Primary UVB-311nm and Adalimumab in Psoriasis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Radiation: UVB-311nm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: left/right<br>left or right body side | Radiation: UVB-311nm<br>* UVB-311nm radiation given 3 times a week to one randomized body-half<br>* Other names: narrow-band UVB radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified PASI (psoriasis area and severity index) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient visual analogue score (VAS) for therapeutic effect |  | 12 months | 
| Patient VAS for severity of skin lesions |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phototherapy, Psoriasis, Biologic, Adalimumab, Narrow-band UVB, half-side comparison