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Reumatol Clin. 2011 Sep-Oct;7(5):284-98. doi: 10.1016/j.reuma.2011.05.002. Epub 2011 Aug 4.

[Consensus statement of the Spanish Society of Rheumatology on risk management of biologic therapy in rheumatic patients].

[Article in Spanish]

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Servicio de Reumatología, Hospital Clínico Universitario, Santiago de Compostela, A Coruña, España.



Due to the increasing use of biologic therapy in rheumatic diseases and the importance of its risk management, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and those involved in the treatment of patients who are using, or about to use biologic therapy irrespectively of the rheumatic disease.


Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Evidence from previous consensus and clinical guidelines was used.


We have produced recommendations on risk management of biologic therapy in rheumatic patients. These recommendations include indication risk management, risk management before the use of biologic therapy, risk management during follow-up, attitude to adverse events, and attitude to special situations.


We present the SER recommendations related to biologic therapy risk management.

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