title: [Consensus statement of the Spanish Society of Rheumatology on risk management of biologic therapy in rheumatic patients].
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  We present the SER recommendations related to biologic therapy risk management.
authors.affiliation: Servicio de Reumatología, Hospital Clínico Universitario, Santiago de Compostela, A Coruña, España.
authors.forename: Juan
authors.initials: J
authors.lastname: Gómez Reino
authors.forename: Estíbaliz
authors.initials: E
authors.lastname: Loza
authors.forename: José Luis
authors.initials: JL
authors.lastname: Andreu
authors.forename: Alejandro
authors.initials: A
authors.lastname: Balsa
authors.forename: Enrique
authors.initials: E
authors.lastname: Batlle
authors.forename: Juan D
authors.initials: JD
authors.lastname: Cañete
authors.forename: Eduardo
authors.initials: E
authors.lastname: Collantes Estévez
authors.forename: Cristina
authors.initials: C
authors.lastname: Fernández Carballido
authors.forename: José Luis
authors.initials: JL
authors.lastname: Fernández Sueiro
authors.forename: Rosario
authors.initials: R
authors.lastname: García de Vicuña
authors.forename: Isidoro
authors.initials: I
authors.lastname: González-Álvaro
authors.forename: Carlos
authors.initials: C
authors.lastname: González Fernández
authors.forename: Xavier
authors.initials: X
authors.lastname: Juanola
authors.forename: Luis Francisco
authors.initials: LF
authors.lastname: Linares
authors.forename: José Luis
authors.initials: JL
authors.lastname: Marenco
authors.forename: Emilio
authors.initials: E
authors.lastname: Martín Mola
authors.forename: Manuel
authors.initials: M
authors.lastname: Moreno Ramos
authors.forename: Juan
authors.initials: J
authors.lastname: Mulero Mendoza
authors.forename: Santiago
authors.initials: S
authors.lastname: Muñoz Fernández
authors.forename: Rubén
authors.initials: R
authors.lastname: Queiro
authors.forename: Patricia
authors.initials: P
authors.lastname: Richi Alberti
authors.forename: Jesús
authors.initials: J
authors.lastname: Sanz
authors.forename: Jesús
authors.initials: J
authors.lastname: Tornero Molina
authors.forename: Pedro
authors.initials: P
authors.lastname: Zarco Montejo
authors.forename: Loreto
authors.initials: L
authors.lastname: Carmona
mesh_terms: D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001691:Biological Therapy; D003697:Delphi Technique; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D060735:Pharmacovigilance; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012308:Risk Management
chemical_list: D000893:Anti-Inflammatory Agents; D018501:Antirheumatic Agents; D007166:Immunosuppressive Agents