Trial Outcomes & Findings for Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis (NCT NCT00655564)

NCT ID: NCT00655564

Last Updated: 2018-09-11

Results Overview

Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2018-09-11

Participant Flow

Fifteen subjects with moderate to severe chronic plaque type psoriasis were recruited from the Wake Forest University Health Sciences Dermatology Clinic

Participant milestones

Measure	Alefacept All subjects will receive 15 mg of alefacept IM per week (unless CD4\<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Alefacept All subjects will receive 15 mg of alefacept IM per week (unless CD4\<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1
Overall Study Desired Alternate Therapy	1

Baseline Characteristics

Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis

Baseline characteristics by cohort

Measure	Alefacept n=15 Participants All subjects will receive 15 mg of alefacept IM per week (unless CD4\<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52

Outcome measures

Measure	Alefacept n=15 Participants Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
Efficacy	1 #Participants

SECONDARY outcome

Timeframe: 52 weeks

Number of participants experiencing CD4 cell counts below 250/uL

Outcome measures

Measure	Alefacept n=15 Participants Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
Safety of Alefacept Using CD4 Counts	2 Participants

Adverse Events

Alefacept

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Alefacept n=15 participants at risk All subjects will receive 15 mg of alefacept IM per week (unless CD4\<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
Immune system disorders Low CD4 cell count	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Severe allergic contact dermatitis	6.7% 1/15 • Number of events 1

Other adverse events

Measure	Alefacept n=15 participants at risk All subjects will receive 15 mg of alefacept IM per week (unless CD4\<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	26.7% 4/15 • Number of events 4
Musculoskeletal and connective tissue disorders Back pain	13.3% 2/15 • Number of events 2
Musculoskeletal and connective tissue disorders Generalized muscle aches	6.7% 1/15 • Number of events 1
Reproductive system and breast disorders Breast tenderness	6.7% 1/15 • Number of events 1
Eye disorders Eye irritation	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Generalized itching	6.7% 1/15 • Number of events 1

Additional Information

Steven Feldman, MD, PhD

Wake Forest University Health Sciences

Phone: 336-716-3775

Email: sfeldman@wakehealth.edu

Results disclosure agreements

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