• M Ramos-Casals, G Ruiz-Irastorza, J Jiménez-Alonso, M A Khamashta, and Comité de Consenso sobre el uso de belimumab, Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Sociedad Española de Medicina Interna (SEMI).
• Servicio de Enfermedades Autoinmunes, Laboratorio de Enfermedades Autoinmunes Josep Font, IDIBAPS, Hospital Clínic, Barcelona, España. mramos@clinic.ub.es
• Rev Clin Esp (Barc). 2013 Jan 1; 213 (1): 42-58.

AbstractBiological therapies are based on the administration of various types of synthetic molecules related to the immune response. Their use has spread in recent years to the field of systemic autoimmune diseases, particularly to systemic lupus erythematosus (SLE). Until 2011, these diseases were not included in the therapeutic indications approved by international regulatory agencies. Therefore, the use of biological therapies was restricted to clinical trials and to compassionate use for cases refractory to standard treatments (off-label use), which require the approval of the Health Ministry. In 2011, belimumab, a human monoclonal antibody that specifically binds to the soluble form of the protein human B lymphocyte stimulator BlyS, was approved for use in patients with SLE. Because the clinical information on the use of this new drug in patients with SLE has only been obtained from the results of randomized trials, the Study Group of Autoimmune Diseases (GEAS) of the Spanish Society of Internal Medicine (SEMI) has developed therapeutic guidelines. These guidelines are based on the current scientific evidence on the use of belimumab in SLE patients in the clinical practice.Copyright © 2012 Elsevier España, S.L. All rights reserved.

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