Psoriasis
Conditions
Keywords
Psoriasis; Biological therapy; Methotrexate; Cyclosporine
Brief summary
PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. It is resulting from the merging of two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on safety issues, and Pso-TEQ, developed by industrials at the request of the French Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues. The overall general objective of PSOBIO is to assess in real life the safety and efficacy of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use of biological therapies in real life and long-term benefit.
Detailed description
PSOBIOTEQ is a national multicentric prospective cohort, including patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. The exposure of interest is the exposure to a biological therapy: infliximab, adalimumab, etanercept, ustekinumab and other biotherapy entering the market. The nature of the systemic treatment as well as its administration modalities are defined by the investigator according to usual practice. All dermatology departments located in the French metropolitan area and using biotherapies as treatment of cutaneous psoriasis will be solicited for participation to the cohort. The inclusion will last at least 3 years with a follow-up of at least 5 years for each patient (8 years maximum), with a 6 month periodicity for the data collection (complying with good clinical practice for these patients). Follow-up duration may be extended in the case of the identification of safety signals in the early years. Each study within the cohort has its specific endpoints according to its specific objectives but the whole data required will be collected at the same time for both studies then registered in a single database (eCRF). The statistical analyses will be performed by the clinical investigation and epidemiology center (INSERM CIE 801) of BICHAT hospital's department of epidemiology and clinical research 2 636 patients will be included with the following distribution:. * Non-exposed group: 1200 patients * Exposed group: 1436 patients (naive or not) with at least 1200 patients naive for biotherapy.
Interventions
None listed
Sponsors
French Health Products Safety Agency
Société de Dermatologie Française
Janssen, LP
Pfizer
AbbVie
Merck Sharp & Dohme LLC
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years * Having been informed of the objectives and conduct of the research and having signed a written informed consent to participate * Consulting or being hospitalized for cutaneous psoriasis (clinical diagnosis) justifying the prescription of a major systemic therapy and for whom cutaneous psoriasis is the main reason for systemic treatment and belonging to one of the two following groups: * Patients exposed to a major conventional systemic therapy (methotrexate or cyclosporine, excluding biotherapies) since at least 3 months and for which there are no plans to institute treatment with biotherapy in the next 6 months : non-exposed group. * Patients exposed to a biological therapy (infliximab, adalimumab, etanercept, ustekinumab and other biotherapy entering the market) : exposed group.
Exclusion criteria
* Patients for whom cutaneous psoriasis is not the main reason for systemic treatment: treatment justified by psoriatic arthritis, concomitant Crohn's disease ...; * Patients unable to comply with the planned cohort monitoring or whose follow-up is expected to be difficult. * Patient for whom the treatment given at baseline cannot be identified (Patient participating to a double-blind trialinvolving biotherapies for example).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of skin cancer | Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month) | Occurrence of skin cancer (spinocellular carcinomas \[including carcinoma in situ (Bowen) and keratoacanthomas\], basocellular carcinomas and melanomas). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival; incidence of serious adverse events;effectiveness;therapeutic strategy,long-term safety(serious and non-serious adverse events,quality of life, rebounds after treatment discontinuation;maintenance of a therapeutic response over time | Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month) | Composite measure |
Countries
France
Outcome results
None listed