Trial Outcomes & Findings for Vascular Inflammation in Psoriasis - Extension Study (NCT NCT01866592)

NCT ID: NCT01866592

Last Updated: 2018-05-22

Results Overview

Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and baseline scans (prior to randomization in the VIP Trial). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR). If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 81 participants
• Primary outcome timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)
• Results posted on: 2018-05-22

Participant Flow

Participant milestones

Measure	Single-Arm, Open-label Extension Trial Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.
Overall Study STARTED	81
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two participants did not respond to question, missing data.

Baseline characteristics by cohort

Measure	Single-Arm, Open-label Extension Trial n=81 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.
Age, Continuous	42.8642 years STANDARD_DEVIATION 14.42 • n=81 Participants
Sex: Female, Male Female	24 Participants n=81 Participants
Sex: Female, Male Male	57 Participants n=81 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=81 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=81 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=81 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=81 Participants
Race (NIH/OMB) Asian	5 Participants n=81 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=81 Participants
Race (NIH/OMB) Black or African American	8 Participants n=81 Participants
Race (NIH/OMB) White	63 Participants n=81 Participants
Race (NIH/OMB) More than one race	0 Participants n=81 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=81 Participants
Psoriasis Duration	16.27 years STANDARD_DEVIATION 13.78 • n=79 Participants • Two participants did not respond to question, missing data.
Psoriatic Arthritis	9 Participants n=79 Participants • Two participants did not respond to question, missing data.
History of Cardiovascular Disease	6 Participants n=81 Participants
Diabetes	3 Participants n=81 Participants
History of Hypertension	14 Participants n=81 Participants
History of Hyperlipidemia	11 Participants n=81 Participants
History of Statin Use	7 Participants n=81 Participants
10 year Framingham Risk	7.44 percentage STANDARD_DEVIATION 8.3 • n=81 Participants
Body Surface Area	24.37 kg/m^2 STANDARD_DEVIATION 14.65 • n=81 Participants
PASI (Psoriasis Area and Severity Index)	19.12 units on a scale STANDARD_DEVIATION 7.41 • n=81 Participants
PGA (Physician's Global Assessment)	3.25 units on a scale STANDARD_DEVIATION .59 • n=81 Participants
DLQI (Dermatology Quality of Life Index)	15.02 units on a scale STANDARD_DEVIATION 6.52 • n=81 Participants
History of Phototherapy	23 Participants n=50 Participants • Data was collected after last follow up visit, only 50 of 81 participants responded.
History of Oral Systemics	28 Participants n=50 Participants • Data was collected after last follow up visit, only 50 of 81 participants responded.
History of Biologics	24 Participants n=50 Participants • Data was collected after last follow up visit, only 50 of 81 participants responded.

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and baseline scans (prior to randomization in the VIP Trial). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR). If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Vascular Inflammation

-3.8 percentage change Interval -6.4 to -1.19

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and start of adalimumab.The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Vascular Inflammation

0.02 percentage change Interval -2.85 to 2.9

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Total Cholesterol. If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Total Cholesterol

3.164 mg/dL Standard Error 4.216

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

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)].

If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Cholesterol Efflux

-0.217 no units Standard Error 0.032

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Low-density lipoprotein particle If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle

22.537 nmol/L Standard Error 44.283

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - High-density lipoprotein particle If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle

-2.984 nmol/L Standard Error .786

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Insulin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Insulin

.118 log(pg/mL) Standard Error .136

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Adiponectin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Adiponectin

-.074 log(ug/mL) Standard Error .068

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Leptin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Leptin

.048 log(pg/mL) Standard Error .195

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log C-reactive protein If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log C-reactive Protein

-.815 log(pg/mL) Standard Error .192

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Tumor Necrosis Factor-Alpha If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha

-.275 log(pg/mL) Standard Error .131

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Interleukin 6 If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Interleukin 6

1.054 log(pg/mL) Standard Error .243

PRIMARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - GlycA If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - GlycA

-29.559 log(pg/mL) Standard Error 7.749

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and the start of adalimumab - Total Cholesterol

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarkers: - Total Cholesterol

1.194 mg/dL Standard Error 3.746

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Cholesterol Efflux

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Cholesterol Efflux

-.225 no units Standard Error .030

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Low-density lipoprotein particle

