title: Predictive risk factors of serious infections in patients with rheumatoid arthritis treated with abatacept in common practice: results from the Orencia and Rheumatoid Arthritis (ORA) registry.
abstract: OBJECTIVE
  Little data are available regarding the rate and predicting factors of serious infections in patients with rheumatoid arthritis (RA) treated with abatacept (ABA) in daily practice. We therefore addressed this issue using real-life data from the Orencia and Rheumatoid Arthritis (ORA) registry.
  
  
  METHODS
  ORA is an independent 5-year prospective registry promoted by the French Society of Rheumatology that includes patients with RA treated with ABA. At baseline, 3 months, 6 months and every 6 months or at disease relapse, during 5 years, standardised information is prospectively collected by trained clinical nurses. A serious infection was defined as an infection occurring during treatment with ABA or during the 3 months following withdrawal of ABA without any initiation of a new biologic and requiring hospitalisation and/or intravenous antibiotics and/or resulting in death.
  
  
  RESULTS
  Baseline characteristics and comorbidities: among the 976 patients included with a follow-up of at least 3 months (total follow-up of 1903 patient-years), 78 serious infections occurred in 69 patients (4.1/100 patient-years). Predicting factors of serious infections: on univariate analysis, an older age, history of previous serious or recurrent infections, diabetes and a lower number of previous anti-tumour necrosis factor were associated with a higher risk of serious infections. On multivariate analysis, only age (HR per 10-year increase 1.44, 95% CI 1.17 to 1.76, p=0.001) and history of previous serious or recurrent infections (HR 1.94, 95% CI 1.18 to 3.20, p=0.009) were significantly associated with a higher risk of serious infections.
  
  
  CONCLUSIONS
  In common practice, patients treated with ABA had more comorbidities than in clinical trials and serious infections were slightly more frequently observed. In the ORA registry, predictive risk factors of serious infections include age and history of serious infections.
authors.affiliation: Rheumatology Department, CHU Reims, Reims, France.
authors.forename: J H
authors.initials: JH
authors.lastname: Salmon
authors.affiliation: Rheumatology Department, National Center for Rare Systemic Autoimmune Diseases, Hôpitaux Universitaires de Strasbourg, CNRS, Institut de Biologie Moléculaire et Cellulaire, Immunopathologie et Chimie Thérapeutique/Laboratory of Excellence Medalis, Université de Strasbourg, Strasbourg, France.
authors.forename: J E
authors.initials: JE
authors.lastname: Gottenberg
authors.affiliation: Centre de Recherche en Epidémiologie et Statistiques, INSERM U1153, Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Descartes University, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Ravaud
authors.affiliation: Rheumatology Center, Purpan Hospital, Paul Sabatier University, Toulouse, France.
authors.forename: A
authors.initials: A
authors.lastname: Cantagrel
authors.affiliation: Rheumatology Department, Lapeyronie University Hospital, Montpellier I University, Montpellier, France.
authors.forename: B
authors.initials: B
authors.lastname: Combe
authors.affiliation: Rheumatology Department, CHRU de Lille, Université de Lille-2, Lille, France.
authors.forename: R M
authors.initials: RM
authors.lastname: Flipo
authors.affiliation: Rheumatology Department, CHU Bordeaux, Bordeaux, France.
authors.forename: T
authors.initials: T
authors.lastname: Schaeverbeke
authors.affiliation: Rheumatology Department, CHU Lomme, Lomme, France.
authors.forename: E
authors.initials: E
authors.lastname: Houvenagel
authors.affiliation: Rheumatology Department, CHU Grenoble, Grenoble, France.
authors.forename: P
authors.initials: P
authors.lastname: Gaudin
authors.affiliation: Rheumatology Department, CHU Nancy, Nancy, France.
authors.forename: D
authors.initials: D
authors.lastname: Loeuille
authors.affiliation: Rheumatology Department, CHR Orléans, Orléans, France.
authors.forename: S
authors.initials: S
authors.lastname: Rist
authors.affiliation: Medicine Faculty, Paris-Descartes University, Paris, UPRES-EA 4058, Cochin Hospital, Rheumatology B, Paris, France.
authors.forename: M
authors.initials: M
authors.lastname: Dougados
authors.affiliation: Rheumatology department, National Center for Rare Systemic Autoimmune Diseases, Hôpitaux Universitaires de Strasbourg, INSERM UMRS_1109, Université de Strasbourg, Strasbourg, France.
authors.forename: J
authors.initials: J
authors.lastname: Sibilia
authors.affiliation: Rheumatology Department, Rouen University Hospital & Inserm U905, Rouen, France.
authors.forename: X
authors.initials: X
authors.lastname: Le Loët
authors.affiliation: Rheumatology Department, Groupe Hospitalier Bichat-Claude Bernard (AP-HP), Paris, France.
authors.forename: O
authors.initials: O
authors.lastname: Meyer
authors.affiliation: Rheumatology Department, CHU Poitiers, Poitiers, France.
authors.forename: E
authors.initials: E
authors.lastname: Solau-Gervais
authors.affiliation: Rheumatology Department, CHU Caen, Caen, France.
authors.forename: C
authors.initials: C
authors.lastname: Marcelli
authors.affiliation: Rheumatology Department, Hôpital Lariboisière, Paris, France.
authors.forename: T
authors.initials: T
authors.lastname: Bardin
authors.affiliation: Centre de Recherche en Epidémiologie et Statistiques, INSERM U1153, Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Descartes University, Paris, France.
authors.forename: I
authors.initials: I
authors.lastname: Pane
authors.affiliation: Centre de Recherche en Epidémiologie et Statistiques, INSERM U1153, Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Descartes University, Paris, France.
authors.forename: G
authors.initials: G
authors.lastname: Baron
authors.affiliation: Centre de Recherche en Epidémiologie et Statistiques, INSERM U1153, Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Descartes University, Paris, France.
authors.forename: E
authors.initials: E
authors.lastname: Perrodeau
authors.affiliation: Rheumatology Department, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U1184, IMVA: Center of Immunology of Viral Infections and Autoimmune Diseases, Paris, France.
authors.forename: X
authors.initials: X
authors.lastname: Mariette
mesh_terms: D000069594:Abatacept / Q000009:adverse effects* / Q000627:therapeutic use; D000328:Adult; D000367:Age Factors; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D015897:Comorbidity; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D016867:Immunocompromised Host; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000139:chemically induced* / Q000453:epidemiology / Q000276:immunology; D012042:Registries; D012307:Risk Factors
chemical_list: D018501:Antirheumatic Agents; D007166:Immunosuppressive Agents; D000069594:Abatacept
keywords: Infections; Rheumatoid Arthritis; Treatment