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

J H Salmon; J E Gottenberg; P Ravaud; A Cantagrel; B Combe; R M Flipo; T Schaeverbeke; E Houvenagel; P Gaudin; D Loeuille; S Rist; M Dougados; J Sibilia; X Le Loët; O Meyer; E Solau-Gervais; C Marcelli; T Bardin; I Pane; G Baron; E Perrodeau; X Mariette; all the investigators of the ORA registry and the French Society of Rheumatology

doi:10.1136/annrheumdis-2015-207362

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

Ann Rheum Dis. 2016 Jun;75(6):1108-13. doi: 10.1136/annrheumdis-2015-207362. Epub 2015 Jun 5.

Authors

J H Salmon¹, J E Gottenberg², P Ravaud³, A Cantagrel⁴, B Combe⁵, R M Flipo⁶, T Schaeverbeke⁷, E Houvenagel⁸, P Gaudin⁹, D Loeuille¹⁰, S Rist¹¹, M Dougados¹², J Sibilia¹³, X Le Loët¹⁴, O Meyer¹⁵, E Solau-Gervais¹⁶, C Marcelli¹⁷, T Bardin¹⁸, I Pane³, G Baron³, E Perrodeau³, X Mariette¹⁹; all the investigators of the ORA registry and the French Society of Rheumatology

Affiliations

¹ Rheumatology Department, CHU Reims, Reims, France.
² 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.
³ 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.
⁴ Rheumatology Center, Purpan Hospital, Paul Sabatier University, Toulouse, France.
⁵ Rheumatology Department, Lapeyronie University Hospital, Montpellier I University, Montpellier, France.
⁶ Rheumatology Department, CHRU de Lille, Université de Lille-2, Lille, France.
⁷ Rheumatology Department, CHU Bordeaux, Bordeaux, France.
⁸ Rheumatology Department, CHU Lomme, Lomme, France.
⁹ Rheumatology Department, CHU Grenoble, Grenoble, France.
¹⁰ Rheumatology Department, CHU Nancy, Nancy, France.
¹¹ Rheumatology Department, CHR Orléans, Orléans, France.
¹² Medicine Faculty, Paris-Descartes University, Paris, UPRES-EA 4058, Cochin Hospital, Rheumatology B, Paris, France.
¹³ Rheumatology department, National Center for Rare Systemic Autoimmune Diseases, Hôpitaux Universitaires de Strasbourg, INSERM UMRS_1109, Université de Strasbourg, Strasbourg, France.
¹⁴ Rheumatology Department, Rouen University Hospital & Inserm U905, Rouen, France.
¹⁵ Rheumatology Department, Groupe Hospitalier Bichat-Claude Bernard (AP-HP), Paris, France.
¹⁶ Rheumatology Department, CHU Poitiers, Poitiers, France.
¹⁷ Rheumatology Department, CHU Caen, Caen, France.
¹⁸ Rheumatology Department, Hôpital Lariboisière, Paris, France.
¹⁹ Rheumatology Department, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U1184, IMVA: Center of Immunology of Viral Infections and Autoimmune Diseases, Paris, France.

PMID: 26048170
DOI: 10.1136/annrheumdis-2015-207362

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.

Keywords: Infections; Rheumatoid Arthritis; Treatment.

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Publication types

Multicenter Study

MeSH terms

Abatacept / adverse effects*
Abatacept / therapeutic use
Adult
Age Factors
Aged
Antirheumatic Agents / adverse effects*
Antirheumatic Agents / therapeutic use
Arthritis, Rheumatoid / drug therapy*
Arthritis, Rheumatoid / epidemiology
Arthritis, Rheumatoid / immunology
Comorbidity
Female
France / epidemiology
Humans
Immunocompromised Host
Immunosuppressive Agents / adverse effects*
Immunosuppressive Agents / therapeutic use
Male
Middle Aged
Opportunistic Infections / chemically induced*
Opportunistic Infections / epidemiology
Opportunistic Infections / immunology
Registries
Risk Factors

Substances

Antirheumatic Agents
Immunosuppressive Agents
Abatacept