Trial Outcomes & Findings for Acitretin and Etanercept in Psoriasis (NCT NCT00156247)

Results Overview

Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2015-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	Etanercept With Acitretin patients on etanercept taking open-label acitretin
Overall Study STARTED	9
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acitretin and Etanercept in Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept With Acitretin n=9 Participants patients on etanercept taking open-label acitretin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.

Outcome measures

Outcome measures
Measure	Etanercept With Acitretin n=8 Participants patients on etanercept taking open-label acitretin
Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy	12.5 percent

SECONDARY outcome

Timeframe: 6 months

Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.

Outcome measures

Outcome measures
Measure	Etanercept With Acitretin n=8 Participants patients on etanercept taking open-label acitretin
Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy	50 percent

SECONDARY outcome

Timeframe: 6 months

Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.

Outcome measures

Outcome measures
Measure	Etanercept With Acitretin n=8 Participants patients on etanercept taking open-label acitretin
Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy	37.5 percent

Adverse Events

Etanercept With Acitretin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Etanercept With Acitretin n=9 participants at risk patients on etanercept taking open-label acitretin
Skin and subcutaneous tissue disorders retinoid dermatitis	22.2% 2/9 • Number of events 2
Skin and subcutaneous tissue disorders dry/chapped lips	22.2% 2/9 • Number of events 2

Additional Information

Melissa Magliocco, MD

UMDNJ-Robert Wood Johnson Medical School

Phone: (732) 235-5735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place