TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

Study Overview
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Brief Summary
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TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are well-tolerated with few side effects. Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some do not respond at all while others respond initially but gradually lose effect despite increased dose and more frequent administration. The cause of treatment failure is largely unknown and it may be production of tnf-alfa neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis and inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.

Official Title
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Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: subjects will receive either infliximab, adalimumab or etanercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age above 18 Psoriasis Indication for treatment with tnf alfa blocking drug Written informed consent obtained Exclusion Criteria: Severe psychiatric disorder No indication for treatment with tnf-alfa blocking drug Pregnancy Breastfeeding No written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tnf-alfa treatment (infliximab, adalimumab, or etanercept)<br>This arm includes all the patients of the study. They are patients who are start treatment with a tnf-alfa blocking drug | Drug: subjects will receive either infliximab, adalimumab or etanercept<br>* The subjects receive treatment with a tnf-alfa blocking according to the official guidelines for the particular drug. The study subjects will receive treatment with one drug only - infliximab or adalimumab or etanercept The consulting dermatologist decides which drug to use according to official guidelines<br>* Other names: etanercept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in concentration of tnf-alfa antibodies in serum | Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies | 3, 6, and 12 months after start of tnf-alfa blocking agent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in severity of psoriasis, PASI | severity of psoriasis assessed by PASI | 3, 6, and 12 months after start of tnf-alfa blocking agent | 
| Presence of psoriatic arthritis | Does the patient have psoriasis arthritis | 3, 6, and 12 months after start of tnf-alfa blocking agent | 
| change in dermatology life quality index (DLQI) | psoriasis severity assessed by the dermatology life quality index (DLQI) | 3, 6, and 12 months after start of tnf-alfa blocking agent | 
| height (cm) | subject´s height in centimeters | 3 months | 
| change in weight (kg) | subjects weight in kilograms | 3, 6, and 12 months after start of tnf-alfa blocking agent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, treatment failure, tnf-alfa