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Abstract Number: 1656

Treatment of Systemic Necrotizing Vasculitides in Patients ≥65 Years Old: Results of the Multicenter Randomized Cortage Trial

Christian Pagnoux1, Thomas Quemeneur2, Jacques Ninet3, Elodie Perrodeau4, Elizabeth Diot5, Xavier Kyndt6, Benoit de Wazières7, jean-Luc Reny8, Xavier Puéchal9, Pierre-Yves Leberruyer10, Olivier Lidove11, Philippe Vanhille12, Pascal Godmer13, Aimé Albath-Sadiki14, Boris Bienvenu15, Pascal Cohen16, Luc Mouthon17, Philippe Ravaud4, Loic Guillevin18 and French Vasculitis Study Group (FVSG)19, 1Internal Medicine, Department of Internal Medicine, National Referral Center for Necrotizing Vasculitides and Systemic Sclerosis, Hôpital Cochin, Assistance Publique – Hôpitaux de Paris, Université Paris – Descartes, Paris, France, Paris, France, 2Internal medicine, CHR de Valenciennes, Valenciennes, France, 3Department of Nephrology and Internal Medicine, Hôpital Edouard Herriot, Lyon, France, Lyon, France, 4Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 5Department of Internal Medicine, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Tours, Tours, France, Tours, France, 6Department of Nephrology and Internal Medicine, CH, Valenciennes, Valenciennes, France, 7Department of Internal Medicine and Gerontology, Hôpital Universitaire Carémeau, Nîmes, France, Nimes, France, 8Service de médecine interne générale Hôpitaux universitaires de Genève, Geneve, Switzerland, 9National Referral Center for Rare Systemic Auto-immune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, France, 10Hôpital Robert Debré, Centre Hospitalier Universitaire de Reims, Reims, France, Reims, France, 11Médecine interne, Hôpital Croix-Saint-Simon, PARIS, France, 12Department of Nephrology and Internal Medicine, Hospital of Valenciennes, Valenciennes, France, Valenciennes, France, 13Department of Internal Medicine, Centre Hospitalier Bretagne Atlantique de Vannes, Vannes, France, 14Urc, Hôpital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, 27 rue du faubourg Saint Jacques, Paris, 75014, France, Paris, France, 15Médecine interne, CHU Côte de Nacre, CAEN, France, 16National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, Paris, France, 17Internal Medicine, Hopital Cochin, Paris, France, 18Internal Medicine, Cochin University Hospital, Paris, France, 19Department of Internal Medicine, National Referral Center for Necrotizing Vasculitides and Systemic Sclerosis, Hôpital Cochin, Assistance Publique – Hôpitaux de Paris, Université Paris – Descartes, Paris, France

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: corticosteroids, geriatrics, randomized trials and vasculitis

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Session Information

Session Title: Vasculitis: Clinical Trials

Session Type: Abstract Submissions (ACR)

Background/Purpose: To optimize the therapeutic strategy for the elderly with systemic necrotizing vasculitides (SNV; polyarteritis nodosa (PAN), granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) or eosinophilic GPA (EGPA)).

Methods: We conducted a multicenter randomized controlled trial on patients ≥65 years old with newly diagnosed SNV to compare conventional therapy (based on Five-Factor Score-assessed disease severity: for all, ~28 mo of corticosteroids (CS) alone or combined with 500-mg/m2cyclophosphamide (CYC) IV pulses every 2–3 wk until remission for EGPA or PAN with FFS≥1 and GPA or MPA, then switched to maintenance azathioprine (AZA) or methotrexate (MTX)) and an experimental regimen, specifically designed for faster CS dose-tapering and systematic but reduced CYC exposure (for all, ~9 mo of CS and 500-mg fixed-dose IV CYC pulse, given every 2–3 wk, and switched after a maximum of 6 pulses to maintenance AZA or MTX). Trial follow-up closure was scheduled 3 yr after enrollment of the last patient. The primary judgment criterion was time to first severe adverse event (SAE: morbidity and mortality) hypothesizing a 30% reduction of experimental arm SAE rate. Secondary endpoints included first remission, death, relapse rates and quality-adjusted time without symptoms or toxicity (Q-TWiST).

Results: Between July 2005 and February 2008, 108 patients were randomized; 4 were excluded (early consent withdrawn, wrong diagnosis, protocol violations). Mean age at diagnosis of the analyzed patients (52 in each arm; 55 males, 49 females; 8 PAN, 13 EGPA, 37 GPA, 46 MPA; 91 ANCA-positive) was 75.2±6.3 yr, with a maximum of 92 yr for 1 MPA patient. FFS=0 for 7 PAN (4 in the conventional arm, 3 in the experimental arm) and 10 EGPA patients (5 in each arm). Baseline clinical features were evenly distributed between arms (fever, 53%; arthralgias, 38%; lung, 64%; ENT, 40%; kidney, 69%; heart, 20%; skin, 35%; peripheral nervous system, 25%; central nervous system, 3%); mean serum creatinine level at diagnosis was 234±199 µmol/l and C-reactive protein 102±87 mg/l. Mean follow-up was 28±11 mo. Hazard ratio for first SAE (primary endpoint) for experimental vs conventional treatment was 0.61 [95% CI, 0.38–0.97], i.e., 39% lower SAE rate (3-yr event-free survival: 37.6% [95% CI, 26.4–53.7] in experimental vs 19.2% [95% CI, 10.9–34.1] in conventional treatment arms; p=0.04). Ninety-one (88%) patients achieved remission with their assigned treatment (47 in experimental treatment arm vs 44 in conventional; p=0.37); 21 (20%) patients died (8 vs 13, respectively; p=0.22) of uncontrolled vasculitis for 7 of them (2 vs 5) and/or infection for 6 (2 vs 4); 16 vs 11 patients suffered ≥1 relapse(s), with comparable 3-yr relapse-free–survival rates (53.2% [CI 95%, 40.7–69.6] vs 54.2% [95% CI, 41.9–70]). Respective Q-TWiST rates were 30.97 and 28.72 (mean difference, 2.25 [95% CI, –1.72 to 6.76]; p=0.29).

Conclusion: Treating SNV in the elderly with a specific regimen limiting exposure to CS and fixed low-dose IV CYC pulses coud become the standard of care because of its lower SAE risk, and similar 3-yr remission and relapse rates, compared to conventional therapy.


Disclosure:

C. Pagnoux,
None;

T. Quemeneur,
None;

J. Ninet,
None;

E. Perrodeau,
None;

E. Diot,
None;

X. Kyndt,
None;

B. de Wazières,
None;

J. L. Reny,
None;

X. Puéchal,
None;

P. Y. Leberruyer,
None;

O. Lidove,
None;

P. Vanhille,
None;

P. Godmer,
None;

A. Albath-Sadiki,
None;

B. Bienvenu,
None;

P. Cohen,
None;

L. Mouthon,
None;

P. Ravaud,
None;

L. Guillevin,
None;

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