Alefacept (Amevive) With or Without Narrowband UVB Treatment in Patients With Psoriasis.
Alefacept is a new anti-psoriatic drug within the group of the so-called biologics. In about 30% of patients alefacept induces a more than 75% improvement of psoriasis after a 12-week treatment period. The start of anti-psoriatic effect by alefacept is delayed, however improvement of psoriatic lesions outlasts the end of alefacept treatment.
Narrowband UVB (UVB-311nm) phototherapy is an established anti-psoriatic treatment regimen with rapid onset of anti-psoriatic efficacy but disease-free intervals after the end of successful treatment courses may be short.
Therefore, in this half-side (left/right side) comparison study we aim to investigate whether an additional narrowband UVB treatment accelerates and improves the anti-psoriatic treatment effects of alefacept.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized Half-side Comparison of Alefacept (Amevive) With or Without UVB-311nm Phototherapy in Patients With Psoriasis (Translated From German)|
- Modified PASI (Psoriasis area and severity index) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- VAS for therapeutic effect; [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- VAS for severity of skin lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||September 2004|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
Drug: Alefacept (drug)
Psoriasis is an inflammatory skin disease that affects an estimated 2% to 3% of the world's population. There are a wide range of local and systemic clinical treatments and agents for clearing, or at least reducing the expression of, psoriatic skin lesions. There is a new generation of antipsoriatic drugs that specifically target T-cell mediated inflammatory pathways and that are approved for the treatment of moderate to severe psoriasis in the United States. Alefacept (Amevive) is one of these so-called biologics. Alefacept appears to have several advantages over other systemic antipsoriatic agents and is very well tolerated by patients. Weekly administration of alefacept for 12 weeks reduced the psoriasis area and severity index (PASI) by greater than 75% in 30% of patients. The maximal antipsoriatic effect, however, apparently occurs after the 12-week course has ended. In vitro studies and previous case reports suggested that alefacept's antipsoriatic effect may be augmented when it is administered in combination with UVB. These findings prompted us to conduct a prospective randomized half-body comparison study, in which we ask whether the clinical response of psoriatic lesions to alefacept could be improved by combining alefacept with standard UVB 311nm phototherapy.
Comparison: Psoriatic patients are treated with intravenous alefacept once per week for 12 weeks. One randomized chosen body-half (left or right side) is additionally treated with narrowband UVB (UVB-311nm) three times per week until complete clearance of psoriatic lesions at the UV-treated side. PASI is evaluated before, weekly during, and for 3 to 12 months after alefacept +/- narrowband UVB treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407342
|Medical University of Graz|
|Graz, Styria, Austria, A-8036|
|Principal Investigator:||Peter Wolf, MD||Research Unit for Photodermatology, Department of Dermatology, Medical University Graz|