PsoBest - The German Psoriasis Registry

Study Overview
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Brief Summary
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Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely confined to systemic therapy in Germany. Systemic therapy includes conventional systemic therapy (e.g. fumaric acids, methotrexate, ciclosporin A) and biological treatment (e.g. adalimumab, etanercept). While short- and middle-term efficacy of most systemic treatments has been shown in clinical studies (and is incorporated in international guidelines), knowledge about long-term outcomes, optimal treatment and effectiveness under real-world conditions is still missing. PsoBest, the German registry on the treatment of moderate to severe Pso and PsA started in 2008 and documents the long-term course of patients being administered any biologic or conventional systemic antipsoriatic drug authorized in Germany for the first time. The registry evaluates the long-term course of 3,500 patients with Pso and PsA treated with systemic antipsoriatics.

Detailed Description
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Background: Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely confined to systemic therapy in Germany. Systemic therapy includes conventional systemic therapy (e.g. fumaric acids, methotrexate, ciclosporin A) and biological treatment (e.g. adalimumab, etanercept). While short- and middle-term efficacy of most systemic treatments has been shown in clinical studies (and is incorporated in international guidelines), knowledge about long-term outcomes, optimal treatment and effectiveness under real-world conditions is still missing. PsoBest, the German registry on the treatment of moderate to severe Pso and PsA started in 2008 and documents the long-term course of patients being administered any biologic or conventional systemic antipsoriatic drug authorized in Germany for the first time. Objectives: Observation and analysis of the following outcomes of treatment with systemic antipsoriatics: Effectiveness in clinical practice (real world) Benefits and needs on the patients' side Effectiveness in a long-term course over years Optimal maintenance dosages Safety and side-effects profile under routine conditions Use in case of and effect on co-morbidity Reliable predictors of response Benefit and effectiveness of possible combination therapies or alternating use of biologics and systemic therapies Methods: The registry evaluates the long-term course of 3,500 patients with Pso and PsA treated with systemic antipsoriatics.The registry started for seven treatment arms: Fumaric acid, methotrexate, ciclosporin A, efalizumab, etanercept, infliximab and adalimumab. While efalizumab was withdrawn from the market, ustekinumab was included after authorization. Patients are included at first initiation of a given treatment and will remain in the registry for 5 years, regardless of subsequent therapy. Nationwide, dermatologic practices and hospital ambulances with expertise in systemic and biologic treatment consecutively enrol patients. Follow-ups will be every 3 to 6 months, comprising patient and treatment characteristics, clinical parameters, patient-defined benefit, quality of life and adverse events. Standardized questionnaires will be addressed to the patient and to the dermatologist 12 times at the dermatologic centres. In interim intervals, patients are directly contacted another 9 times by mail. PsoBest is member of the ENCePP network of psoriasis-registries (www.psonet.eu).

Official Title
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Long-Term Benefits and Safety of Systemic Psoriasis Therapy: German Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics

Conditions
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Psoriasis, Psoriatic-arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a dermatologist age ≥ 18 years being administered a specific systemic drug for the first time informed consent to participate sufficient language skills (German) Exclusion criteria: lack of informed consent patients being participants of clinical trials at the day of admission to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analysed separately)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fumaric acid esters<br>Intervention: Drug: conventional systemic: Fumaric acid esters, including Dimethylfumarate, all dosages, frequencies and durations prescribed | |
| Methotrexate<br>Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed | |
| Cyclosporine A<br>Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed | |
| Efalizumab (withdrawn)<br>Intervention: Biological: Efalizumab, all dosages, frequencies and durations prescribed | |
| Etanercept<br>Intervention: Biological and biosimilars: Etanercept, all dosages, frequencies and durations prescribed | |
| Infliximab<br>Intervention: Biological and Biosimilars/-identicals: Infliximab, all dosages, frequencies and durations prescribed | |
| Adalimumab<br>Intervention: Biological and Biosimilars: Adalimumab, all dosages, frequencies and durations prescribed | |
| Ustekinumab<br>Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed | |
| Golimumab<br>Intervention: Biological: Golimumab, all dosages, frequencies and durations prescribed | |
| Secukinumab<br>Intervention: Biological: Secukinumab, all dosages, frequencies and durations prescribed | |
| Apremilast<br>Intervention: Small molecule: Apremilast, all dosages, frequencies and durations prescribed | |
| Certolizumab<br>Intervention: Biological: Certolizumab, all dosages, frequencies and durations prescribed | |
| Retinoids<br>Intervention: Drug: conventional systemic: Retinoids, all dosages, frequencies and durations prescribed | |
| Leflunomids<br>Intervention: Drug: conventional systemic: Leflunomids, all dosages, frequencies and durations prescribed | |
| systemic PUVA<br>Intervention: Drug: conventional systemic: systemic PUVA, all dosages, frequencies and durations prescribed | |
| Guselkumab<br>Intervention: Biological: Guselkumab all dosages, frequencies and durations prescribed | |
| Brodalumab<br>Intervention: Biological: Brodalumab, all dosages, frequencies and durations prescribed | |
| Tildrakizumab<br>Intervention: Biological: Tildrakizumab, all dosages, frequencies and durations prescribed | |
| Risankizumab<br>Intervention: Biological: systemic Risankizumab, all dosages, frequencies and durations prescribed | |
| Bimekizumab<br>Intervention: Biological: Bimekizumab, all dosages, frequencies and durations prescribed | |
| Tofacitinib<br>Intervention: JAK-Inhibitor: Tofacitinib, all dosages, frequencies and durations prescribed | |
| Upadacitinib<br>Intervention: JAK-Inhibitor: Upadacitinib, all dosages, frequencies and durations prescribed | |
| Baricitinib<br>Intervention: JAK-Inhibitor: Baricitinib, all dosages, frequencies and durations prescribed | |
| Deucravacitinib<br>Intervention: JAK-Inhibitor: Deucravacitinib, all dosages, frequencies and durations prescribed | |
| Ixekizumab<br>Intervention: Biological: Ixekizumab, all dosages, frequencies and durations prescribed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area Severity Index (PASI) | To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | every 6 month for 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Life Quality Index (DLQI) | To evaluate disease related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | every 3 month for 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Germany, patient registry, psoriasis, psoriatic-arthritis, biologics, Psonet, effectiveness, safety, biosimilars