Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
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).
Inclusion Criteria:

 -  Patient aged 18 or over

 -  Had been informed about the objectives and progress of the research, and not opposed
 to the collection of his data

 -  Consulting or hospitalized in one of the departments participating in the study :

 -  For a cutaneous psoriasis (clinical diagnosis)

 -  And at least one of the two criteria below must be met :

 -  In whom a systemic treatment is initiated (excluding phototherapy or acitretin)
 that he has never received in the past * (a patient who has already received a
 biomedicine (princeps and / or biosimilar (s)) in the past cannot be included
 under the same biomedicine (princeps and / or biosimilar (s)). Patients
 initiating treatment with methotrexate or ciclosporin must be naïve of any
 biomedicine.

 -  Patients included in the PSOBIOTEQ 1 cohort

 Exclusion Criteria:

 -  Patient for whom cutaneous psoriasis is not the main reason for systemic treatment
 (psoriatic arthritis, or concomitant Crohn's disease, etc.);

 -  Patient unable to comply with the registry's follow-up procedures (not reachable by
 phone, unable to complete the self-questionnaire) or whose monitoring is deemed
 difficult;

 -  Patient for whom the treatment administered at inclusion cannot be identified (patient
 included in a randomized double-blind biomedicine research protocol, for example).

 -  Patient under guardianship or curatorship