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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
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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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References
[1.]
J.A. Lipani, V. Strand, K. Johnson, T. Woodworth, D. Furst, G. Singh, et al.
A proposal for developing a large patient population cohort for longterm safety monitoring in rheumatoid artritis.
J Rheumatol, 28 (2001), pp. 1170-1173
[2.]
L. Carmona, I. González, A. Balsa, M. Ángel Belmonte, X. Tena, R. Sanmartí.
Rheumatoid arthritis in Spain: occurrence of extra-articular manifestations and estimates of disease severity.
Ann Rheum Dis, 62 (2003), pp. 897-900
[3.]
Comité Científico de, BIOBADASE.R., BIOBADASER: registro español de acontecimientos adversos de terapias biológicas en enfermedades reumáticas.
Rev Esp Reumatol, 29 (2002), pp. 292-299
[4.]
J.J. Gómez-Reino, L. Carmona, V.R. Valverde, E.M. Mola, M.D. Montero, Comité Científico de BIOBADASER.
Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: A multicenter active-surveillance report.
Arthritis Rheum, 48 (2003), pp. 2122-2127
[5.]
J.A. Caminero, J.A. Cayla, N. Lara, Working Group on the Current Status of Tuberculosis in Spain.
Evaluation of tuberculosis trends in Spain, 1991–1999.
Int J Tuberc Lung Dis, 7 (2003), pp. 236-242
[66.]
B. Bresnihan, G. Cunnane.
Infection complications associated with the use of biologic agents.
Rheum Dis Clin North Am, 29 (2003), pp. 185-202
[7.]
S. Kroesen, A.F. Widmer, A. Tyndall, P. Hasler.
Serious bacterial infections in patients with rheumatoid arthritis under anti-TNF-alpha therapy.
Rheumatology, 42 (2003), pp. 617-621
[8.]
T. Ellerin, R. Rubin, M. Weinblatt.
Infections and anti-tumor necrosis factor therapy.
Arthritis Rheum, 48 (2003), pp. 3013-3022
[9.]
M.H. Weisman.
What are the risks of biologic therapy in rheumatoid arthritis? An update on safety.
J Rheumatol, Suppl65 (2002), pp. 33-38
[10.]
Agencia del Medicamento y Productos Sanitarios. Nota informativa de la Agencia Española del Medicamento sobre riesgo de medicamentos. Ref: 2002/01. February 2002 [cited 13 Feb 2005]. Available from: www.agemed.es/documentos/notasPrensa/csmh/2002/cont_Infliximab_feb02_ps.htm
[11.]
L. Carmona, J.J. Gómez-Reino, V. Rodríguez-Valverde, D. Montero, E. Pascual-Gómez, E.M. Mola, et al.
Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists.
Arthritis Rheum, 52 (2005), pp. 1766-1772

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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