title: Rituximab versus azathioprine for ANCA-associated vasculitis maintenance therapy: impact on global disability and health-related quality of life.
abstract: OBJECTIVE
  To investigate the effects on health-related quality of life (HRQOL) and functional capability of rituximab vs azathioprine for ANCA-associated vasculitis (AAV) maintenance therapy.
  
  
  METHODS
  In a 24-month phase III randomised-controlled trial, 115 patients over time received rituximab or azathioprine for AAV maintenance therapy. Mean changes of 36-item Short-form Health Survey (SF-36) and Health Assessment Questionnaire (HAQ) scores from baseline were analysed.
  
  
  RESULTS
  Mean improvements of HAQ scores, from baseline to month 24 were significantly better for the rituximab (0.16 points lower) than the azathioprine group (p=0.038). As demonstrated by SF-36, study patients' baseline HRQOL was significantly impaired compared with age- and sex-matched US norms. At month 24, mean changes from baseline of SF-36 physical component score tended to be better for the rituximab group (+3.95 points, p=0.067) whereas mean changes from baseline of the SF-36 mental component score were significantly better for the azathioprine group (+4.23 points, p=0.041).
  
  
  CONCLUSIONS
  Azathioprine-treated patients' for AAV maintenance therapy showed a decline in physical abilities when compared to RTX at M24 in the MAINRITSAN trial.
  
  
  BACKGROUND
  ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00748644.
authors.affiliation: National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris; and Toulouse University Hospital, Internal Medicine Department, Toulouse, France. pugnet.g@chu-toulouse.fr.
authors.forename: Grégory
authors.initials: G
authors.lastname: Pugnet
authors.affiliation: Department of Rheumatology, Mount Sinai Hospital, University of Toronto, Canada.
authors.forename: Christian
authors.initials: C
authors.lastname: Pagnoux
authors.affiliation: National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Terrier
authors.affiliation: Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, INSERM Unité 738, Assistance Publique-Hôpitaux de Paris, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: Perrodeau
authors.affiliation: National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Puéchal
authors.affiliation: Unité de Néphrologie, Hôpital Européen Georges-Pompidou, Université Paris Descartes, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Karras
authors.affiliation: Service de Pneumologie, Centre de Référence pour Maladies Pulmonaires Rares, Hôpital Universitaire Louis Pradel, Lyon, France.
authors.forename: Chahéra
authors.initials: C
authors.lastname: Khouatra
authors.affiliation: Division of Internal Medicine, Centre Hospitalier Universitaire, Hôpital Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Aumaître
authors.affiliation: National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Cohen
authors.affiliation: Department of Internal Medicine, Hôpitaux privés de Metz, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Maurier
authors.affiliation: Département de Médecine Interne, Hôpitaux Universitaires de Rennes, Hôpital Sud, Université Rennes I, IGDR-UMR 6290, Rennes, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Decaux
authors.affiliation: Department of Nephrology and Internal Medicine, Hôpital Edouard Herriot, Lyon, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Ninet
authors.affiliation: Service de Médecine Interne et Néphrologie, Hôpital Général Henri Duffaut, Avignon, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Gobert
authors.affiliation: Département de Néphrologie et Département de Médecine Interne, Centre Hospitalier de Valenciennes, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Quemeneur
authors.affiliation: Service de Médecine Interne, Hôpital de Niort, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Blanchard-Delaunay
authors.affiliation: Department of Internal Medicine, Centre Hospitalier Bretagne Atlantique de Vannes, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Godmer
authors.affiliation: Service de Néphrologie, Dialyse et Transplantation, Centre Hospitalier Universitaire de Grenoble, France.
authors.forename: Pierre-Louis
authors.initials: PL
authors.lastname: Carron
authors.affiliation: Service de Médecine Interne, Centre National de Référence de la Sclérodermie Systémique, Hôpital Claude Huriez, Université Lille Nord de France, Centre Hospitalier Universitaire de Lille, France.
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Hatron
authors.affiliation: Service de Médecine Interne, Centre de Référence Labellisé pour la Prise en Charge des Cytopénies Auto-immunes de l'Adulte, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Limal
authors.affiliation: Département de Médecine Interne, Centre Hospitalier Universitaire Hôtel-Dieu, Nantes, France.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Hamidou
authors.affiliation: Service de Néphrologie, Centre Hospitalier d'Annecy, France.
authors.forename: Maïzé
authors.initials: M
authors.lastname: Ducret
authors.affiliation: Hôpital Bichat, Université Paris Diderot, Service de Néphrologie, INSERM Unité 699, Département Hospitalo-Universitaire FIRE, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Daugas
authors.affiliation: Bichat Hospital, Département de Médecine Interne, Paris, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Papo
authors.affiliation: Service de Médecine Interne et d'Immunologie Clinique, Centre Hospitalier Universitaire de Dijon, Université de Bourgogne, IFR100, Dijon, and INSERM, UMR, 1098, Besançon, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Bonnotte
authors.affiliation: Hospital Saint-Louis, Service de Médecine Interne, University Paris 7, France.
authors.forename: Alfred
authors.initials: A
authors.lastname: Mahr
authors.affiliation: Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, INSERM Unité 738, Assistance Publique-Hôpitaux de Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.affiliation: National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Mouthon
authors.affiliation: National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.
authors.forename: Loic
authors.initials: L
authors.lastname: Guillevin
mesh_terms: D000328:Adult; D000368:Aged; D056648:Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D001379:Azathioprine / Q000627:therapeutic use*; D006233:Persons with Disabilities; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D000069283:Rituximab / Q000627:therapeutic use*
chemical_list: D000069283:Rituximab; D001379:Azathioprine