale | Standard Deviation 5.934 |
Secondary
Mean Change From Baseline in ESIF for Soles
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Population: Analysis was based on the ITT subject population and performed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 4 | -0.35 units on a scale | Standard Deviation 3.915 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 2 | -0.57 units on a scale | Standard Deviation 1.619 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 8 | -0.96 units on a scale | Standard Deviation 4.017 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 12 | -1.91 units on a scale | Standard Deviation 3.965 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 16 | -2.39 units on a scale | Standard Deviation 4.62 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 20 (open-label) | -2.57 units on a scale | Standard Deviation 5.358 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 24 (open-label) | -2.09 units on a scale | Standard Deviation 5.608 |
| Placebo/Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 28 (open-label) | -2.30 units on a scale | Standard Deviation 5.431 |
| Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 28 (open-label) | -5.31 units on a scale | Standard Deviation 6.378 |
| Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 16 | -5.18 units on a scale | Standard Deviation 7.132 |
| Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 2 | -2.92 units on a scale | Standard Deviation 4.65 |
| Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 4 | -3.39 units on a scale | Standard Deviation 5.553 |
| Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 24 (open-label) | -5.37 units on a scale | Standard Deviation 7.082 |
| Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 8 | -4.04 units on a scale | Standard Deviation 5.972 |
| Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 20 (open-label) | -5.47 units on a scale | Standard Deviation 6.959 |
| Adalimumab | Mean Change From Baseline in ESIF for Soles | Week 12 | -5.35 units on a scale | Standard Deviation 6.515 |
Secondary
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).
Time frame: Baseline and Weeks 8, 16, and 28
Population: Analysis was performed in the ITT subject population for subjects with nail involvement at baseline only and is based on LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Adalimumab | Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Week 8 | -0.63 units on a scale | Standard Deviation 1.061 |
| Placebo/Adalimumab | Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Week 16 | -0.13 units on a scale | Standard Deviation 1.246 |
| Placebo/Adalimumab | Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Week 28 (open-label) | -1.00 units on a scale | Standard Deviation 1.852 |
| Adalimumab | Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Week 8 | -0.88 units on a scale | Standard Deviation 1.211 |
| Adalimumab | Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Week 16 | -1.67 units on a scale | Standard Deviation 1.593 |
| Adalimumab | Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Week 28 (open-label) | -2.00 units on a scale | Standard Deviation 2.177 |
Secondary
Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)
The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).
Time frame: Baseline and Weeks 2, 8, 16, and 28
Population: Analysis was based on the ITT subject population and performed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Adalimumab | Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | Week 2 | -2.85 units on a scale | Standard Deviation 4.332 |
| Placebo/Adalimumab | Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | Week 16 | -2.64 units on a scale | Standard Deviation 6.637 |
| Placebo/Adalimumab | Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | Week 8 | -2.43 units on a scale | Standard Deviation 4.057 |
| Placebo/Adalimumab | Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | Week 28 (open-label) | -3.32 units on a scale | Standard Deviation 5.719 |
| Adalimumab | Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | Week 28 (open-label) | -2.65 units on a scale | Standard Deviation 5.031 |
| Adalimumab | Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | Week 2 | -2.86 units on a scale | Standard Deviation 4.449 |
| Adalimumab | Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | Week 8 | -1.80 units on a scale | Standard Deviation 4.796 |
| Adalimumab | Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | Week 16 | -2.14 units on a scale | Standard Deviation 4.659 |
Secondary
Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain
On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).
Time frame: Baseline and Weeks 16 and 28
Population: Analysis was based on the ITT subject population and performed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Adalimumab | Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain | Week 16 | -12.45 mm on scale | Standard Deviation 28.637 |
| Placebo/Adalimumab | Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain | Week 28 (open-label) | -16.25 mm on scale | Standard Deviation 24.95 |
| Adalimumab | Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain | Week 16 | -17.49 mm on scale | Standard Deviation 34.451 |
| Adalimumab | Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain | Week 28 (open-label) | -16.59 mm on scale | Standard Deviation 34.43 |
Secondary
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)
WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 \[psoriasis having no effect\] to 10 \[psoriasis completely prevented subject from working\]), % overall work impairment (on a scale from 0 \[psoriasis having no effect\] to 10 \[psoriasis completely prevented subject from working\]), and % activity impairment (on a scale from 0 \[psoriasis having no effect on daily activities\] to 10 \[psoriasis completely prevented subject from doing daily activities\]).
