Etanercept Plus UVB-311nm Phototherapy in Psoriasis

Study Overview
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Brief Summary
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Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity has been approved for the treatment of moderate to severe psoriasis. However, in a substantial portion of cases etanercept does not induce reduction in psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study the researchers aim to determine in a randomized half-side comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the therapeutic efficacy of etanercept.

Detailed Description
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Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Etanercept is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter on a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in PASI to < 3) for a maximum of another 6 weeks (until week 12). PASI score and patient disease score is assessed weekly; patient life quality score at week 0, 6, and 12; all scores at follow-up visits at month 3, 6, and 12. Paired statistical testing (T-test or Wilcoxon) for differences in PASI and patient disease and life quality 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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Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment

Conditions
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Psoriasis

Intervention / Treatment
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* Radiation: UVB-311nm radiation
* Other: No treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater Exclusion Criteria: Pregnancy or lactation 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 |
| --- | --- |
| Experimental: left/right<br>half-body comparison | Radiation: UVB-311nm radiation<br>* UVB-311nm radiation randomized to one body half given 3 times a week for 6 weeks; the other body half remains UV-non-irradiated.<br>* Other names: Narrow band UVB radiation;Other: No treatment<br>* no UV exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of PASI (psoriasis activity score index) |  | prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient disease and life quality score |  | prospective | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, UVB radiation, Biologics, Etanercept, PASI