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| Name | Class |
|---|---|
| Berufsverband der Deutschen Dermatologen e.V. (www.bvdd.de) | UNKNOWN |
| Deutsche Dermatologische Gesellschaft e.V. (https://derma.de) | UNKNOWN |
| AbbVie | INDUSTRY |
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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.
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:
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 While efalizumab was withdrawn from the market, ustekinumab was included after authorization.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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fumaric acid esters | Intervention: Drug: conventional systemic: Fumaric acid esters, including Dimethylfumarate, all dosages, frequencies and durations prescribed | ||
| Methotrexate | Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed | ||
| Cyclosporine A | Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed | ||
| Efalizumab (withdrawn) | Intervention: Biological: Efalizumab, all dosages, frequencies and durations prescribed | ||
| Etanercept | Intervention: Biological and biosimilars: Etanercept, all dosages, frequencies and durations prescribed | ||
| Infliximab | Intervention: Biological and Biosimilars/-identicals: Infliximab, all dosages, frequencies and durations prescribed | ||
| Adalimumab |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse and serious adverse events | Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | 6 month |
| Patient Benefit Index (PBI) |
Inclusion Criteria:
Exclusion criteria:
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Patients with plaque-type psoriasis or psoriatic-arthritis starting the first systemic treatment with authorized atipsoriatic drugs in Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Augustin, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide group of dermatological centers, hospitals and medical offices | Recruiting | Hamburg | Germany |
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| Label | URL |
|---|---|
| PsoBest - the German psoriasis registry | View source |
| German Center for Health Services Research in Dermatology | View source |
| PsoNet - the European registry of psoriasis |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
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| Biogen |
| INDUSTRY |
| Janssen-Cilag G.m.b.H | INDUSTRY |
| medac GmbH | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
| Novartis Pharmaceuticals | INDUSTRY |
| Pfizer Pharmaceuticals Ltd. | INDUSTRY |
| Merck Serono GmbH, Germany | INDUSTRY |
| PsoNet.eu (http://www.psonet.eu/) | UNKNOWN |
| Celgene | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
| Amgen | INDUSTRY |
| Almirall Hermal GmbH | INDUSTRY |
| UCB Pharma | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
| Viatris Inc. | INDUSTRY |
| LEO Pharma | INDUSTRY |
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Intervention: Biological and Biosimilars: Adalimumab, all dosages, frequencies and durations prescribed
| Ustekinumab | Intervention: Biological and Biosimilars: Ustekinumab, all dosages, frequencies and durations prescribed |
| Golimumab | Intervention: Biological: Golimumab, all dosages, frequencies and durations prescribed |
| Secukinumab | Intervention: Biological: Secukinumab, all dosages, frequencies and durations prescribed |
| Apremilast | Intervention: Small molecule: Apremilast, all dosages, frequencies and durations prescribed |
| Certolizumab | Intervention: Biological: Certolizumab, all dosages, frequencies and durations prescribed |
| Retinoids | Intervention: Drug: conventional systemic: Retinoids, all dosages, frequencies and durations prescribed |
| Leflunomids | Intervention: Drug: conventional systemic: Leflunomids, all dosages, frequencies and durations prescribed |
| systemic PUVA | Intervention: Drug: conventional systemic: systemic PUVA, all dosages, frequencies and durations prescribed |
| Guselkumab | Intervention: Biological: Guselkumab all dosages, frequencies and durations prescribed |
| Brodalumab | Intervention: Biological: Brodalumab, all dosages, frequencies and durations prescribed |
| Tildrakizumab | Intervention: Biological: Tildrakizumab, all dosages, frequencies and durations prescribed |
| Risankizumab | Intervention: Biological: systemic Risankizumab, all dosages, frequencies and durations prescribed |
| Bimekizumab | Intervention: Biological: Bimekizumab, all dosages, frequencies and durations prescribed |
| Tofacitinib | Intervention: JAK-Inhibitor: Tofacitinib, all dosages, frequencies and durations prescribed |
| Upadacitinib | Intervention: JAK-Inhibitor: Upadacitinib, all dosages, frequencies and durations prescribed |
| Deucravacitinib | Intervention: JAK-Inhibitor: Deucravacitinib, all dosages, frequencies and durations prescribed |
| Ixekizumab | Intervention: Biological: Ixekizumab, all dosages, frequencies and durations prescribed |
| No treatment | Intervention: no systemic treatment in observation episodes |
To evaluate the patient benefit of conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
| every 3 months for 10 years |
| EuroQol Questionnaire (EQ-5D) | To evaluate general state of health of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | every 3 months for 10 years |
| Questionnaire on Supply Quality in Dermatology (FVQ-d) | To evaluate care characteristics of conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | every 3 months for 10 years |
| Health Assessment Questionnaire (HAQ) | To evaluate arthritis severity of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | every 6 months for 10 years |
| Patient Global Assessment (Skin: PaGAs, Arthritis: PaGAa) | To evaluate global severity of skin and arthritis in patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | every 3 months for 10 years |
| Physician Global Assessment (Skin: PGAs, Arthritis: PGAa) | To evaluate global severity of skin and arthritis in patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | every 6 months for 10 years |
| Disease Activity Score 28 (DAS 28), American College of Rheumatology Score (ACR20), Psoriatic Arthritic Response Criteria (PsARC) | To evaluate arthritis severity of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | every 6 months for 10 years |
| View source |
| Swiss Dermatology Network for Targeted Therapies (SDNTT) | View source |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |