ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2168

Tolerance and Efficacy of Rituximab in Elderly Patients with Rheumatoid Arthritis Enrolled in the French Society of Rheumatology Air Registry

Sarah Payet1, Jacques-Eric Gottenberg2, Xavier Mariette3, Philippe Ravaud4, Elodie Perrodeau5, Thomas Bardin6, Patrice Cacoub7, Alain G. Cantagrel8, Bernard Combe9, Maxime Dougados10, Rene-Marc Flipo11, Bertrand Godeau12, Loic Guillevin13, Xavier X. Le Loet14, Eric Hachulla15, Thierry Schaeverbeke16, Jean Sibilia17, Isabelle Pane18, Gabriel Baron19 and Martin Soubrier20, 1Rheumatology, CHU G.-Montpied, Clermont-Ferrand, France, 2Rheumatology, Strasbourg University Hospital, Strasbourg, France, 3Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France, 4Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 5Epidemiologist, Paris, France, 6Rheumatology, Hôpital Lariboisière, Paris, France, 7Internal Medicine, Assistance Publique-Hôpitaux de Paris, Hopital Pitié-Salpétrière, Paris, France, 8Dept of Rheumatology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France, 9Rheumatology, Hopital Lapeyronie, Montpellier, France, 10Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, 11Rheumatology, Hopital R Salengro CHRU, Lille, France, 12Internal Medicine, University of Paris, AP-HP, Hôpital Mondor Créteil, Creteil, France, 13Internal Medicine, Division of Internal Medicine, Hôpital Cochin, University Paris Descartes, Paris, France, 14Rheumatology Department, CHU de ROUEN, Rouen, France, 15Department of Internal Medicine, Claude Huriez University Hospital, Lille, France, 16Service de Rhumatologie, Groupe Hospitalier Pellegrin, Bordeaux, France, 17Université de Strasbourg, EA4438 Laboratoire Physiopathologie des Arthrites, Illkirch-Strasbourg, France, 18Hotel Dieu University Hospital Paris, Hotel Dieu University Hospital Paris, Paris, France, 19Hotel Dieu University Hospital Paris, Epidemiology, Paris, France, 20Rheumatology, CHU CLERMONT-FERRAND, Clermont-Ferrand, 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: This study aimed to compare the efficacy and the safety of Rituximab (RTX)in elderly (aged ≥ 65years) and younger patients (aged 18-64 years) with active rheumatoid arthritis (RA).

Methods: We included all the RA patients in the «Auto-immunity and RTX » 7-years prospective registry with 2 years follow-up and divided them in 2 main groups on the basis of their age ( aged ≥ 65 and aged <65). A minor group with the very old patients ( 75years old or more) was studied too. The primary efficacy outcome was EULAR response (good, moderate and no response) , the secondary efficacy outcome were low disease activity and remission. The primary tolerance outcome was drug discontinuation rates due to side effects.

Results: Among the 1709 patients having at least 2 years of follow up, 608 were ≥ 65years of whom 191 were ≥ 75years old, and 1101 were <65years. At baseline, the elderly patients showed a longer disease duration, a higher rate of CRP and ESR (medians respectively 21 vs 14mg/L, p<0.001, and 35 vs 32 mm, p<0.001), lower rate of previous aTNF therapy (71% vs 79.6%, p<0.001) and lower number of aTNF previously used (medians 1 vs 2, p<0.001). Disease activity, previous DMARDs rates, rheumatoid or aCCP rates and corticotherapy (yes/no)  were not statistically different between the 2 groups. At 24 months, no significant difference was showed between groups for RTX discontinuation rates for side effects: 5.8% if < 65years, 4.9% if ≥ 65 years and 4.2% if ≥ 75years old. However, death rates increased with age: 2.5% if < 65years, 7.7% if ≥ 65 years and 16.2% if ≥ 75years old, p<0.001.The EULAR response criteria were not statistically different after 2 years (n=506) in the younger (<65 years, n=354)and older groups (≥ 65years, n=152) with respectively 64.1% and 68.4% of responders including 39.5% and 48% moderate responders, and 24.6% and 20.4%  good responders respectively. However, there were  significant differences  concerning very old patients (≥75ans). Before adjustment younger patients and patients between 65 and 75years had more chances to be good responders at one year follow-up (n=642) than patients ≥ 75years old, with respectively OR= 3.54 ( 95% IC= [1.2-10.47]) and OR= 4.53 (95 IC= [1.12-12.33]). After adjustment, this difference was only significant between the old (≥ 65years) and very old patients (≥ 75years): OR= 3.71, 95% IC= [1.12;12.33] (n= 475). At 24 months, these differences were no longer significant with or without adjustment. Concerning remission, there was no significant difference between the young and the elderly, either at 1 year or at 2 years, respectively 12.05% vs 13%  (adjusted p=0.372) , and 15.6% vs 11.04% (adjusted p= 0.410).

Conclusion: This study is the first to date to compare tolerance and effectiveness of RTX between elderly and younger patients with RA. No significant difference in efficacy or  discontinuation rate  after 2 years of follow-up. Increase of mortality in the oldest patients is probably due to the decrease of life expectancy with age.

Disclosure:

S. Payet,
None;

J. E. Gottenberg,
None;

X. Mariette,
None;

P. Ravaud,
None;

E. Perrodeau,
None;

T. Bardin,
None;

P. Cacoub,
None;

A. G. Cantagrel,

Chugai, BMS, Roche, UCB, Abbott, Pfizer,

5,

UCB, Pfizer,

2;

B. Combe,
None;

M. Dougados,
None;

R. M. Flipo,
None;

B. Godeau,
None;

L. Guillevin,
None;

X. X. Le Loet,
None;

E. Hachulla,
None;

T. Schaeverbeke,
None;

J. Sibilia,
None;

I. Pane,
None;

G. Baron,
None;

M. Soubrier,
None.

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