Regulatory T-cells in Psoriasis Patients as Targets for Therapy

Study Overview
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Brief Summary
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The aim of this study is to understand which therapies will suppress effector cells and promote regulatory T cells and To test whether patients with a better response to therapy and longer psoriasis-free periods develop a higher numerical ratio of regulatory to effectors T-cells and/or regulatory cells more able to suppress the effectors.

Detailed Description
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This is an observational study for the effect of different treatment options of psorisis on regulatory T-cells. Patients in whom a decision to treat with one of the following therapies (Dovobet, neotigason, narrow-band UVB and anti TNF alpha therapy) and agreed to take part in the study will be selected. Allocation of different treatments to patients is not part of the study. We will enroll 40 patients with moderate to severe psoriasis in the age range from 18 to 70. patients must be treatment-free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis. females of child bearing potential must be on reliable contraception. Children below 18 years, patients above 70 years, pregnant and lactating patients and immunosuppressed patients are excluded from this study. Blood and tissue samples will be taken before and after treatment. We will also invite 10 patients who are receiving ellipse excisions of naevi, and who known not to have psoriasis, to provide control samples of distal skin beyond the margins required to demonstrate complete removal and control donation of blood.

Official Title
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Enumeration and Functional Evaluation of Regulatory T-cells in Psoriasis Patients Before and After Treatment With: Calcipotriol/Betamethasone, Acitretin, Narrow-Band UVB and Anti-TNF Alpha Therapy (Etanercept, Adalimumab and Infliximab)

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Male and female patients in the age range from 18 to 70 who are diagnosed with moderate to severe psoriasis. Patients must be treatment free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis. Women of child bearing potential must be on reliable contraception. Patients in whom a decision to treat with one of the following therapies has already been made based on normal clinical care: Dovobet Neotigason Narrow-band UVB Etanercept Adalimumab Infliximab 10 normal controls Exclusion Criteria: • Children below 18 years and patients over 70 years. Pregnant and lactating patients. Patients who are known to have immunosuppressive disease (e.g. HIV) or on any immunosuppressive therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Betamethasone/Calcipotriol (Dovobet)<br>patients in whom decision to treat with Dovobet by their dermatologist | Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab<br>* Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks<br>|
| Acitretin (neotigason)<br>patients in whom decision to treat with neotigason by their dermatologist | Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab<br>* Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks<br>|
| narrow-band UVB<br>patients in whom decision to treat with narrow band UVB by their dermatologist | Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab<br>* Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks<br>|
| Anti TNF-alpha<br>patients in whom decision to treat with anti TNF-alpha(adalimumab-etanercept-infliximab) by their dermatologist | Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab<br>* Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clincal-immunological correlation of treatment outcome in psoriasis patients | Primary outcome measures will be the first correlations of treatment outcome in psoriasis patients assessed by PASI score and PGA, with changes in the balance between Treg and effector T cells. This will test whether changes to this balance should be a major target for future therapies. In the short term, the results will also determine whether the balance provides a useful predictive biomarker for response to treatment. It is anticipated that the results will be disseminated through publications in high impact journals and presentation at relevant scientific and clinical meetings | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regulatory T-cells, psoriasis, IL-10.