ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1778

Rituximab Versus Azathioprine for ANCA-Associated Vasculitis Maintenance Therapy: Impact in Health-Related Quality of Life

Grégory Pugnet1,2, Christian Pagnoux3, Alexandre Karras4, Chahéra Khouatra5, Olivier Aumaître6, Pascal Cohen1, Francois Maurier7, Olivier Decaux8, Jacques Ninet9, Pierre Gobert10, Thomas Quemeneur11, Claire Blanchard-Delaunay12, Pascal Godmer13, Xavier Puéchal1, Pierre-Louis Carron14, Pierre-Yves Hatron15, Nicolas Limal16, Mohamed Hamidou17, Eric Daugas18, Thomas Papo19, Bernard Bonnotte20, Alfred Mahr21, Benjamin Terrier1, Philippe Ravaud22, Luc Mouthon1 and Loïc Guillevin1, 1National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, Paris, France, 2Toulouse University Hospital, Internal Medicine Department, Toulouse, France, 3Division of Rheumatology, University of Toronto, Toronto, ON, Canada, 4Nephrology, Hôpital Européen Georges Pompidou, APHP, Paris, France, 5CHU Louis Pradel, Lyon, Lyon, France, 6Division of internal Medicine, Centre Hospitalier Universitaire, Hôpital Gabriel Montpied, Clermont–Ferrand, Clermont–Ferrand, France, 7HP Metz Belle Isle Hospital, Department of Internal Medicine, Metz, France, 8Department of Internal Medicine, Rennes University Hospital, Rennes, France, 9Department of Nephrology and Internal Medicine, Hôpital Edouard Herriot, Lyon, France, Lyon, France, 10Nephrology, Centre Hospitalier d'Avignon, Avignon, France, 11Internal Medicine, CH, Valenciennes, France, 12Internal Medicine, Hôpital de Niort, Niort, France, 13Department of Internal Medicine, Centre Hospitalier Bretagne Atlantique de Vannes, Vannes, France, 14Internal Medicine, Centre Hospitalier de Grenoble, Grenoble, France, 15CHU Lille, Lille, France, 16Department of Internal Medicine, Hôpital Henri Mondor, APHP, Creteil, France, 17CHU Hôtel Dieu, Nantes, Nantes, France, 18Internal Medicine, AP-HP Hôpital Bîchat, Paris, France, 19Internal Medicine, Bichat Hospital, Paris, Paris, France, 20Dijon University Hospital, INSERM UMR 1098, Besançon ; University of Burgundy, Faculty of Medicine, IFR100 ; Department of Internal Medicine and Clinical Immunology, Dijon, France, 21Internal Medicine, Hospital Saint-Louis, University Paris 7, Paris, France, 22Epidemiology, AP-HP Cochin Hospital, Paris, France

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords:

Session Information

Title: Vasculitis

Session Type: Abstract Submissions (ACR)

Background/Purpose

A key goal in the management of ANCA-Associated Vasculitis (AAV) is to improve and preserve health-related quality of life (HRQOL). Several studies have found that patients with AAV have reduced HRQOL. We conducted a non-blinded, randomized–controlled, remission-maintenance trial (MAINRITSAN)  to investigate the effects of rituximab versus azathioprine for AAV maintenance therapy on health-related quality of life.

Methods

In the phase III MAINRITSAN study, once complete remission was obtained for eligible patients (18-75 years old) with a combined glucocorticoid and pulse cyclophosphamide, 115 patients with newly diagnosed (2/3 of the enrolments) or relapsing (1/3) AAV, who fulfilled the American College of Rheumatology classification criteria(5) and/or the Chapel Hill Consensus Conference definition classification for AAV (6), were enrolled and randomly assigned, at a 1:1 ratio, to receive a 500-mg rituximab (RTX) infusion on D1, D15, 5.5 months later, then every 6 months for a total of 5 infusions over 18 months, or azathioprine (AZA) maintenance therapy for 22 months at the initial dose of 2 mg/kg/d. Mean changes every 3 months  in SF-36 and HAQ from baseline to month 24 were analyzed. ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00748644

Results

Mean improvements in HAQ, from baseline to month 24 were statistically significantly greater in the rituximab group (-0.16 points) than in the control group (P = 0.038). As demonstrated by SF-36, baseline HRQOL in study patients was significantly impaired compared with age- and gender-matched US norms. At month 24, mean changes from baseline in SF-36 PCS scores trended to be greater in rituximab group (-3.95 points, P = 0.067) but surprisingly mean changes from baseline in SF-36 MCS were statistically significantly greater in azathioprine group (-4.23 points, P = 0.041). 

Conclusion Rituximab treatment to maintain AAV remission in the MAINRITSAN trial resulted in statistically significant but maybe not clinically meaningful improvement in physical functions.

Disclosure:

G. Pugnet,
None;

C. Pagnoux,
None;

A. Karras,
None;

C. Khouatra,
None;

O. Aumaître,
None;

P. Cohen,
None;

F. Maurier,
None;

O. Decaux,
None;

J. Ninet,
None;

P. Gobert,
None;

T. Quemeneur,
None;

C. Blanchard-Delaunay,
None;

P. Godmer,
None;

X. Puéchal,
None;

P. L. Carron,
None;

P. Y. Hatron,
None;

N. Limal,
None;

M. Hamidou,
None;

E. Daugas,
None;

T. Papo,
None;

B. Bonnotte,
None;

A. Mahr,
None;

B. Terrier,
None;

P. Ravaud,
None;

L. Mouthon,
None;

L. Guillevin,
None.

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