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle

23.313 nmol/L Standard Error 42.860

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - High-density lipoprotein particle

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle

-2.630 umol/L Standard Error .778

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Insulin

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Insulin

.188 log(pg/mL) Standard Error .134

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Adiponectin

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Adiponectin

-.055 log(ug/mL) Standard Error .067

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Leptin

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Leptin

.077 log(pg/mL) Standard Error .201

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log C-reactive protein

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log C-reactive Protein

-.615 log(pg/mL) Standard Error .189

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Tumor Necrosis Factor-Alpha

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha

-.197 log(pg/mL) Standard Error .132

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Interleukin 6

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - Log Interleukin 6

1.309 log(pg/mL) Standard Error .232

PRIMARY outcome

Timeframe: 52 weeks of adalimumab treatment

Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - GlycA

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Cardiometabolic Biomarker - GlycA

-17.454 log(pg/mL) Standard Error 7.394

SECONDARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

Change in psoriasis activity will be assessed using the following standardized measurement tools for psoriasis: Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). PASI combines the assessment of the severity of lesions and the area affected into a single score with range 0 (no disease) to 72 maximal disease. The PGA is an average assessment of all psoriatic lesions based on erythema, scale, and induration with score range 0 (no disease/clear) to 5 (maximal disease).

If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure	Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.
Psoriasis Activity (PASI and PGA) PASI 75	40 Participants
Psoriasis Activity (PASI and PGA) PGA Clear/Almost Clear	35 Participants

SECONDARY outcome

Timeframe: Baseline - Week 52

Safety will be assessed by evaluating all subject reported adverse events through the duration of the study.

Outcome measures

Measure	Single-Arm, Open-label Extension Trial n=81 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.
Safety/Adverse Events upper respiratory infection	11 Participants
Safety/Adverse Events musculoskeletal pain	6 Participants

SECONDARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

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.

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Patient-Reported Quality of Life Outcomes-EuroQol EQ-5D

.09 units on a scale Interval 0.04 to 0.14

SECONDARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

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.

If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Patient-Reported Quality of Life Outcomes - Dermatology Life Quality Index (DLQI)

-9.37 units on a scale Interval -11.14 to -7.61

SECONDARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

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. This assessment looks at eight different categories of foods and assigns points by type of food and serving size ranging from 0 points (do not consume that food group) to 21 points (consume food group, largest serving size). Your final score is the total of all points for all food categories.

If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Patient-Reported Quality of Life Outcomes - MEDFICTS Dietary Assessment

-10.9 units on a scale Interval -16.7 to -5.12

SECONDARY outcome

Timeframe: 52 weeks (continuation group) or 64 weeks (crossover group)

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

Per Office of Disease Prevention and Health Promotion's Physical Activity Guidelines:

A range of 500 to 1,000 MET-minutes of activity per week provides substantial [health] benefit, and amounts of activity above this range have even more benefit. Amounts of activity below this range also have some benefit. The dose-response relationship continues even within the range of 500 to 1,000 MET-minutes, in that the health benefits of 1,000 MET-minutes per week are greater than those of 500 MET-minutes per week.

If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

Outcome measures

Measure

Single-Arm, Open-label Extension Trial n=67 Participants Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Change in Patient-Reported Quality of Life Outcomes - International Physical Activity Questionnaire (IPAQ)

459 MET-minutes per week Interval -1233.0 to 2150.0

Adverse Events

Single-Arm, Open-label Extension Trial

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure

Single-Arm, Open-label Extension Trial n=81 participants at risk Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

General disorders syncope

1.2% 1/81 • Number of events 1 • 4 years

Other adverse events

Measure	Single-Arm, Open-label Extension Trial n=81 participants at risk Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks. Adalimumab: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.
Infections and infestations upper respiratory infection	13.6% 11/81 • Number of events 11 • 4 years
Musculoskeletal and connective tissue disorders musculoskeletal pain	7.4% 6/81 • Number of events 6 • 4 years

Additional Information

Suzette Baez VanderBeek, MPH

University of Pennsylvania

Phone: 2156623514

Email: suzette.baezvanderbeek@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place