[Biobadaser 2.0: analysis and trends in 2009].

Abstract

OBJECTIVE:

To update the information on long-term safety of biological therapies used for the treatment of rheumatic diseases.

METHODS:

BIOBADASER is a safety registry of biological therapies established by the Spanish Society of Rheumatology. A description of BIOBADASER 2.0, a cohort composed of 14 centres within BIOBADASER is reported from 2000 until 2009.

RESULTS:

The 14 centres have registered 5,493 patients, who have received 8,081 cycles of treatment with biological therapies. 30% (1,666) has received treatment with more than one biologic agent during follow-up. There have been 3,784 treatment discontinuations, with inefficacy or loss of efficacy being the most frequent cause (1,453; 38%), followed by adverse events (1,297; 34%). Up to 7,289 adverse events (AE) have been reported, of which 80% (5,764) were considered as non serious, nearly 19% (1,340) were notified as serious and about 2% (110) were fatal. The most frequent AE were infections (2,668; 37%), followed by general problems and administration related events (10%). Cardiovascular events and cancer amounted a 7% of the total AE.

CONCLUSIONS:

There does not seem to be a trend regarding different risks in BIOBADASER 2.0 with respect to the general registry, or to previous years.

• Authors: Miguel Ángel Descalzo, Loreto Carmona, Grupo de Estudio BIOBADASER
• Journal: Reumatologia clinica (Reumatol Clin) 2010 Sep-Oct Vol. 6 Issue 5 Pg. 240-3 ISSN: 1885-1398 [Electronic] Spain
• Vernacular Title: Biobadaser 2.0: análisis y tendencias en 2009.
• PMID: 21794723 (Publication Type: English Abstract, Journal Article)
• Copyright: Copyright © 2010 Elsevier España, S.L. All rights reserved.