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  • 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

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Clinical and epidemiological research
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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
  1. J H Salmon1,
  2. J E Gottenberg2,
  3. P Ravaud3,
  4. A Cantagrel4,
  5. B Combe5,
  6. R M Flipo6,
  7. T Schaeverbeke7,
  8. E Houvenagel8,
  9. P Gaudin9,
  10. D Loeuille10,
  11. S Rist11,
  12. M Dougados12,
  13. J Sibilia13,
  14. X Le Loët14,
  15. O Meyer15,
  16. E Solau-Gervais16,
  17. C Marcelli17,
  18. T Bardin18,
  19. I Pane3,
  20. G Baron3,
  21. E Perrodeau3,
  22. X Mariette19
  23. on behalf of all the investigators of the ORA registry and the French Society of Rheumatology
  1. 1Rheumatology Department, CHU Reims, Reims, France
  2. 2Rheumatology 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
  3. 3Centre 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
  4. 4Rheumatology Center, Purpan Hospital, Paul Sabatier University, Toulouse, France
  5. 5Rheumatology Department, Lapeyronie University Hospital, Montpellier I University, Montpellier, France
  6. 6Rheumatology Department, CHRU de Lille, Université de Lille-2, Lille, France
  7. 7Rheumatology Department, CHU Bordeaux, Bordeaux, France
  8. 8Rheumatology Department, CHU Lomme, Lomme, France
  9. 9Rheumatology Department, CHU Grenoble, Grenoble, France
  10. 10Rheumatology Department, CHU Nancy, Nancy, France
  11. 11Rheumatology Department, CHR Orléans, Orléans, France
  12. 12Medicine Faculty, Paris-Descartes University, Paris, UPRES-EA 4058, Cochin Hospital, Rheumatology B, Paris, France
  13. 13Rheumatology department, National Center for Rare Systemic Autoimmune Diseases, Hôpitaux Universitaires de Strasbourg, INSERM UMRS_1109, Université de Strasbourg, Strasbourg, France
  14. 14Rheumatology Department, Rouen University Hospital & Inserm U905, Rouen, France
  15. 15Rheumatology Department, Groupe Hospitalier Bichat-Claude Bernard (AP-HP), Paris, France
  16. 16Rheumatology Department, CHU Poitiers, Poitiers, France
  17. 17Rheumatology Department, CHU Caen, Caen, France
  18. 18Rheumatology Department, Hôpital Lariboisière, Paris, France
  19. 19Rheumatology Department, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U1184, IMVA: Center of Immunology of Viral Infections and Autoimmune Diseases, Paris, France
  1. Correspondence to Dr X Mariette, Service de Rhumatologie, Hôpital de Bicêtre, 78 rue du Général Leclerc, Le Kremlin Bicêtre 94275, France; xavier.mariette{at}bct.aphp.fr and JE Gottenberg, CHU Strasbourg, 1 avenue Molière, 67000 Strasbourg, France; jacques-eric gottenberg@chru-strasbourg.fr

Abstract

Objectives 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.

  • Rheumatoid Arthritis
  • Infections
  • Treatment

https://doi.org/10.1136/annrheumdis-2015-207362

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