Document Detail


Abatacept therapy and safety management.
MedLine Citation:
PMID:  19560051     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: 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. CONCLUSION: 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:
Thao Pham; Pascal Claudepierre; Arnaud Constantin; Bruno Fautrel; Laure Gossec; Jacques-Eric Gottenberg; Philippe Goupille; Eric Hachulla; Charles Masson; Jacques Morel; Alain Saraux; Thierry Schaeverbeke; Daniel Wendling; Xavier Mariette; Jean Sibilia
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  Joint, bone, spine : revue du rhumatisme     Volume:  76 Suppl 1     ISSN:  1778-7254     ISO Abbreviation:  Joint Bone Spine     Publication Date:  2009 May 
Date Detail:
Created Date:  2009-06-29     Completed Date:  2009-10-06     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100938016     Medline TA:  Joint Bone Spine     Country:  France    
Other Details:
Languages:  eng     Pagination:  S3-S55     Citation Subset:  IM    
Affiliation:
Service de Rhumatologie, CHU Conception, Marseille, France. thao.pham@mail.ap-hm.fr
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MeSH Terms
Descriptor/Qualifier:
Antirheumatic Agents / adverse effects,  therapeutic use*
Arthritis, Rheumatoid / drug therapy*
Humans
Immunoconjugates / adverse effects,  therapeutic use*
Safety Management / methods*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antirheumatic Agents; 0/Immunoconjugates; 0/abatacept

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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