ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1309

Predictive Risk Factors of Serious Infections in RA Patients Treated with Abatacept in Real Life: Results in the Orencia and Rheumatoid Arthritis (ORA) Registry

Jacques-Eric Gottenberg1, Philippe Ravaud2, Alain G. Cantagrel3, Bernard Combe4, René-Marc Flipo5, Thierry Schaeverbeke6, Eric Houvenagel7, Philippe Gaudin8, Damien Loeuille9, Stephanie Rist10, Maxime Dougados11, Jean Sibilia12, Xavier Le Loet13, Christian Marcelli14, Thomas Bardin15, Isabelle Pane16, Elodie Perrodeau17, Gabriel Baron18 and Xavier Mariette19, 1Rheumatology, Strasbourg University Hospital, Strasbourg, France, 2Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 3Rheumatology, Place du Docteur Baylac, Toulouse, France, 4Rheumatology, Hopital Lapeyronie, Montpellier, France, 5Rheumatology Department, Lille University Hospital, Lille, France, 6Service de Rhumatologie, Groupe Hospitalier Pellegrin, Bordeaux, France, 7Service de Rhumatologie, St Philibert Hospital, Lomme 59462, France, 8Rheumatology Department, CHU Hôpital Sud, Grenoble Teaching Hospital, Echirolles, France, 9Rheumatology, CHU Brabois, Vandoeuvre les Nancy, France, 10Hospital University Orléans, France, 11Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, 12Rheumatology, CHU Hautepierre, Strasbourg, France, 13Rheumatology Department, CHU de ROUEN, Rouen, France, 14Rheumatology Department, Caen University Hospital, 15Rheumatology, Hôpital Lariboisière, Paris, France, 16Hotel Dieu University Hospital Paris, Hotel Dieu University Hospital Paris, Paris, France, 17Epidemiologist, Paris, France, 18Hotel Dieu University Hospital Paris, Epidemiology, Paris, France, 19Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

Session Type: Abstract Submissions (ACR)

Background/Purpose: Little data is available regarding the rate and predicting factors of serious infections in patients with rheumatoid arthritis 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 registry promoted by the French Society of Rheumatology which includes RA patients treated with abatacept. At baseline, 3, 6 months and every 6 months or at disease relapse, during 5 years, standardized information are prospectively collected by trained clinical nurses in each center. Central reviewing of charts of patients with SAEs is performed by the two coordinators of the study.

Results: – Baseline characteristics and comorbidities

1032 patients (79.1% of women) were included in the ORA registry. Median age of patients was 58 years and median disease duration was 15 years. 5.8% of patients had a history of cancer, 34.6% a record of serious infection, and 11.8% had diabetes. 12.9% of patient had not received any anti-TNF prior to ABA. 29.8% of patients had previously received rituximab.

-Rate of serious infections

Among the 977 patients with a follow-up of at least 3 months (median follow-up of 1766 patient-years (PY)), 118 serious infections occurred in 99 patients during treatment with ABA (64 infections) and/or within the 6 months following ABA discontinuation (54 infections). Thus, 6.7 serious infections/100 PY were observed (3.6/100 PY during treatment with ABA and 3.1/100 PY within the 6 months following discontinuation of ABA).

– Predicting factors of severe infections

On univariate analysis, an older age, record of previous serious or recurrent infections, diabetes, chronic lung disease, a lower number of previous anti-TNF, and a higher corticosteroid dosage at initiation of ABA were associated with a higher risk of serious infections. Disease duration, previous treatment with rituximab, concomitant treatment with a synthetic DMARD, disease activity were not significantly associated with an increased risk of serious infections. On multivariate analysis, only age (OR 1.5 CI95% [1.2-1.7], P<0.001) and record of previous serious or recurrent infections (2.2 [1.5-3.5], P< 0.001) were significantly associated with a higher risk of serious infections.

Conclusion:

In ORA registry, severe infections in patients treated with abatacept were slightly more frequent than in clinical trials. This might be related to the fact that a high proportion of patients with comorbidities, who would have been excluded from controlled trials, are treated with ABA in real life. Characteristics of RA (duration, previous treatments including anti-TNF or rituximab, disease activity) were not associated with serious infections. Predictive risk factors of serious infections in patients treated for RA with ABA in common practice included age and previous record of serious infections.

Disclosure:

J. E. Gottenberg,
None;

P. Ravaud,
None;

A. G. Cantagrel,
None;

B. Combe,
None;

R. M. Flipo,
None;

T. Schaeverbeke,
None;

E. Houvenagel,
None;

P. Gaudin,
None;

D. Loeuille,
None;

S. Rist,
None;

M. Dougados,
None;

J. Sibilia,
None;

X. Le Loet,
None;

C. Marcelli,
None;

T. Bardin,
None;

I. Pane,
None;

E. Perrodeau,
None;

G. Baron,
None;

X. Mariette,
None.

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