Psoriasis
Conditions
Keywords
psoriasis, golimumab, TNF-alpha inhibition, phototherapy, 311-nm
Brief summary
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
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.
Interventions
RADIATIONUVB-311nm radiation
UVB-311nm radiation given 3 times a week to one randomized body-half
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site | week 6 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions | week 6 |
Countries
Austria
Outcome results
None listed