Trial Outcomes & Findings for Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis (NCT NCT01265823)

Last Updated: 2013-03-11

Results Overview

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

150 participants

Primary outcome timeframe

Week 4

Results posted on

2013-03-11

Participant Flow

A total of 187 participants were screened and 37 were considered screening failures.

Participant milestones

Participant milestones
Measure	Adalimumab Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Study STARTED	150
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Study Unsatisfactory Response Efficacy	1
Overall Study Failure to Return	4
Overall Study Protocol Violation	1
Overall Study Participant Request	1

Baseline Characteristics

Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Age Continuous	44.6 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants
Region of Enrollment Mexico	150 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4	31 percentage of participants	—

PRIMARY outcome

Timeframe: Week 16

Population: Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16	85 percentage of participants	—

PRIMARY outcome

Timeframe: Week 4

Population: Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.

Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score \<6 indicates that psoriasis has small or no effect at all on participant's life.

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4	65 percentage of participants	—

PRIMARY outcome

Timeframe: Week 16

Population: Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16	86 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Participants with evaluable data at given time points.

Outcome measures

Outcome measures
Measure	Adalimumab n=148 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4 Score at Baseline	11.7 units on a scale Standard Deviation 6.3	—
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4 Score at Week 4	5.2 units on a scale Standard Deviation 6.4	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants with evaluable data at given time points.

Outcome measures

Outcome measures
Measure	Adalimumab n=143 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16 Score at Baseline	11.7 units on a scale Standard Deviation 6.3	—
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16 Score at Week 16	1.8 units on a scale Standard Deviation 2.0	—

SECONDARY outcome

Timeframe: Week 4

Population: ITT population. Participants with missing scores were considered nonresponders.

Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Dermatology Life Quality Index (DLQI) Categories at Week 4 No Effect	42 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 4 Small Effect	52 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 4 Moderate Effect	32 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 4 Very Large Effect	18 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 4 Extremely Large Effect	3 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 4 Missing	3 participants	—

SECONDARY outcome

Timeframe: Week 16

Population: ITT population. Participants with missing scores were considered nonresponders.

Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Dermatology Life Quality Index (DLQI) Categories at Week 16 No Effect	105 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 16 Small Effect	18 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 16 Moderate Effect	15 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 16 Very Large Effect	6 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 16 Extremely Large Effect	0 participants	—
Dermatology Life Quality Index (DLQI) Categories at Week 16 Missing	6 participants	—

SECONDARY outcome

Timeframe: Week 4

Population: ITT population. Participants with missing scores were considered nonresponders.

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4 PASI-50	58.6 percentage of participants	—
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4 PASI-90	10.6 percentage of participants	—
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4 PASI-100	2.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 16

Population: ITT population. Participants with missing scores were considered nonresponders.

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16 PASI-50	92.6 percentage of participants	—
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16 PASI-90	73.3 percentage of participants	—
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16 PASI-100	49.3 percentage of participants	—

SECONDARY outcome

Timeframe: Week 4

Population: ITT population. Participants with missing scores were considered nonresponders.

The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present).

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Physician's Global Assessment (PGA) at Week 4 Severe	3 participants	—
Physician's Global Assessment (PGA) at Week 4 Moderate to Severe	12 participants	—
Physician's Global Assessment (PGA) at Week 4 Moderate	44 participants	—
Physician's Global Assessment (PGA) at Week 4 Mild to Moderate	37 participants	—
Physician's Global Assessment (PGA) at Week 4 Mild	36 participants	—
Physician's Global Assessment (PGA) at Week 4 Almost Clear	11 participants	—
Physician's Global Assessment (PGA) at Week 4 Clear	3 participants	—
Physician's Global Assessment (PGA) at Week 4 Missing	4 participants	—

SECONDARY outcome

Timeframe: Week 16

Population: ITT population. Participants with missing scores were considered nonresponders.

Outcome measures

Outcome measures
Measure	Adalimumab n=150 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Physician's Global Assessment (PGA) at Week 16 Severe	1 participants	—
Physician's Global Assessment (PGA) at Week 16 Moderate to Severe	1 participants	—
Physician's Global Assessment (PGA) at Week 16 Moderate	9 participants	—
Physician's Global Assessment (PGA) at Week 16 Mild to Moderate	8 participants	—
Physician's Global Assessment (PGA) at Week 16 Mild	9 participants	—
Physician's Global Assessment (PGA) at Week 16 Almost Clear	44 participants	—
Physician's Global Assessment (PGA) at Week 16 Clear	71 participants	—
Physician's Global Assessment (PGA) at Week 16 Missing	7 participants	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants with available data at given time points.

