Psoriasis
Conditions
Keywords
Psoriasis, Biologic, Adalimumab, Narrow-band UVB, phototherapy, half-side comparison
Brief summary
Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether initial narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.
Detailed description
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.
Interventions
UVB-311nm radiation given 3 times a week to one randomized body-half
Sponsors
Study design
Eligibility
Inclusion criteria
* Psoriasis patients who are scheduled for treatment with adalimumab.
Exclusion criteria
* Pregnancy or lactation * History of skin cancer * Presence of or history of malignant skin tumors * Dysplastic melanocytic nevus syndrome * Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB) * Autoimmune disorders such as Lupus erythematosus or Dermatomyositis * Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others * General poor health status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified PASI (psoriasis area and severity index) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient visual analogue score (VAS) for therapeutic effect | 12 months |
| Patient VAS for severity of skin lesions | 12 months |
Countries
Austria