Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Alefacept (Amevive) in Subjects With Moderate to Severe Atopic Dermatitis (NCT NCT00832585)

Results Overview

The Eczema Area Severity Index (EASI) measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) using 0=none, 1=mild, 2=moderate, 3=severe. Head/neck, upper limbs, trunk, lower limbs are rated from 1 to 6 (0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%). The proportional factor for the head/neck =.01, upper limbs=.02, trunk=.03 and lower limbs=.04. The algorithm for calculating the EASI is the sum of E+I+Ex+L multiplied by the area, multiplied by the proportional factor. The total score is the sum of the four body-region scores, max=72, min=0.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Week 1 to week 16

Results posted on

2011-03-10

Participant Flow

Subjects were recruited from physician referrals and advertisements placed within the Rush University Medical Center campus. Recruitment was opened between Jan 08 through Sept 09

Participant milestones

Participant milestones
Measure	Alefacept Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Alefacept Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of Alefacept (Amevive) in Subjects With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alefacept n=5 Participants Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	32.84 years STANDARD_DEVIATION 6.34 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

PRIMARY outcome

Timeframe: Week 1 to week 16

Population: 8 (4 female and 4 male) atopic patients, ranging in age from 24 to 54 yrs of age, were screened for the study. 5 patients were enrolled for 12 wks of treatment, but only 3 completed the study.

The Eczema Area Severity Index (EASI) measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) using 0=none, 1=mild, 2=moderate, 3=severe. Head/neck, upper limbs, trunk, lower limbs are rated from 1 to 6 (0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%). The proportional factor for the head/neck =.01, upper limbs=.02, trunk=.03 and lower limbs=.04. The algorithm for calculating the EASI is the sum of E+I+Ex+L multiplied by the area, multiplied by the proportional factor. The total score is the sum of the four body-region scores, max=72, min=0.

Outcome measures

Outcome measures
Measure	Alefacept n=3 Participants Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Change in Eczema Area Severity Index (EASI) Score From Baseline (Week 1) to Week 16.	26.4 Scores on a scale. Interval 13.2 to 29.8

SECONDARY outcome

Timeframe: Week 1 to week 16

The Physician Global Assessment (PGA) evaluates the overall severity of Atopic Dermatitis (AD) at a given time using a four point scale (0=clear, 0.5=clear to mild, 1=mild, 1.5=mild to moderate, 2=moderate, 2.5=moderate to severe, and 3=severe).

Outcome measures

Outcome measures
Measure	Alefacept n=3 Participants Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Change in Physician Global Assessment (PGA) Score From Baseline (Week 1) to Week 16.	1 Scores on a scale Interval 1.0 to 1.5

Adverse Events

Alefacept

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alefacept n=5 participants at risk Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Musculoskeletal and connective tissue disorders Joint Infection	20.0% 1/5 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael D. Tharp

Rush University Medical Center - Department of Dermatology

Phone: 312-563-4001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place