Centro Studi GISED

The PsoReal registry is a program of "outcomes research" on psoriasis in its various forms which originates from the PsoCare project coordinated in Italy by Centro Studi GISED from 2005 to 2010.

The PsoReal program involves:

• the establishment of a network of reference dermatological centers in different Italian regions;
• the enrollment of consecutive patients receiving for the first time in their life a new systemic agent with the indication "psoriasis" and/or "psoriatic arthritis" at the participating centers; in addition, to new patients, patients already enrolled in the Psocare registry in the participating centres will be considered;
• the follow-up of patients enrolled with a regular update on the treatment received, outcome variables, and any adverse event.

The information will be collected by doctors and inserted into a web-based database. The information in the database will be updated on a biannual basis.

The following systemic agents will be specifically considered: acitretin, cyclosporine, methotrexate, etanercept, infliximab, adalimumab, ustekinumab, secukinumab, apremilast.


Aims

The aim is to collect data on at least 1,500 patients and to follow them up for a minimum period of three years, describing the long-term outcome of different systemic treatments, and the benefits and risks of the medications employed, possibly identifying specific groups of patients at increased risk of adverse outcomes or lack of clinical benefit.

The study started on December 2015 with the participation of 17 centers in the Lombardy and Piedmont regions.


Results

A first data analysis concerned the use of conventional and biologic systemic agents in 11,500 patients enrolled in the PsoReal registry between 2009 and 2017 in Italy, with a focus on patients treated with fumaric acid derivatives.

Most frequently used conventional drugs were cyclosporine, methotrexate and retinoids, while ,among biologics, they were etanercept and infliximab. Regarding fumaric acid derivatives it was observed that these medications can be used over long time periods, have side effects similar to other drugs and their medical costs is lower.

Results of this study were published on the Italian Journal of Dermatology and Venerology:

Damiani G, Cazzaniga S, Naldi L; PsoReal Study Group. Use of fumaric acid derivatives (FADs) in Italian reference centres for psoriasis. G Ital Dermatol Venereol. 2019 Jan 9.


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