title: Abatacept therapy and safety management.
abstract: OBJECTIVE
  To elaborate a how-to-use abatacept material intended to help physicians in the management of patients with inflammatory diseases treated with this drug in routine practice.
  
  
  METHODS
  1) Selection of the relevant domains by a rheumatologists' panel; 2) Search for published evidence in each domain; 3) Elaboration of the clinical tool guide with a 3-level gradation of evidence (evidence-based medicine EBM, official recommendations and expert's opinion). The experts were 11 academic rheumatologists with a large experience in prescribing abatacept and in managing rheumatoid arthritis. They were all members of the CRI (Club Rhumatismes et Inflammation), a section of the French Rheumatology Society dedicated to the inflammatory rheumatic diseases. Each fact sheet was reviewed by two other experts; 4) Regular updating based on medical literature and postmarketing surveillance data.
  
  
  RESULTS
  Four domains were considered relevant: abatacept contraindications, management of side effects or associated diseases appearing during abatacept treatment, management of "practical situations" such as surgery or pregnancy, physician and patient information. After the literature analysis and discussion during an experts' meeting, a consensus was reached on: a pre-treatment checklist aimed at searching abatacept contraindications; a what-to-do document when facing side effects or associated diseases (autoimmune pathology, bacterial or viral infections, cardiovascular diseases, intolerance to abatacept, solid or haematological malignancy) or "practical situations" (surgery, pregnancy, vaccination, travel, drug-drug interactions); an example of standard information letter to be addressed to the attending physician (rheumatologist and general practitioner); an example of standard information letter to be addressed to the patient.
  
  
  CONCLUSIONS
  Based on both an EBM approach and an expert's opinion approach, this abatacept clinical tool guide should provide assistance to all physicians attending patients treated with abatacept. For a better implementation in clinical practice, this tool guide will be available online at www.cri-net.com and regularly updated.
authors: Service de Rhumatologie, CHU Conception, Marseille, France. thao.pham@mail.ap-hm.fr
authors: Thao
authors: T
authors: Pham
authors: Pascal
authors: P
authors: Claudepierre
authors: Arnaud
authors: A
authors: Constantin
authors: Bruno
authors: B
authors: Fautrel
authors: Laure
authors: L
authors: Gossec
authors: Jacques-Eric
authors: JE
authors: Gottenberg
authors: Philippe
authors: P
authors: Goupille
authors: Eric
authors: E
authors: Hachulla
authors: Charles
authors: C
authors: Masson
authors: Jacques
authors: J
authors: Morel
authors: Alain
authors: A
authors: Saraux
authors: Thierry
authors: T
authors: Schaeverbeke
authors: Daniel
authors: D
authors: Wendling
authors: Xavier
authors: X
authors: Mariette
authors: Jean
authors: J
authors: Sibilia
mesh_terms: D000069594:Abatacept; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000627:therapeutic use*; D017751:Safety Management / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D018796:Immunoconjugates; D000069594:Abatacept