THE PSOCARE PROJECT IN ITALY 2005-2007

The Psocare project has been developed within the Italian National Health System as a nationwide outcome study of patients receiving for the first time in their life a new systemic treatment for psoriasis [1]. The main objectives are the analysis of factors affecting efficacy and the assessment of toxicity with a focus on long-term infrequent adverse reactions [2]. The programme was started on September 1, 2005, and involves a total of 152 dermatological centres appointed by the Italian Regional Health Authorities, as reference centres for the treatment of moderate to severe psoriasis in Italy.

All the patients being started on a systemic treatment for psoriasis they had never previously received, at centres participating in the Psocare network, are eligible for the study. Systemic agents being surveyed include conventional treatments, e.g., methotrexate, and the new biological agents registered at the European central level for the treatment of chronic plaque psoriasis, i.e., efalizumab, etanercept, infliximab and, more recently, adalimumab. After giving their informed consent, eligible patients are registered in the study and assigned an univocal code which ensures that their data remains anonymous.

Enrolled patients are followed up for a minimum period of three years after entry even in the event of suspension or change of the systemic treatment prescribed at entry. The information is gathered by the treating physicians with the aid of a web-based electronic data collection form that allows for a wide range of internal quality controls and guarantees data confidentiality. The study website hosting the data collection form (www.psocare.it) also provides general information on the project and regular updates .

The Psocare project is fully supported by the Italian Drug Agency, Agenzia Italiana del Farmaco (AIFA), it is supervised by the Psocare Study Group, and it is technically coordinated by Centro Studi GISED (www.centrostudigised.it) .

Patient recruitment and treatment prescribed at entry

By June 27, 2008, a total of 13,320 patients have been enrolled in the Psocare cohort. The medication prescribed at entry included (in decreasing frequency order): etanercept (n=3228), ciclosporine (n=3020), acitretin (n=1621), efalizumab (n=1601), methotrexate (n=1441), infliximab (n=1052), PUVA (n=486), others or unspecified (n=1440). Large variations are observed among different geographic areas in terms of prescription habits. Overall, PASI-75, was achieved by about 35% of patients at 8 weeks and 50% of patients at 16 weeks.with the highest rate in patients on infiximab and ciclosporine. A total of 1026 relevant adverse events have been reported occuring in the cohort after a median follow-up period of 8 months.

The Psocare programme offers an invaluable resource to assess the long term outcome of systemic treatments for psoriasis. A first paper on the impact of Body Mass Index and obesity on clinical response to conventional and biological agents is in press [3]. The first analyses on safety issues are expected to be released by the end of this year. The Psocare programme participates in an international collaboration of similar registries in other European countries called Psonet (www.psonet.eu).

References

1. Psocare. Assessment of the outcomes concerning the treatment of psoriasis in Italy. BIF 2004; XI (5-6):189-193.
2. Naldi L. The search for effective and safe disease control in psoriasis. Lancet. 2008;371:1311-2.
3. Psocare Study Network.Impact of Body Mass Index and obesity on clinical response to systemic treatment for psoriasis. Evidence from the Psocare project. Dermatology (in press)

Acknowledgements

The Italian Psocare Centres listed below are greatly acknowledged