Psocare Italy: recent activities

The Psocare programme has been conceived as a nationwide outcome study of patients receiving for the first time in their life a new systemic treatment for psoriasis. The main focus is on long-term effectiveness and infrequent or rare adverse reactions. The project is supported by the Italian Drug Agency, Agenzia Italiana del Farmaco (AIFA),  and involves all the 154 centres appointed by the Italian Regional Health Authorities, as reference centres for the treatment of moderate to severe psoriasis in Italy. Registration of patients newly treated by systemic agents for psoriasis is compulsory within the programme. In addition, such a registration enables to get reimbursement by the National Health System for the prescription of biological agents. The Psocare system addresses in an efficient way the requirement for a pro-active pharmacovigilance recently put forward by the European Medicines Agency (EMEA).

A few months ago, the first analyses from the project were published. It was documented that overweight and obesity may influence the short term clinical response to systemic treatment for psoriasis irrespective of the administered drug [1]. These results and more general data on the functioning of the programme and on safety signals originated in its framework, were discussed during the 2nd Psocare meeting last October in Rome (www.psocare.it). The Psocare programme was initially planned with a follow-up period of three years. However, the maintenance of the programme which has been continuously supported by the two main Italian Dermatological Societies, SIDEMAST and ADOI, involved the main psoriasis patient organisation ADIPSO, and has been technically coordinated by Centro Studi GISED in Bergamo, is critically important to get long-term data and to enable the surveillance of drugs which may enter the market in the not distant future, such as ustekinumab. The Psocare meeting was briefly introduced by the new General Director of AIFA, Prof. Guido Rasi, who gave reassurance about his willingness to maintain the programme over the next few years.

Not only has the Psocare programme represented a sort of study model for pro-active pharmacovigilance in dermatology [2], but it has also contributed to improve the management of psoriasis in Italy, through the definition of standard of care and the dissemination of guidelines. Recently, a survey was conducted among the Psocare centres to learn about organisation and know-how for the management of psoriatic arthritis at the centres. Based on the data collected, 119 out of the total 154 centres were organised in such a way that the management of psoriatic arthritis could be efficiently carried out at the centres.

Further data to appear soon!

1. Naldi L, Addis A, Chimenti S, et al. Impact of body mass index and obesity on clinical response to systemic treatment for psoriasis. Evidence from the psocare project. Dermatology. 2008;217:365-73.

2. Nijsten T, Wakkee M. Psocare: Italy shows the way in postmarketing studies. Dermatology. 2008;217:362-4.

Luigi Naldi for the Psocare Study Group(*)

(*) Antonio Addis, Mario Tomino, Mauro Venegoni, Giuseppe Traversa, Alberto Giannetti, Sergio Chimenti, Mauro Picardo, Mara Maccarone, Rosanna Cuscito