UVB-311nm After Initial Slow Response to Adalimumab in Psoriasis

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 additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic lesions in adalimumab-treated patients after initial slow response.

Detailed Description
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Patients with moderate to severe psoriasis who have received treatment with adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Adalimumab is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter one 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, visual analogue score (VAS) patient score for therapeutic response, and VAS patient score 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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Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab

Conditions
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Psoriasis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Psoriasis patients with PASI reduction of less than 75% after at least 6 weeks of 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;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 |
| --- | --- | --- |
| Modified PASI (psoriasis area and severity index) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS patient score for therapeutic effect |  | 12 months | 
| VAS patient score 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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Psoriasis, Biologic, adalimumab, narrowband UVB, phototherapy, half-side comparison