Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational [Patient Registry]

Summary: 
      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.
    

Detailed description: 
      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).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The studied population corresponds to adult patients initiating systemic treatment
        (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis in the
        centers participating to the PSOBIOTEQ Registry.

        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.
      
Keywords: Psoriasis; Adult; Systemic treatment; Biological therapy; Biosimilar therapy; small-molecule inhibitor of phosphodiesterase 4 (PDE4); Methotrexate; Ciclosporin