PSOBIOTEQ is a national multicentric prospective non interventional study which aims to constitute a French registry of cutaneous psoriasis patients initiating systemic treatment (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis. The general objective of PSOBIOTEQ registry is to describe the use, benefits and risks of conventional, biological, biosimilar and small-molecule inhibitor of phosphodiesterase 4 (PDE4) systemic treatments in a real-life setting. The registry aims to meet many specific objectives and to fulfill ancillary studies. The PSOBIOTEQ registry concerns a largely similar population and has same objectives than the PSOBIOTEQ Cohort (NCT01617018). Indeed, data from the PSOBIOTEQ cohort will constitute the historical part of the registry and the cohort patients will pursue their follow-up in the registry framework, in order to enrich their follow up with new collected data.
PSOBIOTEQ is a national multicentric prospective non interventional study which aims to constitute a French registry of cutaneous psoriasis patients initiating systemic treatment (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis. The exposure of interest is the exposure to any major systemic treatment (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis and marketed in France at the time of inclusion of the patient in the registry. The nature of the systemic treatment as well as its administration modalities are defined by the investigator according to usual practice. The dermatology departments participating to the PSOBIOTEQ cohort were solicited for participation to the PSOBIOTEQ registry. The PSOBIOTEQ registry will start in 2020 with 28 dermatology departments. The PSOBIOTEQ cohort started in 2012 and was finalized in 2020. The PSOBIOTEQ registry continues from 2020 till 2025. The inclusion will last 4 years with a follow-up of at least 1 year of the latest patient and until the end of the research for the other patients with a 6 month periodicity and at least one visit per year, for the data collection (complying with good clinical practice for these patients). Each included patient remains followed-up as long as he doesn't object. All data required will be collected and registered in a single database (eCRF). The statistical analyses planned in the research protocol and those responding to requests for additional data from the Transparency Committee in the context of the provision of biomedicines, their biosimilars or other major systemic treatments obtaining Marketing Authorization in the treatment of cutaneous psoriasis, will be performed by the pharmaco-epidemiology center (CEPHEPI) under the responsibility of Pr Florence TUBACH of La Pitié Salpêtrière hospital. The ancillary studies analyses responding to general objectives of the registry dealing with psoriasis and its course, the terms of use or the benefits and risks of its treatments (for example in case of identification of safety signals) or new research questions emerging during the conduct of the study (or after the study), whose realization is validated by the scientific committee of the registry may be carried out by CEPHEPI or the academic teams participating in the PSOBIOTEQ registry. A calculation of the sample size is not justified for this study as it aims to describe all the patients initiating systemic treatment for cutaneous psoriasis in the participating centers. However, based on the rate of inclusion in the PSOBIOTEQ cohort, an inclusion rate of 500 patients per year can be estimated (therefore 2000 patients to be included in 4 years).
Study Type
OBSERVATIONAL
Enrollment
2,000
Hôpital Henri Mondor
Créteil, France
Occurrence of skin cancer
Occurrence of skin cancer (spinocellular carcinomas \[including carcinoma in situ (Bowen) and keratoacanthomas\], basocellular carcinomas and melanomas).
Time frame: Up to 5 years of follow up for each patient
Physicians global assessment of disease (PGA) score
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Psoriasis Area and Severity Index (PASI) Score
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Body surface area
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Dermatology Life Quality Index (DLQI) Score
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Global Self Assessed (GSA) Score
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) index score
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Patient Report of Extent of Psoriasis Involvement (PREPI) score
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients reporting acceptable symptom state : acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients reporting clinically important improvement in psoriasis activity during the last 48 hours compared to baseline
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Occurrence of Adverse Events and Serious Adverse Events
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Occurrence of Events of special interest such as infectious diseases, autoimmune diseases, lymphoma and blood disorders, multiple solid tumors, cardiovascular diseases, etc.
Time frame: [Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Drug survival rate (proportion of patients still exposed to treatment
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Socio-demographic and clinical data: age, sex, socio-professional category, body mass index (BMI) and phototype (Fitzpatrick)
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Lifestyle data: family life, tobacco consumption, alcohol consumption and history of natural and artificial UV exposure
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients with history and comorbidities
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients with previous systemic treatments including phototherapy and acitretin
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients with systemic treatments
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients with concomitant treatments
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Daily dose of systemic treatments
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Therapeutic strategy: duration of systemic treatments, dosages, change in systemic treatments, reasons for modifications of systemic treatments
Time frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
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