FIRST BRAZILIAN REGISTRY OF BIOLOGICAL TREATMENT IN PSORIASIS PATIENTS- PRELIMINARY CONCEPT AND RESULTS
Author(s)
Felix PAO1, Azulay-Abulafia L21Hospital do Servidor Estadual, Rio de Janeiro, Rio de Janeiro, Brazil, 2Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Rio de Janeiro, Brazil
OBJECTIVES Monitorize PsO patients under biological therapy to evaluate their epidemiologic aspects, therapy safety profile and reveal scientific knowledge based on Registry data. METHODS GBB initiative was created in Rio de Janeiro involving eight sites. Patients are monitored according to GBB Clinical Research Form (CRF) that include social-economic aspects, disease history, previous treatment and safety and efficacy data. A software has been developed to collect on-line data at the sites. RESULTS One hundred twenty-six (126) patients have already been included in the Registry since 2006. The interim analysis has shown that 66% are men and 34% women, mainly white (65%). The mean age is 48.5 years old (range of 20 to 80 years old). The most frequent disease form was plaque PsO (82%), followed by erythrodermic form (23%). Overall, 71% of patients are under Etanercept treatment, 25% Infliximab and 4% Adalimumab. Regarding treatment safety, 4/48 patients of Etanercept and 7/28 patients of Infliximab presented adverse events. In general, infectious events were rare. Related to time of the disease, 46% of patients presents up to 10 years, 45% 11 to 30 years and 9% more than 31 years. CONCLUSIONS Patient registries are an essential complement to data obtained from randomized, controlled trials. It clarifies important questions about the use of therapeutic options in the real life and in a long-term perspective. GBB preliminary data has shown the first demographic and clinical data regarding PsO in our country. In addition is the first biological treatment monitorization among those patients. Therefore GBB project is revealing important data that will guide Brazilian clinical practice and elucidate important issues in PsO scenario. This pivotal initiative will have its data collection intensified and also intends to be disseminated trough other services in Brazil.
Conference/Value in Health Info
2009-09, ISPOR Latin America 2009, Rio de Janeiro, Brazil
Value in Health, Vol. 12, No. 7 (October 2009)
Code
PSY1
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Sensory System Disorders, Systemic Disorders/Conditions