Normal values: C-reactive protein (CRP) 0-0.79 mg/dL; cholesterol 30-199 mg/dL; high density lipoprotein (HDL) 40-100 mg/dL; very low density lipoprotein (VLDL) 0-34 mg/dL; low density lipoprotein (LDL) 20-99 mg/dL; triglycerides 50-149 mg/dL.

Outcome measures

Outcome measures
Measure	Adalimumab n=144 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 C-reactive Protein at Baseline	0.6 mg/dL Standard Deviation 0.9	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 C-reactive Protein at Week 16	0.5 mg/dL Standard Deviation 1.6	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 Cholesterol at Baseline	190.7 mg/dL Standard Deviation 38.8	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 Cholesterol at Week 16	185.3 mg/dL Standard Deviation 33.8	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 High Density Lipoprotein (HDL) at Baseline	41.6 mg/dL Standard Deviation 9.7	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 High Density Lipoprotein (HDL) at Week 16	42.6 mg/dL Standard Deviation 10.8	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 Very Low Density Lipoprotein (VLDL) at Baseline	37.7 mg/dL Standard Deviation 26.3	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 Very Low Density Lipoprotein (VLDL) at Week 16	37.8 mg/dL Standard Deviation 20.9	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 Low Density Lipoprotein (LDL) at Baseline	120.8 mg/dL Standard Deviation 28.7	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 Low Density Lipoprotein (LDL) at Week 16	120.3 mg/dL Standard Deviation 29.9	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 Triglycerides at Baseline	185.3 mg/dL Standard Deviation 123.1	—
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16 Triglycerides at Week 16	189.1 mg/dL Standard Deviation 104.3	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants with available data at given time points.

Normal values for homocysteine were 5-13.9 µmol/L.

Outcome measures

Outcome measures
Measure	Adalimumab n=143 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Mean Homocysteine Levels at Baseline and Week 16 Baseline	11.6 µmol/L Standard Deviation 4.3	—
Mean Homocysteine Levels at Baseline and Week 16 Week 16	10.9 µmol/L Standard Deviation 4.0	—

SECONDARY outcome

Timeframe: Week 16

Population: ITT Population

The Body Mass Index (BMI) was used to determine the groups of participants who were overweight and who were considered obese. A BMI of 18.5 to 25 was considered normal range, 25 to 30 as overweight and 30 and above as obesity, in both men and women. Response to treatment in participants with obesity (based on Body Mass Index) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of \<6 (see Outcome Measure 3 for details).

Outcome measures

Outcome measures
Measure	Adalimumab n=66 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants n=84 Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16 PASI-75	76 percentage of participants	92 percentage of participants
Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16 DLQI <6	80 percentage of participants	90 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: ITT population

The Waist-Hip Ratio was used to determine the groups of participants who were overweight and who were considered obese. Obesity was defined as a ratio of \>1 for men and \>0.8 for women. Response to treatment in participants with obesity (based on Waist-Hip Ratio) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of \<6 (see Outcome Measure 3 for details).

Outcome measures

Outcome measures
Measure	Adalimumab n=66 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants n=84 Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16 PASI-75	77 percentage of participants	91 percentage of participants
Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16 DLQI <6	84 percentage of participants	87 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Participants with available data at given time points.

Normal values for folic acid were 3-15 ng/mL.

Outcome measures

Outcome measures
Measure	Adalimumab n=143 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Serum Levels of Folic Acid at Baseline and Week 4 Baseline	18.1 ng/mL Standard Deviation 20.0	—
Serum Levels of Folic Acid at Baseline and Week 4 Week 4	17.8 ng/mL Standard Deviation 11.4	—

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Participants with available data at given time points.

Normal values for vitamin B6 were 18-175 nmol/L.

Outcome measures

Outcome measures
Measure	Adalimumab n=141 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Serum Levels of Vitamin B6 at Baseline and Week 4 Baseline	11.2 nmol/L Standard Deviation 12.5	—
Serum Levels of Vitamin B6 at Baseline and Week 4 Week 4	11.7 nmol/L Standard Deviation 11.6	—

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Participants with available data at given time points.

Normal values for vitamin B12 were 200-1100 pg/mL.

Outcome measures

Outcome measures
Measure	Adalimumab n=143 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Serum Levels of Vitamin B12 at Baseline and Week 4 Baseline	542.6 pg/mL Standard Deviation 615.5	—
Serum Levels of Vitamin B12 at Baseline and Week 4 Week 4	439.6 pg/mL Standard Deviation 438.9	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants with available data at given time point.

