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Reumatol Clin. 2007 Jan;3(1):4-20. doi: 10.1016/S1699-258X(07)73593-3. Epub 2008 Nov 13.

[Spanish Registry for Adverse Events of Biological Therapy in Rheumatic Diseases (BIOBADASER): state report, January 26 th, 2006].

[Article in Spanish]

Author information

1
Unidad de Investigación. Fundación Española de Reumatología. Madrid. España.

Abstract

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 26(th) 2006, 6,969 patients from 100 centers were included in BIOBADASER. In total, 8,321 treatments with biological therapies have been registered.

RESULTS:

Treatment was discontinued in 2,351 (28%) occasions, mostly as a result of an adverse event (960;41%) or inefficacy (942;40%). A total of 2,503 adverse events were notified. Of these, the most frequent ones were infections (909;36%), followed by postinfusion 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.

PMID:
21794390
DOI:
10.1016/S1699-258X(07)73593-3
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