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Rituximab versus azathioprine for ANCA-associated vasculitis maintenance therapy: impact on global disability and health-related quality of life

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28

 

  1. 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
  2. Department of Rheumatology, Mount Sinai Hospital, University of Toronto, Canada.
  3. National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.
  4. Centre d’Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, INSERM Unité 738, Assistance Publique-Hôpitaux de Paris, France.
  5. National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.
  6. Unité de Néphrologie, Hôpital Européen Georges-Pompidou, Université Paris Descartes, France.
  7. Service de Pneumologie, Centre de Référence pour Maladies Pulmonaires Rares, Hôpital Universitaire Louis Pradel, Lyon, France.
  8. Division of Internal Medicine, Centre Hospitalier Universitaire, Hôpital Gabriel Montpied, Clermont-Ferrand, France.
  9. National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.
  10. Department of Internal Medicine, Hôpitaux privés de Metz, France.
  11. Département de Médecine Interne, Hôpitaux Universitaires de Rennes, Hôpital Sud, Université Rennes I, IGDR–UMR 6290, Rennes, France.
  12. Department of Nephrology and Internal Medicine, Hôpital Edouard Herriot, Lyon, France.
  13. Service de Médecine Interne et Néphrologie, Hôpital Général Henri Duffaut, Avignon, France.
  14. Département de Néphrologie et Département de Médecine Interne, Centre Hospitalier de Valenciennes, France.
  15. Service de Médecine Interne, Hôpital de Niort, France.
  16. Department of Internal Medicine, Centre Hospitalier Bretagne Atlantique de Vannes, France.
  17. Service de Néphrologie, Dialyse et Transplantation, Centre Hospitalier Universitaire de Grenoble, France.
  18. 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.
  19. 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.
  20. Département de Médecine Interne, Centre Hospitalier Universitaire Hôtel-Dieu, Nantes, France.
  21. Service de Néphrologie, Centre Hospitalier d’Annecy, France.
  22. Hôpital Bichat, Université Paris Diderot, Service de Néphrologie, INSERM Unité 699, Département Hospitalo-Universitaire FIRE, France.
  23. Bichat Hospital, Département de Médecine Interne, Paris, France.
  24. Service de Médecine Interne et d’Immunologie Clinique, Centre Hospitalier Universitaire de Dijon, Université de Bourgogne, IFR100, Dijon, and INSERM, UMR, 1098, Besançon, France.
  25. Hospital Saint-Louis, Service de Médecine Interne, University Paris 7, France.
  26. Centre d’Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, INSERM Unité 738, Assistance Publique-Hôpitaux de Paris, France.
  27. National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.
  28. National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France.

for the French Vasculitis Study Group

CER8967
2016 Vol.34, N°3 ,Suppl.97
PI 0054, PF 0059
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PMID: 27049404 [PubMed]

Received: 12/09/2015
Accepted : 09/10/2015
In Press: 25/03/2016
Published: 27/05/2016

Abstract

OBJECTIVES:
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. Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00748644.

Rheumatology Article