Time frame: Baseline and Weeks 8, 16, and 28
Population: Analysis was based on the ITT subject population and performed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Impairment While Working Week 28 (OL) | -5.33 units on a scale | Standard Deviation 20.999 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Impairment While Working Week 8 | 0.71 units on a scale | Standard Deviation 29.733 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Overall Work Impairment Week 8 | -0.48 units on a scale | Standard Deviation 29.988 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Overall Work Impairment Week 16 | -5.45 units on a scale | Standard Deviation 22.432 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Work Time Missed due to Psoriasis Week 28 (OL) | 2.60 units on a scale | Standard Deviation 26.628 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Overall Work Impairment Week 28 (OL) | -5.79 units on a scale | Standard Deviation 20.996 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Activity Impairment Week 8 | -9.09 units on a scale | Standard Deviation 32.5 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Work Time Missed due to Psoriasis Week 8 | 6.32 units on a scale | Standard Deviation 24.953 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Activity Impairment Week 16 | -9.09 units on a scale | Standard Deviation 22.234 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Impairment While Working Week 16 | -4.67 units on a scale | Standard Deviation 20.656 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Activity Impairment Week 28 (OL) | -15.91 units on a scale | Standard Deviation 27.196 |
| Placebo/Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Work Time Missed due to Psoriasis Week 16 | 7.72 units on a scale | Standard Deviation 33.299 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Activity Impairment Week 28 (OL) | -14.69 units on a scale | Standard Deviation 32.539 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Work Time Missed due to Psoriasis Week 28 (OL) | 3.16 units on a scale | Standard Deviation 18.198 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Overall Work Impairment Week 8 | -8.97 units on a scale | Standard Deviation 27.355 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Overall Work Impairment Week 28 (OL) | -9.88 units on a scale | Standard Deviation 31.045 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Work Time Missed due to Psoriasis Week 16 | 5.34 units on a scale | Standard Deviation 20.25 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Impairment While Working Week 8 | -8.21 units on a scale | Standard Deviation 27.087 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Impairment While Working Week 16 | -5.94 units on a scale | Standard Deviation 27.103 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Impairment While Working Week 28 (OL) | -8.44 units on a scale | Standard Deviation 31.429 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Overall Work Impairment Week 16 | -7.19 units on a scale | Standard Deviation 26.556 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Activity Impairment Week 8 | -11.02 units on a scale | Standard Deviation 23.562 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Activity Impairment Week 16 | -13.88 units on a scale | Standard Deviation 27.6 |
| Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | % Work Time Missed due to Psoriasis Week 8 | 4.70 units on a scale | Standard Deviation 12.778 |
Secondary
Number of Subjects Achieving a DLQI of 0
Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Time frame: Baseline and Weeks 2, 8, 16, and 28
Population: Analysis was based on the ITT subject population and performed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects Achieving a DLQI of 0 | Week 2 | 1 subjects |
| Placebo/Adalimumab | Number of Subjects Achieving a DLQI of 0 | Week 16 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects Achieving a DLQI of 0 | Week 28 (open-label) | 1 subjects |
| Placebo/Adalimumab | Number of Subjects Achieving a DLQI of 0 | Week 8 | 1 subjects |
| Adalimumab | Number of Subjects Achieving a DLQI of 0 | Week 28 (open-label) | 6 subjects |
| Adalimumab | Number of Subjects Achieving a DLQI of 0 | Week 2 | 3 subjects |
| Adalimumab | Number of Subjects Achieving a DLQI of 0 | Week 8 | 3 subjects |
| Adalimumab | Number of Subjects Achieving a DLQI of 0 | Week 16 | 7 subjects |
Secondary
Number of Subjects With Difficulties According to PHQ-9
Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score \> 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).
