title: [Spanish registry of adverse events of biological therapies in rheumatic diseases (BIOBADASER): report as of january 14, 2005].
abstract: 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.
authors.affiliation: Unidad de Investigación. Fundación Española de Reumatología. Madrid. España.
authors.forename: L
authors.initials: L
authors.lastname: Carmona
authors.forename: J
authors.initials: J
authors.lastname: Gómez-Reino
authors.forename: R
authors.initials: R
authors.lastname: González-González