Swiss Dermatology Network of Targeted Therapies (SDNTT) (SDNTT)

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

The purpose of this study is to evaluate the long-term course of patients with psoriasis and psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A patient will be included at first initiation of the treatment and will remain in the registry for 10 years, regardless of subsequent therapy.

The registry will also evaluate safety clinical outcomes and health related quality of life.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Adalimumab; Biological: Etanercept; Biological: Infliximab; Biological: Ustekinumab; Drug: Cyclosporine A; Drug: Fumaric acids; Drug: Methotrexate; Drug: Other anti-psoriatic systemic treatments

Detailed Description

Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) in Switzerland is largely performed with systemic therapies. This includes conventional systemic therapy such as fumaric acids, methotrexate, cyclosporin A, retinoids, systemic PUVA, Acitretin and biological treatments such as etanercept, infliximab, adalimumab and within a pre-registration program ustekinumab. 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. SDNTT, the Swiss registry on the treatment of moderate to severe Pso and PsA documents the long-term course of patients being administered a defined biologic or conventional systemic drug. Following outcomes are observed: Effectiveness on the long-term, of combined/alternating treatments and under comorbidity conditions; patient-defined benefits and quality of life, maintenance dosages, prediction of response and safety.

The study evaluates the long-term course of patients with Pso and PsA in systemic treatments. A patient will be included at first initiation of the treatment and will remain in the registry for 5 years, regardless of subsequent therapy. Nationwide, initially 35 (long-term approx. 50-80) dermatologic practices and hospital ambulances with expertise in systemic and biologic treatment will consecutively enroll patients. Follow-ups will be every 3 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.

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• Switzerland
  • Aarau, Switzerland, CH-5001
    • Recruiting
    • Aarau Cantonal Hospital
    • Contact: Marcus Streit, Dr. med.; Phone Number: 062 838 68 38; Email: markus.streit@ksa.ch
    • Principal Investigator: Marcus Streit, Dr. med.
  • Basel, Switzerland, CH-4031
    • Recruiting
    • Basel university hospital
    • Contact: Alexander Navarini, Prof.; Email: Alexander.Navarini@usb.ch
    • Principal Investigator: Alexander Navarini, Prof.
  • Bern, Switzerland, CH-3001
    • Recruiting
    • Inselspital - Bern University Hospital
    • Contact: Luca Borradori, Prof.; Phone Number: 031 632 2111; Email: Luca.Borradori@insel.ch
    • Contact: Nikhil Yawalkar, Prof.
    • Principal Investigator: Nikhil Yawalkar, Prof.
  • Lausanne, Switzerland, CH-1011
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois (Chuv)
    • Contact: Michel Gilliet, Prof.; Email: michel.gilliet@chuv.ch
    • Principal Investigator: Curdin Conrad, PD Dr. med.
  • St. Gallen, Switzerland, CH-9007
    • Recruiting
    • St. Gallen Cantonal Hospital
    • Contact: Antonio Cozzio, Prof.; Email: Antonio.Cozzio@kssg.ch
    • Principal Investigator: Antonio Cozzio, Prof.
  • Zurich, Switzerland, CH-8091
    • Recruiting
    • Zurich University Hospital
    • Contact: Tatjana Maul, PD Dr.; Email: Julia-Tatjana.Maul@usz.ch
    • Principal Investigator: Tatjana Maul, Dr.

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Any patient with psoriasis or psoriatic-arthritis meeting the inclusion criteria and not meeting the exclusion criteria will be eligible to participate in this registry.

Description

Inclusion Criteria:

• Patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a dermatologist,
• age ≥ 18,
• Being administered a specific biologic/conventional systemic drug for the first time
• Sufficient language skills (German, French, Italian and English) for the informed consent to participate
• Informed consent to participate

Exclusion Criteria:

• Lack of informed consent
• Patients being participants of clinical trials at the day of registration to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analyzed separately)

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Methotrexate; Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed	Drug: Methotrexate; all dosages, frequencies and durations prescribed
Cyclosporine A; Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed	Drug: Cyclosporine A; all dosages, frequencies and durations prescribed
Etanercept; Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed	Biological: Etanercept; all dosages, frequencies and durations prescribed; Other Names: Enbrel
Infliximab; Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed	Biological: Infliximab; all dosages, frequencies and durations prescribed; Other Names: Remicade
Adalimumab; Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed	Biological: Adalimumab; all dosages, frequencies and durations prescribed; Other Names: Humira
Ustekinumab; Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed	Biological: Ustekinumab; all dosages, frequencies and durations prescribed; Other Names: Stelara
Fumaric acids; Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed	Drug: Fumaric acids; all dosages, frequencies and durations prescribed
Other anti-psoriatic systemic treatments; e.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed	Drug: Other anti-psoriatic systemic treatments; all dosages, frequencies and durations prescribed

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 months for 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatology Life Quality Index (DLQI)	To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 6 months 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	10 years

Collaborators and Investigators

• Sponsor: Swiss Dermatology Network for Targeted Therapies
• Investigators: Principal Investigator: Alexander Navarini, Prof Dr med, Swiss Society of Dermatology and Venereology (SSDV); Principal Investigator: Julia-Tatjana Maul, PD Dr med, Swiss Society of Dermatology and Venereology (SSDV)

Publications and helpful links

Helpful Links

• SDNTT
• German registry PsoBest

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): June 1, 2032
• Study Completion (Anticipated): June 1, 2033

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 15, 2012

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Psoriasis; Methotrexate; Psoriatic arthritis; Infliximab; Adalimumab; Ustekinumab; Cyclosporine A; Etanercept; Skin disease; Acitretin; Systemic PUVA; Fumaric acids
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Antifungal Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Calcineurin Inhibitors; Etanercept; Adalimumab; Methotrexate; Infliximab; Cyclosporine; Cyclosporins; Ustekinumab
• Other Study ID Numbers: IMM 10-0138; P21007224R; CNTO1275PSO4028; AG110401-IIR (Other Grant/Funding Number: AbbVie, Janssen Pharmaceutica, Novartis, Eli Lilly, Amgen)