Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis
Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment
course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) are exposed
to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per
week for six weeks and/or until complete response (defined as reduction in PASI to < 3).
PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS
for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and
12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer
exact test is applied to determine differences in complete remission, PASI reduction > 90%,
> 75% and/or 50% between body sites.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Modified PASI (psoriasis area and severity index)
Peter Wolf, MD
Medical University of Graz, Austria
Austria: Federal Ministry for Health and Women
19-134 ex 07/08