Trial Outcomes & Findings for Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet (NCT NCT00585650)

Results Overview

Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index (PPPASI) is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4, with 4 being the most severe.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Week 12

Results posted on

2023-08-18

Participant Flow

Subjects were recruited from the dermatology clinics.

Participant milestones

Participant milestones
Measure	Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks Subjects were randomized to receive etanercept 50mg twice weekly injection for 12 weeks. Subjects were then treated for another 12 weeks with etanercept 50 mg twice weekly. An additional follow-up visit performed on week 28.	Subjects Receiving Placebo for 12 Weeks Subjects randomized to receive placebo injection twice weekly for 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50 mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
Overall Study STARTED	8	12
Overall Study COMPLETED	8	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks n=8 Participants Subjects randomized to use etanercept 50mg twice weekly for 12 weeks.	Subjects Receiving Placebo for 12 Weeks n=12 Participants Subjects randomized to placebo injection twice weekly for 12 weeks.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	12 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intention to treat

Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index (PPPASI) is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4, with 4 being the most severe.

Outcome measures

Outcome measures
Measure	Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks n=8 Participants Subjects randomized to use etanercept 50mg twice weekly for 12 weeks.	Subjects Receiving Placebo for the First 12 Weeks n=12 Participants Subjects randomized placebo injection for 12 weeks.
The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks.	8 participants	12 participants

Adverse Events

Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Subjects Receiving Placebo for 12 Weeks

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks n=8 participants at risk Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.	Subjects Receiving Placebo for 12 Weeks n=12 participants at risk Subjects randomized placebo injection for 12 weeks. An additional follow-up visit was performed on week 28.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	37.5% 3/8 • Number of events 3 • Adverse event data were collected over a 28 week period.	33.3% 4/12 • Number of events 4 • Adverse event data were collected over a 28 week period.

Additional Information

Steven Feldman, MD, PhD

Wake Forest Baptist Health, Department of Dermatology

Phone: 336-716-3775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place