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

Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab

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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Radiation: UVB-311nm; Other: No treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-8036
    • Recruiting
    • Medical University of Graz, Department of Dermatology
    • Sub-Investigator: Wolfgang Salmhofer, MD
    • Sub-Investigator: Angelika Hofer, MD
    • Sub-Investigator: Franz Legat, MD
    • Contact: Peter Wolf, MD; Phone Number: 80315 +43 316 385; Email: peter.wolf@medunigraz.at
    • Contact: Angelika Hofer, MD; Phone Number: 13254 +43 316 385; Email: angelika.hofer@medunigraz.at
    • Principal Investigator: Peter Wolf, MD
    • Sub-Investigator: Alexandra Gruber-Wackernagel, MD
    • Sub-Investigator: Wolfgang Weger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: left/right; left or right body side	Radiation: UVB-311nm; UVB-311nm radiation given 3 times a week to one randomized body half; Other Names: narrow-band UVB radiation; Other: No treatment; no UV exposure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
VAS patient score for therapeutic effect	12 months
VAS patient score for severity of skin lesions	12 months

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: March 12, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (Estimate): March 19, 2008

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Psoriasis; phototherapy; Biologic; adalimumab; narrowband UVB; half-side comparison
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 19-133 ex 07/08