Spanish Registry for Adverse Events of Biological Therapy in Rheumatic Diseases (BIOBADASER): State Report, January 26th, 2006

Objective BIOBADASER is a prospective registry of rheumatic patients treated with biological therapies, which aim is the analysis of long-term survival and safety of these agents. Patients and methods As of January 26th 2006, 6969 patients from 100 centers were included in BIOBADASER. In total, 8321 treatments with biological therapies have been registered. Results Treatment was discontinued in 2351 (28%) occasions, mostly as a result of an adverse event (960; 41%) or inefficacy (942; 40%). A total of 2503 adverse events were notified. Of these, the most frequent ones were infections (909; 36%), followed by post-infusion reactions (500; 20%), skin lesions (255; 10%) and cardiovascular events (165; 7%). Conclusions The analysis reassures us in the increased rate of infections with biological therapies. Neither the rates of neoplasm nor of cardiac failure are significantly increased with these therapies. Specific measures have proved useful in preventing the occurrence of defined events.