Time frame: Baseline and Weeks 2, 8, 16, and 28
Population: Analysis was based on the ITT subject population. Missing values were imputed as extremely difficult.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Baseline | 9 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Baseline | 3 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Week 2 | 9 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Week 2 | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Week 2 | 7 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Baseline | 4 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Baseline | 7 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Week 2 | 5 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Week 8 | 4 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Week 8 | 8 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Week 8 | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Week 8 | 9 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Week 16 | 3 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Week 16 | 8 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Week 16 | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Week 16 | 10 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Week 28 (OL) | 4 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Week 28 (OL) | 5 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Week 28 (OL) | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Week 28 (OL) | 12 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Week 8 | 15 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Baseline | 19 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Week 16 | 1 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Baseline | 5 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Week 2 | 21 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Week 8 | 5 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Week 28 (OL) | 1 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Very difficult - Week 2 | 3 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Week 8 | 11 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Week 2 | 9 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Week 28 (OL) | 21 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Week 16 | 19 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Baseline | 20 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Week 16 | 19 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Extremely difficult - Baseline | 5 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Week 28 (OL) | 6 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Week 2 | 16 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Somewhat difficult - Week 16 | 10 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Week 8 | 18 subjects |
| Adalimumab | Number of Subjects With Difficulties According to PHQ-9 | Not difficult at all - Week 28 (OL) | 21 subjects |
Secondary
Number of Subjects With Marked Improvement in ESIF From Baseline
Number of subjects that achieved \> 75% reduction from Baseline in ESIF
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Population: Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 12 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 4 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 16 | 1 subjects |
| Placebo/Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 24 (open-label) | 4 subjects |
| Placebo/Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 20 (open-label) | 5 subjects |
| Placebo/Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 8 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 28 (open-label) | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 2 | 0 subjects |
| Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 28 (open-label) | 11 subjects |
| Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 4 | 5 subjects |
| Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 8 | 7 subjects |
| Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 24 (open-label) | 12 subjects |
| Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 2 | 3 subjects |
| Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 16 | 14 subjects |
| Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 20 (open-label) | 13 subjects |
| Adalimumab | Number of Subjects With Marked Improvement in ESIF From Baseline | Week 12 | 11 subjects |
Secondary
Number of Subjects With Moderate Improvement in ESIF From Baseline
Number of subjects that achieved \> 50% reduction from Baseline in ESIF.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Population: Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 2 | 1 subjects |
| Placebo/Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 4 | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 8 | 3 subjects |
| Placebo/Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 12 | 6 subjects |
| Placebo/Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 16 | 4 subjects |
| Placebo/Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 20 (open-label) | 6 subjects |
| Placebo/Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 24 (open-label) | 6 subjects |
| Placebo/Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 28 (open-label) | 3 subjects |
| Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 28 (open-label) | 19 subjects |
| Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 2 | 8 subjects |
| Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 16 | 21 subjects |
| Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 4 | 10 subjects |
| Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 24 (open-label) | 21 subjects |
| Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 8 | 17 subjects |
| Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 20 (open-label) | 19 subjects |
| Adalimumab | Number of Subjects With Moderate Improvement in ESIF From Baseline | Week 12 | 20 subjects |
Secondary
Number of Subjects With PASI 100
Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time frame: Baseline and Weeks 16 and 28
