PsoBest - the German Psoriasis Registry

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Psoriatic-arthritis

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).

• Study Type: Observational
• Enrollment (Estimated): 3500

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Recruiting
    • Nationwide group of dermatological centers, hospitals and medical offices
    • Contact: Matthias Augustin, Prof. Dr.
    • Contact: Matthias Augustin, Prof. Dr.; Email: m.augustin@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with plaque-type psoriasis or psoriatic-arthritis starting the first systemic treatment with authorized atipsoriatic drugs in Germany.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

25

Cohorts and Interventions

Group / Cohort
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
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
Fumaric acid esters; Intervention: Drug: conventional systemic: Fumaric acid esters, including Dimethylfumarate, 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; Intervention: Biological and Biosimilars: Adalimumab, 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
Ustekinumab; Intervention: Biological and Biosimilars: Ustekinumab, all dosages, frequencies and durations prescribed
No treatment; Intervention: no systemic treatment in observation episodes

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company; UCB Pharma; Merck Sharp & Dohme LLC; AbbVie; Novartis Pharmaceuticals; Celgene; Biogen; LEO Pharma; Amgen; Viatris Inc.; Merck Serono GmbH, Germany; Janssen-Cilag G.m.b.H; medac GmbH; Almirall Hermal GmbH; Pfizer Pharmaceuticals Ltd.; Berufsverband der Deutschen Dermatologen e.V. (www.bvdd.de); Deutsche Dermatologische Gesellschaft e.V. (https://derma.de); PsoNet.eu (http://www.psonet.eu/)
• Investigators: Principal Investigator: Matthias Augustin, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

Helpful Links

• PsoBest - the German psoriasis registry
• German Center for Health Services Research in Dermatology
• PsoNet - the European registry of psoriasis
• Swiss Dermatology Network for Targeted Therapies (SDNTT)

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: April 7, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimated): May 7, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: patient registry; safety; effectiveness; psoriasis; biologics; Germany; biosimilars; psoriatic-arthritis; Psonet
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: IVDP-085-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED