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

ObjectiveBIOBADASER 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 methodsAs of January 26th 2006, 6969 patients from 100 centers were included in BIOBADASER. In total, 8321 treatments with biological therapies have been registered.ResultsTreatment 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%).ConclusionsThe 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.

ObjetivoBIOBADASER es un registro de pacientes reumatológicos en tratamiento con agentes biológicos, para el seguimiento de la supervivencia y la seguridad a largo plazo.Pacientes y métodosEl 26 de enero de 2006, se ha registrado a 6.969 pacientes procedentes de 100 centros, que aportan información de 8.321 tratamientos con terapias biológicas.ResultadosEl tratamiento se suspendió en 2.351 ocasiones (28%), principalmente como resultado de un acontecimiento adverso (960; 41%), seguido de ineficacia (942; 40%). Se comunicaron 2.503 acontecimientos adversos, de los cuales el más frecuente fue la infección (909; 36%), seguido de las reacciones infusionales (500; 20%), y los trastornos cutáneos (255; 10%) y cardiovasculares (165; 7%).ConclusionesEl análisis actual de BIOBADASER constata el aumento de las infecciones con el tratamiento, no así el de neoplasias o insuficiencia cardíaca. Las medidas específicas son útiles para la prevención de acontecimientos definidos.