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Vol. 3. Issue 1.
Pages 4-20 (January - February 2007)
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Vol. 3. Issue 1.
Pages 4-20 (January - February 2007)
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Spanish Registry for Adverse Events of Biological Therapy in Rheumatic Diseases (BIOBADASER): State Report, January 26th, 2006
Registro Español de Acontecimientos Adversos de Terapias Biológicas en Enfermedades Reumáticas (BIOBADASER): informe de la situación, 26 de enero de 2006
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Miguel Ángel Descalzo
Corresponding author
lcarmona@ser.es

Correspondence: Unidad de Investigación. Fundación Española de Reumatología. Marqués del Duero, 5, 1.o A. 28001 Madrid. España.
, BIOBADASER Scientific Committee, and the BIOBADASER Study Group
Unidad de Investigación, Fundación Española de Reumatología, Madrid, Spain
Related content
Reumatol Clin. 2007;3:14510.1016/S2173-5743(07)70232-0
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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 26th 2006, 6969 patients from 100 centers were included in BIOBADASER. In total, 8321 treatments with biological therapies have been registered.

Results

Treatment 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%).

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.

Key words:
Biological therapies
Follow-up
Adverse events
Registry
Objetivo

BIOBADASER 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 métodos

El 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.

Resultados

El 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%).

Conclusiones

El 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.

Palabras clave:
Terapias biológicas
Seguimiento
Acontecimientos adversos
Registro
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The listing of the members of BIOBADASER appears in the last page of the article.

BIOBADASER is carried out in collaboration with the Division of Pharmacoepidemiology and Pharmacovigilance of the Spanish Agency of Medications and Sanitary Products.

Copyright © 2007. Sociedad Española de Reumatología and Colegio Mexicano de Reumatología
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