Normal values for folic acid were 3-15 ng/mL.

Outcome measures

Outcome measures
Measure	Adalimumab n=140 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Serum Levels of Folic Acid at Baseline and Week 16 Baseline	18.2 ng/mL Standard Deviation 20.2	—
Serum Levels of Folic Acid at Baseline and Week 16 Week 16	17.9 ng/mL Standard Deviation 7.1	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants with available data at given time points.

Normal values for vitamin B6 were 18-175 nmol/L.

Outcome measures

Outcome measures
Measure	Adalimumab n=138 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Serum Levels of Vitamin B6 at Baseline and Week 16 Baseline	11.4 nmol/L Standard Deviation 12.6	—
Serum Levels of Vitamin B6 at Baseline and Week 16 Week 16	11.8 nmol/L Standard Deviation 7.6	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants with available data at given time points.

Normal values for vitamin B12 were 200-1100 pg/mL.

Outcome measures

Outcome measures
Measure	Adalimumab n=140 Participants Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.	Adalimumab in Non-obese Participants Non-obese participants were defined as having a BMI \< 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Serum Levels of Vitamin B12 at Baseline and Week 16 Baseline	541.9 pg/mL Standard Deviation 620.5	—
Serum Levels of Vitamin B12 at Baseline and Week 16 Week 16	441.8 pg/mL Standard Deviation 533.8	—

Adverse Events

Adalimumab

Serious events: 1 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab n=150 participants at risk Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Gastrointestinal disorders Cholelithiasis	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.

Other adverse events

Other adverse events
Measure	Adalimumab n=150 participants at risk Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Blood and lymphatic system disorders Anemia	2.0% 3/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Blood and lymphatic system disorders Leukopenia	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Blood and lymphatic system disorders Polycythemia	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Blood and lymphatic system disorders Thrombocytopenia	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Cardiac disorders Aortic arteriosclerosis	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Cardiac disorders Chest pain precordial	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Cardiac disorders Hypertension aggravated	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Ear and labyrinth disorders Otitis externa	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Ear and labyrinth disorders Otitis media	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Ear and labyrinth disorders Vertigo	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Eye disorders Corneal injury	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Abdominal pain	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Cholelithiasis	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Diarrhoea	1.3% 2/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Epigastric discomfort	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Flatulence	1.3% 2/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Food poisoning	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Gastrointestinal infection	1.3% 2/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Nausea	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Oral infection	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Gastrointestinal disorders Vomiting	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Renal and urinary disorders Calculus urethral	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Renal and urinary disorders Nefrolithiasis	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Renal and urinary disorders Penis disorder	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Renal and urinary disorders Prostatitis	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Renal and urinary disorders Urinary tract infection	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Renal and urinary disorders Urinary tract pain	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Infections and infestations Vaginal infection	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Metabolism and nutrition disorders C-Reactive Protein increase	1.3% 2/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Metabolism and nutrition disorders Diabetes	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Metabolism and nutrition disorders Hyperglycemia	10.7% 16/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Metabolism and nutrition disorders Hypertransaminasemia	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Metabolism and nutrition disorders Hypertriglyceridemia	4.7% 7/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Metabolism and nutrition disorders Hypervitaminosis B12	2.0% 3/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Metabolism and nutrition disorders Hypervitaminosis B6	1.3% 2/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Metabolism and nutrition disorders Hypoglycemia	1.3% 2/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Metabolism and nutrition disorders Weight loss	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Musculoskeletal and connective tissue disorders Ankle sprain	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 10/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Musculoskeletal and connective tissue disorders Joint injury	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Psychiatric disorders Anxiety	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Nervous system disorders Seizures	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Psychiatric disorders Depressed mood	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Psychiatric disorders Depression	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Nervous system disorders Dizziness	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Nervous system disorders Headache	5.3% 8/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Respiratory, thoracic and mediastinal disorders Pharyngitis	4.0% 6/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	11.3% 17/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Skin and subcutaneous tissue disorders Cold sores (herpetic)	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Skin and subcutaneous tissue disorders Folliculitis	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Skin and subcutaneous tissue disorders Papillomatosis	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Skin and subcutaneous tissue disorders Urticaria	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
General disorders Application site pain and/or pruritus	4.7% 7/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
General disorders Fatigue	2.7% 4/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
General disorders Fever	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
General disorders Pruritus generalized	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
General disorders Psoriasis aggravated	1.3% 2/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
General disorders Skin disorder	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
General disorders Skin nodule	0.67% 1/150 • Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER