Vascular Inflammation in Psoriasis Trial (The VIP Trial)

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01553058
• Collaborator: (none)
• Enrollment: 97
• Locations: 9
• Arms: 3
• Duration (Months): 51.9
• Patients Per Site: 10.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis.

This study will look for systemic vascular inflammation in subjects with a test called FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardio metabolic (heart disease and metabolic factors such as diabetes) identifiers in the blood. A blood sample will be taken that will look for these markers identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation.

This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB phototherapy or placebo injection on psoriasis activity and severity. The study will also compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This study will also evaluate subjects' reported outcomes through a questionnaire that will assess quality-of-life in subjects living with psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis; Cardiovascular Disease	Drug: Adalimumab (Humira); Drug: Placebo Injection; Other: NB-UVB phototherapy	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Trial to Determine the Effect of Psoriasis Treatment on Cardiometabolic Disease
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Aug 8, 2016
• Actual Study Completion Date: Oct 27, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Adalimumab (Humira) Injection of the active drug Humira.	Drug: Adalimumab (Humira); Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
Placebo Comparator: Placebo Injection Injection of placebo in place of active Humira injection.	Drug: Placebo Injection; Placebo injection will be given according to the same dose and schedule as the active comparator.
Active Comparator: NB-UVB phototherapy NB-UVB Phototherapy 3 times per week, no other intervention.	Other: NB-UVB phototherapy; Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.

Outcome Measures

Primary Outcome Measures

1. Change in Vascular Inflammation [Baseline - Week 12]

   Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12. The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).

2. Change in Cardiometabolic Biomarkers: Total Cholesterol [Baseline - Week 12]

   To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on total cholesterol.

3. Change in Cardiometabolic Biomarkers: Cholesterol Efflux [Baseline - Week 12]

   To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on cholesterol efflux capacity. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)]. The pooled plasma was obtained from five healthy volunteers.

4. Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total [Baseline - Week 12]

   To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on low density lipoprotein particle total.

5. Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total [Baseline - Week 12]

   To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on high density lipoprotein particle total.

6. Change in Cardiometabolic Biomarkers: Log Insulin [Baseline - Week 12]

   To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log insulin.

7. Change in Cardiometabolic Biomarkers: Log Adiponectin [Baseline - Week 12]

   To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log adiponectin.

8. Change in Cardiometabolic Biomarkers: Log Leptin [Baseline - Week 12]

   To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log leptin.

9. Change in Cardiometabolic Biomarkers: Log C-reactive Protein [Baseline - Week 12]

   To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log C-reactive protein (CRP).

10. Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha [Baseline - Week 12]

    To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log Tumor necrosis factor-alpha.

11. Change in Cardiometabolic Biomarkers: Log Interleukin 6 [Baseline - Week 12]

    To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log interleukin 6.

12. Change in Cardiometabolic Biomarkers: GlycA [Baseline - Week 12]

    To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on GlycA

Secondary Outcome Measures

1. Change in Psoriasis Activity (PASI-75 and PGA) [Baseline - Week 12]

   Psoriasis activity will be assessed using standard psoriasis measurements, PASI75 and PGA Clear/Almost Clear

2. Change in Patient-reported Outcomes-EuroQol EQ-5D [Baseline -Week 12]

   EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale ranging from 1 (no health state problem) to 3 (extreme health state problems). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0, worst health state, to 100, best health state. A scoring function is used to assign a value (i.e., EQ-5D™ index score) to self-reported health states from a set of population-based preference weights. For the U.S. general population, the possible EQ-5D index scores range from -0.11 to 1.0 where 0.0 = death and 1.0 = perfect health.

3. Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI) [Baseline - Week 12]

   Patient reported quality of life outcomes will be assessed using DLQI. The DLQI is calculated by summing the score of 10 questions regarding impact of skin condition on daily life resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

4. Change in Patient-reported Outcomes-MEDFICTS Dietary Assessment) [Baseline to Week 12]

   Patient reported dietary outcomes will be assessed using MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument for properly assessing cardiovascular diet. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of <40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day).

5. Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ) [Baseline week 4, 8 and 12]

   Patient reported physical activity will be assessed using IPAQ. IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.

6. Number of Patients With Adverse Events. [Baseline - Week 12]

   Safety will be assessed by comparing how many patients have adverse events depending on whether they are on adalimumab, as compared to NB-UVB phototherapy or placebo.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Males and females 18 years of age and older.

2. Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by Investigator.

3. Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week

1. as determined by subject interview of his/her medical history.

1. Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the Baseline (Week 0) visit.

2. PASI (psoriasis assessment and severity index) score of ≥ 12 at the Baseline (Week 0) visit.

3. Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite prior treatment with topical agents.

4. Women are eligible to participate in the study if they meet one of the following criteria:

5. Women of childbearing potential who are willing to undergo regular pregnancy testing and agree to use one method of contraception throughout the study are eligible to participate

6. Women who are postmenopausal (for at least one year), sterile, or hysterectomized are eligible to participate

7. Women who have undergone tubal ligation are eligible to participate

8. Women who agree to be sexually abstinent, defined as total abstinence from sexual intercourse, as a form of contraception are eligible to participate in the study.

9. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, and 12-lead electrocardiogram (ECG) performed at screening.

10. Able and willing to give written informed consent and to comply with requirements of this study protocol.

Exclusion Criteria:

1. Previous adverse event following exposure to a TNF-alpha antagonist and/or UV phototherapy that led to discontinuation of either of these therapies and contraindicates future treatment.

2. Previous lack of response to a TNF-alpha antagonist and/or UV phototherapy that led to discontinuation of either of these therapies.

3. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.

4. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.

5. Cannot avoid UVB phototherapy for at least 14 days prior to the Baseline (Week 0) visit.

6. Cannot avoid psoralen-UVA phototherapy for at least 30 days prior to the Baseline (Week 0) visit and during the study.

7. Cannot discontinue systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study:

• Systemic (investigational or marketed) therapies must be discontinued at least 30 days prior to the Baseline (Week 0) visit except for biologics.

• All biologics, except ustekinumab, must be discontinued for at least 90 days prior to Baseline (Week 0).

• The IL-12/IL-23 antagonist ustekinumab (half-life of 45.6 ± 80.2 days) must be discontinued for at least 180 days prior to Baseline (Week 0).

• Investigational agents must be discontinued at least 30 days or 5 half-lives (whichever is longer) prior to the Baseline (Week 0) visit.

1. Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.

2. Poorly controlled medical condition, such as unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the subject at risk by participation in the study.

3. History of diabetes mellitus, type 1 or type 2 - note that patients with type 2 diabetes may be enrolled if the duration of diabetes is <10 years and HbA1c is <7.0%)

4. Uncontrolled hypertension, with measured systolic blood pressure >180 mmHg or diastolic blood pressure >90 mmHg

5. History of demyelinating diseases or lupus.

6. Subject has infection or risk factors for severe infections, for example:

• Positive serology or known history of HIV, hepatitis B or C, or other severe, recurrent, or persistent infections;

• Excessive immunosuppression or other factors associated with it, including human immunodeficiency virus infection;

• Active tuberculosis (TB) disease;

• Evidence of latent TB infection demonstrated by Purified Protein Derivative (PPD) ≥ 5 mm of induration or positive Quantiferon-GOLD results; except if prophylactic treatment for TB, as recommended by local guidelines, is initiated prior to administration of study drug or if there is documentation that the subject has received prophylactic treatment for TB previously.

• Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Baseline;

• Infection requiring treatment with oral or parenteral antibiotics within 14 days prior to Baseline;

• Subject has received vaccination with Bacille Calmette-Guerin (BCG) within 365 days prior to Screening;

• Subject has received vaccination with a live viral agent 30 days prior to Screening or will require a live vaccination during study participation including up to 30 days after the last dose of study drug.

1. Subject has history of hematological or solid malignancy other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical carcinoma in situ.

2. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.

3. Screening clinical laboratory analyses showing any of the following abnormal results:

• Hemoglobin (Hgb) < 10 g/dL in females or <12 g/dL in males;

• White blood cell (WBC) count <2.5 x 109/L

o Subject can be included if WBC count is <2.5 x x 109/L and absolute neutrophil count (ANC) is >1000 cells / mm3.

• WBC count > 15 x 109/L;

• Platelet count < 100 x 109/L;

• Serum aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 upper limits of normal (ULN);

• Serum total bilirubin ≥2 mg/dL (≥26 µmol/L); or

• Serum creatinine >1.6 mg/dL (>141 µmol/L).

1. Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.

2. History of any substance abuse within 365 days of screening visit

3. Alcohol use >14 drinks per week at the screening visit or within 30 days of the screening period

4. If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to week 0 and remain stable throughout the duration of the study.

5. History of photosensitivity of medical condition that may be exacerbated by UV exposures such as lupus or dermatomyositis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Davis Health System	Sacramento	California	United States	95816
2	The University of Colorado	Denver	Colorado	United States	80045
3	National Heart, Lung, and Blood Institute	Bethesda	Maryland	United States	20892
4	Buffalo Medical Group	Buffalo	New York	United States	14221
5	Oregon Health & Science University	Portland	Oregon	United States	97239
6	The University of Pennsylvania	Philadelphia	Pennsylvania	United States	19140
7	Menter Dermatology Research Institute	Dallas	Texas	United States	75246
8	Center for Clinical Studies	Houston	Texas	United States	77004
9	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Joel Gelfand, MD MSCE, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01553058
• Other Study ID Numbers: 814278
• First Posted: Mar 13, 2012
• Last Update Posted: May 22, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by University of Pennsylvania: Psoriasis; Cardiovascular Disease; FDG/PET-CT; NB-UVB Phototherapy; Vascular Inflammation; Lipid Biomarkers
• Additional relevant MeSH terms: Cardiovascular Diseases; Psoriasis; Adalimumab

Study Results

Participant Flow

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Period Title: Overall Study
STARTED	33	31	33
COMPLETED	32	30	30
NOT COMPLETED	1	1	3

Baseline Characteristics

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy	Total
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.	Total of all reporting groups
Overall Participants	33	31	33	97
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.15 (13.97)	44.32 (14.50)	41.97 (13.97)	43.46 (14.03)
Sex: Female, Male (Count of Participants)
Female	9 27.3%	11 35.5%	10 30.3%	30 30.9%
Male	24 72.7%	20 64.5%	23 69.7%	67 69.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 15.2%	3 9.7%	7 21.2%	15 15.5%
Not Hispanic or Latino	27 81.8%	28 90.3%	26 78.8%	81 83.5%
Unknown or Not Reported	1 3%	0 0%	0 0%	1 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 3.2%	0 0%	1 1%
Asian	1 3%	2 6.5%	2 6.1%	5 5.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	3 9.1%	3 9.7%	3 9.1%	9 9.3%
White	27 81.8%	24 77.4%	26 78.8%	77 79.4%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	2 6.1%	1 3.2%	2 6.1%	5 5.2%
Psoriasis Duration (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.94 (14.73)	19.29 (13.59)	15.87 (13.55)	16.7 (13.94)
Psoriatic Arthritis (Count of Participants)
Count of Participants [Participants]	4 12.1%	2 6.5%	3 9.1%	9 9.3%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.93 (7.42)	31.95 (7.74)	32.61 (8.66)	31.83 (7.91)
History of Cardiovascular Disease (Count of Participants)
Count of Participants [Participants]	2 6.1%	3 9.7%	2 6.1%	7 7.2%
Diabetes (Count of Participants)
Count of Participants [Participants]	3 9.1%	1 3.2%	0 0%	4 4.1%
Hypertension (Count of Participants)
Count of Participants [Participants]	6 18.2%	7 22.6%	5 15.2%	18 18.6%
Hyperlipidemia (Count of Participants)
Count of Participants [Participants]	5 15.2%	5 16.1%	4 12.1%	14 14.4%
Statin Use (Count of Participants)
Count of Participants [Participants]	1 3%	4 12.9%	3 9.1%	8 8.2%
10year Framingham Risk % (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	8.43 (7.75)	7.91 (8.83)	6.12 (7.68)	7.53 (8.09)
Body Surface Area (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	23.39 (14.48)	25.70 (15.02)	22.96 (13.37)	23.98 (14.19)
PASI (Psoriasis Area and Severity Index) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.89 (5.59)	18.33 (7.64)	19.32 (8)	18.85 (7.08)
PGA (Physician's Global Assessment) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.36 (.56)	3.22 (.59)	3.27 (.66)	3.28 (.6)
DLQI (Dermatology Quality of Life Index) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	15.88 (5.53)	13.48 (7.58)	14.61 (6.52)	14.68 (6.58)
History of Phototherapy (Count of Participants)
Count of Participants [Participants]	5 15.2%	11 35.5%	13 39.4%	29 29.9%
H/O Oral Systemics (Count of Participants)
Count of Participants [Participants]	10 30.3%	10 32.3%	11 33.3%	31 32%
H/O Biologics (Count of Participants)
Count of Participants [Participants]	10 30.3%	11 35.5%	8 24.2%	29 29.9%

