Trial Outcomes & Findings for A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis (NCT NCT01126619)

NCT ID: NCT01126619

Last Updated: 2012-10-25

Results Overview

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value \* 100.

• Recruitment status: COMPLETED
• Target enrollment: 103 participants
• Primary outcome timeframe: Baseline and Weeks 4, 8, 16 and 24
• Results posted on: 2012-10-25

Participant Flow

Participant milestones

Measure	Anti-TNF Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Study STARTED	103
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Anti-TNF Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Study Not eligible for the study	2
Overall Study Investigator decision	4
Overall Study Serious adverse event	1
Overall Study Withdrawal by Subject	9
Overall Study Non-compliance	1

Baseline Characteristics

A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis

Baseline characteristics by cohort

Measure	Anti-TNF n=103 Participants Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Age Continuous	44.9 years STANDARD_DEVIATION 13.9 • n=93 Participants
Gender Female	40 participants n=93 Participants
Gender Male	62 participants n=93 Participants
Region of Enrollment Turkey	103 participants n=93 Participants
Weight	78.5 kg STANDARD_DEVIATION 16.0 • n=93 Participants
Height	166.9 cm STANDARD_DEVIATION 13.5 • n=93 Participants
Body Mass Index (BMI)	29.3 kg/m^2 STANDARD_DEVIATION 14.9 • n=93 Participants
Psoriasis Area and Severity Index (PASI) Score	20.8 scores on a scale STANDARD_DEVIATION 11.2 • n=93 Participants
Dermatology Life Quality Index (DLQI) Score	15.1 scores on a scale STANDARD_DEVIATION 7.3 • n=93 Participants
Duration of Psoriasis	15.7 years STANDARD_DEVIATION 9.2 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline and Weeks 4, 8, 16 and 24

Population: Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.

Outcome measures

Measure	Anti-TNF n=86 Participants Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.	Week 24 Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Week 4	48.65 Percent change Standard Deviation 36.27	—
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Week 8	75.70 Percent change Standard Deviation 36.11	—
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Week 16	87.85 Percent change Standard Deviation 36.91	—
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Week 24	90.29 Percent change Standard Deviation 25.49	—

PRIMARY outcome

Timeframe: Baseline and Weeks 4, 8, 16 and 24

Population: Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.

The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Outcome measures

Measure	Anti-TNF n=86 Participants Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.	Week 24 Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
Percentage of Participants With 75% Reduction in PASI Score Week 4	31.4 percentage of participants	—
Percentage of Participants With 75% Reduction in PASI Score Week 8	51.2 percentage of participants	—
Percentage of Participants With 75% Reduction in PASI Score Week 16	67.4 percentage of participants	—
Percentage of Participants With 75% Reduction in PASI Score Week 24	70.9 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.

In the dynamic physician global assessment of change in psoriasis, the physician compared sets of standardized photographs taken at Baseline and at Week 24 for each participant and rated the change of psoriasis severity on the dynamic PGA scale from -5 (considerable deterioration), 0 (no or minimal change) to +5 (considerable improvement).

Outcome measures

Measure	Anti-TNF n=86 Participants Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.	Week 24 Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
Dynamic Physician Global Assessment (PGA) of Change in Psoriasis	1.51 scores on a scale Standard Deviation 2.24	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.

In the dynamic patient global assessment of change in psoriasis, the participant compared their own sets of standardized photographs taken at Baseline and at Week 24 and rated the change of the severity of psoriasis using the dynamic photographic scale adapted to a visual analog scale ranging from -5 (very large deterioration) to +5 (very large improvement).

Outcome measures

Measure	Anti-TNF n=86 Participants Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.	Week 24 Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
Dynamic Patient Global Assessment (PGA) of Change in Psoriasis	1.51 scores on a scale Standard Deviation 2.26	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.

In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale:

Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis.

Outcome measures

Measure	Anti-TNF n=86 Participants Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.	Week 24 n=86 Participants Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
Static Physician Global Assessment (PGA) of Psoriasis Severe psoriasis	23 participants	0 participants
Static Physician Global Assessment (PGA) of Psoriasis Clear psoriasis	0 participants	14 participants
Static Physician Global Assessment (PGA) of Psoriasis Psoriasis almost clear	0 participants	38 participants
Static Physician Global Assessment (PGA) of Psoriasis Mild psoriasis	0 participants	19 participants
Static Physician Global Assessment (PGA) of Psoriasis Mild to moderate psoriasis	1 participants	4 participants
Static Physician Global Assessment (PGA) of Psoriasis Moderate psoriasis	35 participants	8 participants
Static Physician Global Assessment (PGA) of Psoriasis Moderate to severe psoriasis	27 participants	3 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 16 and 24

Population: Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.

Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.

Outcome measures

Measure	Anti-TNF n=86 Participants Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.	Week 24 Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Week 4	53.13 percent change Interval -133.33 to 100.0	—
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Week 8	66.40 percent change Interval -80.0 to 100.0	—
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Week 16	73.98 percent change Interval -58.33 to 100.0	—
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Week 24	65.72 percent change Interval -166.67 to 100.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. The first 3 domains (work time missed, work impairment and overall loss of work productivity) were assessed on a sub-group of participants who had full time jobs (n=30).

The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):

• Percent work time missed in the last 7 days due to problems associated with psoriasis;
• Percent impairment at work, based on the participant's assessment of how much psoriasis affected their productivity while they were working in the last 7 days;
• Percent overall loss of work productivity, based on hours missed and impairment while working due to psoriasis;
• Percent general activity impairment, based on the participant's assessment of how much psoriasis affected their ability to perform regular daily activities, such as work around the house, shopping, child care, exercising, studying, etc.

Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.

Outcome measures

Measure	Anti-TNF n=86 Participants Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.	Week 24 Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
Percent Change From Baseline in Work Productivity and Activity Impairment Work time missed	96 percent change Interval 0.0 to 100.0	—
Percent Change From Baseline in Work Productivity and Activity Impairment Impairment at work	72 percent change Interval 0.0 to 100.0	—
Percent Change From Baseline in Work Productivity and Activity Impairment Overall loss of work productivity	75 percent change Interval 0.0 to 100.0	—
Percent Change From Baseline in Work Productivity and Activity Impairment Activity impairment	72 percent change Interval 0.0 to 100.0	—

SECONDARY outcome

Timeframe: 24 Weeks

Population: All enrolled participants.

The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above.

Please see the Adverse Event module below for additional details.

Outcome measures

Measure	Anti-TNF n=103 Participants Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.	Week 24 Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
Number of Participants With Adverse Events (AEs) Any adverse event	28 participants	—
Number of Participants With Adverse Events (AEs) Serious adverse event	3 participants	—

Adverse Events

Anti-TNF

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anti-TNF n=103 participants at risk Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Gastrointestinal disorders Hepatotoxicity, Toxic Hepatitis	0.97% 1/103 • 24 weeks.
Respiratory, thoracic and mediastinal disorders Gangrenous emphysema	0.97% 1/103 • 24 weeks.
Infections and infestations Catheter infection, infected endocarditis	0.97% 1/103 • 24 weeks.

Other adverse events

Measure	Anti-TNF n=103 participants at risk Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
General disorders Injection site reaction	6.8% 7/103 • 24 weeks.

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

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

Restriction type: OTHER