An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01644396

Enrollment

Registered

2012-07-19

Start date

2012-05-31

Completion date

2013-09-30

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Moderate to Severe Plaque Psoriasis

Brief summary

This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.

Detailed description

During the treatment period, participants will receive an initial adalimumab 80 milligram (mg) subcutaneous (sc) dose, followed by adalimumab 40 mg sc every other week starting one week after initial dose. Safety and effectiveness assessments will be completed at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 24. Participants may discontinue adalimumab treatment at any time during study participation. Participants that end study participation early will have a Premature Discontinuation visit. All participants who do not initiate commercial Humira® will have a follow-up phone call 70 days after the last administration of study drug to obtain information on any new or ongoing Adverse Events (AEs). The 70-day follow-up phone call will not be required for any participant that initiates adalimumab therapy not supplied in the context of the clinical trial after the end of study participation.

Interventions

BIOLOGICALAdalimumab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

A patient will be eligible for study participation if he/she meets the following criteria: 1. Male and female patients ≥ 18 years of age. 2. Clinical diagnosis of psoriasis for at least 6 months as determined by patient interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator. 3. Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history. 4. Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit. 5. PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit.

Exclusion criteria

1. Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis. 2. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis. 3. Patient who cannot discontinue topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids at least 14 days prior to the Baseline (Week 0) visit and during the study. Participants are allowed to use: * Shampoos that contain no corticosteroid; * Bland (without beta or alpha hydroxy acids or containing no psoriasis treatment) emollients; * Low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only. 4. Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study. 5. Patient who cannot avoid PUVA (psoralen + ultraviolet A) phototherapy for at least 28 days prior to the Baseline (Week 0) visit and during the study.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24	Baseline and Week 24	The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the 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.

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal	Weeks 2, 4, 8, 12, 16 and 24	The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared; * 1: Occasional fine scale over \<5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal; * 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild; * 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate; * 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked; * 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe. The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported.
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)	Baseline and Weeks 2, 4, 8, 12, 16 and 24	The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared; * 1: Occasional fine scale over \<5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal; * 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild; * 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate; * 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked; * 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe. The percentage of participants achieving a shift from Baseline to a less severe category is reported.
Percentage of Participants Achieving a PASI 50 Response	Baseline and Weeks 2, 4, 8, 12, 16, and 24	The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the 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.
Percentage of Participants Achieving a PASI 75 Response	Baseline and Weeks 2, 4, 8, 12, and 16	The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the 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.
Percentage of Participants Achieving a Physician's Global Assessment of Clear	Weeks 2, 4, 8, 12, 16 and 24	The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared; * 1: Occasional fine scale over \<5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal; * 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild; * 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate; * 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked; * 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe. The percentage of participants achieving a PGA score of clear (0) is reported.
Percentage of Participants Achieving a PASI 90 Response	Baseline and Weeks 2, 4, 8, 12, 16, and 24	The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the 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.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	Baseline and Weeks 2, 4, 8, 12, 16, and 24	PASI is a combination of the intensity of psoriasis, assessed by the 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. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Percent Change From Baseline in Dermatology Life Quality Index (DLQI)	Baseline and Weeks 8, 12, and 24	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 answer 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 an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)	Baseline and Week 24	NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Percentage of Participants Achieving a PASI 100 Response	Baseline and Weeks 2, 4, 8, 12, 16, and 24	The percentage of participants with a 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the 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.

Other

Measure	Time frame	Description
Change From Baseline in Uric Acid	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Inorganic Phosphate	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Calcium, Sodium and Potassium	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Glucose	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Albumin	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Total Protein	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Cholesterol	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Triglycerides	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Hemoglobin	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Urine pH	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Urine Specific Gravity	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance.
Change From Baseline in Blood Pressure	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Pulse	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Respiratory Rate	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Weight	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Body Temperature	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Number of Participants With Adverse Events (AEs)	From the first dose of study drug until 70 days after the last dose (up to 33 weeks).	An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. The investigator rated the severity of each AE as either: Mild: The AE is transient and easily tolerated; Moderate: The AE causes the participant discomfort and interrupts usual activities. Severe: The AE causes considerable interference with usual activities and may be incapacitating or life-threatening. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. Drug-related AEs are those assessed by the investigator as either probably or possibly related. Other malignancy excludes lymphoma, hepatosplenic T-cell lymphoma (HSTCL), leukemia, non-melanoma skin cancer (NMSC), and melanoma.
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Hematocrit	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events. The hematocrit measures the volume of red blood cells compared to the total blood volume (red blood cells and plasma).
Change From Baseline in Red Blood Cell Count	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Blood Cell Counts	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Erythrocyte Sedimentation Rate	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Alanine Aminotransferase	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Aspartate Aminotransferase	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Alkaline Phosphatase	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Total Bilirubin	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Creatinine	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.
Change From Baseline in Blood Urea Nitrogen (BUN)	Baseline and Week 24 (or Early Termination Visit)	Safety variables included laboratory data, vital signs and adverse events.

Countries

Russia

Participant flow

Participants by arm

Arm	Count
Adalimumab Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.	50
Total	50

Baseline characteristics

Characteristic	Adalimumab
Age, Continuous	41.5 years STANDARD_DEVIATION 9.86
Region of Enrollment Russian Federation	50 participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	36 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	14 / 50
serious Total, serious adverse events	0 / 50

Outcome results

Primary

Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24

The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the 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 and Week 24

Population: Intent-to-treat population; non-responder imputation (NRI) was used, where participants with a missing value were counted as a non-responders.