Population: Analysis was based on the ITT subject population and performed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With PASI 100 | Week 16 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects With PASI 100 | Week 28 (open-label) | 1 subjects |
| Adalimumab | Number of Subjects With PASI 100 | Week 16 | 7 subjects |
| Adalimumab | Number of Subjects With PASI 100 | Week 28 (open-label) | 8 subjects |
Secondary
Number of Subjects With PASI 75
Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time frame: Baseline and Weeks 16 and 28
Population: Analysis was based on the ITT subject population and performed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With PASI 75 | Week 16 | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With PASI 75 | Week 28 (open-label) | 4 subjects |
| Adalimumab | Number of Subjects With PASI 75 | Week 16 | 15 subjects |
| Adalimumab | Number of Subjects With PASI 75 | Week 28 (open-label) | 11 subjects |
Secondary
Number of Subjects With PASI 90
Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time frame: Baseline and Weeks 16 and 28
Population: Analysis was based on the ITT subject population and performed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With PASI 90 | Week 16 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects With PASI 90 | Week 28 (open-label) | 4 subjects |
| Adalimumab | Number of Subjects With PASI 90 | Week 16 | 10 subjects |
| Adalimumab | Number of Subjects With PASI 90 | Week 28 (open-label) | 10 subjects |
Secondary
Number of Subjects With PGA of Clear
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
Population: Analysis was based on the ITT subject population and performed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With PGA of Clear | Week 2 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear | Week 8 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear | Week 20 (open-label) | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear | Week 4 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear | Week 24 (open-label) | 3 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear | Week 12 | 0 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear | Week 28 (open-label) | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear | Week 16 | 1 subjects |
| Adalimumab | Number of Subjects With PGA of Clear | Week 28 (open-label) | 7 subjects |
| Adalimumab | Number of Subjects With PGA of Clear | Week 2 | 1 subjects |
| Adalimumab | Number of Subjects With PGA of Clear | Week 4 | 2 subjects |
| Adalimumab | Number of Subjects With PGA of Clear | Week 8 | 3 subjects |
| Adalimumab | Number of Subjects With PGA of Clear | Week 12 | 6 subjects |
| Adalimumab | Number of Subjects With PGA of Clear | Week 16 | 6 subjects |
| Adalimumab | Number of Subjects With PGA of Clear | Week 20 (open-label) | 8 subjects |
| Adalimumab | Number of Subjects With PGA of Clear | Week 24 (open-label) | 7 subjects |
Secondary
Number of Subjects With PGA of Clear or Almost Clear
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time frame: Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28
Population: Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 4 | 1 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 20 (open-label) | 5 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 8 | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 24 (open-label) | 5 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 12 | 3 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 28 (open-label) | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 2 | 1 subjects |
| Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 28 (open-label) | 12 subjects |
| Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 8 | 12 subjects |
| Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 2 | 4 subjects |
| Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 4 | 10 subjects |
| Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 12 | 14 subjects |
| Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 20 (open-label) | 11 subjects |
| Adalimumab | Number of Subjects With PGA of Clear or Almost Clear | Week 24 (open-label) | 12 subjects |
Secondary
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
Population: Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 2 | 2 subjects |
| Placebo/Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 4 | 3 subjects |
| Placebo/Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 8 | 6 subjects |
| Placebo/Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 12 | 8 subjects |
| Placebo/Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 16 | 6 subjects |
| Placebo/Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 20 (open-label) | 8 subjects |
| Placebo/Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 24 (open-label) | 7 subjects |
| Placebo/Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 28 (open-label) | 4 subjects |
| Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 28 (open-label) | 23 subjects |
| Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 2 | 15 subjects |
| Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 16 | 25 subjects |
| Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 4 | 21 subjects |
| Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 24 (open-label) | 20 subjects |
| Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 8 | 21 subjects |
| Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 20 (open-label) | 23 subjects |
| Adalimumab | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Week 12 | 24 subjects |
Secondary
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50
Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time frame: Baseline and Weeks 16 and 28
Population: Analysis was based on the ITT subject population and performed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/Adalimumab | Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 | Week 16 | 5 subjects |
| Placebo/Adalimumab | Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 | Week 28 (open-label) | 8 subjects |
| Adalimumab | Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 | Week 16 | 21 subjects |
| Adalimumab | Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 | Week 28 (open-label) | 21 subjects |