Spanish Registry of Systemic Treatments in Psoriasis

The Spanish Registry for Adverse Events of Biological Therapies in Dermatology (BIOBADADERM) was launched in October 2008, as a pharmacovigilance effort for psoriatic patients. The registry is managed by the Foundation of the Spanish Academy of Dermatology and Venereology (AEDV). BIOBADADERM has been promoted by the AEDV, in collaboration with the Spanish Agency for Medicines and Health Products (AEMPS) and the Research Unit of the Spanish Foundation of Rheumatology (FER) and the Research Unit of the Fundacion AEDV. BIOBADADERM is part of PSONET, a European network for sharing data from records of patients treated with biologics.

BIOBADADERM is a prospective cohort of patients receiving biologic drugs that can be compared with another cohort of patients receiving other systemic treatments. One of the cohorts is made up of all consecutive psoriasis patients who begin any biological therapy (including infliximab (INF), etanercept (ET), efalizumab (EFA), adalimumab (ADA), rituximab (RTX) and ustekinumab (UTK)) in each centre. The control cohort consists of psoriasis patients who begin, for the first time, a nonbiologic systemic treatment (methotrexate, cyclosporine or acitretin).

The objectives of BIOBADADERM are:

• Identify adverse events (AEs) occurring during the relevant treatment with biologic therapies, and estimate their frequency;
• Identify unexpected AEs, particularly those that may occur after long periods of exposure;
• Identify relevant AEs that arise after discontinuation of treatment;
• Estimate the relative risk of developing AEs with biologic therapies in patients with psoriasis compared to psoriatic patients exposed to other systemic (non-biological); and
• Identify risk factors for AEs in patients with these treatments.

Data were initially collected retrospectively in hospitals with a list of all patients who had received biologic drugs between 1 January 2005 and 30 October 2008 and check-ups with a frequency of at least every 6 months. Since 2008, data have been captured prospectively.