Arm	Measure	Value (NUMBER)
Adalimumab	Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24	82.0 percentage of participants

Secondary

Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)

The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared; * 1: Occasional fine scale over \<5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal; * 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild; * 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate; * 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked; * 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe. The percentage of participants achieving a shift from Baseline to a less severe category is reported.

Time frame: Baseline and Weeks 2, 4, 8, 12, 16 and 24

Population: Intent-to-treat population; non-responder imputation was used.

Arm	Measure	Group	Value (NUMBER)
Adalimumab	Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)	Week 2	40.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)	Week 4	74.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)	Week 8	98.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)	Week 12	98.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)	Week 16	100 percentage of participants
Adalimumab	Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)	Week 24	96.0 percentage of participants

Secondary

Percentage of Participants Achieving a PASI 100 Response

The percentage of participants with a 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the 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 and Weeks 2, 4, 8, 12, 16, and 24

Population: Intent-to-treat population; non-responder analysis was used.

Arm	Measure	Group	Value (NUMBER)
Adalimumab	Percentage of Participants Achieving a PASI 100 Response	Week 2	0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 100 Response	Week 4	0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 100 Response	Week 8	2.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 100 Response	Week 12	20.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 100 Response	Week 16	50.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 100 Response	Week 24	64.0 percentage of participants

Secondary

Percentage of Participants Achieving a PASI 50 Response

The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the 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 and Weeks 2, 4, 8, 12, 16, and 24

Population: Intent-to-treat population; non-responder imputation was used.

Arm	Measure	Group	Value (NUMBER)
Adalimumab	Percentage of Participants Achieving a PASI 50 Response	Week 2	8.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 50 Response	Week 4	36.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 50 Response	Week 8	84.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 50 Response	Week 12	88.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 50 Response	Week 16	94.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 50 Response	Week 24	96.0 percentage of participants

Secondary

Percentage of Participants Achieving a PASI 75 Response

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

Population: Intent-to-treat population; non-responder imputation was used.

Arm	Measure	Group	Value (NUMBER)
Adalimumab	Percentage of Participants Achieving a PASI 75 Response	Week 2	0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 75 Response	Week 4	4.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 75 Response	Week 8	44.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 75 Response	Week 12	76.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 75 Response	Week 16	82.0 percentage of participants

Secondary

Percentage of Participants Achieving a PASI 90 Response

The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the 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 and Weeks 2, 4, 8, 12, 16, and 24

Population: Intent-to-treat population; non-responder imputation was used.

Arm	Measure	Group	Value (NUMBER)
Adalimumab	Percentage of Participants Achieving a PASI 90 Response	Week 2	0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 90 Response	Week 4	0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 90 Response	Week 8	20.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 90 Response	Week 12	48.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 90 Response	Week 16	72.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a PASI 90 Response	Week 24	76.0 percentage of participants

Secondary

Percentage of Participants Achieving a Physician's Global Assessment of Clear

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared; * 1: Occasional fine scale over \<5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal; * 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild; * 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate; * 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked; * 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe. The percentage of participants achieving a PGA score of clear (0) is reported.

Time frame: Weeks 2, 4, 8, 12, 16 and 24

Population: Intent-to-treat population; non-responder imputation was used.

Arm	Measure	Group	Value (NUMBER)
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear	Week 2	0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear	Week 4	0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear	Week 8	6.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear	Week 12	20.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear	Week 16	60.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear	Week 24	70.0 percentage of participants

Secondary

Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal

Time frame: Weeks 2, 4, 8, 12, 16 and 24

Population: Intent-to-treat population; non-responder imputation was used.

Arm	Measure	Group	Value (NUMBER)
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal	Week 4	12.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal	Week 2	2.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal	Week 8	34.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal	Week 12	72.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal	Week 16	86.0 percentage of participants
Adalimumab	Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal	Week 24	80.0 percentage of participants

Secondary

Percent Change From Baseline in Dermatology Life Quality Index (DLQI)

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 answer 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 an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.

Time frame: Baseline and Weeks 8, 12, and 24

Population: Intent-to-treat population with available data; last observation carried forward (LOCF) imputation was used.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adalimumab	Percent Change From Baseline in Dermatology Life Quality Index (DLQI)	Week 8	-60.04 percent change	Standard Deviation 40.435
Adalimumab	Percent Change From Baseline in Dermatology Life Quality Index (DLQI)	Week 12	-75.03 percent change	Standard Deviation 45.311
Adalimumab	Percent Change From Baseline in Dermatology Life Quality Index (DLQI)	Week 24	-79.16 percent change	Standard Deviation 34.784

Secondary

Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)

NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.

Time frame: Baseline and Week 24

Population: Intent-to-treat population who had a NAPSI score ≥ 0 at the Baseline visit; last observation carried forward (LOCF) imputation was used.

Arm	Measure	Value (MEAN)	Dispersion
Adalimumab	Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)	-68.06 percent change	Standard Deviation 34.134

Secondary

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

PASI is a combination of the intensity of psoriasis, assessed by the 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. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.

Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 24

Population: Intent-to-treat population; last observation carried forward (LOCF) imputation was used.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adalimumab	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	Week 2	-20.42 percent change	Standard Deviation 15.586
Adalimumab	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	Week 4	-45.75 percent change	Standard Deviation 17.444
Adalimumab	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	Week 8	-69.28 percent change	Standard Deviation 20.759
Adalimumab	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	Week 12	-81.74 percent change	Standard Deviation 25.039
Adalimumab	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	Week 16	-89.42 percent change	Standard Deviation 19.789
Adalimumab	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	Week 24	-91.18 percent change	Standard Deviation 16.579

Other Pre-specified