PsoBest - The German Psoriasis Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Psoriasis, Psoriatic-arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-Term Benefits and Safety of Systemic Psoriasis Therapy: German Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
Overview
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
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:
1. Effectiveness in clinical practice ("real world") 2. Benefits and needs on the patients' side 3. Effectiveness in a long-term course over years 4. Optimal maintenance dosages 5. Safety and side-effects profile under routine conditions 6. Use in case of and effect on co-morbidity 7. Reliable predictors of response 8. 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).
Primary outcome measures
- Psoriasis Area Severity Index (PASI) [Time frame: every 6 month for 10 years]
Secondary outcome measures (1)
- Dermatology Life Quality Index (DLQI) [Time frame: every 3 month for 10 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Nationwide group of dermatological centers, hospitals and medical offices — Hamburg
Identifiers
NCT: NCT01848028 · IVDP-085-07