Golimumab Plus UVB-311nm in Psoriasis

Study Overview
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Brief Summary
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Golimumab, a TNF-alpha antibody, has been approved in the EC and USA for the treatment of psoriatic arthritis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic skin lesions in golimumab-treated patients.

Detailed Description
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Psoriatic skin lesions of patients with psoriatic arthritis who receive standard treatment with golimumab (50 mg or 100 mg s.c. once a month depending on total body weight whether below or above 100 kg, respectively) 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). A patient qualifies if A) golimumab was started within a week or B) after 3 months of golimumab treatment the PASI reduction is smaller than 90%. 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. The primary hypothesis is that phototherapy increases the PASI reduction on the exposed body site by more than 20%. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fisher 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 Study of the Combination of Golimumab and UVB-311nm Phototherapy in Patients With Psoriatic Arthritis and Psoriatic Skin Lesions

Conditions
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Psoriasis

Intervention / Treatment
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* Radiation: UVB-311nm radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Patients with psoriatic arthritis who receive treatment with golimumab Patient wish for treatment of psoriatic skin lesions Exclusion Criteria: Pregnancy or lactation Presence and/or history of malignant melanoma Presence and/or history of invasive squamous cell carcinoma of the skin Presence and/or history of more than 3 basal cell carcinomas Dysplastic nevus syndrome Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB) Autoimmune disorders such as lupus erythematosus or dermatomyositis Abnormal photosensitivity and 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

| Intervention/Treatment |
| --- |
|Radiation: UVB-311nm radiation|UVB-311nm radiation given 3 times a week to one randomized body-half|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site | The effect of treatment on PASI will be determined. The primary hypothesis is that UVB-311nm treatment leads to a difference in the reduction of PASI from baseline by > 20% comparing the UV-irradiated vs. the non-irradiated body site at week 6 of treatment. | week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions |  | week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, golimumab, TNF-alpha inhibition, phototherapy, 311-nm