1. Abatacept therapy and safety management
- Author
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Thao Pham, Pascal Claudepierre, Arnaud Constantin, Bruno Fautrel, Laure Gossec, Jacques-Éric Gottenberg, Philippe Goupille, Éric Hachulla, Charles Masson, Jacques Morel, Alain Saraux, Thierry Schaeverbeke, Daniel Wendling, Xavier Mariette, Jean Sibilia, Service de Rhumatologie [Hôpital de la Conception - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de rhumatologie [Strasbourg], CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Service de rhumatologie, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Médecine Interne, Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille, CHU Bordeaux [Bordeaux], Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Hôpital Bicêtre-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11), Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CHU Pitié-Salpêtrière [AP-HP], Hôpital Cochin [AP-HP], Génétique, immunothérapie, chimie et cancer (GICC), UMR 6239 CNRS [2008-2011] (GICC UMR 6239 CNRS), Université de Tours (UT)-Centre National de la Recherche Scientifique (CNRS), Hôpital Lapeyronie [Montpellier] (CHU), Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Hôpital Bicêtre, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Cambefort, Jeanne, Service de Rhumatologie [CHU Pitié Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Henri Mondor - Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CHU Pitié-Salpêtrière [APHP], CHU Cochin [APHP], Génétique, Immunothérapie, Chimie et Cancer (GICC), Université François Rabelais - Tours - Centre National de la Recherche Scientifique (CNRS), Hôpital Lapeyronie, Université Montpellier 1 (UM1) - Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier) - Hôpital Lapeyronie, CHU Bordeaux [Bordeaux] - Groupe hospitalier Pellegrin, Université Paris-Sud - Paris 11 (UP11) - Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Bicêtre, Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Tours-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille ( APHM ) -Hôpital de la Conception [CHU - APHM] ( LA CONCEPTION ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor, Service de Rhumatologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP], CHRU Tours, Hôpital Claude Huriez, Agents pathogènes et inflammation - UFC (EA 4266) ( API ), Université de Franche-Comté ( UFC ), and Université Paris-Sud - Paris 11 ( UP11 ) -Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Bicêtre
- Subjects
musculoskeletal diseases ,Safety Management ,MESH: Antirheumatic Agents ,Immunoconjugates ,Monitoring ,MESH : Safety Management ,[SDV]Life Sciences [q-bio] ,MESH : Treatment Outcome ,Arthritis, Rheumatoid ,[ SDV.MHEP.RSOA ] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,Abatacept ,MESH : Immunoconjugates ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,MESH: Immunoconjugates ,Humans ,030304 developmental biology ,MESH: Treatment Outcome ,030203 arthritis & rheumatology ,0303 health sciences ,MESH: Arthritis, Rheumatoid ,MESH: Humans ,MESH : Humans ,MESH : Antirheumatic Agents ,Health services ,3. Good health ,[SDV] Life Sciences [q-bio] ,Treatment Outcome ,MESH: Safety Management ,[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,Antirheumatic Agents ,MESH : Arthritis, Rheumatoid ,Safety - Abstract
International audience; 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 post-marketing surveillance data. Results: Four domains were considered relevant: abatacept contraindication s, 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 contra indications; - 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.
- Published
- 2009
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