BIOBADASER es un registro de pacientes reumatológicos en tratamiento con agentes biológicos, para el seguimiento de la supervivencia y seguridad a largo plazo.

A fecha de 14 de enero de 2005, se registraron 5.361 pacientes en BIOBADASER, procedentes de 100 centros, e información sobre 6.109 tratamientos biológicos. El tratamiento se interrumpió en 1.515 ocasiones (25%), principalmente como resultado de un acontecimiento adverso (n = 666; 44%), seguido de ineficacia (n = 581; 38%). Se comunicaron 1.814 acontecimientos adversos, de los cuales el más frecuente fue la infección (n = 649; 36%), seguida de las reacciones infusionales (n = 384; 21%) y las afecciones cutáneas (n = 162; 9%) y cardiovasculares (n=127; 7%).

El análisis 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.

BIOBADASER is a registry of rheumatic patients treated with biological therapies. The purpose of thisregistry is to provide information on long-term survival and the safety of these agents. As of January 14th 2005, 5361 patients from 100 centers were included in BIOBADASER. In total, 6109 treatments with biological therapies have been registered. Treatment was discontinued on 1515 occasions (25%), mainly because of an adverse event (666 [44%]) or inefficacy (581 [38%]). A total of 1814 adverse events were notified. Of these, the most frequent were infections (649 [36%]), followed by post-infusion reactions (384 [21%]), skin lesions (162 [9%]), and cardiovascular events (127 [7%]).

This analysis confirms the increased rate of infections with biological therapies. However, these therapies do not significantly increase the rate of neoplasms or cardiac failure. Specific measures have proved useful in preventing the occurrence of some well-defined events.