Outcome Measures

1. Primary Outcome

Title	Change in Vascular Inflammation
Description	Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12. The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [Tissue-to-background ratio (TBR)]	-.067 (.213)	-.052 (.112)	-.079 (.020)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of Differences
Statistical Test of Hypothesis	p-Value	0.795
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.647
	Comments
	Method	Regression, Linear
	Comments

2. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: Total Cholesterol
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on total cholesterol.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [mg/dL]	1.48 (21.25)	5.00 (25.22)	3.15 (32.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.386
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of Differences
Statistical Test of Hypothesis	p-Value	0.280
	Comments
	Method	Regression, Linear
	Comments

3. Secondary Outcome

Title	Change in Psoriasis Activity (PASI-75 and PGA)
Description	Psoriasis activity will be assessed using standard psoriasis measurements, PASI75 and PGA Clear/Almost Clear
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	32	30	30
PASI75	15 45.5%	2 6.5%	14 42.4%
PGA Clear/Almost Clear	14 42.4%	2 6.5%	8 24.2%

4. Secondary Outcome

Title	Change in Patient-reported Outcomes-EuroQol EQ-5D
Description	EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale ranging from 1 (no health state problem) to 3 (extreme health state problems). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0, worst health state, to 100, best health state. A scoring function is used to assign a value (i.e., EQ-5D™ index score) to self-reported health states from a set of population-based preference weights. For the U.S. general population, the possible EQ-5D index scores range from -0.11 to 1.0 where 0.0 = death and 1.0 = perfect health.
Time Frame	Baseline -Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [units on a scale]	.07 (.14)	.0 (.17)	.16 (.19)

5. Secondary Outcome

Title	Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI)
Description	Patient reported quality of life outcomes will be assessed using DLQI. The DLQI is calculated by summing the score of 10 questions regarding impact of skin condition on daily life resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [units on a scale]	-7.91 (8.77)	-3.73 (8)	-9.27 (4.70)

6. Secondary Outcome

Title	Change in Patient-reported Outcomes-MEDFICTS Dietary Assessment)
Description	Patient reported dietary outcomes will be assessed using MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument for properly assessing cardiovascular diet. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of <40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day).
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [units on a scale]	-10.17 (17.47)	-13.66 (28.59)	-16.29 (20.94)

7. Secondary Outcome

Title	Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ)
Description	Patient reported physical activity will be assessed using IPAQ. IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.
Time Frame	Baseline week 4, 8 and 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [MET-minutes/week]	1282 (4837)	141 (2921)	18 (2994)

8. Secondary Outcome

Title	Number of Patients With Adverse Events.
Description	Safety will be assessed by comparing how many patients have adverse events depending on whether they are on adalimumab, as compared to NB-UVB phototherapy or placebo.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
erythema	0 0%	0 0%	14 42.4%
pruritis	0 0%	0 0%	6 18.2%
photosensitivity	0 0%	0 0%	3 9.1%
upper respiratory infection	3 9.1%	4 12.9%	2 6.1%
nasal congestion	1 3%	1 3.2%	2 6.1%
cough	0 0%	2 6.5%	0 0%
sore throat	0 0%	2 6.5%	1 3%
headache	1 3%	2 6.5%	2 6.1%
myalgia	0 0%	2 6.5%	1 3%
joint range of motion decrease	2 6.1%	0 0%	0 0%
depression	0 0%	0 0%	2 6.1%
tooth infection	0 0%	2 6.5%	0 0%

9. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: Cholesterol Efflux
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on cholesterol efflux capacity. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)]. The pooled plasma was obtained from five healthy volunteers.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [unitless]	0.05 (0.25)	0.00 (0.15)	0.04 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of Differences
Statistical Test of Hypothesis	p-Value	0.357
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of Differences
Statistical Test of Hypothesis	p-Value	0.496
	Comments
	Method	Regression, Linear
	Comments

10. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on low density lipoprotein particle total.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	njection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [nmol/L]	-25.70 (263.32)	-34.90 (319.42)	17.42 (187.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of Differences
Statistical Test of Hypothesis	p-Value	0.897
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.467
	Comments
	Method	Regression, Linear
	Comments

11. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on high density lipoprotein particle total.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [umol/L]	0.59 (4.00)	-1.97 (7.03)	1.35 (5.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.089
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.030
	Comments
	Method	Regression, Linear
	Comments

12. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: Log Insulin
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log insulin.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [log(pg/mL)]	-0.19 (0.71)	-0.21 (0.74)	-0.13 (0.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.934
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.679
	Comments
	Method	Regression, Linear
	Comments

13. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: Log Adiponectin
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log adiponectin.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [log(ug/mL)]	-0.07 (2.05)	0.07 (0.45)	-0.08 (.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.672
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.655
	Comments
	Method	Regression, Linear
	Comments

14. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: Log Leptin
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log leptin.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [log(pg/mL)]	-0.06 (0.55)	0.03 (0.47)	0.08 (0.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.504
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.695
	Comments
	Method	Regression, Linear
	Comments

15. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: Log C-reactive Protein
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log C-reactive protein (CRP).
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [log(pg/mL)]	-0.52 (1.00)	0.35 (1.06)	-0.50 (1.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	Regression, Linear
	Comments

16. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log Tumor necrosis factor-alpha.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [log(pg/mL)]	-0.27 (0.33)	0.14 (0.38)	-0.04 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of Differences
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.065
	Comments
	Method	Regression, Linear
	Comments

17. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: Log Interleukin 6
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log interleukin 6.
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [log(pg/mL)]	-0.57 (1.08)	0.20 (0.99)	-0.49 (1.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	Regression, Linear
	Comments

18. Primary Outcome

Title	Change in Cardiometabolic Biomarkers: GlycA
Description	To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on GlycA
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adalimumab (Humira)	Placebo Injection	NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.	Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.	NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Measure Participants	33	31	33
Mean (Standard Deviation) [log(pg/mL)]	-35.89 (40.38)	5.28 (66.83)	-1.92 (52.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (Humira), Placebo Injection
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Injection, NB-UVB Phototherapy
	Comments
	Type of Statistical Test	Other
	Comments	Difference of differences
Statistical Test of Hypothesis	p-Value	0.628
	Comments
	Method	Regression, Linear
	Comments

Adverse Events

Time Frame	Baseline - Week 12
Arm/Group Title	Adalimumab (Humira)		Placebo Injection		NB-UVB Phototherapy
Arm/Group Description	Injection of the active drug Humira. Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.		Injection of placebo in place of active Humira injection. Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.		NB-UVB Phototherapy 3 times per week, no other intervention. NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
All Cause Mortality
	Adalimumab (Humira)		Placebo Injection		NB-UVB Phototherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Adalimumab (Humira)		Placebo Injection		NB-UVB Phototherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/33 (6.1%)		0/31 (0%)		0/33 (0%)
General disorders
vasovagal syncope	2/33 (6.1%)	2	0/31 (0%)	0	0/33 (0%)	0
Other (Not Including Serious) Adverse Events
	Adalimumab (Humira)		Placebo Injection		NB-UVB Phototherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/33 (21.2%)		15/31 (48.4%)		33/33 (100%)
General disorders
nasal congestion	1/33 (3%)	1	1/31 (3.2%)	1	2/33 (6.1%)	2
cough	0/33 (0%)	0	2/31 (6.5%)	2	0/33 (0%)	0
sore throat	0/33 (0%)	0	2/31 (6.5%)	2	1/33 (3%)	1
headache	1/33 (3%)	1	2/31 (6.5%)	2	2/33 (6.1%)	2
Infections and infestations
upper respiratory infection	3/33 (9.1%)	3	4/31 (12.9%)	4	2/33 (6.1%)	2
tooth infection	0/33 (0%)	0	2/31 (6.5%)	2	0/33 (0%)	0
Musculoskeletal and connective tissue disorders
myalgia	0/33 (0%)	0	2/31 (6.5%)	2	1/33 (3%)	1
joint range of motion decrease	2/33 (6.1%)	2	0/31 (0%)	0	0/33 (0%)	0
Psychiatric disorders
depression	0/33 (0%)	0	0/31 (0%)	0	2/33 (6.1%)	2
Skin and subcutaneous tissue disorders
pruritis	0/33 (0%)		0/31 (0%)		6/33 (18.2%)	6
erythema	0/33 (0%)		0/31 (0%)		14/33 (42.4%)	14
photosensitivity	0/33 (0%)	0	0/31 (0%)	0	3/33 (9.1%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.