French Multicentric Prospective Observational Cohort of Patients Receiving Systemic Treatment for Psoriasis
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 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 to 3 836 patients will be included with the following distribution:.
- Non-exposed group: 1200 patients
- Exposed group: 1200 patients naive for biotherapy ; 1436 patients (naive or not)
Observational Model: Cohort, Time Perspective: Prospective
Occurrence of skin cancer
Occurrence of skin cancer (spinocellular carcinomas [including carcinoma in situ (Bowen) and keratoacanthomas], basocellular carcinomas and melanomas).
Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month)
Olivier Chosidow, Md, Phd
Assistance Publique - Hôpitaux de Paris
France: Agence Nationale de Sécurité du Médicament et des produits de santé